Castror Oil for Labor Induction in Women With Previous Cesarean Section

Not Applicable

Completed

• Conditions: Induction of Labor
• Interventions: Drug: placebo; Drug: Castor Oil

• Registration Number: NCT03958981
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-22
• Study Start: 2019-07-15
• Primary Completion: 2020-05-30
• Study Completion: 2020-07-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-19
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	Patients will receive sunflower oil as a placebo
castor oil group	Castor Oil	60 mL of castor oil in 140 mL of orange juice

Primary Outcome Measures

Name	Time	Method
Percentage of women entering active phase within 24 hours of administering castor oil/placebo	two weeks	Actual time of delivery
number of successful VBAC cases	24 hours	number of successful cases who delivered vaginally

Secondary Outcome Measures

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

Trial Locations

Locations (1)

faculty of medicine Cairo university; 🇪🇬 Cairo, Egypt