The pupose of the study is to determine wheteher castor oil is effective in inducing labor

Condition	Intervention
Prolonged Pregnancy	Drug: Castor oil

Further study details as provided by Hadassah Medical Organization:

Primary Outcomes: Delivery within 24 hours of administering castor oil/placebo
Secondary Outcomes: Neonatal apgar scores; Umbilical artery pH and Base Excess; Neonatal complications including hospitalization in NICU; Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
Expected Total Enrollment:  84

Castor oil is traditionaly 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 thier 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.

Ages Eligible for Study:  18 Years   -   50 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00244738

Shay Porat, MD      00 972 50 8573212    shay.porat@gmail.com

Israel
      Hadassah Medical Organization, Jerusalem,  Israel

Study chairs or principal investigators

Shay Porat, MD,  Principal Investigator,  Hadassah-Hebrew University Medical Center   
Drorit Hochner-Celnikier, MD,  Study Director,  Hadassah-Hebrew University Medical Center   

Study ID Numbers:  CASTOR- HMO-CTIL
Last Updated:  December 8, 2005
Record first received:  October 26, 2005
ClinicalTrials.gov Identifier:  NCT00244738
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10