Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
Healthy Volunteers
NCT06325007

Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

Led by Holy Family Hospital, Nazareth, Israel · Updated on 2026-04-13

142

Participants Needed

2

Research Sites

142 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this randomized controlled trial is to examine the efficacy of combining castor oil ingestion with extra-amniotic single balloon catheter for cervical ripening on time from induction to delivery in nulliparous women. The main question it aims to answer are: Does the addition of the use of castor oil to extra-amniotic single balloon reduce the time until birth? Does the addition of the castor oil affect other perinatal outcomes during childbirth? Are the side effects of the castor tolerated by the mothers? Participants will be randomly divided into 2 groups: the study group will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, an extra-amniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline. In the control group, a foley catheter will be inserted into cervical canal without ingestion of castor oil.

CONDITIONS

Official Title

Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

Who Can Participate

Age: 18Years - 60Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women above 18 years old
  • Sign an informed consent
  • Term pregnancy (>37 weeks)
  • Viable fetus
  • Singleton pregnancy
  • Baby in vertex (head-down) position
  • Intact membranes
  • Cervix with Bishop score 6
Not Eligible

You will not qualify if you...

  • Previous cesarean delivery
  • Major fetal malformations
  • Contraindication to spontaneous vaginal delivery
  • Amniotic fluid index >25cm
  • Chorioamnionitis at admission
  • Placental abruption
  • Previous prostaglandin use for induction of labor
  • Low-lying placenta (up to 2 cm from the internal os)
  • Carriers of hepatitis B or C or HIV
  • History of allergy to latex
  • History of allergy to castor oil

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Holy Family hospital, Nazareth

Nazareth, Israel

Not Yet Recruiting

2

Holy Family Hospital

Nazareth, Israel

Actively Recruiting

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Research Team

R

Raed Salim, MD

CONTACT

W

wiaam khatib, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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