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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00244738
First received: October 26, 2005
Last updated: March 18, 2012
Last verified: November 2005
  Purpose

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


Condition Intervention
Prolonged Pregnancy
Dietary Supplement: Castor oil
Dietary Supplement: Sunflower oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Delivery within 24 hours of administering castor oil/placebo [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Actual time of delivery


Secondary Outcome Measures:
  • Neonatal apgar scores [ Time Frame: 1 minute and 5 minute after delivery ] [ Designated as safety issue: Yes ]
    Neonatal APGAR scores

  • Umbilical artery pH and Base Excess [ Time Frame: Immediately at birth ] [ Designated as safety issue: Yes ]
    Umbilical artery gases

  • Neonatal complications including hospitalization in NICU [ Time Frame: immediately after birth ] [ Designated as safety issue: Yes ]
    Were there any admissions to NICU, what was the reason ?

  • Mode of delivery (ie. Normal delivery Vs. Cesarean delivery) [ Time Frame: Within two weeks of enrollment ] [ Designated as safety issue: Yes ]
    Mode of delivery


Enrollment: 82
Study Start Date: February 2006
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00244738     History of Changes
Other Study ID Numbers: CASTOR- HMO-CTIL
Study First Received: October 26, 2005
Last Updated: March 18, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014