Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

NCT06325007 | Recruiting DMC

• 1 other identifier: 293-2024-HFH
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

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 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

Induction of Labor Affected Fetus / Newborn

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 after catheter expulsion

  12 hours

• Fetal presentation at the delivery

  48 hours

• Duration of the active phase of labor

  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

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.

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 (2)

Holy Family hospital, Nazareth

Nazareth, Israel

NOT YET RECRUITING

Holy Family Hospital

Nazareth, Israel

RECRUITING

Related Publications (1)

• 1.Clinical management guidelines for Obstetrician-Gynecologists. The American College of Obstetricians and Gynecologists 2009. Vol.114, No.2, Part1. 2. Grobman W, et al. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. The new England journal of medicine 2018;379;6. 3. Jones MN,et al. Balloon catheters versus vaginal prostaglandins for labour induction (CPI Collaborative): an individual participant data meta-analysis of randomised controlled trials. Lancet 2022;400:1681-1692. 4. Cheng YW, et al. The association between the length of first stage of labor, mode of delivery, and perinatal outcomes in women undergoing induction of labor. Am J Obstet Gynecol. 2009;201:477.e1-7. 5. Cheng YW, et al. Length of the first stage of labor and associated perinatal outcomes in nulliparous women. Obstet Gynecol 2010;116:1127-35. 6. Gagnon J, et al. Intracervical Foley catheter with and without oxytocin for labor induction with Bishop score ≤3: a secondary analysis. Am J Obstet Gynecol MFM 2021;3:100350. 7. Edwards RK, et al. Controlled Release Dinoprostone Insert and Foley Compared to Foley Alone: A Randomized Pilot Trial. Am J Perinatol 2021;38:e57-e63. 8. DeMariaa A, et al. Castor oil as a natural alternative to labor induction: A retrospective descriptive study. Women and Birth 2018;31:e99-e104. 9. Moradi M, et al. Effect of Castor Oil on Cervical Ripening and Labor Induction: a systematic review and meta-analysis. Journal Of Pharmacopuncture 2022;25:71-78. 10. Shalev-Ram H, et al. Is there a difference in labor patterns after induction with prostaglandins and double-balloon catheters? American Journal of Obstetrics and Gynecology 2023;3:100198. 11. Tunarua S, et al. Castor oil induces laxation and uterus contraction via ricinoleic acid activating prostaglandin EP3 receptors. Proceedings of the National Academy of Sciences 2012. 12. Kelly AJ, et al. Castor oil, bath and/or enema for cervical priming and induction of labour. Cochrane Database Syst Rev 2013;2013:CD003099. 13. Bayoumi YA, et al. Castor oil for labor initiation in women with a previous cesarean section: a double-blind randomized study. J Matern Fetal Neonatal Med 2022;35:8945-8951. 14. Gilada R, et al. Castor oil for induction of labor in post-date pregnancies: A randomized controlled trial. Women and Birth 2018;e26-e31. 15. Salim R, et al. Single-balloon compared with double-balloon catheters for induction of labor: a randomized controlled trial. Obstet Gynecol 2011;118:79-86. 16. American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, et al. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol 2014;210:179-93.

  RESULT

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 22, 2024
• Study Start: April 11, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 31, 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 (2)