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Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous
Sponsor: Holy Family Hospital, Nazareth, Israel
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 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.
Official title: The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2024-04-11
Completion Date
2026-03-31
Last Updated
2025-04-20
Healthy Volunteers
Yes
Interventions
Induction of labor
The study group only will drink a mixture of 60 ml of castor oil mixed with 140 ml of orange juice. Thirty minutes later, in both groups, an extraamniotic single balloon catheter will be inserted above the internal cervical os and filled with 60 mL of normal saline. Following removal, artificial rupture of the membranes will be performed as long as it is safe with regards to fetal head position. Oxytocin infusion will be commenced at once if contraction has not begun spontaneously (2 to 3 regular uterine contractions per 10 minutes). Continuous electronic fetal monitoring will be used throughout labor. Labor will be managed by the attending obstetricians and midwives. Labor progress abnormalities will be diagnosed and managed according to the department protocol based on the recommendations of the American College of Obstetricians and Gynecologists.
Locations (2)
Holy Family hospital, Nazareth
Nazareth, Israel
Holy Family Hospital
Nazareth, Israel