Giant PANDA
Research type
Research Study
Full title
Pregnancy ANtihypertensive Drugs: which Agent is best?
IRAS ID
284958
Contact name
L Chappell
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2020-003410-12
ISRCTN Number
ISRCTN12792616
Clinicaltrials.gov Identifier
Sponsor number, RG_19-169
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
WHAT IS THE STUDY’S AIM?
The study aims to find out which blood pressure medication is best at treating high blood pressure in pregnancy.WHY IS IT IMPORTANT?
Around 10% of women in the UK have high blood pressure in pregnancy, which without treatment can cause serious complications for the woman and baby. We want to find out which of the two most commonly used medicines to treat high blood pressure in pregnancy (labetalol and nifedipine) in the NHS is best at treating high blood pressure without having troublesome side-effects for the woman or baby. Both medications have been widely used in the UK for many years and are considered safe in pregnancy.WHAT DOES THE STUDY INVOLVE?
Over 2300 pregnant women with high blood pressure from around 50 maternity units in the UK that need treatment for their blood pressure with will be offered information about the study and decide if they would like to take part. Women will be asked for their consent to take part and to complete a short questionnaire about how they are feeling. Women will then be randomly allocated (by chance) to either labetalol or nifedipine using a computer. To ensure women are treated safely, women and their healthcare team will know which medication group they are in. All women will continue to have their usual antenatal care including adding and switching their blood pressure medication and changing dose as needed. Two weeks after joining the study women will be asked to complete a few short questionnaires about how they are finding their blood pressure medication. Women and their babies will be followed through the pregnancy until they leave hospital after birth.HOW WILL THE STUDY RESULTS BE USED?
Study results will help to understand which medication best treats high blood pressure in pregnancy and is safe for the baby, helping doctors and women with high blood pressure decide which medication is best for each woman and their baby.REC name
London - South East Research Ethics Committee
REC reference
20/LO/1110
Date of REC Opinion
27 Oct 2020
REC opinion
Favourable Opinion