Table 3 Eleven core outcomes in the final core outcome set for studies of pregnant women with multimorbidity
From: The development of a core outcome set for studies of pregnant women with multimorbidity
Core outcomes | Concepts of the outcomes and key points for consideration in the next stage of defining outcomes |
|---|---|
Maternal outcomes | |
1. Maternal death | Important to document timing and cause of death. |
2. Severe maternal morbidity | Many of the pregnancy complications that were initially included were removed from the core outcome set as severe maternal morbidity would represent the severe manifestation of the pregnancy complications. |
3. Change in existing long-term conditions (physical and mental) | Includes the worsening, relapse or improvement of pre-existing long-term physical and mental health conditions. |
4. Quality and experience of care | Important to include whether women were involved in their care decisions. |
5. Development of new mental health conditions | This would include the development of new onset mild, moderate and severe mental health conditions that are acute or chronic. |
Child outcomes | |
1. Survival of baby | To include early pregnancy loss (miscarriage) and death of the baby at different time points (e.g. intrauterine fetal demise, stillbirth, perinatal death, neonatal death, infant death). Important to include the time frame, e.g. death within 28 days for neonatal death. |
2. Gestational age at birth | This outcome together with birth weight and sex can be used to derive other outcomes, such as preterm/post-term birth, small/large for gestational age, fetal growth restriction. |
3. Neurodevelopmental conditions/impairment | Important to determine what is the definition, what conditions to include, and the severity level at which it impairs function. Important to ensure research is conducted ethically. |
4. Quality of life | Will need the development of measurement tools to measure this outcome in very young babies. |
5. Birth weight | Studies should also document the sex of the baby alongside this outcome to enable meaningful interpretation. |
6. Separation of baby from mother for health care needs | This would be a proxy for baby or mother needing additional care, such as admission to neonatal unit or intensive care unit. |