Induction of Labor at Term Versus Expectant Management Among Women With Abnormal Maternal Serum Biochemical Markers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Placental abruption
研究概览
简要总结
Induction of labor at term versus expectant management among women with abnormal maternal biochemical markers. A randomized controlled trial
详细描述
Pregnancy-associated plasma protein A (PAPP-A), alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and inhibin A, are biochemical markers that are part of the first and second trimester screening test, for Down syndrome and neural tube defects in pregnancy. These biochemical markers have been shown also to be associated with slightly increased risk for adverse pregnancy outcomes in the absence of aneuploidy or neural tube defects, for example; preeclampsia, low birth weight, placental abruption, preterm labor, and intrauterine fetal death.
There are no guidelines regarding the management of these cases assuming a reassuring maternal and fetal status are normal, at term (38 - 39 weeks). However, adverse events may still develop between 38 to 42 weeks when calculated according to ongoing pregnancy.
Investigators aim in this randomized trial to examine the effect of induction of labor at 38 - 39 weeks compared to expectant management among women with abnormal first or second biochemical screening tests on maternal and perinatal outcomes.
Enrollment: 320 women in both groups. Interim analyses will be performed after enrolling 50% of the participants.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HCG, AFP or Inhibin greater than 2 multiple of median (MOM) or PAPPA less than 0.15 MOM.
- •Singleton.
- •Appropriate for gestational age fetus.
- •Reassuring fetal status including normal amniotic fluid index.
排除标准
- •Any hypertensive disorder.
- •Indication for induction of labour at enrollment.
- •Any contraindication of induction of labour.
- •Prior cesarean delivery.
- •Any contraindication for a trial of vaginal delivery.
研究组 & 干预措施
Induction of labour
Induction of labour at 38-39 weeks
干预措施: Induction of labour (Other)
Expectant management
Expectant management until 41 weeks.
干预措施: Expectant management (Other)
结局指标
主要结局
Placental abruption
时间窗: 4 weeks
Clinical diagnosis. Co-primary endpoint #1.
Gestational hypertension
时间窗: 4 weeks
Blood pressure above 140/90 mmHg. Co-primary endpoint #2
Small of gestational age
时间窗: 4 weeks
Birth Weight less than the 10th percentile. Co-primary endpoint #3
Intra-uterine death
时间窗: 4 weeks
Fetal death. Co-primary endpoint #4
次要结局
- Mode of delivery(4 weeks)
- Intrapartum fever(4 weeks)
- Neonatal Apgar score(4 weeks)
研究者
Manal Massalha
Principal Investigator
HaEmek Medical Center, Israel