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Completed

NCT Number: NCT00244738

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

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

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Key information

Conditions

Prolonged Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Prolonged Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Castor oil

Dietary Supplement

Patients who received castor oil for labor induction

Sunflower oil

Dietary Supplement

Patients who received sunflower oil as a placebo

Primary outcomes

  1. Delivery within 24 hours of administering castor oil/placebo

    Time frame: two weeks

    Actual time of delivery

Secondary outcomes

  1. Neonatal apgar scores

    Time frame: 1 minute and 5 minute after delivery

    Neonatal APGAR scores

  2. Umbilical artery pH and Base Excess

    Time frame: Immediately at birth

    Umbilical artery gases

  3. Neonatal complications including hospitalization in NICU

    Time frame: immediately after birth

    Were there any admissions to NICU, what was the reason ?

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

    Time frame: Within two weeks of enrollment

    Mode of delivery

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2005
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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