Pre-eclampsia in women between 34+0 and 36+6 weeks of gestation Pregnancy and Childbirth Gestational [pregnancy-induced] hypertension with significant proteinuria
Conditions
Interventions
Planned immediate delivery of women with pre-eclampsia between 34+0 and 36+6 weeks of gestation versus expectant management and delivery at 37 weeks of gestation.
Women will be followed up to until
Sponsors
King's College London
Guy’s and St Thomas’ NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 05/10/2016: 1. Women between 34+0 and 36+6 weeks of gestation 2. Confirmed as having pre-eclampsia (as defined as defined by International Society for the Study of Hypertension in Pregnancy {ISSHP} 2014 statement) 3. Singleton or dichorionic diamniotic (DCDA) twin pregnancy 4. Aged 18 years or over at the time of screening 5. Able to give written informed consent Previous inclusion criteria: 1. Women between 34+0 and 36+6 weeks of gestation 2. Confirmed as having pre-eclampsia (as defined by the NICE guidelines on Hypertension in Pregnancy) 3. An in-patient in a consultant-led maternity unit 4. Singleton or dichorionic diamniotic (DCDA) twin pregnancy 5. Aged 18 years or over at the time of screening 6. Able to give written informed consent
Exclusion criteria
Exclusion criteria: Women will be excluded from participating in the study if a decision has already been made to delivery within the next 48 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary short-term maternal outcome: Composite of maternal morbidity of fullPIERS (Pre-eclampsia Integrated Estimate of RiSk) outcomes with the addition of recorded systolic blood pressure >160 mmHg post randomisation. Primary short-term perinatal outcome: Composite of perinatal deaths (antenatal/intrapartum stillbirths and deaths within 7 days of delivery but not deaths due to congenital anomalies) or admissions to infant discharge. Primary long-term infant outcome: Neurodevelopmental assessment at 2 years of age (age corrected for prematurity) using PARCA-R Parent Report Composite. Added 05/10/2016: PEACOCK (PHOENIX-2) sub-study: Primary short-term maternal outcome: Clinically indicated need for delivery for pre-eclampsia (or related complications) within 7 days of assessment. PHOEBE (PHOENIX-3) sub-study: Primary long-term maternal outcome: Composite of diastolic and systolic function classified according to the American College of Cardiology as assessed by echocardiography with tissue Doppler studies at 6 months postpartum. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary short-term maternal outcomes: Individual components of the composite primary outcome plus 1. Use of anti-hypertensive drugs 2. Progression to severe pre-eclampsia post-randomisation (defined as systolic blood pressure = 160 mmHg, platelet count 70 iu/litre]) 3. Estimated fetal weight (on ultrasound scan) 2 hours of supplemental oxygen is required 14. Need for ventilation support (CPAP/high flow/endotracheal ventilation) 15. Abnormal cerebral ultrasound scan 16. Confirmed sepsis (positive blood or cerebrospinal fluid cultures) 17. Necrotising enterocolitis (Bell?s stage 2 and 3) 18. Seizures (confirmed by EEG and requiring anticonvulsant therapy) 19. Encephalopathy grade (worst at any time: mild, moderate, severe) 20. Hypoglycaemia (blood glucose <2.6 mmol/l on two or more occasions) 21. Other indications and main diagnoses resulting in NNU admission 22. Discharged home fully breast-fed Secondary long-term maternal outcomes: Maternal physical and mental health using the validated SF-12 questionnaire assessed at 6 months post delivery and 2 years (based on infant's age corrected for prematurity) Health economic and quality of life outcomes: 1. Quality of life using the validated quality of life questionnaire EQ-5D immediately after randomisation, at 6 months and when the infant is 2 years of age corrected age for prematurity 2. Hospital attendances, nights and diagnostic tests from randomisation until delivery 3. Cost of delivery 4. Cost of neonatal care (hospital admissions, surgery and diagnostic tests) 5. Retrospective 6-month health/social care use by mother and infant at 6 months and 2 years 6. EQ-5D for the calculation of maternal quality-adjusted life-years (QALYs) Added 05/10/2016: PEACOCK (PHOENIX-2) sub-study: 1. Clinically indicated need for delivery for pre-eclampsia within 48 hours and within 14 days of assessment 2. Perinatal death 3. NNU admission PHOEBE (PHOENIX-3) sub-study: Diastolic blood pressure, systolic blood pressure, heart ra | — |
Countries
England, United Kingdom
Outcome results
None listed