跳至主要内容
临床试验/CTRI/2024/07/070024
CTRI/2024/07/070024尚未招募4 期

A multicenter randomized trial of screening with sFlt1/ PlGF and planned delivery to prevent preeclampsia at term.

Roche International3 个研究点 分布在 1 个国家目标入组 8,302 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
8,302
试验地点
3
主要终点
Impact of a policy of planned delivery from 37 weeks of gestation in nulliparous women at risk for preeclampsia as defined by a sFlt1/PlGF ratio more than 90th centile at

研究概览

简要总结

Preeclampsia (PE) remains a leading cause of maternal morbidity and mortality in the world. Prediction and prevention of term PE remains unsolved. Recent evidence showsthatsFlt1-PlGF ratio at 35-37 weeks predicts term PE with 80% detection rate. Likewise, recent studies demonstrate that induction of labor from 37 weeks is safe. • The investigators hypothesize that a single-step universal screening for term PE based on sFlt1/PlGF ratio at 35.0-36.6 weeks followed by planned delivery (e.g. induction of labor) from 37.0 weeks 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 35.0-36.6 weeks. Women will be assigned to revealed (sFlt-1/PlGF known to clinicians and participants) versus concealed (unknown to clinicians and participants) arms. A cutoff of >90th centile will be used to define high risk of term PE and planned delivery will be offered from 37.0 weeks. If successful, the results of this trial will provide evidence to support a simple universal screening strategy to reduce 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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Nulliparous women
  • Singleton pregnancies
  • 318 years old
  • 35.0-36.6 weeks of gestation
  • Maternal written consent form.

排除标准

  • 1.Fetuses neonates with major malformations or genetic anomalies that could modify the timing of delivery or has an impact on obstetric outcome.
  • Participation in another interventional study that could modify the delivery timing.
  • Gest HT Chr HT.

结局指标

主要结局

Impact of a policy of planned delivery from 37 weeks of gestation in nulliparous women at risk for preeclampsia as defined by a sFlt1/PlGF ratio more than 90th centile at

时间窗: 37 or more than 37 weeks of gestation

35.0-36.6 weeks of gestation on the prevalence of term PE.

时间窗: 37 or more than 37 weeks of gestation

次要结局

  • evaluate the impact of the sFlt1 PlGF screening on:(1. Perinatal morbidity)

研究者

发起方
Roche International
申办方类型
Other [Diagnostic Firm]
责任方
Principal Investigator
主要研究者

K. Aparna Sharma

AIIMS New Delhi, Department of Obstetrics and Gynaecology

研究点 (3)

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