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

NCT07848412 | Not Yet Recruiting

• 2 other identifiers: RC31/26/0338ID-RCB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Keywords

pregnancy; balloon induction

Outcome Measures

Primary Outcomes (1)

• Evaluation of obstetric outcomes

  vaginal delivery rate

  6 days after the inclusion

Secondary Outcomes (1)

• Evaluation of postpartum patient satisfaction

  6 days after the inclusion

Study Arms (2)

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

Questionnaire and Physical Exam OTHER

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

Pregnant patients undergoing balloon induction and returning home; Pregnant patients undergoing balloon induction in a standard hospital setting

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant patients with an indication for balloon induction

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Service de gynécologie, Hôpital Paule de Viguier

Toulouse, Oui, 31000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires; Restraint, Physical

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Central Study Contacts

Thomas PARSY

CONTACT

05 67 77 12 31; parsy.t@chu-toulouse.Fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 6, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)