Inducing labor with cervical balloons at home versus in the hospital
Induction to Labour With Double Cervical Ballon at Home Versus at Hospital to Improve the Vaginal Delivery Rate, Maternal Satisfaction and Reduce Costs: Multicentric Randomized Clinical Trial
This study is testing if using cervical balloons to induce labor at home is as safe and effective as doing it in the hospital for pregnant women who are at low to intermediate risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 834 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06053073 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the outcomes of labor induction using cervical balloons at home versus in a hospital setting. It aims to determine if home induction can increase the rate of vaginal deliveries, enhance maternal satisfaction, and improve cost-effectiveness in medical circuits. Participants will be randomly assigned to either the home or hospital induction group, and outcomes will be evaluated to assess the safety and effectiveness of the home-based approach. The study is multicentric and focuses on low to intermediate risk pregnant women.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old, with a singleton, cephalic presentation, and between 37 to 42 weeks of gestation, who have low to intermediate risk indications for labor induction.
Not a fit: Patients with complications such as breech presentation, severe congenital fetal conditions, or those with a Bishop score of seven or higher prior to induction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more comfortable and satisfying labor induction experience for patients while potentially increasing vaginal delivery rates.
How similar studies have performed: While the approach of home-based cervical ripening is relatively novel, similar studies have shown promising results in improving patient satisfaction and outcomes in labor induction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women with ages \>18 y.o * Being able to read and understand the informed consent * Accept to join the study when signing the informed consent * Singleton * Cephalic presentation * Weeks of gestation between equal or more than 37 and less than 42 * Low risk indication of labor induction: Cronologically prolonged gestation * Intermediate risk indication of labor induction: Macrosoma, Elevated maternal age, Intrahepatic Gestacional Colestasis, Gestational Diabetes Mellitus treated with diet, Gestational Diabetes Mellitus with insulin therapy and correct metabollic controls, Small for gestacional age fetus, Stable chronic hypertension, anterior caesarean section Exclusion Criteria: * Premature rupture of membranes (PROM) * Breech presentation * Unstable presentation * Polihydramnios * Severe congenital fetal afection * Fetal growth restriction * Suspected fetal well-being loss on CTG * Bishop score equal or higher than seven before insertion of the CRB * High cephalic presentation * Home further than 30min from Hospital * Preeclampsia * Diabetes Mellitus type 1 * Maternal Hypertension * Other maternal pathology with severe compromise * Vaginal delivery Exclusion: * Oclusive and non-occlusive placenta previa (marginal or low insertion) * Vasa previa * Transverse / Oblique situation * Cord prolapse * History of previous caesarean section with uterine incission in inverted T * History of uterine rupture * Two or more previous Caesarean section * Active genital herpetical infection
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Elisa Llurba Olivé — Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Study coordinator: Maria del Carmen Medina Mallén
- Email: mmedinam@santpau.cat
- Phone: 0034646337446
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.