Preeclampsia prevention by timing of birth: a randomised trial

  • Research type

    Research Study

  • Full title

    Preeclampsia prevention by timing of birth: a randomised trial

  • IRAS ID

    315444

  • Contact name

    Kypros Nicolaides

  • Contact email

    k.nicolaides@nhs.net

  • Sponsor organisation

    King's College Hospital NHS Foundation Trust

  • ISRCTN Number

    ISRCTN41632964

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Pre-eclampsia develops in about 3% of pregnancies. It is characterised by high blood pressure and protein in the urine or abnormal blood tests, but pre-eclampsia can lead to serious complications for both the mother and the baby.
    At 35-36 weeks of pregnancy, all women in our unit are offered an ultrasound scan of the baby. At that time, research in our unit has shown that women can be given their personal chance of developing pre-eclampsia, by combining information from their medical history, measurement of their blood pressure, and results of a blood test. However, we do not know whether having that information improves pregnancy outcomes for mothers and babies.
    In this study women who agree to participate will be given an equal chance of being in one of two timing of birth groups at term gestational age (at or after 37 weeks).
    • One group of women will be managed as usual, with a 35-36 week scan, and routine antenatal visits until they give birth.
    • The other group of women will have screening for preeclampsia risk at the time of their 35-36 week scan, and their timing of birth will be planned to minimise the chance of developing pre-eclampsia. For example, in a few women with a very high risk for pre-eclampsia (that is, 1 in 2 or higher), delivery will be at 37 weeks of pregnancy, following either induction of labour or caesarean section, depending on a woman’s needs. Notably, more than half of women in this very high risk group give birth before 38 weeks anyway. For women with a risk between 1 in 2 and 1 in 5, delivery will be at 38 weeks. Slight lower risk women will be recommended to deliver at 39 or 40 weeks. In most women, the risk of pre-eclampsia is less than 1 in 50, and in such cases, there is no need for planned earlier term delivery and women will be recommended to wait for spontaneous labour or another reason to give birth.

    The advantage of earlier term delivery in the higher risk groups could be prevention of pre-eclampsia and the associated risks for mothers and babies. The disadvantage could be that some babies may need some care in the newborn baby unit, for reasons like breathing problems.

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    22/LO/0794

  • Date of REC Opinion

    17 Feb 2023

  • REC opinion

    Further Information Favourable Opinion