RecruitingNot ApplicableNCT06053073

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


Sponsor

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

Enrollment

834 participants

Start Date

Mar 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares starting labor induction at home versus in the hospital using a double balloon cervical catheter — a device that gently opens the cervix to prepare for childbirth. Home induction may be more comfortable and efficient for low-risk pregnancies. **You may be eligible if...** - You are pregnant, over 18, with a single baby in head-first position - You are between 37 and 42 weeks pregnant - Your induction reason is low to intermediate risk (e.g., post-dates pregnancy, gestational diabetes, or a large baby) - You are able to read and understand the consent form **You may NOT be eligible if...** - Your water has already broken (PROM) - Your baby is in a breech or abnormal position - You have active bleeding, a serious pregnancy complication, or a prior classical (vertical) C-section scar - You have a contraindication to vaginal birth Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECervical 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

DEVICECervical 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


Locations(1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

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NCT06053073


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