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

Prolonged Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244738
• Other study ID #: CASTOR- HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: October 26, 2005
• Last updated: March 18, 2012
• Start date: February 2006
• Est. completion date: September 2010

Study information

• Verified date: November 2005
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy, Prolonged
• Prolonged Pregnancy

Intervention

Dietary Supplement:
• Castor oil
Patients who received castor oil for labor induction
• Sunflower oil
Patients who received sunflower oil as a placebo

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery within 24 hours of administering castor oil/placebo	Actual time of delivery	two weeks	No
Secondary	Neonatal apgar scores	Neonatal APGAR scores	1 minute and 5 minute after delivery	Yes
Secondary	Umbilical artery pH and Base Excess	Umbilical artery gases	Immediately at birth	Yes
Secondary	Neonatal complications including hospitalization in NICU	Were there any admissions to NICU, what was the reason ?	immediately after birth	Yes
Secondary	Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)	Mode of delivery	Within two weeks of enrollment	Yes