Health Condition 1: O149- Unspecified pre-eclampsia
Conditions
Interventions
Intervention1: Planned early delivery: Early delivery to be undertaken as soon as is safe and feasible. The target will be to commence delivery within 48 hours from randomisation. Delivery will be thr
Sponsors
King s College London
Eligibility
Inclusion criteria
Inclusion criteria: PAPAGAIO Delivery Preeclampsia confirmed with abnormal PlGF result Between 34 and 36 plus 6 weeks gestation Singleton pregnancy Live pregnancy Able to give informed consent PAPAGAIO Diagnosis Hypertension or other clinical suspicion of preeclampsia Between 20 and 36 plus 6 weeks gestation Singleton pregnancy Live pregnancy Able to give informed consent Prepare for PAPAGAIO QUALITATIVE STUDY Women will be eligible for recruitment to an interview or focus group if they are Over 18 years of age Able to give valid consent Currently pregnant with a viable, ongoing pregnancy, or have had previous lived experience of preeclampsia Attending or previously attended one of the designated trial sites for antenatal care Partners and family members will be eligible for recruitment to an interview focus group if they are Over 18 years of age Able to give valid consent The partner, or close family member, of a woman participating in a focus group who has given her permission for her partner or family member to be invited. Stakeholders will be eligible for recruitment to an interview or focus group if they are Over 18 years of age Able to give valid consent Identified as being a key stakeholder in the stakeholder analysis
Exclusion criteria
Exclusion criteria: PAPAGAIO Delivery In active labour Indication for immediate delivery Decision to deliver within 48 hours already made Clinician diagnosis of preeclampsia and a normal PlGF result these women will not be randomised but will be followed up in an observational cohort PAPAGAIO Diagnosis In active labour Decision to deliver within 24 hours already made
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PAPAGAIO Delivery: Maternal: A composite of severe maternal adverse outcomes relating to pre-eclampsia: maternal mortality; eclampsia; stroke; cortical blindness; retinal detachment; pulmonary oedema/severe breathing difficulty; severe acute kidney injury (creatinine more than 150 micro mol per Litre); liver capsule haematoma or rupture; placental abruption; post-partum haemorrhage; hepatic dysfunction; platelets more than 50 times 10 to the power of 9 platelets per Litre; ICU admission; intubation and ventilation (other than for delivery); termination pre-viability for maternal preeclampsia. PAPAGAIO - Diagnosis: Composite maternal and perinatal outcome of: Maternal mortality; eclampsia; placental abruption; termination pre-viability for maternal preeclampsia; stillbirth or early neonatal deathTimepoint: Up to 7 days postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| PAPAGAIO Delivery: Tested Maternal Outcomes: Severe hypertension more than or equal to 160mmHg, Time to delivery, Time to initiation of delivery, Mode of birth (vaginal, assisted vaginal, caesarean section), Eclampsia, Placental abruption, Postpartum haemorrhage requiring transfusion or hysterectomy, Length of stayTimepoint: Up to discharge;PAPAGAIO Delivery: Tested Perinatal Outcomes; Stillbirth, Early neonatal death (within 7 days of life), Neonatal unit admission, Gestational age at delivery, Preterm birth before 37 weeks gestation, Preterm birth before 34 weeks gestation, Birthweight less than 10th centile (Intergrowth-21) Timepoint: Up to 7 days postpartum;PAPAGAIO Delivery: Perinatal Outcomes; Neonatal death (7 28 days of life), Respiratory support, Sepsis, Neonatal seizures, Birthweight, Birthweight less than 3rd centile (Intergrowth-21), Length, Antibiotics given, APGARs at 1 and 5 minutes, Need for neonatal resuscitation, Hypoxic Ischaemic Encephalopathy and grade, Respiratory distress syndrome, Supplementary oxygen and duration, Administration of surfactant, Hypoglycaemias requiring intervention, Hypothermia Temp less than 35.6, Neonatal jaundice requiring phototherapy, Necrotising enterocolitis, Nasogastric feeding required, Umbilical pHs, Abnormal cerebral ultrasoundTimepoint: Up to 28 days of life;PAPAGAIO Delivery: Health resource use outcomes for budget impact analysis; number of POC-PlGF cartridges used, wastage of consumables e.g. due to protracted time un-refrigeratedTimepoint: Up to the completion of sample assay;PAPAGAIO Delivery: Maternal; Antenatal outpatient attendances, Inpatient days, Intensive care unit useTimepoint: Up to 28 days postpartum;PAPAGAIO Delivery: Perinatal; Total days in hospital, Total days in each level of care (intensive care, high dependency and special care unit days)Timepoint: Up to discharge | — |
Countries
Brazil, India, Sierra Leone, Zambia
Contacts
Public ContactDr Shivaprasad S Goudar
J N Medical College, KLE Academy of Higher Education and Research Belagavi
Outcome results
None listed