Castor Oil Ingestion and Balloon Catheter for Labor Induction in Multiparous

NCT06335017 | Recruiting DMC

• 1 other identifier: 294-2024-HFH
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (1)

• time to delivery

  Time from catheter insertion to vaginal delivery

  48 hours

Secondary Outcomes (32)

• balloon expulsion time

  12 hours after insertion

• Bishop score at catheter expulsion

  12 hours

• Number of women that will have non-vertex presentation after removal of the catheter

  48 hours

• Duration of active phase

  4 hours

• Duration of second stage

  4 hours

Study Arms (2)

group 1 - study group

ACTIVE COMPARATOR

Candidates will drink a mixture of 60 ml of castor oil and 140 ml of orange juice. 30 minutes later, A 22-French Foley catheter will be inserted above internal cervical os and will be filled with 60 mL of normal saline.

Dietary Supplement: Induction of labor

group 2- control

ACTIVE COMPARATOR

A foley catheter will be inserted into cervical canal as described above according to the department protocol without ingestion of castor oil.

Dietary Supplement: Induction of labor

Interventions

Induction of labor DIETARY_SUPPLEMENT

In both groups the balloon catheter will be removed at nearly 12 hours after insertion. 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.

group 1 - study group; group 2- control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women above 18 years old
• Sign an informed consent
• Term pregnancy (\>37 weeks)
• Viable fetus
• Singleton
• Vertex presentation
• Intact membranes
• Cervix with Bishop score ≤6

You may not qualify if:

• 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
• A low-lying placenta (up to 2 cm from the internal os)
• Carriers of hepatitis B or C or human immunodeficiency viruses,
• Women with a history of allergy to latex.
• Women with a history of allergy to castor oil

Sponsors & Collaborators

• Holy Family Hospital, Nazareth, Israel: lead

Study Sites (1)

Holy Family hospital, Nazareth

Nazareth, Israel

RECRUITING

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Raed Salim, MD

  Holy Family Hospital, Nazareth, Israel

  STUDY CHAIR

Central Study Contacts

Raed Salim, MD

CONTACT

: +972544986960; r.salim@hfhosp.org

Wiaam Khatib, MD

CONTACT

+972549192433; wiaam.khatib.95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of obstetrics and gynecology department

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 28, 2024
• Study Start: April 10, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: Access to IPD can be requested by qualified researchers and will be granted after review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement. For more information or to apply, please contact the Principal Investigator

Locations

IL (1)