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

Primary Purpose

Prolonged Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Castor oil
Sunflower oil
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolonged Pregnancy focused on measuring pregnancy, post-date, induction of labor, castor oil

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts 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)

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Patients who received castor oil for labor induction

Patients who received sunflower oil as a placebo

Outcomes

Primary Outcome Measures

Delivery within 24 hours of administering castor oil/placebo
Actual time of delivery

Secondary Outcome Measures

Neonatal apgar scores
Neonatal APGAR scores
Umbilical artery pH and Base Excess
Umbilical artery gases
Neonatal complications including hospitalization in NICU
Were there any admissions to NICU, what was the reason ?
Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
Mode of delivery

Full Information

First Posted
October 26, 2005
Last Updated
March 18, 2012
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00244738
Brief Title
The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
Official Title
The Use of Castor Oil as a Labor Initiator in Post-date Pregnancies
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolonged Pregnancy
Keywords
pregnancy, post-date, induction of labor, castor oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Patients who received castor oil for labor induction
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients who received sunflower oil as a placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Castor oil
Intervention Description
Patients who received castor oil for labor induction
Intervention Type
Dietary Supplement
Intervention Name(s)
Sunflower oil
Intervention Description
Patients who received sunflower oil as a placebo
Primary Outcome Measure Information:
Title
Delivery within 24 hours of administering castor oil/placebo
Description
Actual time of delivery
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Neonatal apgar scores
Description
Neonatal APGAR scores
Time Frame
1 minute and 5 minute after delivery
Title
Umbilical artery pH and Base Excess
Description
Umbilical artery gases
Time Frame
Immediately at birth
Title
Neonatal complications including hospitalization in NICU
Description
Were there any admissions to NICU, what was the reason ?
Time Frame
immediately after birth
Title
Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)
Description
Mode of delivery
Time Frame
Within two weeks of enrollment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shay Porat, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Drorit Hochner-Celnikier, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
10631825
Citation
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.
Results Reference
background

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

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