Castror Oil for Labor Induction in Women With Previous Cesarean Section

Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958981
• Other study ID #: castor oil
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 15, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Drug:
• Castor Oil
The intervention group will be given 60 mL of castor oil in 140 mL of orange juice
• placebo
the control group will be given a sunflower oil as a placebo with a similar texture to castor oil

Locations

Country	Name	City	State
Egypt	faculty of medicine Cairo university	Cairo

Sponsors (5)

Lead Sponsor	Collaborator
Cairo University	Dina latif, Mohamed El Sharkawy, mohamed hisham gouda, Yomna Bayoumi

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of women entering active phase within 24 hours of administering castor oil/placebo	Actual time of delivery	two weeks
Primary	number of successful VBAC cases	number of successful cases who delivered vaginally	24 hours
Secondary	Neonatal apgar scores	Neonatal APGAR scores	1 minute and 5 minute after delivery
Secondary	Neonatal complications including hospitalization in NICU	Were there any admissions to NICU, what was the reason ?	immediately after birth
Secondary	Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)	Mode of delivery	Within two weeks of enrollment
Secondary	duration of labor	duration of labor in hours	24 hours
Secondary	number of cases needing oxytocin augmentation	number of cases needing oxytocin augmentation	24 hours