Induction to Labour With Double Cervical Ballon at Home Versus at Hospital

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.

Conditions

• Induced; Birth
• Cervical Dilatation
• Live Birth

Interventions

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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  lead OTHER

Principal Investigators

• Elisa Llurba Olivé · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Maria del Carmen Medina Mallén · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Anna Mundó Fornell · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Ignacio Montoro Pacha · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Bruna Miarons Ferré · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

• Mitsury Flores · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-27

Primary Completion

2025-03-31

Completion

2026-03-31

FDA Device

Yes

Countries

• Spain

Study Locations