Castror Oil for Labor Induction in Women With Previous Cesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Castor Oil for Induction of Labour in Women With Previous Caesarean Delivery: a Randomized Controlled Trial

Conditions
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Induction of Labor

Intervention / Treatment
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* Drug: Castor Oil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: castor oil group<br>60 mL of castor oil in 140 mL of orange juice | Drug: Castor Oil<br>* The intervention group will be given 60 mL of castor oil in 140 mL of orange juice<br>|
| Placebo Comparator: placebo group<br>Patients will receive sunflower oil as a placebo | Drug: placebo<br>* the control group will be given a sunflower oil as a placebo with a similar texture to castor oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of women entering active phase within 24 hours of administering castor oil/placebo | Actual time of delivery | two weeks | 
| number of successful VBAC cases | number of successful cases who delivered vaginally | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal apgar scores | Neonatal APGAR scores | 1 minute and 5 minute after delivery | 
| Neonatal complications including hospitalization in NICU | Were there any admissions to NICU, what was the reason ? | immediately after birth | 
| Mode of delivery (ie. Normal delivery Vs. Cesarean delivery) | Mode of delivery | Within two weeks of enrollment | 
| duration of labor | duration of labor in hours | 24 hours | 
| number of cases needing oxytocin augmentation | number of cases needing oxytocin augmentation | 24 hours |