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

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ClinicalTrials.gov Identifier: NCT00244738
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : March 20, 2012
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

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

Condition or disease Intervention/treatment
Prolonged Pregnancy Dietary Supplement: Castor oil Dietary Supplement: Sunflower oil

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  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
Study Start Date : February 2006
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Castor Oil
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Delivery within 24 hours of administering castor oil/placebo [ Time Frame: two weeks ]
    Actual time of delivery


Secondary Outcome Measures :
  1. Neonatal apgar scores [ Time Frame: 1 minute and 5 minute after delivery ]
    Neonatal APGAR scores

  2. Umbilical artery pH and Base Excess [ Time Frame: Immediately at birth ]
    Umbilical artery gases

  3. Neonatal complications including hospitalization in NICU [ Time Frame: immediately after birth ]
    Were there any admissions to NICU, what was the reason ?

  4. Mode of delivery (ie. Normal delivery Vs. Cesarean delivery) [ Time Frame: Within two weeks of enrollment ]
    Mode of delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244738


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Shay Porat, MD Hadassah Medical Organization
Study Director: Drorit Hochner-Celnikier, MD Hadassah Medical Organization

Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00244738     History of Changes
Other Study ID Numbers: CASTOR- HMO-CTIL
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: November 2005

Keywords provided by Hadassah Medical Organization:
pregnancy
post-date
induction of labor
castor oil

Additional relevant MeSH terms:
Pregnancy, Prolonged
Pregnancy Complications
Castor Oil
Cathartics
Gastrointestinal Agents