The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Delivery within 24 hours of administering castor oil/placebo
研究概览
简要总结
The purpose of the study is to determine whether castor oil is effective in inducing labor.
详细描述
Castor oil is traditionally given by midwives in order to induce labor. Its efficacy as an initiator of labor was previously tested only in one clinical trial. Unfortunately this study (by Garry et al.) was not sufficiently controlled.
We intent to recruit 84 healthy pregnant women with no contraindication to vaginal delivery that had past their due date. Women will be randomly and blindly divided into equal sized intervention group and control group. Intervention group will be given 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcome to be tested is the percentage of women entering active labor within 24 hours of administration.
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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •Pregnant women at 40-42 weeks gestation
- •Good obstetrical dating
- •Singleton
- •Intact membranes
- •Preinterventional Bishop score less than or equals 4
- •No evidence of effective uterine contractions by external tocography
- •Living close to hospital
排除标准
- •Multiple gestation
- •Oligohydramnios or Polyhydramnios
- •Abnormal FHR tracing
- •Obstetric complication (hypertension, bleeding)
- •Ruptured membranes
- •Suspected intrauterine growth restriction
- •Biophysical score < 8
- •Previous cesarean section / myomectomy / Other uterine operation
- •Fever, malaise at recruitment
- •Chronic illness (renal, hepatic, endocrine)
结局指标
主要结局
Delivery within 24 hours of administering castor oil/placebo
时间窗: two weeks
Actual time of delivery
次要结局
- Neonatal apgar scores(1 minute and 5 minute after delivery)
- Umbilical artery pH and Base Excess(Immediately at birth)
- Neonatal complications including hospitalization in NICU(immediately after birth)
- Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)(Within two weeks of enrollment)