Comparative Analysis of Labor Induction Using a Balloon Catheter at Home Versus in the Hospital (BALHOME)

September 23, 2026 updated by: University Hospital, Toulouse

Comparative Prospective Analysis of Labor Induction Using a Balloon Catheter at Home Versus in the Hospital: Obstetric Outcomes and Patient Satisfaction

An increasing proportion of patients undergo labor induction at the end of pregnancy. Balloon induction at home is a method validated in the literature.

Home-based balloon induction is already part of routine care at the Paule de Viguier maternity unit. However, a prospective evaluation of this home induction option has not yet been conducted at our facility or elsewhere in France.

Our study will evaluate obstetric outcomes and patient satisfaction regarding this induction method at our center.

This is an observational, non-interventional, prospective, and comparative-though non-randomized-study.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Oui
      • Toulouse, Oui, France, 31000
        • Service de gynécologie, Hôpital Paule de Viguier
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

pregnant patients with an indication for balloon induction

Description

Inclusion Criteria:

  • Medical indication or request for induction
  • Patients between 37 and 41+5 weeks of gestation
  • Singleton pregnancy, cephalic presentation, intact membranes
  • Normal amniotic fluid volume at the time of induction
  • Residing within 30 minutes of the maternity unit and having access to a vehicle
  • Access to a telephone, good understanding of monitoring instructions

Exclusion Criteria:

  • Scarred uterus
  • Multiple pregnancy
  • Breech presentation
  • Rupture of membranes, hydramnios
  • Placenta previa or low-lying placenta, or significant unexplained bleeding
  • Intrauterine growth restriction, small for gestational age, or known fetal condition requiring fetal monitoring or prompt care at birth
  • Intrauterine fetal death or medical termination of pregnancy
  • Preeclampsia or gestational hypertension
  • Maternal condition requiring hospital monitoring.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant patients undergoing balloon induction and returning home
Other: Questionnaire and Physical Exam

A satisfaction questionnaire is given to the patient during her stay at the maternity ward.
Pregnant patients undergoing balloon induction in a standard hospital setting
Other: Questionnaire and Physical Exam

A satisfaction questionnaire is given to the patient during her stay at the maternity ward.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of obstetric outcomes
Time Frame: 6 days after the inclusion

vaginal delivery rate
6 days after the inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of postpartum patient satisfaction
Time Frame: 6 days after the inclusion

Satisfaction survey
6 days after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 6, 2027

Study Registration Dates

First Submitted

September 23, 2026

First Submitted That Met QC Criteria

September 23, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)

September 30, 2026

Last Update Submitted That Met QC Criteria

September 23, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/26/0338
  • ID-RCB (Other Identifier: 2026-A02099-42)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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