A. Lay Summary (Max. 250 words)
It is becoming more common for pregnant women to live with 2 or more long-term physical or mental health conditions. However, we do not know enough about how having multiple long-term conditions may affect the pregnancy, the birth of the baby, and the women and baby’s long-term health. Having this information may help women make informed decisions with their clinicians for their pregnancy and their care.
To do so, we will use information from electronic health records for pregnant women with multiple long-term conditions and their children. We will use health records from primary and secondary care. We will compare what happen to mothers (and their babies) with and without multiple long-term conditions.
The outcomes that we will study come from a core outcome set. This is a minimum set of research outcomes that stakeholders have agreed should be reported for studies of pregnant women with multiple long-term conditions. Stakeholders included women with lived experience, their partners, health care professionals and researchers. We will study outcomes for pregnant women with multiple long-term conditions and their children, at different stages of pregnancy (before, during and after birth).
AMENDED TECHNICAL SUMMARY
The aim of the study is to understand how maternal pre-existing multiple long-term conditions affect the pregnancy, mother and child. We will investigate the association of maternal multiple long-term conditions with maternal and children’s outcome at different stages of pregnancy.
This will be a retrospective cohort study of women with recorded pregnancies from year 2000 onwards in the CPRD Pregnancy Register. The exposure of two or more pre-existing, maternal long-term physical or mental health conditions will be defined from a list of health conditions predetermined by women and clinicians. The association of maternal multiple long-term conditions with (i) antenatal, (ii) peripartum, (iii) postnatal and long-term, and (iv) mental health outcomes, for both women and their children will be examined. Outcomes of interest will be guided by a recently completed core outcome set that were prioritised by patients, clinicians and researchers through consensus setting methods.
Comparisons will be made between pregnant women with and without multiple long-term conditions using logistic and Cox regression. We will estimate crude and causal association, using directed acyclic graph to consider potential confounders and mediators. Generalised estimating equation will account for the clustering effect of women who had more than one pregnancy episode. Where appropriate, multiple imputation with chained equation will be used for missing data.
A. Outcomes to be Measured
(1) Antenatal outcomes
o Miscarriage
o Termination of pregnancy
o Hypertensive disorder of pregnancy: gestational hypertension, pre-eclampsia, eclampsia, HELLP syndrome
o Placenta abruption
o Placenta insufficiency
o Venous thromboembolism
o Fetal growth restriction
o Intraterine fetal death
o Gestational diabetes
o Obstetric cholestasis
- Hyperemesis gravidarum
- Vomiting
- Gestational hypertension
- Chorioamnionitis
(2) Peripartum outcomes
o Maternal mortality (death up to 6 weeks, and 1 year, after end of pregnancy)
o Neonatal and infant mortality
o Stillbirth
o Modes of birth: e.g. emergency caesarean section
o Induction of labour
o Preterm birth
o Preterm premature rupture of membrane
o Birth weight
o Severe maternal morbidity
o Postpartum haemorrhage
o Admission to ITU (mother and baby)
o Hysterectomy
o Maternal infection
o Perinatal admissions and readmissions
o Analgesia during labour
o Anaesthesia during labour
o Shoulder dystocia
o Perineal trauma
- Epidural
- Length of hospital stay
- Blood transfusion (for the pregnant women)
(3) Postpartum and long-term outcomes
o Neonatal resuscitation
o Neonatal intubation / ventilation
o Birth injury (baby)
o Neonatal sepsis
o Neonatal admission / readmission to hospital
o Neonatal respiratory distress syndrome
o Neonatal abstinence syndrome
o Meconium aspiration
o Necrotising enterocolitis
o Retinopathy of prematurity
o Visual impairment /blindness (baby)
o Brain injury (baby)
o Chronic lung disease (baby)
o Congenital anomaly
o Cerebral palsy
o Neurodevelopmental disorder of the offspring
o Infant death
o Development of new long-term conditions for the women
o Impact on women’s long-term conditions
- Neonatal hypoglycaemia
- Neonatal jaundice
- Hearing impairment / deafness
- Faltering growth / failure to thrive
- Breastfeeding
- Incontinence (women)
(4) Mental health outcomes
o Perinatal mental health: e.g. postnatal depression, puerperal psychosis
o Suicide
o Self-harm
o Post-traumatic stress disorder
o Children mental health and behavioural disorder
Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Siang Ing Lee - Corresponding Applicant - University of Birmingham
Anuradhaa Subramanian - Collaborator - University of Birmingham
Holly Hope - Collaborator - University of Birmingham
Jingya Wang - Collaborator - University of Birmingham
Katherine Phillips - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Megha Singh - Collaborator - University of Birmingham
Steven Wambua - Collaborator - University of Birmingham
Holly Hope - Collaborator - University of Manchester
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation;CPRD Aurum Mother-Baby Link;CPRD Aurum Pregnancy Register;CPRD GOLD Mother-Baby Link;CPRD GOLD Pregnancy Register