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

March 18, 2012 updated by: Hadassah Medical Organization
The purpose of the study is to determine whether castor oil is effective in inducing labor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
Patients who received castor oil for labor induction
Dietary supplement: Castor oil
Patients who received castor oil for labor induction
Placebo Comparator: Control
Patients who received sunflower oil as a placebo
Dietary supplement: Sunflower oil
Patients who received sunflower oil as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery within 24 hours of administering castor oil/placebo
Time Frame: two weeks
Actual time of delivery
two weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Study Director: Drorit Hochner-Celnikier, MD, Hadassah Medical Organization
  • Principal Investigator: Shay Porat, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 26, 2005

First Submitted That Met QC Criteria

October 26, 2005

First Posted (Estimate)

October 27, 2005

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 18, 2012

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASTOR- HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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