Clinical trial NCT03958981: Castror Oil for Labor Induction in Women With Previous Cesarean Section
Official title: The Use of Castor Oil for Induction of Labour in Women With Previous Caesarean Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Mohamed El Sharkawy
name: Yomna Bayoumi
name: mohamed hisham gouda
name: Dina latif
First posted: 2019-05-22
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of women entering active phase within 24 hours of administering castor oil/placebo
timeFrame: two weeks
measure: number of successful VBAC cases
timeFrame: 24 hours
Secondary outcomes:
measure: Neonatal apgar scores
timeFrame: 1 minute and 5 minute after delivery
measure: Neonatal complications including hospitalization in NICU
timeFrame: immediately after birth
measure: Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
timeFrame: Within two weeks of enrollment
measure: duration of labor
timeFrame: 24 hours
measure: number of cases needing oxytocin augmentation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine Cairo university
Study officials:
affiliation: Cairo University
name: Yomna Bayoumi, MD
role: PRINCIPAL_INVESTIGATOR
References: