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临床试验/NCT00984347
NCT00984347Unknown不适用

Breast Pump Nipple Stimulation Versus Pitocin for Induction of Labor: Efficacy, Safety and Satisfaction

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
time from induction to delivery

研究概览

简要总结

The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 years and older
  • completed 37 weeks gestation
  • singleton pregnancy
  • reassuring fetal heart rate at admission monitor

排除标准

  • multiple pregnancies
  • known fetal malformations
  • non reassuring NST
  • polyhydramnios (AFI>220)
  • oligohydramnios
  • macrosomia (EFW >4000g)
  • antepartum bleeding
  • maternal fever

研究组 & 干预措施

Oxytocin induction

Active Comparator

women in need for induction of labor due to medical indications, will receive continuous IV oxytocin

干预措施: Oxytocin (Drug)

Breast Stimultion

Active Comparator

nipple stimulation with a breast pump, calibrated at the lowest suction strength,operated alternately: 15 min one breast, 15 min second breast, 15 min rest, till appearance of regular uterine contractions (3 contractions in 10 min). the manipulation will continue for 3 hours of regular contractions.

干预措施: breast pump nipple stimulation (Procedure)

结局指标

主要结局

time from induction to delivery

时间窗: 24h

次要结局

  • fetal distress (monitor assessment, cord ph)(24 h)
  • cesarean section rate(24h)

研究者

申办方类型
Other

研究点 (1)

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