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

NCT00244738 — Not applicable, Completed, 82 participants, Hadassah Medical Organization

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT00244738
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	82 (Actual)
Sponsor	Hadassah Medical Organization (Other)
Conditions	Prolonged Pregnancy
Interventions	Castor oil, Sunflower oil (Dietary supplement)
Dates	start 2006-02-01, primary completion 2010-09-01, completion 2010-09-01, first posted 2005-10-27, last updated 2012-03-20
Locations	1 site in Israel

-Summary

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

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intervention	Active comparator	Dietary Supplement: Castor oil	Patients who received castor oil for labor induction
Control	Placebo comparator	Dietary Supplement: Sunflower oil	Patients who received sunflower oil as a placebo

Castor oil (Dietary supplement): Patients who received castor oil for labor induction
Sunflower oil (Dietary supplement): Patients who received sunflower oil as a placebo

+Outcome measures

Primary outcomes

Delivery within 24 hours of administering castor oil/placebo [two weeks]: Actual time of delivery

Secondary outcomes

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

+Eligibility

Sex: Female, ages: 18 Years to 50 Years, accepts healthy volunteers

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)

+Locations (1)

Facility	City	Country	Status
Hadassah Medical Organization	Jerusalem	Israel

+Publications

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. PMID 10631825

+Investigators

Shay Porat, MD, Principal investigator, Hadassah Medical Organization
Drorit Hochner-Celnikier, MD, Study director, Hadassah Medical Organization