The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies

Not Applicable

Completed

• Conditions: Prolonged Pregnancy
• Interventions: Dietary Supplement: Castor oil; Dietary Supplement: Sunflower oil

• Registration Number: NCT00244738
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The purpose of the study is to determine whether castor oil is effective in inducing labor.

Detailed Description

Castor oil is traditionally given by midwives in order to induce labor. Its efficacy as an initiator of labor was previously tested only in one clinical trial. Unfortunately this study (by Garry et al.) was not sufficiently controlled.

We intent to recruit 84 healthy pregnant women with no contraindication to vaginal delivery that had past their due date. Women will be randomly and blindly divided into equal sized intervention group and control group. Intervention group will be given 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcome to be tested is the percentage of women entering active labor within 24 hours of administration.

Study Timeline

• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-27
• Status Verified: 2005-11
• Study Start: 2006-02
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2012-03-18
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

• Pregnant women at 40-42 weeks gestation
• Good obstetrical dating
• Singleton
• Intact membranes
• Preinterventional Bishop score less than or equals 4
• No evidence of effective uterine contractions by external tocography
• Living close to hospital

Exclusion Criteria

• Multiple gestation
• Oligohydramnios or Polyhydramnios
• Abnormal FHR tracing
• Obstetric complication (hypertension, bleeding)
• Ruptured membranes
• Suspected intrauterine growth restriction
• Biophysical score < 8
• Previous cesarean section / myomectomy / Other uterine operation
• Fever, malaise at recruitment
• Chronic illness (renal, hepatic, endocrine)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Castor oil	Patients who received castor oil for labor induction
Control	Sunflower oil	Patients who received sunflower oil as a placebo

Primary Outcome Measures

Name	Time	Method
Delivery within 24 hours of administering castor oil/placebo	two weeks	Actual time of delivery

Secondary Outcome Measures

Name	Time	Method
Neonatal apgar scores	1 minute and 5 minute after delivery	Neonatal APGAR scores
Umbilical artery pH and Base Excess	Immediately at birth	Umbilical artery gases
Neonatal complications including hospitalization in NICU	immediately after birth	Were there any admissions to NICU, what was the reason ?
Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)	Within two weeks of enrollment	Mode of delivery

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel