Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

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.

NCT Number	NCT06325007
Lead Sponsor	Holy Family Hospital, Nazareth, Israel
Conditions	Induction of Labor Affected Fetus / Newborn
Enrollment	142 participants
Start Date	2024-04-11
Primary Completion	2026-11-15 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-13