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

ConditionPregnancy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Scarred uterus

Multiple pregnancy

Breech presentation

Rupture of membranes, hydramnios

Trial population

pregnant patients with an indication for balloon induction

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire and Physical Exam

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Pregnant patients undergoing balloon induction and returning home1 intervention
Group B: Pregnant patients undergoing balloon induction in a standard hospital setting1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: