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

NCT ID: NCT00244738

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2010-09-30

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.

Conditions

Prolonged Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Patients who received castor oil for labor induction

Group Type: ACTIVE_COMPARATOR

Castor oil

Intervention Type: DIETARY_SUPPLEMENT

Patients who received castor oil for labor induction

Control

Patients who received sunflower oil as a placebo

Group Type: PLACEBO_COMPARATOR

Sunflower oil

Intervention Type: DIETARY_SUPPLEMENT

Patients who received sunflower oil as a placebo

Interventions

Castor oil

Patients who received castor oil for labor induction

Intervention Type: DIETARY_SUPPLEMENT

Sunflower oil

Patients who received sunflower oil as a placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shay Porat, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Drorit Hochner-Celnikier, MD

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Locations

Hadassah Medical Organization

Jerusalem, , Israel

Countries

Israel

References

Garry D, Figueroa R, Guillaume J, Cucco V. Use of castor oil in pregnancies at term. Altern Ther Health Med. 2000 Jan;6(1):77-9.

Reference Type: BACKGROUND

PMID: 10631825 (View on PubMed)

Other Identifiers

CASTOR- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id