Evaluating membrane stripping for cervical ripening in labor induction
Evaluation of Stripping for Cervical Ripening - A Randomized Controlled Study
This study tests whether a method called membrane stripping works better than a double balloon catheter for helping women get ready for labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Meir Medical Center Academic / other |
| Locations | 1 site (Kfar Saba, Central District) |
| Trial ID | NCT06591247 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to assess the effectiveness of membrane stripping compared to double balloon catheter induction for cervical ripening in women undergoing labor induction. The study will evaluate the time required for cervical ripening, delivery duration, and maternal and fetal outcomes associated with both methods. Participants will include women with a cervical dilation of at least 1 cm and full-term pregnancies, while those with contraindications to vaginal delivery will be excluded.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and above with a cervical dilation of at least 1 cm and full-term pregnancies.
Not a fit: Patients who may not benefit include those with contraindications to vaginal delivery or those who do not require cervical ripening.
Why it matters
Potential benefit: If successful, this study could provide a more effective method for cervical ripening, potentially leading to improved labor outcomes.
How similar studies have performed: Other studies have explored cervical ripening methods, but this specific comparison of membrane stripping and double balloon catheter induction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 and above * Patients with a cervical dilation of at least 1 cm * Full-term pregnancy * Cephalic presentation * No contraindication to vaginal delivery Exclusion Criteria: * Patients with rupture of membranes * Patients who do not require cervical ripening and proceed directly to the delivery room for induction with oxytocin * Patients for whom the use of a double-balloon catheter/PGE2 is contraindicated * Twin pregnancies * Pregnancies with macrosomic fetuses where vaginal delivery is contraindicated * Patients with maternal or fetal pathologies that do not allow for vaginal delivery due to concerns about fetal or maternal distress
Where this trial is running
Kfar Saba, Central District
- Meir Medical Center — Kfar Saba, Central District, Israel (Recruiting)
Study contacts
- Study coordinator: Gal Cohen, MD
- Email: galcwork@gmail.com
- Phone: +972545915788
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.