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Contact Information:

Mrs Lisa Leighton
+44 (0)121 415 9110
Giant-PANDA@trials.bham.ac.uk


Study Location:

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Be Part of Research - Trial Details - The Giant PANDA study: which blood pressure medication is best for pregnant women with high blood pressure?
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The Giant PANDA study: which blood pressure medication is best for pregnant women with high blood pressure?

Recruiting

Open to: Female

Age: Adult

Southampton London Birmingham Leicester Kingston upon Thames Bradford Oxford Nottingham Bath Bristol London London Liverpool Leeds Wolverhampton Manchester Colchester London

Medical Conditions

Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


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.
The study aims to find out which blood pressure medication is best at treating high blood pressure in pregnancy.
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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jan 2021 31 Dec 2024

Publications

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37700365/ (added 14/09/2023)2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39375814/ Inclusion of people with multiple long-term conditions in pregnancy research: patient, public and stakeholder involvement and engagement in a randomised controlled trial (added 08/10/2024)

Over 2,300 pregnant women with high blood pressure from around 50 maternity units in the UK that need treatment for their blood pressure 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 the hospital after birth.


Pregnant women with hypertension, aged 18 years or over

You can take part if:



You may not be able to take part if:


1. Contraindication to either labetalol or nifedipine2. 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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southampton General Hospital
    University Hospital Southampton NHS Foundation Trust Tremona Road
    Southampton
    SO16 6YD
  • Homerton University Hospital NHS Foundation Trust
    Homerton Row
    London
    E9 6SR
  • Birmingham Women's and Children's NHS Foundation Trust
    Steelhouse Lane
    Birmingham
    B4 6NH
  • Leicester Royal Infirmary
    University Hospitals of Leicester NHS Trust Infirmary Square
    Leicester
    LE1 5WW
  • Kingston Hospital NHS Foundation Trust
    Galsworthy Road
    Kingston upon Thames
    KT2 7QB
  • Bradford Royal Infirmary
    Bradford Teaching Hospitals NHS Foundation Trust Duckworth Lane
    Bradford
    BD9 6RJ
  • John Radcliffe Hospital
    Oxford University Hospitals NHS Foundation Trust Headley Way Headington
    Oxford
    OX3 9DU
  • Queen's Medical Centre
    Nottingham University Hospitals NHS Trust Derby Road
    Nottingham
    NG7 2UH
  • Royal United Hospital
    Combe Park
    Bath
    BA1 3NG
  • Bristol Royal Infirmary
    University Hospitals Bristol and Weston NHS Foudnation Trust Marlborough Street
    Bristol
    BS1 3NU
  • St Thomas' Hospital
    Guy's and St Thomas' NHS Foundation Trust Westminster Bridge Road
    London
    SE1 7EH
  • Chelsea and Westminster Hospital
    369 Fulham Road
    London
    SW10 9NH
  • Liverpool Women’s Hospital
    Liverpool Women's NHS Foundation Trust Crown Street
    Liverpool
    L8 7SS
  • St James University Hospital
    Leeds Teaching Hospitals NHS Trust Beckett Street
    Leeds
    LS9 7TF
  • New Cross Hospital
    Royal Wolverhampton NHS Trust Wolverhampton Road
    Wolverhampton
    WV10 0QP
  • Manchester University Hospitals NHS Foundation Trust
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • Colchester Dist General Hospital
    East Suffolk and North Essex NHS Foundation Trust Turner Road
    Colchester
    CO4 5JL
  • St George's Hospital
    St George's University Hospitals NHS Foundation Trust Blackshaw Road Tooting
    London
    ST17 0QT

Taking part will help us to understand how best to treat women with high blood pressure in pregnancy. Because women were about to be prescribed one of these two medications to treat their high blood pressure, there is very little risk to taking part. The only possible disadvantage is the additional time spent with the study team. We will keep these contacts as brief as possible, and if it is easier for women the two-week check-in can be over the phone or by email.
The doctor or healthcare professional prescribing their medication will explain any side effects as they usually would, and they can ask them at any time if they are not sure. The commonest side-effect reported for both drugs in pregnancy is a headache. Some women also reported dizziness or breathlessness. All women will continue to receive their usual NHS care during pregnancy while in this study.

Mrs Lisa Leighton
+44 (0)121 415 9110
Giant-PANDA@trials.bham.ac.uk



The study is sponsored by University of Birmingham and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR128721; National Institute for Health Research (NIHR) (UK).



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Read full details for Trial ID: ISRCTN12792616

Or CPMS 47078

Last updated 08 October 2024

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