Using castor oil and a balloon catheter to induce labor in first-time mothers
Official title: The Effect of Combining Single Balloon Catheter With Castor Oil Ingestion for Cervical Ripening on Time to Delivery Among Nulliparous Women.
Run by Holy Family Hospital, Nazareth, Israel · NCT06325007 · Data updated 2026-11-12
This study is testing if using castor oil along with a balloon catheter can help first-time mothers have their babies faster compared to just using the balloon catheter alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 142 (estimated) |
| Sponsor | Holy Family Hospital, Nazareth, Israel Academic / other |
| Locations | 2 sites (Nazareth and 1 other locations) |
| Status | Recruiting |
| Started | April 11, 2024 |
| Main results expected | November 15, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT06325007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are nulliparous women over 18 years old with a term pregnancy and a viable singleton fetus.
✕Probably not a fit
Patients who have had a previous cesarean delivery or have contraindications to vaginal delivery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of combining castor oil ingestion with an extra-amniotic single balloon catheter for cervical ripening in nulliparous women. Participants will be randomly assigned to either a study group, which will consume a mixture of castor oil and orange juice followed by the insertion of a balloon catheter, or a control group that will only receive the balloon catheter without castor oil. The study aims to determine if this combination reduces the time from induction to delivery and assesses any potential side effects for the mothers and perinatal outcomes. The trial will require a sample size of 57 women in each group to achieve statistically significant results.
Why it matters
Potential benefit: If successful, this approach could lead to shorter labor times and improved outcomes for first-time mothers.
How similar studies have gone: Previous studies have shown mixed results regarding the combination of balloon catheters with pharmacological agents for labor induction, making this approach somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Holy Family Hospital
Nazareth, Israel Recruiting -
Holy Family hospital, Nazareth
Nazareth, Israel Not yet recruiting
Study contacts
- Study coordinator: Raed Salim, MD
- Email: r.salim@hfhosp.org
- Phone: +972544986960
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Outpatient cervical ripening using a Foley catheter
This study is testing if using a Foley catheter at home to help prepare the cervix for labor can reduce the need for C-sections and improve safety for first-time moms and their babies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.