Pregnancy ANtihypertensive Drugs: which Agent is best? (Giant PANDA)

Phase 1

• Conditions: Hypertension in pregnancy (chronic hypertension, gestational hypertension or pre-eclampsia); Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-003410-12-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-04
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 2300

Inclusion Criteria

TRIAL INCLUSION CRITERIA:
-Pregnancy 11+0 and 34+0 weeks’ gestation inclusive
-Diagnosis of pregnancy hypertension (chronic/gestational hypertension or pre-eclampsia)
-Clinician decision to initiate or continue use of antihypertensive drugs
-Aged 18 years or over
-Able to give informed consent

OBSERVATIONAL STUDY INCLUSION CRITERIA:
Women will be eligible to participant in the observational study at any gestational age up to and including 34+0 weeks. Women are able to take part in the observational study prior to 11+0 weeks gestation where use of any antihypertensive drugs prescribed in clinical care will be recorded but will not form part of the interventional trial.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

TRIAL EXCLUSION CRITERIA:
-Contraindication to either labetalol or nifedipine
-Already taking both labetalol and nifedipine, and not able to be randomised to a single drug

OBSERVATIONAL STUDY EXCLUSION CRITERIA:
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified