Chronic or gestational hypertension that develops by 37+6 weeks gestation Pregnancy and Childbirth Gestational [pregnancy-induced] hypertension
Conditions
Interventions
Current interventions as of 07/07/2023:
Randomisation will be provided through a bespoke database provided by BCTU.
1. Planned early-term delivery at 38+0 to 38+3 weeks by labour induction (local prot
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
Female
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Maternal age =16 years 2. Diagnosis of chronic or gestational hypertension 3. Singleton pregnancy 4. Live fetus 5. Gestational age of 36+0 to 37+6 weeks 6. Able to give written informed consent to participate
Exclusion criteria
Exclusion criteria: 1. Contraindication to either one of the trial arms (e.g., evidence of pre-eclampsia) 2. Severe hypertension [i.e., blood pressure (BP) =160 mmHg systolic or =110 mmHg diastolic] until BP falls below this level (i.e. it is ‘controlled’) 3. Major fetal anomaly anticipated to require neonatal unit admission 4. Participation in another timing of delivery trial NOTE: Women with co-morbidities (e.g., diabetes) and fetal size will not be exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maternal co-primary outcome: Composite of poor maternal outcome until primary hospital discharge home or 28 days after delivery birth (whichever is earlier), defined as: 1.1. Severe hypertension (i.e., systolic BP (sBP) =160 or diastolic BP =110mmHg); or 1.2. Maternal death; or 1.3. Maternal morbidity defined as any of the following: GCS<13; stroke; TIA; eclampsia; blindness; uncontrolled hypertension; inotropic support; pulmonary oedema; respiratory failure; SpO2 <90%; myocardial ischaemia or infarction; hepatic dysfunction, hepatic haematoma or rupture; acute kidney injury or dialysis; platelet count <50x109/L; transfusion; or placental abruption. These were adapted from a Delphi consensus in hypertensive pregnancy. Measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 2. Neonatal co-primary outcome: Neonatal care unit admission for = 4 hours, measured by review of maternity or neonatal notes/electronic records until primary hospital discharge home or 28 days after delivery birth (whichever is earlier) | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal: 1. Caesarean delivery, measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 2. Instrumental vaginal delivery or Caesarean delivery (vs. spontaneous vaginal delivery), measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 3. Individual components of maternal co-primary outcome, measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 4. Elevated liver enzymes, measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 5. Platelet count <100x109/L, measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 6. Pre-eclampsia, measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 7. Sepsis, measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 8. Postpartum haemorrhage (PPH), measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) 9. Intensive care unit (ITU) admission, measured by review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whichever is earlier) Potential co-interventions (only among women randomised): 1. Antihypertensive therapy taken, measured using review of maternity notes/electronic records ntil uprimary hospital discharge home or 28 days after birth (whichever is earlier) 2. Magnesium sulphate, measured using review of maternity notes/electronic records until primary hospital discharge home or 28 days after birth (whicheve | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed