NCT00244738

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 20, 2012

Status Verified

November 1, 2005

Enrollment Period

4.6 years

First QC Date

October 26, 2005

Last Update Submit

March 18, 2012

Conditions

Prolonged Pregnancy

Keywords

pregnancypost-dateinduction of laborcastor oil

Outcome Measures

Primary Outcomes (1)

  • Delivery within 24 hours of administering castor oil/placebo

    Actual time of delivery

    two weeks

Secondary Outcomes (4)

  • Neonatal apgar scores

    1 minute and 5 minute after delivery

  • Umbilical artery pH and Base Excess

    Immediately at birth

  • Neonatal complications including hospitalization in NICU

    immediately after birth

  • Mode of delivery (ie. Normal delivery Vs. Cesarean delivery)

    Within two weeks of enrollment

Study Arms (2)

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

Castor oilDIETARY_SUPPLEMENT

Patients who received castor oil for labor induction

Intervention
Sunflower oilDIETARY_SUPPLEMENT

Patients who received sunflower oil as a placebo

Control

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (1)

  • 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: 10631825BACKGROUND

MeSH Terms

Conditions

Pregnancy, Prolonged

Interventions

Castor OilSunflower Oil

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Fats, UnsaturatedFatsLipidsPlant OilsOilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Shay Porat, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Drorit Hochner-Celnikier, MD

    Hadassah Medical Organization

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2005

First Posted

October 27, 2005

Study Start

February 1, 2006

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

March 20, 2012

Record last verified: 2005-11

Locations

IL(1)