The Use of Castor Oil as a Labor Initiator in Post-date P... | NCT00244738

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

NCT00244738

Sponsor

Hadassah Medical Organization

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

82Actual

Phase

Not Applicable

Conditions

Prolonged Pregnancy

Interventions

Castor oil
Sunflower oil

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Oct 26, 2005

First Submission Date that Met QC Criteria

Oct 26, 2005

First Posted Date

Oct 27, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	Patients who received castor oil for labor induction	Dietary Supplement: Castor oil
Control	Placebo Comparator	Patients who received sunflower oil as a placebo	Dietary Supplement: Sunflower oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Castor oil	Dietary Supplement	Patients who received castor oil for labor induction	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shay Porat, MD	Hadassah Medical Organization	Principal Investigator
Drorit Hochner-Celnikier, MD	Hadassah Medical Organization	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10631825	Background	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.

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D002368	Castor Oil
D000074242	Sunflower Oil

ID	Term
D005224	Fats, Unsaturated
D005223	Fats
D008055	Lipids
D010938	Plant Oils
D009821