Timing of delivery in late preterm pre-eclampsia Pregnancy and Childbirth Pre-eclampsia
Conditions
Interventions
Randomisation will be managed by a secure web-based randomisation facility hosted by MedSciNet. The allocation ratio of intervention (planned early delivery) to control (expectant management) will be
Sponsors
King's College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Able to give valid written, informed consent (in the countries where we are working the age of consent is 18 years old) 2. Viable ongoing pregnancy at time of recruitment 3. Clinical diagnosis of pre-eclampsia confirmed by the obstetric team: must fulfil minimum criteria of hypertension and proteinuria after 20 weeks' gestation. Hypertension will be defined as a systolic blood pressure of = 140mmHg and/or a diastolic blood pressure of =90mmHg (or on anti-hypertensive drug at enrolment). Proteinuria will be defined as a 'positive' (= 1 + protein) urine dipstick result. 4. Gestational age between 34+0 and 36+6 confirmed by a doctor (as determined by known LMP date validated by early or late ultrasound scan if available)
Exclusion criteria
Exclusion criteria: A decision to deliver within 48hrs has already been made by a senior clinician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary maternal outcome: Maternal mortality and morbidity based on the miniPIERS composite of adverse maternal outcomes, during pregnancy and delivery until primary hospital discharge with the addition of severe hypertension (systolic blood pressure of =160mmHg) Primary short-term perinatal outcome: Composite of stillbirths, neonatal deaths and neonatal unit admissions for >48hrs due to neonatal morbidity, until primary hospital discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| During pregnancy and delivery until primary hospital discharge: Secondary maternal outcomes: 1. Individual components of the primary outcome 2. Time and mode of onset (spontaneous, induced or pre-labour caesarean section) and mode of delivery (spontaneous vaginal delivery, assisted vaginal delivery, caesarean section) 3. Primary and additional indications for delivery in both arms 4. ICU admission 5. Length of stay 6. Time from randomisation to delivery 7. Use of Magnesium Sulphate 8. Use of Antenatal Corticosteroids 9. Use of Anti-hypertensives Secondary perinatal outcomes will include: 1. Individual components of the primary outcome 2. Gestational age at delivery 3. Birthweight 4. Birthweight centile 5. Admissions to NNU (and main indication) 6. Total number of nights in hospital and number of nights in each level of care 7. Sepsis - with evidence of confirmed infection 8. Course of antibiotics given for Possible Serious Bacterial Infection (according to WHO's Integrated Management of Childhood Illness (IMCI) guidelines) 9. APGAR score at 5 and 10 minutes post-birth 10. Need for neonatal resuscitation 11. Hypoxic Ischaemic Encephalopathy and Grade 12. Neonatal seizures 13. Respiratory Distress Syndrome (RDS) 14. Supplementary oxygen & duration required 15. CPAP & duration required 16. Invasive ventilation support & duration required 17. Administration of surfactant 18. Hypo-glycaemia requiring intervention 19. Hypothermia (Temperature <36.5 degrees Celsius) 20. Neonatal jaundic | — |
Countries
India, Zambia
Contacts
Public ContactAlice Beardmore-Gray
Outcome results
None listed