The Giant PANDA study: which blood pressure medication is best for pregnant women with high blood pressure?

INTERVENTION: 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 2,300 pregnant women (less than 34 weeks’ gestation), with pregnancy hypertension (chronic or gestational hypertension or pre‐eclampsia), over 18 years, able to provide consent and where the decision has been made to initiate or continue use of anantihypertensive drug. Women will be identified by referral letters and/or at antenatal clinics and approached by a member of the direct clinical care team or the local research team (part of the direct care team) and provided with information on the study and given appropriate time to make the decision to participate. Following informed consent completion, women will be asked to complete a short questionnaire about how they feel. Women will then be randomised, by random allocation (1:1), to treatment with any preparation of modified release nifedipine, a calcium channel blocker, (intervention arm) or any preparation of labetalol, a mixed alpha/ beta blocker, (active control arm). Two weeks after randomisation women will be contacted by the research team and asked to complete a few short questionnaires about their blood pressure medication. Women and their babies will be in the study from consent until primary hospital discharge or 28 days post birth, whichever occurs sooner. This study is open‐label to ensure women are effectively and safely treated, with healthcare professionals and women aware of their treatment allocation. Dose titration, switching, or add to the randomised antihypertensive drug will occur as in usual clinical practice as clinically indicated th CONDITION: Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium ; Pregnancy and Childbirth PRIMARY OUTCOME: ; 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); 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 SECONDARY OUTCOME: ; 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);