Comparing tension and no tension in Foley bulb induction for labor
A Prospective, Randomized Comparison of Tension Versus no Tension With Foley Transcervical Catheters for Pre-induction Cervical Ripening
This study is testing if putting tension on a Foley balloon can help first-time moms have their babies faster during labor induction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hawaii Pacific Health Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT03588585 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effects of applying tension versus no tension on Foley transcervical catheters used for cervical ripening prior to labor induction. Patients scheduled for labor induction at Kapiolani Medical Center will be included in the study, which seeks to determine whether tension on the Foley balloon can reduce the time from the start of induction to delivery. The study will focus on nulliparous women with specific eligibility criteria to ensure a controlled environment for assessing outcomes.
Who should consider this trial
Good fit: Ideal candidates are nulliparous women with singleton pregnancies who are undergoing labor induction.
Not a fit: Patients who are multiparas, have multiple gestations, or any contraindications to vaginal delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to shorter labor induction times for eligible patients.
How similar studies have performed: While this specific approach is being tested, similar studies have explored Foley bulb induction methods, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparas with singleton live intrauterine pregnancies undergoing labor induction at Kapiolani Medical Center for Women and Children. * Cephalic presentation * Intact fetal membranes * Bishop score less than or equal to 6 * Age greater than or equal to 18 years Exclusion Criteria: * Multiparas * Multiple gestation * Previous uterine/cervical surgery * Ruptured fetal membranes * Fetal malpresentation * Any contraindication to vaginal delivery at time of admission
Where this trial is running
Honolulu, Hawaii
- Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Study coordinator: Holly Olson, MD
- Email: olsonh@hawaii.edu
- Phone: 808-983-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.