Castror Oil for Labor Induction in Women With Previous Cesarean Section

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

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.

Study Overview

• Status: Completed
• Conditions: Induction of Labor
• Intervention / Treatment: Drug: Castor Oil; Drug: placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11562
    • Faculty of Medicine Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Mohamed El Sharkawy; Yomna Bayoumi; mohamed hisham gouda; Dina latif
• Investigators: Principal Investigator: Yomna Bayoumi, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; Castor Oil
• Other Study ID Numbers: castor oil

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No