PregnancyBALHOMENCT07848412
Comparative Analysis of Labor Induction Using a Balloon Catheter at Home Versus in the Hospital
An observational study of Pregnancy, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Questionnaire and Physical Exam
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 6 Nov 2027
- How long will I take part?
- 6 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: pregnant patients with an indication for balloon induction
Who may be able to join
- 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
Who cannot join
- 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
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- Intrauterine fetal death or medical termination of pregnancy
- Preeclampsia or gestational hypertension
- Maternal condition requiring hospital monitoring.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service de gynécologie, Hôpital Paule de Viguier
Toulouse, Oui, 31000
Emeline Muller, 0561778707 ext. +33, muller.E@chu-toulouse.Fr
About this study
Official title: 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.
- Conditions
- Pregnancy
- Being tested
- Questionnaire and Physical Exam
- Keywords
- pregnancy, balloon induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamOther
A satisfaction questionnaire is given to the patient during her stay at the maternity ward.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant patients undergoing balloon induction and returning home | Not described Receives: Other: Questionnaire and Physical Exam | |
| Pregnant patients undergoing balloon induction in a standard hospital setting | Not described Receives: Other: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of obstetric outcomes
vaginal delivery rate
Measured: 6 days after the inclusion
Secondary outcomes (1)
Evaluation of postpartum patient satisfaction
Satisfaction survey
Measured: 6 days after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion6 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848412
- Sponsor's protocol ID
- RC31/26/0338
- Other IDs
- ID-RCB
- Acronym
- BALHOME
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Prospective Analysis of Labor Induction Using a Balloon Catheter at Home Versus in the Hospital: Obstetric Outcomes and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07848412
- Acronym / sponsor ID
- BALHOME / RC31/26/0338
- Conditions
- Pregnancy
- Keywords
- pregnancy, balloon induction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 6 Nov 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant patients with an indication for balloon induction
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- Scarred uterus
- Multiple pregnancy
- Breech presentation
- Rupture of membranes, hydramnios
- Placenta previa or low-lying placenta, or significant unexplained bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire and Physical ExamA satisfaction questionnaire is given to the patient during her stay at the maternity ward. | Other | Pregnant patients undergoing balloon induction and returning home, Pregnant patients undergoing balloon induction in a standard hospital setting |
Primary outcome
Evaluation of obstetric outcomes
Time frame: 6 days after the inclusion
vaginal delivery rate
1 secondary outcome
Evaluation of postpartum patient satisfaction
Time frame: 6 days after the inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas PARSY (05 67 77 12 31 ext. +33, parsy.t@chu-toulouse.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of obstetric outcomes (time frame: 6 days after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.