Clinical Trial

Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous

Recruiting
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Summary
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 multiparous 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, 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, the catheter will be inserted into cervical canal without ingestion of castor oil.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-03-21; most recent amendment 2026-04-07.
Status change: Not Yet Recruiting → Recruiting 2024-04-10
Trial Details
NCT Number NCT06335017
Lead Sponsor Holy Family Hospital, Nazareth, Israel
Conditions Induction of Labor
Enrollment 216 participants
Start Date 2024-04-10
Primary Completion 2026-11 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-13