Castror Oil for Labor Induction in Women With Previous Cesarean Section

NCT03958981 | Completed

• 1 other identifier: castor oil
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Neonatal apgar scores

  1 minute and 5 minute after delivery

• Neonatal complications including hospitalization in NICU

  immediately after birth

• Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)

  Within two weeks of enrollment

• duration of labor

  24 hours

• number of cases needing oxytocin augmentation

  24 hours

Study Arms (2)

castor oil group

EXPERIMENTAL

60 mL of castor oil in 140 mL of orange juice

Drug: Castor Oil

placebo group

PLACEBO COMPARATOR

Patients will receive sunflower oil as a placebo

Drug: placebo

Interventions

Castor Oil DRUG

The intervention group will be given 60 mL of castor oil in 140 mL of orange juice

castor oil group

placebo DRUG

the control group will be given a sunflower oil as a placebo with a similar texture to castor oil

placebo group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Mohamed El Sharkawy: collaborator
• Yomna Bayoumi: collaborator
• mohamed hisham gouda: collaborator
• Dina latif: collaborator

Study Sites (1)

faculty of medicine Cairo university

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

Castor Oil

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Yomna Bayoumi, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of obstetrics and gynecology

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: July 15, 2019
• Primary Completion: May 30, 2020
• Study Completion: July 15, 2020
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

EG (1)