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Not yet recruitingNCT07848412BALHOMEUpdated Sep 30, 2026

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

An observational study in Pregnancy, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
Female
01

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.

02

Conditions studied

  • Pregnancy

Keywords

  • pregnancy
  • balloon induction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

pregnant patients with an indication for balloon induction

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
6 Days
Patient registry
Yes

Groups and cohorts

  • Pregnant patients undergoing balloon induction and returning home

    Other: Questionnaire and Physical Exam

  • Pregnant patients undergoing balloon induction in a standard hospital setting

    Other: Questionnaire and Physical Exam

Interventions

  • OtherQuestionnaire and Physical Exam

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

05

What researchers measure

Primary outcomes

  1. Evaluation of obstetric outcomes

    vaginal delivery rate

    Time frame: 6 days after the inclusion

Secondary outcomes

  1. Evaluation of postpartum patient satisfaction

    Satisfaction survey

    Time frame: 6 days after the inclusion

06

Study locations

1 site
  • Service de gynécologie, Hôpital Paule de Viguier
    Toulouse, Oui 31000, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07848412
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2027 (estimated)
Completion
Nov 6, 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Thomas PARSY
Contact
parsy.t@chu-toulouse.Fr
05 67 77 12 31 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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