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

Not Applicable

• Conditions: Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium; Pregnancy and Childbirth

• Registration Number: ISRCTN12792616
• Lead Sponsor: niversity of Birmingham

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37700365/ (added 14/09/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Last Update Posted: 15 July 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 2300

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Maternal: Blood pressure measured using a sphygmomanometer daily between randomisation and birth<br>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)