Trial finds planned early term birth helps to avoid complications in women with high blood pressure

A trial led by King’s College London and designed, conducted and analysed by Birmingham Clinical Trials Unit (BCTU) has found that a planned early term birth can avoid maternal complications for mothers and babies.

A randomised trial funded by the National Institute for Health and Care Research (NIHR) has found that a planned early term birth at 38 weeks of pregnancy may be the best option for women with chronic or gestational hypertension who are nearing their due date to remain well.

Hypertension, or high blood pressure complicates approximately 10% of pregnancies, and can develop either before pregnancy (as chronic hypertension) or during pregnancy (as gestational hypertension or pre-eclampsia). Pre-eclampsia can be particularly dangerous for both mothers and babies, leading to problems such as bleeding or babies needing neonatal care.

Experts from BCTU designed, conducted, analysed and supported researchers from King’s College London to deliver the WILL (When to Induce Labour to Limit risk in pregnancy hypertension) trial, which recruited 403 women with chronic or gestational hypertension across 50 consultant-led maternity units across the UK. All of the women were offered either a planned early term birth at 38 weeks of pregnancy, or usual care at term (the control group), with the trial finding that pre-eclampsia developed less frequently in the former group. There was also no evidence of a difference between either group in terms of poor maternal outcome (such as severe hypertension, maternal illness or death), or neonatal outcomes for the baby such as respiratory issues or admission in a newborn baby care unit for four or more hours.

“The Birmingham Clinical Trials Unit offer scientific, technical and computing expertise needed to support clinical trial research from conception to completion. In this instance we designed and supported the trial to investigate planned early term birth in pregnant women with high blood pressure. The trial was designed to assess two aspects, impact on mother and impact on baby. Our statistics team advised on protocol development and performed all analyses throughout the duration of the trial, including the final analysis and a bespoke database was designed by our programmers to collect all the trial data.”

Katie Kirkham, Senior Trial Manager

A robust team of experts, including the Director of the BCTU, Katie Morris, and the Head of the School of Health Sciences, Tracy Roberts, provided key expertise and advice throughout the trial and a bespoke database was designed by BCTU programmers to collect trial data. Collaborating organisations included the Universities of Southampton, Nottingham, Adelaide, as well as the Action on Pre-eclampsia and The Stillbirth and Neonatal Death Charity.

The full paper is available via PLoS Medicine.