Castor Oil Ingestion and Balloon Catheter for Labor Induction in Nulliparous

The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.

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.

Study Overview

• Status: Recruiting
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Dietary supplement: Induction of labor

Detailed Description

The rate of labor induction has increased up to 25.7% in 2018 for several demographic and obstetric reasons. In nulliparous women the reported rate is nearly 32%.

Various methods are used to induce labor worldwide, including natural, mechanical and pharmacological agents. of all methods balloon catheters were proven to cause fewer adverse perinatal events.

Though induction is considered a safe and effective procedure, it may lead to a prolonged labor which is associated with complications such postpartum hemorrhage, infection, and operative delivery.

Based on these data several studies have examined the combinations of balloon catheters with other pharmacological agents on labor durations. The results were inconsistent, and several reports showed that the combination reduced significantly the length of labor. Nevertheless, pharmacological agents may be associated with adverse events including uterine hyperstimulation, placental abruption, and postpartum hemorrhage, though the overall risk is small.

Castor oil, extracted from the seeds of Ricinus communis plant, is a natural effective substance for induction of labor. it's considered a safe and inexpensive though the exact mechanism by which it induces labor is still unclear.

Our hypothesis suggests that ingestion of castor oil combined with the balloon catheter will shorten the time to delivery. In order to show a reduction by 3 hours, a sample size of 57 in each group will be needed assuming 80% power and a two-tailed alpha of 5%.

Since the success rate of vaginal delivery is nearly 85%, the sample size was calculated to 67 women in each group. Additional 5% are planned to be recruited to account for trial drop out for any reason, yielding a total final sample size of 71 women in each group (142 in both groups).

• Study Type: Interventional
• Enrollment (Estimated): 142
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Raed Salim, MD; Phone Number: +972544986960; Email: r.salim@hfhosp.org
• Study Contact Backup: Name: wiaam khatib, MD; Phone Number: +972549192433; Email: wiaam.khatib.95@gmail.com

Study Locations

• Israel
  • Nazareth, Israel
    • Recruiting
    • Holy Family Hospital
    • Contact: Raed Salim, MD; Email: r.salim@hfhosp.org
  • Nazareth, Israel
    • Not yet recruiting
    • Holy Family hospital, Nazareth
    • Contact: Wiaamk Khatib, MD; Phone Number: 0549192433; Email: wiaam.khatib.95@gmail.com
    • Principal Investigator: Wiaam Khatib, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1 - study group; 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; 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.
Active Comparator: group 2- control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to delivery	Time from catheter insertion to vaginal delivery.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
balloon expulsion time	The time until balloon was spontaneously expelled	12 hours after insertion
Bishop score after catheter expulsion	Bishop score after removal of the catheter where a high score (above 7) indicates a better outcome.	12 hours
Fetal presentation at the delivery	The insertion of a balloon may lead to a change in the presenting part of the fetus. A change to a non-vertex presentation is carried as an undesired outcome.	48 hours
Duration of the active phase of labor	Duration of the time from 6 cm cervical dilatation to 10 cm cervical dilatation	4 hours
Duration of second stage	the time from 10 cm cervical dilatation until the delivery of the baby	4 hours
Mode of delivery	Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section.	48 hours
Indications for cesarean or operative vaginal deliveries	Was the reason for operative vaginal delivery or cesarean delivery due to non progress labor, fetal status, or a combination of both?	48 hours
Intrapartum fever	Number of patients that will have intrapartum fever ≥ 38 °C	48 hours
Number of patients that will require use of intrapartum use of antibiotic treatment.	Number of patients that will require use of intrapartum use of antibiotic treatment due to intrapartum infection.	48 hours
Number of Participants with that will develop clinical signs of chorioamnionitis.	Clinical signs of chorioamnionitis includes abdominal tenderness, abnormal discharge, intrapartum fever, tachycardia	48 hours
Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.	Obstetric anal sphincter injury	48 hours
Number of Participants with develop postpartrum hemorrhage.	early postpartum hemorrhage (PPH)	48 hours
Number of Participants with need blood transfusion.	PPH that required blood transfusion	72 hours
Side effects related to castor oil use	nausea, vomiting, uterine hyperstimulation> the 5 contractions: 10 minutes	48 hours
Oxytocin maximal dosage	Oxytocin maximal dosage	48 hours
Number of participants with Umbilical Cord prolapse.	Umbilical cord prolapse is when the umbilical cord exits the cervical os before the fetal presenting part that may result in fetal hypoxia.	48 hours
Apgar score (0 to 10).	APGAR< 7 after 1 and 5 minutes where lower scores mean a worse outcome.	48 hours
pH taken from umbilical artery	Cord artery pH <7.1	48 hours
Neonatal birthweight	Neonatal birthweight	48 hours
Number of neonates with Neonatal fever ≥ 38 °C	Neonatal fever >38	72 hours
The number of neonates that will develop neonatal sepsis.	Diagnosis of neonatal sepsis based on clinical signs of sepsis and positive cultures.	72 hours
The number of neonates that will require antibiotic treatment.	Need for antibiotic treatment	72 hours
Neonatal complications	respiratory distress syndrome, transient tachypnea of newborn, intracranial hemorrhage, intraventricular hemorrhage, seizures, Meconium aspiration syndrome ,Hypoxic ischemic encephalopathy	48 hours
The number of neonates that will Admit to neonatal intensive care unit (NICU)	Neonatal admission to NICU	30 days
Length of stay in NICU.	Neonatal length of stay in NICU.	30 days
neonatal death	neonatal death	30 days
Maternal hemoglobin level after delivery.	higher level of Hemoglobin and indicate better outcome.	48 hours
Number of participants that will require postpartum hysterectomy.	Maternal hysterectomy	72 hours following delivery.
Number of participants that will require postpartum laparotomy.	Number of participants that will require postpartum laparotomy after vaginal delivery or re-laparotomy after cesarean section.	72 hours following delivery.
postpartum maternal complications	endometritis	72 hours following the delivery.
The length of stay from birth to discharge home.	The length of stay in days from birth to discharge home.	up to 10 days
Maternal satisfaction from delivery process.	1 = Very dissatisfied, 10 = Very satisfied	up to 10 days after delivery

Collaborators and Investigators

• Sponsor: Holy Family Hospital, Nazareth, Israel
• Investigators: Study Chair: Raed Salim, MD, Holy Family Hospital, Nazareth, Israel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Delivery, Obstetric; Obstetric Surgical Procedures; Labor, Induced
• Other Study ID Numbers: 293-2024-HFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No