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Secondary Outcome(s)
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Gestation of pregnancy at delivery.
This outcome will be assessed by calculating the difference between the estimated due date (EDD) of pregnancy (confirmed by first trimester ultrasound; or by the clinician's nominated agreed EDD where no ultrasound was completed at <13 weeks' gestation) and the date of delivery.
[Assessed after the puerperium (>6 weeks following birth) by maternal medical history and clinical pathology review.]
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Composite of the following fetal/neonatal complications/adverse outcomes: A) Respiratory distress syndrome (defined as the need for oxygen support or supplemental oxygen for >4 hours) B) Clinical diagnosis of intraventricular haemorrhage =>grade II C) Clinical diagnosis of necrotizing enterocolitis resulting in surgery D) Sepsis with confirmed bacteraemia in blood cultures E) Anaemia resulting in blood transfusion F) Retinopathy of prematurity[These complications and adverse events will be assessed by medical history and clinical pathology results review >28 days following the baby's birth, and after their discharge from hospital, in case of the emergence of complications during the neonatal period. ]
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Composite of adverse maternal outcomes, including: A) All-cause maternal mortality (from recruitment up to 6 weeks postpartum); B) Eclampsia (diagnosed using ACOG guidelines); C) pulmonary oedaema; D) Severe renal impairment; E) Cerebrovascular event; F) Liver haematoma or rupture; G) Placental abruption[Assessed after the puerperium (>6 weeks following birth) by maternal medical history and clinical pathology review.]
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Exploratory measurement of preeclampsia-related maternal biomarkers (sFLT-1, sEng, PIGF, ET-1 and VCAM-1) in a subset of participants attending Mercy Hospital for Women for their pregnancy care. This will form a nested longitudinal sub-study within the main study.
[Blood samples will be collected at recruitment (12-20 weeks), ~28 weeks and ~36 weeks of pregnancy. The samples will be sent for laboratory analysis as a group within 12 months of the completion of recruitment at Mercy Hospital for Women.
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Mode of birth (unassisted vaginal birth; forceps assisted vaginal birth; vacuum assisted vaginal birth; elective lower uterine segment caesarean section; emergency lower uterine segment caesarean section; or classical caesarean section).
[Assessed after the puerperium (>6 weeks following birth) by maternal medical history review.]
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Baby's birth weight (g)
[The first documented bare weight taken after baby's birth, collected during neonatal history review (performed >28 days post-birth and following hospital discharge; or following still birth/neonatal death).
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Maternal gestational weight gain (GWG) in kg.
Assessment of the relative change in maternal weight from recruitment until last documented weight prior to delivery.
[Assessed after the puerperium (>6 weeks following birth) by maternal medical history review.]
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Neonatal Intensive Care Unit admission[Data will be collected during neonatal history review (>28 days post-birth and following hospital discharge; or following still birth/neonatal death). ]
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Apgar scores at 1 minute and 5 minutes of life[Data will be collected during neonatal history review (>28 days post-birth and following hospital discharge; or following still birth/neonatal death). ]
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Incidence of preterm delivery (<37 weeks' gestation).
This outcome will be assessed by calculating the difference between the estimated due date (EDD) of pregnancy (confirmed by first trimester ultrasound; or by the clinician's nominated agreed EDD if no ultrasound was completed at <13 weeks' gestation) and the date of delivery.
[Assessed after the puerperium (>6 weeks following birth) by maternal medical history and clinical pathology review.]
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Gestational hypertension without preeclampsia[Assessed after the puerperium by maternal medical history review]
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Indication for delivery. Delivery may occur spontaneously or due to medical intervention (induction or caesarean) for maternal or fetal reasons. This outcome will be assessed from the clinical notes made in the maternal and neonatal medical histories. In cases where more than one indication for delivery existed, each indication will be noted.[After the puerperium, by medical history review]
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Incidence of term preeclampsia (preeclampsia subtype diagnosed at =>37 weeks' gestation) according to ISSHP diagnostic criteria.[Assessed after the puerperium (>6 weeks following birth) by maternal medical history and clinical pathology review.]
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Length of neonatal hospital stay[Data will be collected during neonatal history review (>28 days post-birth and following hospital discharge; or following still birth/neonatal death). ]
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Customised neonatal birthweight centile <10% (using the GROW International Customized Centile Calculator)[Data will be collected during neonatal history review (>28 days post-birth and following hospital discharge; or following still birth/neonatal death). ]
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Incidence of early preeclampsia (preeclampsia subtype diagnosed <34 weeks + 0 days of pregnancy) according to ISSHP diagnostic criteria.
[Assessed after 34 weeks of pregnancy by maternal medical history and clinical pathology review.]
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Incidence of pre-term preeclampsia (preeclampsia subtype diagnosed between 34 weeks + 0 days - 36 weeks + 6 days of pregnancy) according to ISSHP diagnostic criteria.
This outcome will be expressed as both 95% confidence intervals (CI) of relative risk (RR) and attributable risk (AR). Hypothesis tests will be performed using Chi-squared tests of association. If the study treatment is successful at reducing the incidence of preeclampsia, it could be expected to see a significant reduction (p=<0.05) in the diagnosis of preterm preeclampsia in the treatment group.[Assessed after 37 weeks of pregnancy by maternal medical history and clinical pathology review.]
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Perinatal loss (the still birth OR neonatal death of a participant's baby) Still birth is defined as a fetal death in utero which occurs =>20 weeks of pregnancy up until birth. This includes losses which occur during labour. Neonatal death is defined as the death of a live born infant within the first 28 days of life. For the purposes of this study, we will also classify any death of a baby which occurs beyond 28 days of life, but during the baby's inpatient hospital stay (e.g. a baby admitted at birth to NICU who dies on day 35 of life), as a neonatal death. These incidences are expected to be inevitable, but rare, within the study population of 5500 mother-baby dyads. [Data will be collected during neonatal history review (>28 days post-birth and following hospital discharge; or following still birth/neonatal death). ]
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