Labor Induction Versus Expectant Management in High-risk Women for Preeclampsia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 825
- 试验地点
- 8
- 主要终点
- the rate of adverse placental outcomes
研究概览
简要总结
Preeclampsia (PE) is one of the leading causes of maternal and perinatal morbidity and mortality. This pregnancy-specific disorder poses to both pregnant women and their offspring an increased risk of immediate and long-term health problems. The study team is conducting a study entitled "FORECAST" (Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial) and established the infrastructure for the first-trimester "screen and prevent" program for preterm PE. However, there is no established evidence regarding the benefit of scheduled labor induction versus expectant management among women identified as high-risk for PE with uncomplicated pregnancy at term. The investigators postulate that induction of labor at 39 weeks' gestation may possibly be an effective intervention to reduce placental complications in women with uncomplicated pregnancy by 39 weeks at high-risk PE women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age no less than 18 years
- •Singleton pregnancy with cephalic presentation and no contraindication to vaginal delivery
- •Live fetus
- •Screened high-risk for PE
- •Informed and written consent
排除标准
- •Multiple pregnancy
- •Pregnant women who plan to have Cesarean delivery
- •Pregnancies complicated by the major fetal abnormality
- •Women who are severely ill, those with learning difficulties, or serious mental illness
- •Pregnant women with medical, obstetric, or fetal complications or any other indications for delivery before 39 weeks' gestation
结局指标
主要结局
the rate of adverse placental outcomes
时间窗: At Delivery
To compare the difference in the rate of adverse placental outcomes (PE, gestational hypertension (GH), SGA, stillbirth, perinatal death, placental abruption) in the induction of labor group with the expectant management group.
次要结局
- the rate of adverse maternal outcomes(6 weeks Postpartum)
- the rate of adverse neonatal outcomes(28 days after birth)
研究者
Chiu Yee Liona Poon
Professor (Clinical)
Chinese University of Hong Kong