Placental growth factor testing and planned early delivery for late preterm pre-eclampsia, compared to usual care in low- and middle-income countries (PAPAGAIO-Delivery): an individualised randomised controlled trial
Pregnancy complicated by late preterm pre-eclampsia
This is an international, multi-centre, parallel-group, individually randomised controlled trial conducted in hospitals in Sierra Leone, Zambia, India, and Brazil. Pregnant women presenting with hypertension between 34+0 and 36+6 weeks of gestation will be screened for eligibility. Interventions Group The intervention is Placental growth factor (PlGF) testing, plus planned early delivery for women with an abnormal PlGF concentration (less than 100 pg/ml) or expectant management for women with a normal PlGF concentration (above 100 pg/ml). Planned delivery to be undertaken as soon as it is safe and feasible. The target will be to commence delivery within 48 hours from randomisation. The use of antenatal corticosteroids for fetal lung maturity will be at the discretion of the clinician in accordance with local guidelines. Delivery will be through induction of labour according to the local protocol (typically administration of misoprostol) or via caesarean section for women in whom an elective procedure was planned; caesarean section will be an option where indicated. Interventions – Control Group Participants allocated to the control group will receive usual care in accordance with local and international clinical guidelines for the management of late preterm pre-eclampsia (34+0 to 36+6 weeks’ gestation). This includes routine maternal and fetal monitoring, antihypertensive and anticonvulsant treatment where indicated, and timing of delivery based on standard clinical assessment and existing practice. Delivery is typically recommended at 37 weeks’ gestation unless earlier delivery is clinically indicated due to maternal or fetal deterioration. PlGF testing will not be used to guide management decisions in the usual care group. Randomisation Method Randomisation will be conducted using a secure web-based randomisation system hosted by OMDA (previously MedSciNet), which will manage allocation and hold the allocation code.
1. Hypertension 2. 34+0-36+6 3. Singleton pregnancy 4. Viable fetus at the time of randomisation 5. Able to give informed consent
1. In labour 2. Decision to deliver within 48 hours already made (including due to indication for immediate delivery, as defined by WHO guidelines and standard local practice)