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

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

Detailed Description
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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.

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

Conditions
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Prolonged Pregnancy

Intervention / Treatment
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* Dietary Supplement: Castor oil
* Dietary Supplement: Sunflower oil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Patients who received castor oil for labor induction | Dietary Supplement: Castor oil<br>* Patients who received castor oil for labor induction<br>|
| Placebo Comparator: Control<br>Patients who received sunflower oil as a placebo | Dietary Supplement: Sunflower oil<br>* Patients who received sunflower oil as a placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery within 24 hours of administering castor oil/placebo | Actual time of delivery | two weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, post-date, induction of labor, castor oil