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Clinical Trials in France / NCT07848412
Starting soon Observational

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

NCT07848412 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Toulouse
Phase
Observational
Started
2026-11-01
Last updated
2026-09-30

Condition(s) studied

Pregnancy

Investigational drug(s) / intervention(s)

Questionnaire and Physical Exam

Questionnaire and Physical Exam: A satisfaction questionnaire is given to the patient during her stay at the maternity ward.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Evaluation of obstetric outcomes — 6 days after the inclusion
    vaginal delivery rate

Trial sites (1)

FacilityCityRegionStatus
Service de gynécologie, Hôpital Paule de Viguier Toulouse Oui

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07848412 on ClinicalTrials.gov ↗ ← All trials in France