* Preeclampsia (PE) affects \~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world. * Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved. * Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings. * Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate. * Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe. * The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. * The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of \>90th centile will be used to define high risk of PE and offer IOL from 37w. * If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.
Nulliparous women
Singleton pregnancies
>18 years old
35.0-36.6 weeks of gestation
Fetuses/neonates with major malformations or genetic anomalies that could modify the timing of delivery or has an impact on obstetric outcome
Suspected fetal growth restriction (estimated fetal weight <3 centile or between the 3rd and 10th centile together with abnormal Doppler in the mean uterine artery Doppler pulsatility index, or in umbilical artery pulsatility index or in the middle cerebral artery or in the cerebral umbilical index (CPR))
Participation in another interventional study that could modify the timing of delivery.
Parallel
sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation
Diagnostic testA ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation
Rate of term Preeclampsia development
Number of participants with term preeclampsia/total number participants.
Maternal morbidity rate
Composite including any of the following: (i) HELLP syndrome; (ii) Central nervous system dysfunction (eclampsia, Glasgow Coma Score \<13, stroke, reversible ischemic neurological deficit or cortical blindness); (iii) hepatic dysfunction; (iv) renal dysfunction; (v) respiratory dysfunction; (vi) cardiovascular dysfunction; (vii) placental abruption; or, (viii) a requirement for transfusion of blood products according to the total deliveries.
Maternal Hospital stay
Days of admission
Caesarean section rate
number of c-section / total deliveries
Perinatal complications rate
Presence of placental abruptio, severe fetal growth restriction (defined as birth weight \<3rd centile), perinatal mortality, an Apgar score at 5-minute below 7.0, an umbilical artery pH below 7.10, need for respiratory support within 72 hours after birth neonatal intraventricular haemorrhage grade III/IV, necrotizing enterocolitis, sepsis, or hypoxic ischemic encephalopathy/total deliveries.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead sponsor
Fundacion Clinic per a la Recerca Biomédica
Collaborator