Core outcome sets for research within the area of maternity care

Overview of completed and ongoing studies

Reading time approx. 61 minutes Published: February 28, 2020 Publication type:

SBU Policy support

identifies and presents available scientific evidence to support policy and decision making, including the development of national guidelines, at other government agencies. In consultation with professional experts, SBU staff generates supporting documentation to address the various questions that have been posed.

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Published: February 28, 2020 Report no: 309 Registration no: SBU 2019/290 ISBN: 978-91-88437-51-8 https://www.sbu.se/309e

Background

When research is synthesised in systematic reviews it becomes clear that studies often overlook outcomes of importance to patients and that different outcomes as well as different methods or timepoints are used when assessing outcomes. This detracts from the potential to synthesise the results of different studies and as a result, the scientific evidence to support many treatment procedures is weakened. It is important that clinical studies use outcomes which are meaningful when patients and healthcare personnel are to make a decision, for example about type of treatment.

A core outcome set (COS) is an agreed standardised set of outcomes that should be assessed and reported, as a minimum, in all clinical trials in specific areas of health or health care (Figure 1). The outcomes to be included in different COS are selected by a consensus process in which healthcare personnel, researchers and patients should be included [1]. The aim with developing and implementing COS is that the results from various studies can be more readily comparable and collated, so that the basis for decisions, for patients and healthcare personnel, is therefore strengthened.

Figure 1 Schematic illustration showing the intended use of COS.

Schematic illustration of 3 research studies that explores 6–8 outomes each, whereas 4 are mutual (Core Outcome Set)

The main target groups for the report are researchers and research funders. The findings may also be of interest to professional associations, organizations and units involved in maternity/obstetric care. The project has been commissioned by the Swedish government, as part of its efforts for the promotion of women’s health.

Aim

The aim is to inventory, compile and analyse existing and ongoing studies which prioritize core outcomes within the field of maternity care (so-called Core Outcome Set (COS)). The report also highlights fields of potential interest for production of new COS, based on the opinions of patients, researchers and healthcare personnel.

Method

In order to identify completed and ongoing COS in the field of maternity care, a search of the literature was conducted (Appendix 1), followed by a summary of studies in the field.

We have also investigated how well the identified COS studies fulfil the proposed reporting criteria, using a checklist modified after Core Outcome Set–STAndards for Reporting (COS-STAR) (Appendix 2) [2]. In order to gain an indication of topics for which there may be a demand for new COS, an open questionnaire was posted on SBU´s website. This allowed relevant interested parties (primarily patients and their relatives, healthcare personnel and researchers) to nominate fields within maternal health which they considered warranted a COS.

The protocol is registered in Prospero and the COMET initiative database.

Inclusion criteria

Population

Pregnant women
Women giving birth (labour and delivery)
Women who suffer an injury or other complication related to childbirth
Women or men suffering from psychiatric disorder during pregnancy or during or after childbirth

Intervention

No restriction.

Control

Not applicable.

Outcome

A list of outcomes included in the COS.

Study design

Ongoing or finalized original studies were outcomes were prioritized using some form of consensus method.

Language

English and Scandinavian languages.

Search period

Final search, June 2019.

Databases searched

MEDLINE, Embase, PsycINFO, Academic Search Elite, CINAHL with Full Text, SocINDEX with Full Text and the Core Outcome Measures in Effectiveness Trials (COMET) Initiative database.

Client/patient involvement

Yes

Results

This report identified 19 completed studies which prioritized outcomes, Table 1, Table 2 and Table 3.

Table 4.2 Discription of the included finished COS studies.
Ref First author Year	Population Intervention Setting	Stakeholders represented in the workgroup	Consensus criteria for an outcome to be included in the final COS	Method used Participants receiving the first survey, % of participants answering all surveys, participants at consensus meeting
NA = Not applicable; IQR = Interquartile range; TTTS = Twin – twin transfusion syndrome
[10] Meher 2018	Postpartum haemorrhage Two core outcomes sets presented one for prevention and one for treatment Clinical trials	Healthcare professionals and women’s representatives from 36 nations Sweden not represented	At least 70% of participants in each stakeholder group to score the outcome as critically important and <15% to score the outcome as not important	A two-round Delphi survey and face-to-face consensus meeting Prevention: 205, 74%, 36 Treatment: 197, 73%, 36
[19] Nijagal 2018	Women and infants The care that they receive during pregnancy and the postpartum period	Consumer representatives and international experts in various fields of perinatal and neonatal care, research and patient advocacy from 8 nations. One person from Sweden included	Outcome domains thought to be “critical” (scored between 7 and 9) by at least 70% of the respondents were included in the set	A series of nine teleconferences, incorporating a modified Delphi process 21, 73%, NA
[16] Bunch 2018	Women in maternity care Monitor the quality of maternity care	Service designers, providers and users from England	≥70% of participants rated the metric 7–9 (high importance) and <15% rated it as 1–3 (low importance)	A two-round Delphi survey and face-to-face consensus meeting 101, 71%, 19
[8] Egan 2017	Women with pregestational diabetes Prepregnancy care Clinical trials	Clinicians’ patient’s policy makers, researchers in the area advocates on behalf of those with diabetes and others from 24 nations. Do not specify which nations that were represented.	At least 70% of participants to score the outcome as critically important (7–9) and <15% to score the outcome as not important (1–3)	A three-round Delphi survey and face-to-face consensus meeting 151, 67%, 14
[14] Van ʼt Hooft 2016	Pregnant women Interventions to Prevent Preterm Birth Clinical trials	Parents, midwives, obstetricians, neonatologists, and re-searcher from 25 nations. Do not specify which nations that were represented	Core outcomes required at least 70% of participants in each stakeholder group to score the outcome as “critical” and less than 15% of participants in each stakeholder group to score the outcome as limited importance	A two-round Delphi survey and face-to-face consensus meeting 228, 76%, 29
[6] Devane 2007	Models of maternity care Clinical trials	Healthcare professionals and women’s representatives from 28 nations Four participants from Sweden	Outcomes with both a mean value greater than the overall group mean for all outcomes combined and rated 4 or more on a 5-point Likert-type scale for importance of inclusion in a minimum data set of outcome measures by at least 70% of respondents	A three-round Delphi survey 320, 48%, NA
[3] Al Wattar 2016	Epilepsy in pregnancy Clinical trials	Healthcare professionals, and patient representatives with lived experience of epilepsy from UK	We included outcomes that scored ≥4 by >70% of participants, and outcomes that scored ≤2 by <15% of participants (used a 5-point scale)	A modified three-round Delphi survey and consultation meeting 99 participants finished first survey, 49%, 15
[7] Dos Santos 2018	Pregnant women Induction of labour Clinical trials	Midwives, obstetricians, neonatologists, and women’s representatives Number of nations not clearly stated	≥70% participants rated outcomes as critical and <15% rated outcomes as limited importance	A two-round Delphi survey and face-to-face consensus meeting 159, 45%, 20
[5] Briscoe 2019	Caesarean deliveries with infectious morbidity outcome Clinical trials	Systematic review authors Number of nations not clearly stated	Consensus of the panel was defined by the majority of respondents	A two-round Delphi survey 41, 34%, NA
[18] Fong 2014	Late-onset preeclampsia Management Maternal and neonatal composite outcomes for trials	Practising senior clinicians and clinical academics from the United Kingdom	We selected the outcomes that had a median score of 4 or more and indicated consensus (IQR ≤2) for evaluation in the third stage. (5-point scale)	A two-round Delphi survey 44, 90% maternal outcomes 75% neonatal outcomes, NA
[15] Bennett 2012	Gestational Diabetes Mellitus Medication and delivery management Clinical trial	Clinical experts Number of nations not clearly stated	Appearing in the top 3 list of two or more of the nine national stakeholders	Regarding prioritization of outcomes, one- survey 20, NA, NA
[20] Rogozinska 2016	Pregnancy Diet and lifestyle Composite outcomes for individual patient data (IPD) meta-analysis	Researchers from the International Weight Management in Pregnancy collaborative network from 11 nations. Sweden not represented	Considered to be critically important by the Delphi panel (score >7), of equal importance, similar rates of occurrence, independent of each other, and evidence of the same trend in effect of the intervention	A two-round Delphi survey 26, 96%, NA
[21] Saldanha 2013	Gestational diabetes mellitus Antenatal drug treatment	Clinicians, primary researchers, research funders, insurers, and patients or patient representatives from 1 nation	Not specified	Prioritization of research questions using the Delphi method for some including prioritization of outcomes. Does not specified how many rounds for outcomes 9 participants
[17] Fiala 2018	Pregnancy First trimester medical termination	Group of European experts, included clinicians, researchers and members of the pharmaceutical industry Number of nations not clearly stated	Not specified	Face-to-face consensus meeting Number of participants not clearly stated
[4] Bogdanet 2019	Women with gestational diabetes treated with insulin and/or oral glucose-lowering agents Follow-up at 1 year and beyond Clinical trails	Patients, clinicians, researchers, policy makers and others from 33 nations. Participants from Sweden included	At least 70% of participants to score the outcome as critically important (7–9) and <15% to score the outcome as not important (1–3)	A three-round Delphi survey and face-to-face consensus meeting 835, 20%, 20
[11] Mehra 2012	Pregnancy weight management clinical trails (Only available as a conference abstract)	20 Consultants from 2 nations	Not enough information provided	A two-round Delphi survey 20 participants
[13] Townsed 2019	Selective fetal growth restriction in twins management clinical trails	Clinicians, obstetricians, fetal medicine specialists, neonatologists, and midwives), researchers, and parents or patients from 23 nations. Do not specify which nations that were represented	Consensus was defined as any outcome achieving a median score of eight after the third round. All outcomes meeting this criterion were taken forwards as potential core outcomes for discussion	A three-round Delphi survey and face-to-face consensus meeting using the modified nominal group technique 102 participants completed first survey, 86%, 19
[12] Perry 2019	Twin – twin transfusion syndrome (TTTS) treatments	Healthcare professionals, researchers and patients or relatives of patients who had experienced TTTS from 29 nations. Do not specify which nations that were represented	Defined a priori using the 15% / 70% definition of the COMET Initiative	A three-round Delphi survey and face-to-face consensus meeting using the modified nominal group technique 103 participants completed first survey, 85%, 16
[99] Healy 2019	Fetal growth restriction prevention and treatment	Healthcare providers, researchers/academics, members of the public from 36 nations. Do not specify which nations that were represented	At least 70% of participants to score the outcome as critically important (7–9) and <15% to score the outcome as not important (1–3)	A three-round Delphi survey and face-to-face consensus meeting 238, 45%, not specified

Table 4.3 Outomes that are included in the identified studies and how ell the studies fulfilled the report demands that are.
Ref First author Year of publication Subject	Final COS	Compliance with COS-STAR Comments
BP =Blood presure; BMI = Body Mass Index; COS = Core Outcome Set; COS-STAR = Core Outcome Set–STAndards for Reporting; GDM = Gestational diabetes mellitus; HbA1c = Hemoglobin A1c (Långtidsblodsockret); MToP = Medical termination of pregnancy; ITU/HDU = Intensive care units (/ high dependency units
[10] Meher 2018 Prevention and treatment of postpartum haemorrhage	Prevention of postpartum haemorrhage: Blood loss Shock Maternal death Use of additional uterotonics Blood transfusion Transfer for higher level of care Women’s sense of wellbeing Acceptability and satisfaction with the intervention Breastfeeding Adverse effects Treatment of postpartum haemorrhage: Blood loss Shock Coagulopathy Hysterectomy Organ dysfunction Maternal death Blood transfusion Use of additional haemostatic intervention Transfer for higher level of care Women’s sense of wellbeing Acceptability and satisfaction with the intervention Breastfeeding Adverse effects	Good compliance with COS-STAR Not able to access protocol
[19] Nijagal 2018 Care for women and infants during pregnancy and the postpartum period	Maternal death Still birth Neonatal death Maternal need for intensive care Maternal length of stay Late maternal complication Transfusion Spontaneous preterm birth Iatrogenic preterm birth Oxygen dependence Neonate length of stay Birth injury Health related quality of life Incontinence Pain with intercourse Success with breastfeeding Confidence with breastfeeding Mother-infant attachment Confidence with role as a mother Postpartum Depression Satisfaction with the results of care Confidence as an active participant in healthcare decisions Confidence in healthcare providers Birth Experience	Some details form COS-STAR not reported No reference to a protocol given Only 2 consumers and 19 clinical expertise in the working group A very large number of outcomes included in the final COS
[16] Bunch 2018 Monitor the quality of maternity care	Smoking rate at booking Rate of birth without intervention Caesarean section delivery rate in Robson group 1 women Caesarean section delivery rate in Robson group 2 women Caesarean section delivery rate in Robson group 5 women Third-and fourth-degree tear rate among women delivering vaginally Rate of postpartum haemorrhage of ≥1500 ml Rate of successful vaginal birth after a single previous caesarean section Smoking rate at delivery Proportion of babies born at term with an Apgar score <7 at 5 minutes Proportion of babies born at term admitted to the neonatal intensive care unit Proportion of babies re admitted to hospital at <30 days of age Breastfeeding initiation rate Breastfeeding rate at 6–8 weeks	Some details form COS-STAR not reported No reference to a protocol given Patients are included in the panel but not represented at the final meeting
[8] Egan 2017 Prepregnancy care for women with pregestational diabetes	Healthcare professional review prior to conception Smoking status at first antenatal visit Use of folic acid preconception Thyroid function at first antenatal visit Use of potentially teratogenic medications at conception Gestational age at first antenatal visit BMI at first antenatal visit BP at first antenatal visit First trimester HbA1c Perinatal mortality Miscarriage Congenital malformation Preterm birth Large for gestational age Small for gestational age Gestational weight gain Severe maternal hypoglycaemia in first trimester	Good compliance with COS-STAR Does not specify the number of non-responders from the first survey Only a few patient representatives present in the workshop
[14] van ʼt Hooft 2016 Interventions to Prevent Preterm Birth	Related to pregnant women: Maternal mortality Maternal infection or inflammation Prelabor rupture of membranes Harm to mother from intervention Related to offspring: Gestational age at birth Off-spring mortality Birth weight Early neurodevelopmental morbidity Late neurodevelopmental morbidity Gastrointestinal morbidity, infection Respiratory morbidity Harm to offspring from intervention	Good compliance with COS-STAR Only a few patient representatives present in the workshop
[6] Devane 2007 Models of maternity care	Maternal death Mode of birth Neonatal death Stillbirth Type of labour onset Neonatal admission to special care and/or intensive care unit Birth injury to infant Ruptured uterus Postpartum haemorrhage Mother requires admission to intensive care Maternal postnatal readmission to hospital Method of infant feeding Vaginal birth after previous caesarean section Gestational age at birth Postnatal depression Place of birth Neonatal resuscitation required Normal (i.e., physiological) birth without intervention Oxytocin augmentation of labour Anal sphincter damage Hypoxic ischemic encephalopathy (a condition of injury to the brain) Intrapartum hypertensive disorders of pregnancy Hypertensive disorders of pregnancy Puerperal psychosis Maternal fecal incontinence Neonatal readmission to hospital Apgar score at 5 min Trial of labour after previous caesarean delivery Breastfeeding at 3 months Maternal satisfaction (postnatal) Infant birthweight Neonatal fitting/seizures Infant requiring intubation Congenital anomaly (chromosomal, genetic, and/or structural) Use of pharmacological analgesia/anesthesia Maternal satisfaction (antenatal) Postnatal hypertensive disorders of pregnancy Maternal satisfaction (intrapartum) Caesarean section wound infection Pulmonary embolism Intrauterine growth restriction Preterm labour Meconium aspiration Intrapartum haemorrhage Neonatal infection Shoulder dystocia HELLP = hemolysis, elevated liver enzymes, and low platelets Birth asphyxia Breastfeeding at discharge	Some details form COS-STAR not reported No reference to a protocol given The PICO for the COS is not clearly stated Very broad area for the COS development and a very large number of outcomes included in the final COS
[3] Al Wattar 2016 Epilepsy in pregnancy	Maternal Seizure control in pregnancy Postpartum seizure control Status epilepticus Maternal mortality Drowning Sudden unexpected death in epilepsy Postnatal depression Maternal quality of life Maternal anti-epileptic drug toxicity Compliance with anti-epileptic drug intake Offspring outcomes Major congenital abnormalities Minor congenital abnormalities Fetal anticonvulsant syndrome Neurodevelopment Autism spectrum disorder Neonatal clinical complications Admission to neonatal intensive care unit Anthropometric measurements, including birthweight Neonatal withdrawal symptoms Neonatal haemorrhagic disease Obstetric outcomes Live birth Stillbirth Miscarriage Ectopic pregnancy Termination of pregnancy Maternal admission to high dependency or intensive care unit Breastfeeding Mode of delivery Preterm birth Pre-eclampsia Eclampsia	Good compliance with COS-STAR Patients participated in a separate survey which consisted of only one round Only persons from UK represented A very large number of outcomes included in the final COS
[7] Dos Santos 2018 Induction of labour	Short-term maternal outcomes Cardiorespiratory arrest Damage to internal organs Death Haemorrhage Hysterectomy Infection Intensive care admission Length of hospital stay Mode of delivery Need for more than one induction agent Oxytocin augmentation Postnatal depression Pulmonary embolus Satisfaction with care Stroke Time from induction to delivery Uterine hyperstimulation Uterine scar dehiscence/rupture Short-term offspring outcomes Admission to the neonatal unit Birth trauma Death Hypoxic ischaemic encephalopathy/need for therapeutic hypothermia Meconium aspiration syndrome Need for respiratory support Infection Seizures Long-term maternal outcomes Operative pelvic floor repair Long-term offspring outcomes Disability including neurodevelopmental delay	Good compliance with COS-STAR Only a few patient representatives present in the workshop A very large number of outcomes included in the final COS
[5] Briscoe 2019 Cesarean deliveries with infectious morbidity outcome	Endometritis (primary outcome) Maternal mortality Wound infection Wound complications Febrile morbidity Neonatal morbidity	Significant details from COS-STAR not reported No reference to a protocol given Only includes authors of systematic reviews in the process
[18] Fong 2014 Composite outcomes regarding management late-onset preeclampsia	The maternal composite outcome included Maternal death Eclampsia Stroke or reversible ischaemic neurological deficit Pulmonary oedema Major obstetric haemorrhage Need for positive inotropic support Haemolysis Elevated liver enzymes and low platelets syndrome and placental abruption The neonatal composite outcome included Neonatal death Respiratory distress syndrome Needing ventilator support and neurological outcomes as cystic periventricular leukomalacia and grade III/IV intraventricular haemorrhage.	Significant details from COS-STAR not reported Aim is not a conventional COS development but a development of a composite outcome No reference to a protocol given No patients included in the process
[15] Bennett 2012 Medication and delivery management for Gestational Diabetes Mellitus	Hypertensive disorders of pregnancy Medication adherence Large for gestational age and macrosomia Gestational weight gain Neonatal hypoglycemia Neonatal intensive care unit admission Chronic disease incidence in offspring Postpartum incident type 2 diabetes mellitus or glucose intolerance/impaired fasting glucose mangaement Cesarean delivery Birth trauma Neonatal intensive care unit admission Patient-reported outcomes (e.g., patient preference, quality of life) Complications of cesarean delivery (e.g., wound infection, wound dehiscence) Vaginal delivery (spontaneous, operative) Hypoxia/anoxia Respiratory distress syndrome	Significant details from COS-STAR not reported The aim is to article is to prioritize research need. For some of the research questions the outcomes to measure were also prioritized No patients included, but two members that served as proxy for the patient/consumer perspective
[20] Rogozinska 2016 Composite outcomes for diet and lifestyle interventions in pregnancy	The maternal composite outcome included Pre-eclampsia/pregnancy induced hypertension Gestational diabetes mellitus (GDM) Elective or emergency caesarean section Preterm delivery The neonatal composite outcome included Intrauterine death Small for gestational age Large for gestational age Admission to a neonatal intensive care unit	Significant details from COS-STAR not reported Aim is not a conventional COS development but a development of a composite outcome No reference to a protocol given Only researchers included in the process
[21] Saldanha 2013 Antenatal drug treatment for gestational diabetes mellitus	Oral agents compared with insulin: Chronic diseases (e.g., obesity and type 2 diabetes) in the offspring Hypertensive disorders of pregnancy (e.g., GDM and pre-eclampsia) in the mother Large for gestational age Macrosomia in the neonate Selective cesarean delivery or the choice of timing of induction: Cesarean delivery (primary cesarean and repeat cesarean) Indication for cesarean delivery in the mother Birth trauma (e.g., bone fractures and cerebral palsy) Neonatal intensive care unit admission	Significant details from COS-STAR not reported The aim is to article is to prioritize research need. For some of the research questions the outcomes to measure were also prioritized No reference to a protocol given
[17] Fiala 2018 First trimester medical termination	Success Failure (ongoing pregnancy) Need for additional treatment (medical or surgical) to complete MToP (missed abortion, incomplete abortion) Complications The woman’s request for additional treatment (medical or surgical)	Significant details from COS-STAR not reported The aim is to article is to standardize the definition of the outcomes No reference to a protocol given No Delphi survey
[4] Bogdanet 2019 Follow-up at 1 year and beyond for women with gestational diabetes treated with insulin and/or oral glucose-lowering agents	Assessment of glycaemic status Diagnosis of type 2 diabetes since the index pregnancy Number of pregnancies since the index pregnancy Number of pregnancies with a diagnosis of GDM since the index pregnancy Diagnosis of prediabetes since the index pregnancy BMI Post-pregnancy weight retention Resting blood pressure Breastfeeding	Good compliance with COS-STAR
[11] Mehra 2012 Weight management interventions in pregnancy	Top 5 clinically important outcomes: Gestational diabetes Preeclampsia Gestational hypertension Maternal admission to ITU/HDU Venous thromboembolism	Not able to check compliance with COS-STAR Conference abstract. Lot of information missing
[13] Townsed 2019 Mamagement of selective fetal growth restriction in twins	Live birth Gestational age at birth Birth weight Inter-twin birthweight discordance Death of surviving twin after death of co-twin Loss during pregnancy or before final hospital discharge (miscarriage, stillbirth, termination of the pregnancy, neonatal death, perinatal death) Parental stress Procedure-related adverse outcome (failure of procedure, procedure to delivery interval, placenta abruption, life threatening haemorrhage, sepsis, maternal death) Length of stay in hospital (neonatal) Neurological abnormalities on postnatal imaging Childhood disability	Good compliance with COS-STAR Does not specify the number of non-responders from the first survey
[12] Perry 2019 Twin – twin transfusion syndrome	Live birth Pregnancy loss (including miscarriage, stillbirth, termination of pregnancy and neonatal mortality) Subsequent death of a cotwin following single-twin demise at the time of treatment Recurrence of TTTS Twin anemia – polycythemiasequence and amniotic band syndrome Gestational age at delivery Birthweight Brain injury syndromes Ischemic limb injury Maternal mortality Admission to Level-2 or -3 care setting One aspirational outcome Neurodevelopment at 18–24 months of age	Good compliance with COS-STAR Does not specify the number of non-responders from the first survey
[9] Healy 2019 Prevention and treatment of fetal growth restriction	Preeclampsia Eclampsia Maternal death Mode of birth Fetal stillbirth/livebirth Gestational age at birth Preterm birth (delivery at <37 weeks gestation) Extremely preterm birth (delivery at<28 weeks gestation) Birthweight Birthweight <10th percentile Birthweight <3rd percentile Need for mechanical ventilation Bronchopulmonary dysplasia/chronic lung disease Necrotizing enterocolitis Neonatal seizures Hypoxic ischemic encephalopathy Neonatal death Childhood cognitive impairment Motor impairment Cerebral palsy Hearing Impairment Visual Impairment	Good compliance with COS-STAR A very large number of outcomes included in the final COS

Table 4.4 Number of outcomes that have been identified in the area and number of outcome in the final COS.
Ref First author	Number of outcomes in first round	Number of outcomes added by participants	Number of outcomes in final COS
GDM = Gestational diabetes mellitus; IQR = Interquartile range; NA = Not applicable; SR = Systematic Review
[10] Meher	Prevention: 161 combined into 35 Treatment: 97 combined into 31	Prevention: 16 Treatment: 18	Prevention: 9 Treatment: 12
[19] Nijagal	Not specified	Not specified	24
[16] Bunch	125	19	14
[8] Egan	86	27	17
[14] Van ʼt Hooft	86 grouped into 29	2	13
[6] Devane	263	73	48
[3] Al Wattar	70 grouped into 48	Not enough information provided	31
[7] Dos Santos	93 reduced to 77 by combining different outcomes after first survey round	4	28
[5] Briscoe	511 Outcomes were grouped into 20 primary outcome groups	4	6
[18] Fong	21 maternal and 24 neonatal outcomes	8	Maternal composite outcome: 7 Neonatal composite outcome: 3
[15] Bennett	>20	NA	Medication management of GDM: 8 Delivery management for women with GDM: 8
[20] Rogozinska	Maternal: 36 Fetal and neonatal: 27	Maternal: 2 Fetal and neonatal: 2	Maternal: 6 (condensed to 4) Fetal and neonatal: 4
[21] Saldanha	Not enough information provided	Not enough information provided	Maternal: 17 Neonatal offspring: 13
[17] Fiala	NA	NA	NA
[4] Bogdanet	121	10	9
[11] Mehra	Not enough information provided	Not enough information provided	Not enough information provided
[13] Townsed	96 identified in SR, 56 included in the first round	7	11
[12] Perry	71	21	12
[9] Healy	103	Not enough information provided	22

Among these, the main aim for 12 was to develop a COS for future research [3-14]. In the remaining seven studies, outcomes were also prioritized, but the main aim of the studies somewhat varied [15-21]. The primary aim of two articles was to prioritize future research questions, and this included prioritizing the outcomes to be assessed [15,21]. Two other articles investigated which outcomes should be prioritized in a composite outcome while other studies considered which outcomes should be assessed in clinical follow-up of patients [16-20]. Of the 19 studies identified, nine met the reporting criteria for COS-studies well [3,4,7-10,12-14]. In addition to these studies, 39 COS-studies in progress were identified: for ten of these, protocols were published (Appendix 4) [22-31].

Most of the COS-studies identified (both completed and ongoing) focused on physical conditions and complications during pregnancy. There was also several COS for different preventive measures during pregnancy.

The result show that COS exist or are under development for many of the specified conditions highlighted by SBU’s open questionnaire, for example gestational diabetes, preeclampsia, maternal birth injuries, miscarriage and stillbirth. The results disclose however a lack of existing COS or COS under development, for mental health problems or mental illness during or after pregnancy.

Of 2543 records through database searching included 58 studies: 19 finished and 39 ongoing studies. Flow chart

Discussion

In the research fields of women’s health and neonatal health, an international network, called CoRe Outcomes in Women’s and Newborn health (CROWN), has been established [32]. It is led by journal editors, and aims to address the widespread, unwarranted variation in reporting of outcomes, which makes comparison between and combination of results across studies difficult, if not impossible. As a result, there is currently considerable activity in the development of various COS in the field of maternity care.

It is however important to point out that there remain many important subfields within obstetrics/childbirth where there are no COS. This applies for example to vaginal delivery and caesarean section, topics nominated in SBU:s questionnaire, primarily by healthcare personnel and researchers. Other fields which completely lack existing COS or COS under development are mental health issues or illness during pregnancy and after childbirth.

COS is a relatively new concept in the world of research. This is the first time SBU has presented an overview of completed and ongoing COS. The aim is that this report shall contribute to dissemination of knowledge about what a COS is, which COS are established within maternal health and which are under development. Moreover, the report can contribute to increasing the potential for Swedish researchers to apply existing COS and to participate in development of COS developed by international actors. As an HTA-organisation, SBU supports the use of COS: in the long term, COS can contribute to scientific evidence of higher certainty. For a COS to be implemented effectively, SBU believes that it is important to discuss how broad the field, for which the COS applies, should be, and how many outcomes can be included in a practically applicable COS. Moreover, it is important to continue to work with various instruments in order to appraise the methodology of established COS and the representativity of the stakeholders who participated in the consensus process.

Project Group

Experts

Maria Jonsson, Associate professor and senior consultant at the Department of Obstetrics and Gynecology, Uppsala university hospital, Sweden.
Alkistis Skalkidou, Professor of Obstetrics and Gynecology, Dept. of Women’s and Children’s Health, Uppsala University and senior consultant at the Gynecologic Department, Uppsala university hospital
Frida Trönnberg, Patient representative

SBU

Marie Österberg (Project Manager)
Christel Hellberg (Project Manager)
Ann-Kristine Jonsson (Information Specialist)
Sara Fundell (Project Administrator)

External reviewers

Eva Uustal, PhD, Senior consultant Department of Obstetrics and Gynecology
Ann Josefsson, Professor, Senior consultant in Obstetrics and Gynecology
Sverker Svensjö, PhD, Senior Consultant, Surgery

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Bennett WL, Robinson KA, Saldanha IJ, Wilson LM, Nicholson WK. High priority research needs for gestational diabetes mellitus. J Womens Health (Larchmt) 2012;21:925-32.
Bunch KJ, Allin B, Jolly M, Hardie T, Knight M. Developing a set of consensus indicators to support maternity service quality improvement: using Core Outcome Set methodology including a Delphi process. BJOG: An International Journal Of Obstetrics And Gynaecology 2018;125:1612-1618.
Fiala C, Cameron S, Bombas T, Parachini M, Agostini A, Lertxundi R, et al. Outcome of first trimester medical termination of pregnancy: definitions and management. European Journal of Contraception & Reproductive Health Care 2018;23:451-457.
Fong F, Rogozinska E, Allotey J, Kempley S, Shah DK, Thangaratinam S. Development of maternal and neonatal composite outcomes for trials evaluating management of late-onset pre-eclampsia. Hypertens Pregnancy 2014;33:115-31.
Nijagal MA, Wissig S, Stowell C, Olson E, Amer-Wahlin I, Bonsel G, et al. Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal. BMC Health Services Research 2018;18:953-953.
Rogozinska E, D'Amico MI, Khan KS, Cecatti JG, Teede H, Yeo S, et al. Development of composite outcomes for individual patient data (IPD) meta-analysis on the effects of diet and lifestyle in pregnancy: a Delphi survey. BJOG: An International Journal of Obstetrics & Gynaecology 2016;123:190-8.
Saldanha IJ, Wilson LM, Bennett WL, Nicholson WK, Robinson KA. Development and pilot test of a process to identify research needs from a systematic review. Journal of Clinical Epidemiology 2013;66:538-45.
Dadouch R, Faheim M, Juando-Prats C, Parsons J, D'Souza R. Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol. Trials 2018;19:655-655.
Duffy JMN, van 't Hooft J, Gale C, Brown M, Grobman W, Fitzpatrick R, et al. A protocol for developing, disseminating, and implementing a core outcome set for pre-eclampsia. Pregnancy Hypertension 2016;6:274-278.
Egan AM, Dunne FP, Biesty LM, Bogdanet D, Crowther C, Dempsey E, et al. Gestational diabetes prevention and treatment: a protocol for developing core outcome sets. BMJ Open 2019;9:e030574.
Kelly LE, Jansson LM, Moulsdale W, Pereira J, Simpson S, Guttman A, et al. A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey. Trials [Electronic Resource] 2016;17:536.
Nielsen KK, O'Reilly S, Wu N, Dasgupta K, Maindal HT. Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol. Trials 2018;19:708-708.
Prins JR, Holvast F, van 't Hooft J, Bos AF, Ganzevoort JW, Scherjon SA, et al. Development of a core outcome set for immunomodulation in pregnancy (COSIMPREG): a protocol for a systematic review and Delphi study. BMJ Open 2018;8:e021619.
Smith P, Cooper N, Dhillon-Smith R, O'Toole E, Clark TJ, Coomarasamy A. Core Outcome Sets in Miscarriage Trials (COSMisT) study: a study protocol. BMJ Open 2017;7:e018535-e018535.
Smith V, Daly D, Lundgren I, Eri T, Begley C, Gross MM, et al. Protocol for the development of a salutogenic intrapartum core outcome set (SIPCOS). BMC Medical Research Methodology 2017;17:61-61.
Viau-Lapointe J, D’Souza R, Rose L, Lapinsky SE. Development of a Core Outcome Set for research on critically ill obstetric patients: A study protocol. Obstetric Medicine (1753-495X) 2018;11:132-136.
Whitehouse KC, Kim CR, Ganatra B, Duffy JMN, Blum J, Brahmi D, et al. Standardizing abortion research outcomes (STAR): a protocol for developing, disseminating and implementing a core outcome set for medical and surgical abortion. Contraception 2017;95:437-441.
The Core Outcomes in Women’s and Newborn health (CROWN). [cited 2020 Jan 30]. Available from: http://www.crown-initiative.org/.

Search strategies

Embase via Elsevier 26 June 2019

Title: Core outcomes sets (COS) in obstetric care
Search terms		Items found
The search result, usually found at the end of the documentation, forms the list of abstracts. /de = Term from the EMTREE controlled vocabulary; /exp = Includes terms found below this term in the EMTREE hierarchy; /mj = Major Topic; :ab = Abstract; :au = Author; :ti = Article Title; :ti:ab = Title or abstract; * = Truncation; “ “ = Citation Marks; searches for an exact phrase
Intervention
1.	'core outcome set'/exp	59
2.	"core outcome":ti,ab or "core event":ti,ab	1620
3.	((core or composite or harmonise* or harmonize* or minimal or prioriti* or standard or standards or standardise* or standardize* or set or sets) NEAR/2 outcome*):ti,ab	17358
4.	1-3 (or)	17425
Population
5.	'childbirth'/exp or 'obstetric anesthesia'/exp or 'obstetric procedure'/exp or 'obstetrics'/exp or 'pregnant woman'/exp or 'pregnancy'/exp	1056620
6.	abortion:ti OR antenatal:ti OR antepartum:ti OR birth:ti OR caesarean:ti OR childbirth:ti OR delivery:ti OR fertilization:ti OR gestation:ti OR labor:ti OR labour:ti OR maternal:ti OR neonatal:ti OR obstretric:ti OR perinatal:ti OR peripart:ti OR postnatal:ti OR postpartum:ti OR pregnan*:ti OR puerperium:ti OR preterm:ti	810053
7.	5 OR 6	1398844
Combined sets
8.	4 AND 7 AND ([medline]/lim OR [pubmed-not-medline]/lim)	1918
9.	4 AND 7 AND [embase]/lim AND ([danish]/lim OR [english]/lim OR [norwegian]/lim OR [swedish]/lim)	979
10.	9 NOT 8	935

Medline (Ebsco) June 26 2019

Title: Core outcomes sets (COS) in obstetric care
Search terms		Items found
The search result, usually found at the end of the documentation, forms the list of abstracts. [MeSH] = Term from the Medline controlled vocabulary, including terms found below this term in the MeSH hierarchy; [MeSH:NoExp] = Does not include terms found below this term in the MeSH hierarchy; [MAJR] = MeSH Major Topic; [TIAB] = Title or abstract; [TI] = Title; [AU] = Author; [OT] = Other term; [TW] = Text Word; Systematic[SB] = Filter for retrieving systematic reviews; * = Truncation
Intervention
1.	("core outcome" or "core event" or ((core or composite or harmoni#e* or minimal or prioriti* or standard or standards or standardi#e* or set or sets) adj2 outcome*)).mp.	10749
Population
2.	exp Pregnancy Complications/ or exp Pregnancy/ or exp Obstetric Surgical Procedures/ or exp Anesthesia, Obstetrical/ or exp Analgesia, Obstetrical/ or exp Obstetrics/ or exp Pregnant Women/ or (abortion or antenatal or antepartum or birth or caesarean or caesarean or caesarean or childbirth or delivery or fertilization or gestation or labor or labour or maternal or neonatal or obstretric* or perinatal or peripart* or postnatal or postpartum or pregnan* or puerperium or preterm).ti	1199069
Combined sets/Limits
	1 and 2 Limiters - Language: Danish, English, Norwegian, Swedish	1028

PsycINFO, Academic Search Elite, CINAHL with Full Text, SocINDEX with Full Text via EBSCO 26 June 2019

Title: Core outcomes sets (COS) in obstetric care
Search terms		Items found
The search result, usually found at the end of the documentation, forms the list of abstracts. AB = Abstract; AU = Author; DE = Term from the thesaurus; MM = Major Concept; TI = Title; TX = All Text. Performs a keyword search of all the database's searchable fields; ZC = Methodology Index; * = Truncation; “ “ = Citation Marks; searches for an exact phrase
Intervention
1.	TI ( ("core outcome" or "core event" or ((core or composite or harmoni#e* or minimal or prioriti* or standard or standards or standardi#e* or set or sets) NEAR/2 outcome)) ) OR AB ( ("core outcome" or "core event" or ((core or composite or harmoni#e or minimal or prioriti* or standard or standards or standardi#e* or set or sets) NEAR/2 outcome*)) )	1414
Population
2.	TI ( (abortion or antenatal or antepartum or birth or caesarean or caesarean or caesarean or childbirth or delivery or fertilization or gestation or labor or labour or maternal or neonatal or obstretric* or perinatal or peripart* or postnatal or postpartum or pregnan* or puerperium or preterm) ) OR AB ( (abortion or antenatal or antepartum or birth or caesarean or caesarean or caesarean or childbirth or delivery or fertilization or gestation or labor or labour or maternal or neonatal or obstretric* or perinatal or peripart* or postnatal or postpartum or pregnan* or puerperium or preterm) ) OR SU ( (abortion or antenatal or antepartum or birth or caesarean or caesarean or caesarean or childbirth or delivery or fertilization or gestation or labor or labour or maternal or neonatal or obstretric* or perinatal or peripart* or postnatal or postpartum or pregnan* or puerperium or preterm) )	2019640
Combined sets
	1 and 2	110

Comet initiative database

Date of Search,"10/06/2019", updated ,"27/01/2020"

Search Options,"search{Health Area - Disease Category{:Anaesthesia & pain control:Gynaecology:Pregnancy & childbirth:Urology:}}",

Checklist modified after Core Outcome Set–STAndards for Reporting (COS-STAR)

Article: ___________________

	Item	Question
Title and abstract	1a	Does the title contain information that the paper reports the development of a COS?
Title and abstract	1b	Does the abstract contain the key information, such as a list of the recommended outcomes in the COS?
Introduction	2a	Is a background and explanation of the rationale for developing the COS provided?
	2b	Are a clear objective presented?
	3a	Is the health condition(s) and population(s) covered by the COS sufficiently described?
	3b	Is the intervention(s) covered by the COS sufficiently described?
	3c	Is the setting(s) in which the COS is to be applied sufficiently described?
Methods	4	Do the authors provide information about were the COS development protocol can be accessed
	5	Is the rationale for which stakeholder groups that are involved and the eligibility criteria for participants described?
	6a	Are the information sources used to identify an initial list of outcomes provided?
	6b	Is it described, with reasons, how outcomes were dropped/combined if this was done?
	7	Is a description for how the consensus process was undertaken provided?
	8	Is a description for how outcomes were scored and summarised, provided?
	9a	Is a description of the consensus definition provided?
	9b	Is a description of the procedure for determining how outcomes were included or excluded from consideration during the consensus process provided
	10	Is a statement regarding the ethics and consent issues for the study provided?
Results	11	Are any motivated deviations from the protocol and their eventual impact on the results described?
	12	Are numbers and relevant characteristics of the people involved at all stages of COS development presented?
	13a	Are all outcomes considered at the start of the consensus process listed?
	13b	Are any new outcomes introduced or any outcomes dropped during the consensus process and the reasons for doing so described?
	14	Is a list of the outcomes in the final core outcome set provided?
Discussion	15	Are limitations with the COS development process discussed?
Discussion	16	Is an interpretation of the final COS in the context of other evidence, and implications for future research given?
Other information	17	Are sources of funding and role of funders given?
Other information	18	Are any conflicts of interest within the study team and how these were managed presented?
Representation (Not included in COS-STAR)	19	Are researchers as well as health care providers and patients included in the development process?

Appendix 3 Excluded studies

Studies considered not relevant
Study	Reason for exclusion
A Core Outcome Set for Very Preterm Birth?, http://www.comet-initiative.org/studies/details/256	Not a Core Outcome Set
Allin B, Bradnock T, Kenny S, Walker G, Knight M. NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung's disease treatment. Trials 2016;17:1-7.	Outside prespecified population
Allin B, Ross A, Marven S, Hall NJ, Knight M, J Hall N. Development of a core outcome set for use in determining the overall success of gastroschisis treatment. Trials 2016;17:1-7.	Outside prespecified population
An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse, http://www.comet-initiative.org/studies/details/525	Not a Core Outcome Set
Bakhbakhi D, Burden C, Fraser A, Hinton L, Duffy J, Redshaw M, et al. Development of a core outcome set and identification of outcome measurement tools for interventions after stillbirth. J Evid Based Med 2019;12:10.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Bakhbakhi D, Duffy JMN, Hinton L, Burden C, Main B, Downe S, et al. Development of a core outcome set for interventions after stillbirth. Int J Gynaecol Obstet 2018;143:235.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Bannatyne AJ, Hughes R, Stapleton P, Watt B, MacKenzie-Shalders K. Signs and symptoms of disordered eating in pregnancy: a Delphi consensus study. BMC Pregnancy Childbirth 2018;18:262-262.	Not a Core Outcome Set
Bunch K, Allin B, Knight M. Authors' reply re: Developing a set of consensus indicators to support maternity service quality improvement: using Core Outcome Set methodology including a Delphi process. BJOG 2019;126:130-130.	Not a Core Outcome Set
Butler MM, Brosnan MC, Drennan J, Feeney P, Gavigan O, Kington M, et al. Evaluating midwifery-led antenatal care: using a programme logic model to identify relevant outcomes. Midwifery 2014;30:e34-41.	Not a Core Outcome Set
Clayton AH, Dennerstein L, Fisher WA, Kingsberg SA, Perelman MA, Pyke RE. Standards for clinical trials in sexual dysfunction in women: research designs and outcomes assessment. J Sex Med 2010;7:541-60.	Outside prespecified population
Dadouch R, Faheim M, Juando-Prats C, Parsons J, D'Souza R. Development of a core outcome set for studies on obesity in pregnant patients (COSSOPP): A study protocol. J Evid Based Med 2019;12:19.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Dadouch R, Rosen C, Parsons J, D'Souza R. Obesity in pregnancy patient-reported outcomes: A qualitative study. J Evid Based Med 2019;12:18-9.	Not a Core Outcome Set
D'Souza R, Hall C, Siu S, Sermer M, Silversides C. Patient-reported outcomes in pregnancy and heart disease: A qualitative study. J Evid Based Med 2019;12:20.	Not a Core Outcome Set
D'Souza R, Thurman R, Sermer M, Siu S, Duffy J, Silversides C. Developing a core outcome set for pregnant women with cardiac disease. J Evid Based Med 2017;10:24-5.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
D'Souza RD, Thomas H, Wuebbolt D, Nguyen V, Sermer M, Krahn M, et al. Preferences of pregnant women with cardiac disease for combined maternal-fetal health states. J Evid Based Med 2017;10:22-3.	Not a Core Outcome Set
Duffy J, Rolph R, Gale C, Hirsch M, Khan KS, Ziebland S, et al. Core outcome sets in women's and newborn health: a systematic review. BJOG 2017;124:1481-9.	Not a Core Outcome Set
Duffy J, Thompson T, Hinton L, Salinas M, McManus RJ, Ziebland S. What outcomes should researchers select, collect and report in pre-eclampsia research? A qualitative study exploring the views of women with lived experience of pre-eclampsia. BJOG 2019;126:637-46.	Not a Core Outcome Set
Egan AM, Smith V, Devane D, Dunne FP. Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey. Trials 2015;16:356-356.	Protocol for a completed COS
Einerson BD, Einerson BD. Getting it right: core outcome sets in quality improvement research. BJOG 2018;125:1619-1619.	Not a Core Outcome Set
Fong F, Rogozinska E, Allotey J, Kempley S, Shah D, Thangaratinam S. Identification of clinically important components of maternal and neonatal composite outcomes to assess the effect of timing of delivery in women with mild to moderate pre-eclampsia at 34 to 37 weeks. Arch Dis Child Fetal Neonatal Ed 2013;98.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Hooft J, van 't Hooft J. A core outcome set for evaluation of interventions to prevent preterm birth: summary for CROWN. BJOG 2016;123:666-666.	Not a Core Outcome Set
Kelly LE, Jansson LM, Moulsdale W, Pereira J, Simpson S, Guttman A, et al. A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey. Trials [Electronic Resource] 2016;17:536.	Outside prespecified population
Khan K. The Core Outcomes in Women's Health (CROWN) Initiative: Journal Editors Invite Researchers to Develop Core Outcomes in Women's Health. Gynecologic And Obstetric Investigation 2015;80:1-2.	Not a Core Outcome Set
Khan K. The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health. BJOG 2016;123:103-4.	Not a Core Outcome Set
Khan K. The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health. Hypertens Pregnancy 2014;33:261-4.	Not a Core Outcome Set
Khan K. The CROWN Initiative: journal editors invite researchers to develop core outcomes in women's health. Journal Of Perinatal Medicine 2014;42:543-4.	Not a Core Outcome Set
Khan K. The CROWN initiative: journal editors invite researchers to develop core outcomes in women's health. Obstetrics And Gynecology 2014;124:487-8.	Not a Core Outcome Set
Killeen S, O'Brien E, Geraghty A, McAuliffe F. Maternal nutrition in pregnancy: A protocol for the development of a core outcome set. Obes Facts 2019;12:222.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Killeen SL, O'Brien EC, Geraghty AA, McAuliffe F. A protocol for the development of a core outcome set for research on maternal nutrition during pregnancy. BJOG 2019;126:46.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Kuo J, Petrie KJ, Alsweiler JM. Prioritising long-term outcomes for babies born preterm: The hip survey. J Paediatr Child Health 2019;55:83.	Outside prespecified population
Lakhanpaul M, Irish C, Jarvis R, Edbrooke-Childs J, Deighton J, Franklin M, et al. A shared outcome perinatal mental health value scorecard to support health visitors to improve outcomes for children 0-5 years and their families. Arch Dis Child 2016;101:A91.	Outside prespecified population
Lumsden MA. Will the development of a core outcome set on prevention and treatment of postpartum haemorrhage add value to research or clinical care? BJOG 2019;126:95-95.	Not a Core Outcome Set
Malinowski AK, Daru J, D'Souza R, Shehata N. Constructing a core outcome set for iron deficiency and iron deficiency anemia in pregnancy and postpartum. J Evid Based Med 2017;10:37.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Malinowski AK, Shehata N, D'Souza R. Constructing a core outcome set for immune thrombocytopenia in pregnancy. J Evid Based Med 2017;10:38.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Malinowski AK, Shehata N, D'Souza R. Constructing a core outcome set for venous thromboembolism in pregnancy. J Evid Based Med 2017;10:37-8.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Mann S, Pratt S, Gluck P, Nielsen P, Risser D, Greenberg P, et al. Assessing quality obstetrical care: development of standardized measures Jt Comm J Qual Patient Saf 2006;32:497-505.	Not a Core Outcome Set
Mawer G. Core outcomes for studies of pregnancy with epilepsy. BJOG 2017;124:668-668.	Not a Core Outcome Set
Medley N, Alfirevic Z, Caldwell DM, Dias S, Dowswell T, Keeney E, et al. Outcomes reported in trials of methods for the induction of labour. Trials 2015;16.	Not a Core Outcome Set
Metabolic follow-up at one year and beyond of women with gestational diabetes treated with insulin and/or oral hypoglycaemic agents, study protocol for the identification of a core outcomes set using a Delphi survey.	Protocol for a completed COS
Myatt L, Redman CW, Staff AC, Hansson S, Wilson ML, Laivuori H, et al. Strategy for standardization of preeclampsia research study design. Hypertension 2014;63:1293-301.	Not a Core Outcome Set
Nguyen V, Wuebbolt D, Thomas H, Shehata N, Krahn M, D'Souza R. Iron deficiency anemia in pregnancy and treatment options: A patient-preference study. J Evid Based Med 2017;10:24.	Not a Core Outcome Set
Outcomes Important to Patients Public and Practitioners (OMIPPP): Breastfeeding, http://www.comet-initiative.org/studies/details/662	Not a Core Outcome Set
Patient Preferences and Experiences in Hyperemesis Gravidarum Treatment: A Qualitative Study, http://www.comet-initiative.org/studies/details/1334	Not a Core Outcome Set
Perry H, Duffy JMN, Umadia O, Khalil A. Outcome reporting across randomized trials and observational studies evaluating treatments for twin-twin transfusion syndrome: systematic review. Ultrasound Obstet Gynecol 2018;52:577-85.	Not a Core Outcome Set
Petersen R, Nijagal M, Wissig S, Stowell C, Franx A. Defining an international standard set of outcomes measures for maternity care: Consensus of the international consortium of health outcomes measurement pregnancy & childbirth working group. Aust N Z J Obstet Gynaecol 2016;56:51-2.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Progressing towards core outcomes for maternal and perinatal clinical trials and reviews. J Paediatr Child Health 2017;53:91-91.	Not a Core Outcome Set
Rahn DD, Abed H, Sung VW, Matteson KA, Rogers RG, Morrill MY, et al. Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials. J Clin Epidemiol 2011;64:293-300.	Outside prespecified population
Ricciardi P, Haydar A. Re: Developing a set of consensus indicators to support maternity service quality improvement: using Core Outcome Set methodology including a Delphi process: The Robson 10-groups classification system - all groups are needed. BJOG 2019;126:129-30.	Not a Core Outcome Set
Rogers J, Spink M, Magrill A, Burgess K, Agius M. Evaluation of a Specialised Counselling Service for Perinatal Bereavement. Psychiatr Danub 2015;27:S482-S5.	Not a Core Outcome Set
Rosen C, Dadouch R, Parsons J, D'Souza R. The comparison of outcomes reported by healthcare professionals and patients on the management of obesity in pregnancy. J Evid Based Med 2019;12:9.	Not a Core Outcome Set
Rysavy MA, Marlow N, Doyle LW, Tyson JE, Serenius F, Iams JD, et al. Reporting Outcomes of Extremely Preterm Births. Pediatrics 2016;138.	Not a Core Outcome Set
Say RE, Thomson RG, Robson SC. Making high quality decisions in pregnancy: How should interventions which aim to improve decision quality be evaluated? Arch Dis Child Fetal Neonatal Ed Edition 2012;97:A114-A5.	Not a Core Outcome Set
Schaap T, Bloemenkamp K, Deneux-Tharaux C, Knight M, Langhoff-Roos J, Sullivan E, et al. Defining definitions: a Delphi study to develop a core outcome set for conditions of severe maternal morbidity. BJOG 2019;126:394-401.	Not a Core Outcome Set
Signs and symptoms of disordered eating in pregnancy: a Delphi consensus study, http://www.comet-initiative.org/studies/details/1339	Not a Core Outcome Set
Slavin V, Gamble J, Creedy DK, Fenwick J. “Coming of Age”: assessing the feasibility of using a core set of value-based health outcomes for pregnancy and childbirth. Women Birth 2018;31:S29-S30.	Not a Core Outcome Set
Smith CA, Betts D. The practice of acupuncture and moxibustion to promote cephalic version for women with a breech presentation: implications for clinical practice and research. Complement Ther Med 2014;22:75-80.	Not a Core Outcome Set
Son M. Core outcome set for induction of labour trials: what's the expectation? BJOG 2018;125:1681-1681.	Not a Core Outcome Set
Spink M, Magrill A, Burgess K, Rogers J, Agius M. Petals: An Assessment of the Outcomes of a Service for Bereavement during Childbirth. Psychiatr Danub 2014;26:211-21.	Not a Core Outcome Set
Standards for clinical trials in sexual dysfunction in women: research designs and outcomes assessment, http://www.comet-initiative.org/studies/details/411	Outside prespecified population
Stevens G, Donnelly KZ, Theiler RN, Washburn H, Woodhams EJ, Lindahl V, et al. (Family) planning ahead: User-centered design of the birth control after pregnancy patient decision aid and protocol for delivery and evaluation. Contraception 2017;96:289.	Outside prespecified population
Strategy for standardization of preeclampsia research study design, http://www.comet-initiative.org/studies/details/610	Not a Core Outcome Set
The core outcomes in women's health (CROWN) initiative. Eur J Obstet Gynecol Reprod Biol 2014;180:A1-A2.	Not a Core Outcome Set
The practice of acupuncture and moxibustion to promote cephalic version for women with a breech presentation: implications for clinical practice and research, http://www.comet-initiative.org/studies/details/728	Not a Core Outcome Set
Toozs-Hobson P, Freeman R, Barber M, Maher C, Haylen B, Athanasiou S, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for reporting outcomes of surgical procedures for pelvic organ prolapse. Neurourol Urodyn 2012;31:415-21.	Not a Core Outcome Set
van der Aa JE, Tancredi A, Goverde AJ, Velebil P, Feyereisl J, Benedetto C, et al. What European gynaecologists need to master: Consensus on medical expertise outcomes of pan-European postgraduate training in obstetrics & gynaecology. Eur J Obstet Gynecol Reprod Biol 2017;216:143-52.	Not a Core Outcome Set
van 't Hooft J, Alfirevic Z, Asztalos EV, Biggio JR, Dugoff L, Hoffman M, et al. CROWN initiative and preterm birth prevention: researchers and editors commit to implement core outcome sets. BJOG 2018;125:8-11.	Not a Core Outcome Set
van 't Hooft J. A core outcome set for evaluation of interventions to prevent preterm birth: summary for CROWN. BJOG 2016;123:107-107.	Not a Core Outcome Set
van 't Hooft J. A core outcome set for evaluation of interventions to prevent preterm birth: summary for CROWN. BJOG 2016;123:666-666.	Not a Core Outcome Set
van Vliet R, Bink M, Polman J, Suntharan A, Grooten I, Zwolsman SE, et al. Patient Preferences and Experiences in Hyperemesis Gravidarum Treatment: A Qualitative Study. J Pregnancy 2018;2018:5378502.	Not a Core Outcome Set
Van't Hooft J, Duffy JMN, Saade GR, Alfirevic Z, Meher S, Mol BWJ, et al. Core outcomes set for studies on primary prevention of preterm birth. Trials 2015;16.	Duplication with a published protocol/registration in the COMET initiative database/or finished COS article
Van't Hooft J, Khan KS. P-hacking can be avoided with core outcome sets: preterm birth research is ready to take this leap. BJOG 2017;124:1017-1017.	Not a Core Outcome Set
Webbe J, Brunton G, Afonso E, Latour JM, Gale C. The importance of core outcome sets and developing one for neonatal care. Infant 2017;13:70-2.	Outside prespecified population
Webbe J, Brunton G, Ali S, Duffy JM, Modi N, Gale C. Developing, implementing and disseminating a core outcome set for neonatal medicine. BMJ Paediatr Open 2017;1:e000048.	Outside prespecified population
Webbe J, Brunton G, Ali S, Wann L, Modi N, Gale C. Using existing data sources to extract parent and patient outcomes for a neonatal core outcome set. J Evid Based Med 2017;10:10-11.	Outside prespecified population
What outcomes should researchers select, collect and report in pre-eclampsia research? A qualitative study exploring the views of women with lived experience of pre-eclampsia, http://www.comet-initiative.org/studies/details/1327	Not a Core Outcome Set
Whitehouse KC, Kim CR, Ganatra B, Duffy JMN, Blum J, Brahmi D, et al. Standardizing abortion research outcomes (STAR): a protocol for developing, disseminating and implementing a core outcome set for medical and surgical abortion. Contraception 2017;95:437-41.	Protocol for a completed COS
Wiegers TA, Keirse MJ, Berghs GA, van der Zee J. An approach to measuring quality of midwifery care. J Clin Epidemiol 1996;49:319-25.	Not a Core Outcome Set
Williamson P. Core outcome sets will improve the quality of obstetrics research. BJOG 2014;121:1196.	Not a Core Outcome Set

Appendix 4 Ongoing studies

Ongoing COS studies
ReferenceFirst author Year	Population	Stakeholders to be included in the workgroup	Methods	Compliance with COS-STAR
[57] (registered in COMET database)	Prevention and treatment of obstetric anal sphincter injuries COS for clinical trials or clinical research and COS for practice	Clinical experts Consumers (patients) Epidemiologists Journal Editors Patient/support group representatives	Systematic review to identify outcome measures International survey of stakeholders to review identified outcomes and other outcomes identified by stakeholders Delphi methodology to achieve a consensus	Not enough information
[18] Egan 2007 Published protocol	Two core outcome sets: Intervention for prevention of gestational diabetes mellitus and intervention for treatment of gestational diabetes mellitus COS for clinical trials or clinical research and COS for practice	Clinical experts Researchers Service users	Systematic review to identify outcome measures A three-round, web-based, e‑Delphi survey Consensus face-to-face meeting	Yes
[46] (registered in COMET database)	Interventions for overweight women before pregnancy and in the first trimester of pregnancy COS for clinical trials or clinical research COS for practice	Clinical experts Consumers (patients) Economists Epidemiologists Families Researchers Service providers Statisticians	Systematic review to identify outcome measures A Delphi process until reduction of the list of identified outcomes to ten or less or on completion of the second round Consensus face-to-face meeting	Not enough information
[13] (registered in COMET database)	Interventions for hyperemesis gravidarum COS for clinical trials or clinical research	Clinical experts Consumers (caregivers) Consumers (patients) Journal editors Patient/support group representatives Researchers	Systematic review to identify outcome measures Two round Delphi survey to achieve a consensus If no consensus has been reached even after additional Delphi rounds, a final consensus meeting will be organized	Not enough information
[40] (registered in COMET database)	Therapeutic interventions for pregnant women with cardiac disease COS for clinical trials or clinical research, COS for practice	Clinical experts Consumers (patients) Guideline developers Journal editors Researchers Service providers Statisticians	Systematic review to identify outcome measures Two round Delphi survey to achieve a consensus Consensus face-to-face meeting Recommendations for outcome measures (measurement/how)	Not enough information
[41] (registered in COMET database)	Identification, assessment and management of iron deficiency and iron deficiency anaemia in pregnancy and postpartum COS for clinical trials or clinical research	Clinical experts Consumers (patients) Researchers	Systematic review to identify outcome measures Two round Delphi survey to achieve a consensus	Not enough information
[42] (registered in COMET database)	Identification, assessment and management of venous thromboembolism in pregnancy COS for clinical trials or clinical research	Clinical experts Consumers (patients) Researchers	Systematic review to identify outcome measures Two round Delphi survey to achieve a consensus	Not enough information
[33] (registered in COMET database)	The evolution and management of immune thrombocytopenia in pregnancy COS for clinical trials or clinical research	Clinical experts Researchers	Systematic review to identify outcome measures Two round Delphi survey to achieve a consensus	Not enough information
[24] (registered in COMET database)	Research in multiple pregnancies, irrespective of chorionicity COS for clinical trials or clinical research	Clinical experts Consumers (patients) Families Patient/support group representatives Researchers	Systematic review to identify outcome measures Delphi survey Consensus face-to-face meeting	Not enough information
[34] (registered in COMET database)	Diagnostic and therapeutic management pregnancies complicated by cancer COS for clinical trials or clinical research and COS for practice	Clinical experts Consumers (caregivers) Consumers (patients) Patient/ support group representatives	Systematic review to identify outcome measures Delphi survey If necessary, consensus meeting	Not enough information
[35] (registered in COMET database)	Antenatal diagnosis and management pregnant women with vasa previa COS for clinical trials or clinical research COS for practice	Charities Clinical experts Conference participants Consumers (caregivers) Consumers (patients) Epidemiologists Families Methodologists Patient/support group representatives Policy makers Researchers	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Delphi survey If necessary, consensus face-to-face meeting Determining How Core Outcomes Should be Measured	Not enough information
[36] (registered in COMET database)	Screening, diagnosing, and managing of invasive placentation COS for clinical trials or clinical research	Clinical experts Consumers (caregivers) Consumers (patients) Journal editors Policy makers Researchers Service providers Service users	Systematic review to identify outcome measures Focus Groups to identify important outcomes from the perspectives of patients Delphi survey Consensus face-to-face meeting	Not enough information
[25] (registered in COMET database)	Management, treatment and frequency of surveillance of twin anaemia polycythaemia sequence COS for clinical trials or clinical research COS for practice	Charities Clinical experts Epidemiologists Families Patient/support group representatives Researchers	Systematic review to identify outcome measures Delphi survey Consensus face-to-face meeting	Not enough information
[37] (registered in COMET database)	Fetal Interventions of myelomeningocele (spina bifida) COS for clinical trials or clinical research COS for practice	Clinical experts Consumers (caregivers) Consumers (patients) Families Patient/ support group representatives Researchers	Systematic review to identify outcome measures Delphi survey Consensus face-to-face meeting	Not enough information
[39] (registered in COMET database)	Management of sickle cell disease in pregnancy COS for clinical trials or clinical research	Clinical experts Consumers (patients) Methodologists Patient/ support group representatives Pharmaceutical industry representatives Researchers Service providers Service users	Systematic review to identify outcome measures Delphi survey Consensus face-to-face meeting	Not enough information
[44] (registered in COMET database)	Maternal nutrition during pregnancy COS for clinical trials or clinical research COS for practice	Clinical experts Consumers (patients) Researchers	Systematic review to identify outcome measures Delphi survey Steering group meeting	Not enough information
[38] (registered in COMET database)	Prenatal interventions for congenital diaphragmatic hernia COS for clinical trials or clinical research	Clinical experts Patient/support group representatives Researchers	Systematic review to identify outcome measures Delphi survey Consensus face-to-face meeting Determining how core outcomes should be measured	Not enough information
[63] (registered in COMET database)	Treatment of female pelvic floor disorders (urinary incontinence, pelvic organ prolapse, childbirth perineal trauma and pelvic pain syndromes) COS for clinical trials or clinical research COS for practice	Charities Clinical experts Consumers (caregivers) Consumers (patients) Governmental agencies Patient/ support group representatives Pharmaceutical industry representatives Policy makers Researchers Service commissioners Service providers Service users	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Delphi survey Consensus face-to-face meeting Determining how core outcomes should be measured	Not enough information
[64] (registered in COMET database)	Treatment of rectovaginal fistula COS for clinical trials or clinical research COS for practice	Charities Clinical experts Conference participants Consumers (caregivers) Consumers (patients) Patient/support group representatives Researchers	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Delphi survey Consensus face-to-face meeting	Not enough information
[56] (registered in COMET database)	Interventions for assessment of fetal wellbeing in labour COS for clinical trials or clinical research	Clinical experts Service users	Systematic review to identify outcome measures Delphi survey Consensus face-to-face meeting	Not enough information
[50] (registered in COMET database)	Interventions for prevention of stillbirth and care after stillbirth COS for clinical trials or clinical research	Unknown	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Delphi survey Consensus face-to-face meeting	Not enough information
[51] (registered in COMET database)	Interventions for the detection and management of reduced fetal movements COS for clinical trials or clinical research	Clinical experts Researchers Service users	Systematic review to identify outcome measures Delphi survey Consensus face-to-face meeting	Not enough information
[52] (registered in COMET database)	Interventions to prevent stillbirth COS for clinical trials or clinical research COS for practice	Clinical experts Consumers (patients) Researchers	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Delphi survey Determining how core outcomes should be measured	Not enough information
[54] (registered in COMET database)	Examining outcomes resulting from operative vaginal birth COS for clinical trials or clinical research COS for practice	Charities Clinical experts Families Journal editors Patient/ support group representatives Researchers Service commissioners Service providers Service users Statisticians	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Delphi survey Consensus face-to-face meeting	Not enough information
[66] (registered in COMET database)	Intervention to support women and infants to breastfeed COS for clinical trials or clinical research	Clinical experts Consumers (caregivers) Researchers	Systematic review to identify outcome measures Delphi survey	Not enough information
[69] (registered in COMET database)	Maternal and fetal Composite Adverse Obstetric Outcomes COS for clinical trials or clinical research	Clinical experts Conference participants Consumers (caregivers) Consumers (patients) Epidemiologists Families Policy makers Researchers Service providers Service users Statisticians	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Delphi survey Consensus face-to-face meeting Determining how core outcomes should be measured	Not enough information
[19] Nielsen Published protocol	Interventions to prevent diabetes after pregnancy for women with previous GDM COS for clinical trials	Clinical experts Conference participants Consumers (patients) Epidemiologists Families Methodologists Researchers	Systematic review to identify outcome measures Semi-structured discussion meeting will inform the Delphi survey development Two-round Delphi survey Consensus face-to-face meeting	Yes
[47] Danouch Published protocol	Antenatal and peripartum intervention for obesity COS for clinical trials	Clinical experts Conference participants Consumers (caregivers) Consumers (patients) Epidemiologists Families Guideline developers Policy makers Researchers Service providers Service users Statisticians Trialists	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Two-round Delphi survey Consensus face-to-face meeting Determining how core outcomes should be measured	Yes
[65] Smith Published protocol	What constitutes positive health and wellbeing (salutogenesis) in maternity care COS for clinical trials and measuring in daily intrapartum clinical care	Clinical experts Consumers (patients) Researchers Service users	Three-round Delphi survey	Yes
[21] Duffy Published protocol	Therapeutic interventions for pre-eclampsia COS for clinical trials or clinical research	Academic research representatives Carer organisation/supportgroup representatives Charities Clinical experts Consumers (patients) Correlative science experts Governmental agencies Individuals with a known interest Patient/support group representatives Pharmaceutical industry representatives Service commissioners Service providers Study investigators Trialists	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Two-three-round Delphi survey Determining how core outcomes should be measured	Yes
[60] Smith Published protocol	Prevention and treatment of miscarriage COS for clinical trials	Clinical experts Consumers (patients) Families Patient/ support group representatives	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Three-round Delphi survey Consensus face-to-face meeting	Yes
[62] Whitehouse Published protocol	Medical and surgical abortion COS for clinical trials	Clinical experts Consumers (patients) Epidemiologists Governmental agencies Service providers	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Two-round Delphi survey Consensus face-to-face meeting	Yes
[31] Viau-Lapointe Published protocol	Research on critically ill obstetric patients COS for clinical trials or clinical research COS for practice	Clinical experts Consumers (caregivers) Consumers (patients) Families Journal editors Researchers Service providers	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Two-round Delphi survey Virtual consensus meeting	Yes
[32] Prins Published protocol	Immune modulation interventions as preventive or therapeutic strategies for pregnancy complications COS for clinical trials or clinical research COS for practice	Clinical experts Consumers (caregivers) Consumers (patients) Patient/support group representatives Researchers	Systematic review to identify outcome measures Three-round Delphi survey Consensus face-to-face meeting	Yes
[28] Kelly Published protocol	Prevention and management strategies of neonatal abstinence syndrome COS for clinical trials or clinical research COS for practice	Clinical experts Consumers (caregivers) Epidemiologists Methodologists Researchers	Systematic review to identify outcome measures Qualitative patient interviews to identify potential core outcomes Three-round Delphi survey Consensus face-to-face meeting	Yes
[29] Viau-Lapointe Conference abstract	Pregnant women requiring mechanical ventilation COS for clinical trials	International group of patients and members of the public	Systematic review to identify outcome measures Delphi survey	Not enough information Conference abstract
[30] Sankaran Published protocol Conference abstract	Obstetric antiphospholipid antibody syndrome (OAPS), the need for low-molecular weight heparin (LMWH for pregnant women COS for clinical trials	Clinicians (rheumatology, obstetrics, maternal-fetal medicine, fertility and haematologists) patients	Systematic review to identify outcome measures Delphi survey	Not enough information Conference abstract
[70] (registered in COMET database)	Uniform Definitions of maternal morbidity Definition	Researchers	Delphi survey Consensus meeting	Not enough information
[27] (registered in COMET database)	Ectopic pregnancy COS for clinical trials or clinical research	Clinical experts Patient/ support group representatives Researchers Service providers	Systematic review to identify outcome measures Delphi survey Consensus face-to-face meeting Recommendations for outcome measures (measurement/how)	Not enough information

Page published February 28, 2020

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