Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium Pregnancy and Childbirth
Conditions
Interventions
The trial is a pragmatic, open-label, multicentre, two-arm randomised controlled trial of a treatment strategy with nifedipine versus labetalol in women with pregnancy hypertension. We aim to recruit
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnancy 11+0 and 34+6 weeks’ gestation inclusive 2. Diagnosis of pregnancy hypertension (chronic/gestational hypertension or pre-eclampsia) 3. Clinician decision to initiate or continue use of antihypertensive drugs 4. Aged 18 years or over 5. Able to give informed consent For observational study: 6. Women will be eligible to participate in the observational study at any gestational age up to and including 34+6 weeks. Women are able to take part in the observational study prior to 11+0 weeks gestation where the use of any antihypertensive drugs prescribed in clinical care will be recorded but will not form part of the interventional trial
Exclusion criteria
Exclusion criteria: 1. Contraindication to either labetalol or nifedipine 2. Already taking both labetalol and nifedipine, and not able to be randomised to a single drug For observational study: 3. Neither exclusion criterion for the trial are relevant for the observational study. Women contraindicated to either labetalol or nifedipine and/or women already taking both labetalol and nifedipine and not able to be randomised to a single drug, are eligible for the observational study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maternal: Blood pressure measured using a sphygmomanometer daily between randomisation and birth 2. Fetal/neonatal: Composite of fetal loss before birth or known neonatal death, or neonatal unit admission between randomisation up to primary hospital discharge or 28 days post-birth, whichever occurs sooner (with no double counting of outcomes) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records: Up to birth: 1. Severe hypertension (defined as any episode of severe maternal hypertension (systolic blood pressure =160 mmHg between randomisation and birth)) 2. Mean antenatal systolic blood pressure (using highest systolic blood pressure per day as collected for the primary outcome) 3. New diagnosis of pre-eclampsia 4. Severe maternal morbidity (fullPIERS consensus definition (von Dadelszen, Payne et al. 2011)) 5. Discontinued allocated antihypertensive drug 6. Undesirable effects of allocated (and other) antihypertensive drug(s) (number of women and number of undesirable effects) At delivery/birth: 1. Indicated delivery (induction of labour or prelabour rupture of membranes (PROM) with stimulation of labour or pre-labour Caesarean section) Between birth and primary hospital discharge or 28 days post-birth, whichever occurs sooner: 1. Neonatal unit admission (separation of baby from mother) 2. Major congenital abnormality as defined by EUROCAT 3. Mode of birth (spontaneous vaginal, assisted vaginal, Caesarean section) 4. Gestational age at birth 5. Birthweight centile 6. Need for treatment for neonatal hypoglycaemia (in those having blood glucose monitoring) | — |
Countries
England, United Kingdom
Outcome results
None listed