Using heated saline in a balloon for cervical ripening during labor induction
Effect of Heated Saline in Duration of Cervical Ripening in Women Having Labor Induction With Cervical Balloon: a Randomized Controlled Study
NA · University Hospital, Geneva · NCT05864326
This study tests if using warm saline in a balloon can help women in labor get ready for delivery faster than using regular room temperature saline.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Geneva (other) |
| Locations | 1 site (Geneva, Genève) |
| Trial ID | NCT05864326 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-center, randomized, controlled trial that investigates the effect of heated saline versus room temperature saline in a balloon catheter for cervical ripening in women undergoing labor induction. The primary goal is to determine if heated saline can reduce the duration of the balloon catheter's use, thereby potentially shortening the overall labor induction process. Participants will be randomly assigned to receive either heated saline at 40°C or standard room temperature saline. The study aims to build on previous findings that suggest warm fluids may enhance cervical ripening.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women at or over 35 weeks gestation with a singleton pregnancy and an unfavorable cervix.
Not a fit: Patients who are in active labor, have had multiple cesarean deliveries, or have contraindications to vaginal delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a more efficient labor induction process, reducing the time women spend in labor.
How similar studies have performed: Previous small studies have shown promising results with the use of warm fluids for cervical ripening, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age at or over 35 weeks * Singleton pregnancy * Alive fetus * Cephalic presentation * Maternal age ≥ 16 years Exclusion Criteria: * Active labor (dilated cervix with spontaneous uterine contractions) * Prelabor rupture of membranes * \>1 Previous cesarean delivery * Fetal malformation leading to a possible obstruction of labor (e.g., hydrocephaly, exteriorized fetal tumors, etc.) * Maternal or fetal disease with indication to accelerate labor (start oxytocin stimulation within 6 hours after insertion of the BC (e.g., pre-eclampsia, chorioamnionitis, etc.)\] * Counterindication to vaginal delivery * Impossibility to give consent to participation
Where this trial is running
Geneva, Genève
- Hôpitaux Universitaires de Genève — Geneva, Genève, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Valeria Lombardi Fäh, Dr
- Email: valeria.lombardifah@hcuge.ch
- Phone: +41796138239
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.
Conditions: Cervical Ripening, Induction of Labor, Unfavorable Cervix, Mechanical Method, Cervical ripening, Unfavorable cervix, Mechanical method