Prolonged Pregnancy
Conditions
Keywords
pregnancy, post-date, induction of labor, castor oil
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.
Interventions
DIETARY_SUPPLEMENTCastor oil
Patients who received castor oil for labor induction
DIETARY_SUPPLEMENTSunflower oil
Patients who received sunflower oil as a placebo
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery within 24 hours of administering castor oil/placebo | two weeks | Actual time of delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal apgar scores | 1 minute and 5 minute after delivery | Neonatal APGAR scores |
| Umbilical artery pH and Base Excess | Immediately at birth | Umbilical artery gases |
| Neonatal complications including hospitalization in NICU | immediately after birth | Were there any admissions to NICU, what was the reason ? |
| Mode of delivery (ie. Normal delivery Vs. Cesarean delivery) | Within two weeks of enrollment | Mode of delivery |
Countries
Israel
Outcome results
None listed