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Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP)

COSCarP is a multi-method study conducted between 2017 and 2024, wherein 110 participants comprising 22 people with lived experience of pregnancy and heart disease / health service users (HSUs) and 88 healthcare professionals (HCPs) from 13 countries identified 12 core outcomes and 12 core reporting checklist items, which researchers are encouraged to measure and report in all future cardio-obstetrics studies. In addition, COSCarP has identified 7 condition-specific core outcomes and 7 other patient -important outcomes, which researchers are encouraged to measure and report where feasible.

Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP)

Study
Study
This is the first iteration of COSCarP. Your feedback and comments on these checklists are very welcome,
and we aim to incorporate them into the next iteration. Please feel free to reach out to us via email at oros@mcmaster.ca.

Core Outcome Set
# Core Outcome Explanations and reporting recommendations Reported
Yes / No		 Location/page number where
item is reported.
Justification if not/partly reported
1.
1.
Maternal Mortality
Maternal Mortality
  • For antepartum deaths, specify gestational age.
  • For post-pregnancy deaths, specify number of days following pregnancy loss or childbirth.
  • In all cases, report the condition directly leading to death (avoid ‘cardiopulmonary arrest’)
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2.
2.
Cardiac arrest (not resulting in death)
Cardiac arrest (not resulting in death) 		Specify gestational age (if antepartum) or days following pregnancy loss or childbirth.
i
3.
3.
Cerebrovascular events
Cerebrovascular events
  • For stroke – report type and location.
  • Report transient ischemic attacks separately.
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4.
4.
Heart failure
Heart failure
  • State if new onset heart failure.
  • State left vs. right heart failure.
  • For left heart failure report left ventricular ejection fraction and its assessment method if available.
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5.
5.
Arrhythmias requiring treatment / Change in treatment
Arrhythmias requiring treatment / Change in treatment 		Describe the type of arrhythmia. Describe medical treatment vs. cardioversion.
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6.
6.
Thromboembolism - valvular or extra-valvular
Thromboembolism - valvular or extra-valvular 		Describe the source of thromboses.
Describe valvular thromboses separately from venous and arterial thromboses.
Describe the location of the embolus.
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7.
7.
Cardiac related Syncope
Cardiac related Syncope 		Specify gestational age (if antepartum) or days following pregnancy loss or childbirth.
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8.
8.
Intensive Care Unit admission for critical care management
Intensive Care Unit admission for critical care management 		Mention the mean/median length of stay in days for treatment and NOT for observation.
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9.
9.
Need for cardiovascular interventions in pregnancy
Need for cardiovascular interventions in pregnancy 		Yes/No. If yes, specify the intervention and gestational age.
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10.
10.
Perinatal loss
Perinatal loss 		Clearly state the threshold of viability used for this study, for e.g., 20 weeks, 24 weeks, etc. Define perinatal loss as follows

INTRAUTERINE / FETAL LOSS

  • Miscarriage: spontaneous fetal loss under the threshold of viability
  • Therapeutic abortion / pregnancy termination: medical or surgical termination of pregnancy under the threshold of viability
  • Stillbirth: intrauterine fetal death between the threshold of viability and birth.
Report gestational ages for each of the above.

NEONATAL DEATH / EX UTERO LOSS
  • Early neonatal death: death within the first 7 days of life
  • Late neonatal deaths: deaths between days 8 – 28 of life
Report age in days following birth

[Any deaths occurring after 28 days of life should be reported as infant deaths specifying the age in days where possible]
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11.
11.
Severe neonatal morbidity
Severe neonatal morbidity 		Serious or life-threatening conditions experienced by neonates. State what conditions/indicators were used to define this term.
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12.
12.
Neonatal intensive care unit (NICU) admissions for > 24 hours
Neonatal intensive care unit (NICU) admissions for > 24 hours 		Mention the mean/median length of stay in days.
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Reporting Checklist Items
# Core - Reporting Checklist Item Explanations and reporting recommendations Reported
Yes / No		 Location/page number where
item is reported.
Justification if not/partly reported
1.
1.
Hypertensive disorders of Pregnancy
Hypertensive disorders of Pregnancy 		Yes/No. If yes, describe classification system used and stratify by type such as gestational hypertension, preeclampsia, preeclampsia with severe symptoms, eclampsia, HELLP syndrome etc.
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2.
2.
Major bleeding
Major bleeding 		Yes/No. If yes,
  • Indicate how major bleeding was defined. Provide citation if available.
  • Describe whether the bleeding occurred in the antepartum, intrapartum or postpartum period, number of episodes, estimated blood loss and interventions needed to control bleeding.
  • For antepartum bleeding, state the time interval between bleeding onset and birth / pregnancy termination.
  • Mention if the patient had disseminated intravascular coagulation.
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3.
3.
Surgical and anaesthetic complications during labour and childbirth
Surgical and anaesthetic complications during labour and childbirth 		Report injuries sustained by mother or baby during the spontaneous or operative birth.
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4.
4.
Serious adverse event following interventions
Serious adverse event following interventions 		State the intervention and nature of the serious adverse event.
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5.
5.
Labor and birth
Labor and birth 		Labor onset: Indicate the proportion of pregnancies in which labor was induced and reasons for labor induction.

Labor duration: Indicate the duration from the beginning of contractions until the cervix is fully dilated (first stage of labour) and duration between full cervical dilation and birth (second stage).

Birth: Indicate the proportion of caesareans and vaginal births.
  • For cesarean births, indicate whether the cesarean was planned or unplanned. Provide indications for cesarean birth such as placenta previa, breech presentation, non-reassuring fetal status, failure to progress in labour, deterioration of cardiac condition (specify), etc.
  • For vaginal births, indicate if the birth was spontaneous or assisted / operative. If assisted, indicate which instrument was used e.g., vacuum (type) or forceps (type) and indication for use of instrument.
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6.
6.
Duration of maternal hospitalization
Duration of maternal hospitalization 		Report the cumulative duration of antenatal or postnatal hospitalization in days, and the primary reasons for admission (e.g., preterm labor, preeclampsia).
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7.
7.
Maternal hospital readmission
Maternal hospital readmission 		Specify the time-period of the study. If possible, include re-admissions up to one year following pregnancy termination or childbirth.
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8.
8.
Maternal compliance to treatment
Maternal compliance to treatment 		Yes/ No. Provide details if possible.
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9.
9.
Fetal growth restriction
Fetal growth restriction 		Report the definition and citation that was used.
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10.
10.
Congenital malformations
Congenital malformations 		Specify any birth defects or congenital anomalies.
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11.
11.
Gestational age at birth
Gestational age at birth 		Where relevant, subcategorize into early preterm (<34 weeks), late preterm (34–36 weeks), and term (≥37 weeks) deliveries.
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12.
12.
Non-severe neonatal morbidity
Non-severe neonatal morbidity 		This includes non-severe neonatal morbidity related to prematurity for e.g. Neonatal hypoglycemia, Neonatal hyperbilirubinemia (jaundice).
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Condition-Specific Core Outcomes
# Condition-Specific Core Outcomes Explanation and reporting recommendations Reported
Yes / No		 Location/page number where
item is reported.
Justification if not/partly reported
1.
1.
Acute Coronary Syndrome
Acute Coronary Syndrome 		Relevant to atherosclerotic conditions and coronary artery disease.
Include unstable angina and myocardial infarction. Where possible, report on vessels involved and interventions.
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2.
2.
Aortic Rupture or Dissection
Aortic Rupture or Dissection 		Relevant to aortopathies.
Yes/No – provide details in manuscript.
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3.
3.
Infective Endocarditis
Infective Endocarditis 		Relevant to several valvular/congenital heart diseases and immunocompromised states.
Yes/No
Report valves affected and nature of intervention.
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4.
4.
Graft or Transplant Rejection / Failure
Graft or Transplant Rejection / Failure 		Relevant to cardiothoracic transplants.
Yes/No – provide details in manuscript.
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5.
5.
Development or Worsening of Cardiomyopathy
Development or Worsening of Cardiomyopathy 		Relevant to prior history of peripartum/other cardiomyopathy.
Provide details on type, severity, and interventions where possible.
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6.
6.
Complication of Cardiac Procedure
Complication of Cardiac Procedure 		Relevant if the patients underwent a cardiac procedure.
Specify the complications and interventions.
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7.
7.
Cyanosis or Low Oxygen Saturation
Cyanosis or Low Oxygen Saturation 		Relevant to studies on cyanotic heart diseases.
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Other Patient-Important Outcomes
# Other Patient - important outcomes The following outcomes although challenging to report in all studies, are deemed important by patients and should be considered in clinical care and measured in subsequent research studies Reported
Yes / No		 Location/page number where
item is reported.
Justification if not/partly reported
1.
1.
Inability to breastfeed
Inability to breastfeed 		As stated.
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2.
2.
Mother-baby bonding after birth
Mother-baby bonding after birth 		As stated.
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3.
3.
Appropriate healthcare management
Appropriate healthcare management 		Whether the healthcare received during pregnancy and up until 6–8 weeks post-delivery was considered appropriate by the health care user.
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4.
4.
Maternal life expectancy
Maternal life expectancy 		The impact of serious cardiovascular events in pregnancy on life expectancy.
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5.
5.
Maternal quality of life or perceived health status
Maternal quality of life or perceived health status 		Include instrument used as well as timing and frequency of measurement. For repeated measurements, provide baseline and follow-up data where applicable. Examples of instruments include EQ-5D, SF-36. Perceived health status may also be determined using surveys or qualitative research methods.
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6.
6.
Baby’s long-term health outcomes
Baby’s long-term health outcomes 		Baby’s physical, neurodevelopmental, cognitive and psychological development after birth requiring ongoing health care monitoring and testing and the age at which this was tested. For a full list of neurodevelopmental outcomes, refer to ICD or DSM.
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7.
7.
Diagnosis of cardiac condition in the baby
Diagnosis of cardiac condition in the baby 		This includes genetic transmission of heart disease in the baby.
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