Blood test and planned delivery for late pregnancy preeclampsia in first-time mothers

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for first-time pregnant women, over 18, carrying one baby at 35.0-36.6 weeks. It tests a blood screening for preeclampsia followed by labour induction from 37 weeks.

Age

Over 18 years old (minimum 18 Years).

Sex

Women only.

Disease stage

Pregnant for the first time, one baby, at 35.0-36.6 weeks of pregnancy.

Biomarker or test result

The sFlt1/PlGF ratio in the mother's blood is measured at 35-36.6 weeks. A ratio above the 90th centile is counted as high risk.

Main reasons for not taking part

• Baby with a major malformation or genetic anomaly that could change the timing of delivery or the birth outcome
• Suspected poor growth of the baby, including abnormal Doppler findings
• Taking part in another trial that could change the timing of delivery
• Having given birth before

This trial only enrols pregnant participants. The registry sentence this rests on: 35.0-36.6 weeks of gestation

The registry criteria, word for word

What the trial wants to find out

* Preeclampsia (PE) affects ~5% of pregnancies. Although improved obstetrical care has significantly diminished associated maternal mortality, PE remains a leading cause of maternal morbidity and mortality in the world. * Term PE accounts for 70% of all PE and a large proportion of maternal-fetal morbidity related with this condition. Prediction and prevention of term PE remains unsolved. * Previously proposed approaches are based on combined screening and/or prophylactic drugs, but these policies are unlikely to be implementable in many world settings. * Recent evidence shows that sFlt1-PlGF ratio at 35-37w predicts term PE with 80% detection rate. * Likewise, recent studies demonstrate that induction of labor (IOL) from 37w is safe. * The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35-37w followed by IOL from 37w would reduce the prevalence of term PE without increasing cesarean section rates or adverse neonatal outcomes. * The investigators propose a randomized clinical trial to evaluate the impact of a screening of term PE with sFlt-1/PlGF ratio in asymptomatic nulliparous women at 35-37w. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cutoff of >90th centile will be used to define high risk of PE and offer IOL from 37w. * If successful, the results of this trial will provide evidence to support a simple universal screening strategy reducing the prevalence of term PE, which could be applicable in most healthcare settings and have enormous implications on perinatal outcomes and public health policies worldwide.

The 2 groups in the trial

• Non-intervention or non-reveal groupNo study treatment, for comparison

  Non-intervention or non-reveal (result unknown) group: routine follow-up and spontaneous delivery

• Intervention group or reveal groupTreatment being tested

  A ratio cutoff of \>p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation

  Treatment: sFlt1/PlGF screening in maternal blood at 35 to 36.6 weeks of gestation