The Use of Castor Oil for Induction of Labour in Women With Previous Caesarean Delivery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage of women entering active phase within 24 hours of administering castor oil/placebo
研究概览
简要总结
Nowadays, more and more women embark on pregnancy with previous Caesarean scar. One in five pregnancies requires induction of labour. The use of non-pharmacological methods (methods without using medication) has been gaining popularity for women who are not good candidates, such as women with previous Caesarean scar, for induction with medications such as prostaglandin. Labour induction with prostaglandin carries a higher risk of uterine rupture and thus it is not routinely offered to women with previous Caesarean delivery in Cairo University Hospital. Non-pharmacological methods of induction of labour appear to be safe in women with previous Caesarean delivery. However, various methods are available and the efficacy among them remain in doubt.
详细描述
In Cairo University Hospital, castor oil, which is a type of induction methods, is routinely offered to women with previous Caesarean delivery who require induction of labor. However, castor oil may not exert its labor induction effect immediately and the delivery may be delayed by up to 8 days. This may render a proportion of women resort to repeated Caesarean section for failed induction. Castor oil is traditionally given by midwives in order to induce labor.
The investigators are intent to recruit 70 healthy pregnant women with a history of previous one cesarean section and with no contraindication to trial of labor after cesarean . Women will be randomly and blindly divided into equal-sized intervention group and control group. Intervention group will be given a single dose 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcomes to be tested are the percentage of women entering active labor within 24 hours of castor oil or placebo administration and the number of successful vaginal deliveries after cesarean.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with one previous lower segment Caesarean section who are admitted to Cairo University Hospital for induction of labor (IOL) will be recruited. The inclusion criteria are age at least 20 years old, gestational age at recruitment from 36 weeks to 38 weeks ±6 days, gestational age at induction= 39 weeks, singleton pregnancy, reassuring fetal status, and Bishop score ≤ 6.
排除标准
- •Prior high-risk uterine scar; uterine rupture, classical CS, hysterotomy, or myomectomy
- •Short inter-delivery interval (<12 months)
- •Complications in the previous CS (e.g. puerperal sepsis)
- •Obstetric indication for CS (either elective or emergency):
- •Placenta praevia
- •Placental abruption
- •Documented evidence of cephalopelvic disproportion
- •Fetal macrosomia (estimated fetal weight >4 kg)
- •Fetal anomalies interfering with vaginal delivery e.g. hydrocephalus
- •Fetal distress or non-reassuring Cardiotocography pattern
研究组 & 干预措施
castor oil group
60 mL of castor oil in 140 mL of orange juice
干预措施: Castor Oil (Drug)
placebo group
Patients will receive sunflower oil as a placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of women entering active phase within 24 hours of administering castor oil/placebo
时间窗: two weeks
Actual time of delivery
number of successful VBAC cases
时间窗: 24 hours
number of successful cases who delivered vaginally
次要结局
- number of cases needing oxytocin augmentation(24 hours)
- Neonatal apgar scores(1 minute and 5 minute after delivery)
- Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)(Within two weeks of enrollment)
- Neonatal complications including hospitalization in NICU(immediately after birth)
- duration of labor(24 hours)
研究者
Ahmed Samy aly ashour
assistant professor of obstetrics and gynecology
Cairo University