NCT06053073

Induction to Labour With Double Cervical Ballon at Home Versus at 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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 834 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial\] is to compare the outcomes between induction to labour at home versus hospitalized. The main questions it aims to answer are: * Can the induction to labour at home with cervical rippening ballon increase the vaginal delivery rate? * Will the induction to labour at home increase maternal satisfaction * Will the induction to labour at home improve medical circuits and coulb it be cost effective? Participants who meet inclusion criteria will undergo randomization so as to be asignated an induction to labour at home or in the hospital. Researchers will compare both labour induction groups to see if the induction to labour at home has better outcomes as described previously.

Detailed description

INDOBAMHOS is a multicentric randomized clinical trial which is based in the principle that cervical rippening with intracervical probes with ballons is as safe as pharmacological induction with PGE2 and it seems to be a suitable option to develop the cervical rippening process of the induction at home rather than in the hospital. The purpouse of the study is to demonstrate that the comfort of performing the cervical rippenning at home will benefit patients with an increase of the vaginal delivery rate and increases maternal satisfaction. And also will improve medical circuits and could be cost-effective when compared to hospitalized labour induction.

Conditions

• Induced; Birth
• Cervical Dilatation
• Live Birth

Interventions

Type	Name	Description
DEVICE	Cervical rippening at home	The experimental arm of the study will undergo cervical rippening at home between 6 and 8 hours and then will come back to the hospital to continue with the labor induction
DEVICE	Cervical rippening in the hospital	The active comparator arm of the study will undergo cervical rippening in the hospital between 6 and 8 hours and then will remain there to continue with the labor induction

Timeline

• Start date: 2023-03-27
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2023-09-25
• Last updated: 2023-09-25

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated device study