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临床试验/NCT03625518
NCT03625518Unknown早期 1 期

Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2018年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
280
试验地点
1
主要终点
mode of delivery

研究概览

简要总结

to compare methods of induction of labor in fetal growth restriction and its effect on maternal and neonatal outcome

详细描述

Intra uterine growth restriction (FGR) is a condition in which the fetus does not realize its growth potential in uterus. The excepted definitions of this condition are fetal weight estimation below the 10th percentile per gestational week. Severe growth restriction is defined as estimated weight below the 3rd percentile. It is well known that fetuses which are growth restricted are subjected to a higher degree of complications during pregnancy and delivery such as fetal distress, hypoxic damage, intra uterine fetal demise and complications in the neonatal period including prolonged NICU hospitalization, cerebral palsy, hypoxic ischemic encephalopathy and also long term affects such as neuro developmental complications.

Common practice in managing these cases is induction of labor at term around 37 weeks of gestations to prevent these complications as it established that during this time there is a substantial rise in pregnancy complications including fetal demise.

There are no clear guide lines how to induce labor in such cases and it is not known what is the safest and the most effective way to induce labor in these cases. Prior studies have found the rate of successful vaginal birth in these cases vary between 50 and 80%. There are a number of methods of labor induction and delivery available including the use of vaginal prostaglandins (PGE2) for cervical ripening, intracervical balloon catheter or planned cesarean. In most cases when aiming for vaginal delivery the choice is between ripening of the cervix with balloon catheter in combination with Pitocin or ripening with prostaglandins. It is not known which method is safer and more successful in growth restricted fetuses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy
  • fetal growth restriction defined as estimated fetal weight between the 3rd and 10th percentile per gestational age and are intended to deliver vaginally
  • Gestational age between 36 and 42 weeks
  • No known fetal anomalies

排除标准

  • Fetal estimated weight below the 3rd percentile
  • Known fetal anomalies
  • Contraindications for vaginal delivery: breech presentation, abnormal Doppler flow velocimetry of fetal ductus venosus.
  • Oligohydramnios defined as amniotic fluid index below 5 cm
  • Contraindication to the use of prostaglandins
  • Fetal distress requiring emergent cesarean section
  • All other condition preventing vaginal delivery as decided by a senior physician

研究组 & 干预措施

prostaglandins

Active Comparator

vaginal prostaglandins insertion (PGE2) for cervical ripening and induction

干预措施: prostaglandins E2 (Drug)

intracervical balloon catheter with pitocin

Active Comparator

insertion of intra cervical balloon catheter combined with intravenous pitocin for ripening and induction of labor

干预措施: intracervical balloon catheter combined with pitocin (Device)

结局指标

主要结局

mode of delivery

时间窗: immediate

vaginal delivery, instrumental delivery or cesarean delivery

次要结局

  • composite neonatal outcome(3 months after delivery)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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