Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB (OutCRIB)

The aim goal of this study is to compare the duration of induction and labor between outpatient and inpatient care in low-risk pregnant women.

The secondary objectives are to compare between the two groups the maternal satisfaction from induction to delivery, the maternal and neonatal morbidity and mortality, impact on service organization and a medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month For women who do not agree to take part in the randomized study, an observational study will be proposed to them in order to collect the reason for their refusal and their maternal satisfaction.

Researchers will compare the return home with conventional hospitalization

Patients presenting with a singleton pregnancy and with an indication for induction of labor will be proposed to participate in the study.

If the pregnant woman refuses to participate in the randomized study, she will be invited to take part in the observational study.

For women who accept, a fetal heart rate recording (FHRR) is made prior to balloon insertion. If there is no fetal heart rhythm abnormality (FHR), the double balloon catheter is inserted by a midwife. A further ERCF is performed to ensure that the procedure is well tolerated.

In the absence of metrorrhagia, fetal heart rate abnormalities, rupture of the water sac or uterine hypertonia/hyperkinesia, the patient will then be randomized to either the in-patient or out-patient arm. The patient will either be placed in a room or go home.

In both cases, the balloon will be removed after 24 hours in hospital in the absence of spontaneous labor, and the patient will be referred to the delivery room for water breakage and/or oxytocin infusion for induction.

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women
• Intervention / Treatment: Other: Outpatient; Other: Inpatient

• Study Type: Interventional
• Enrollment (Estimated): 258
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MARION GAUTIER; Phone Number: +33253526204; Email: marion.gautier@chu-nantes.fr

Study Locations

• France
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Recruiting
      • CHU de Nantes
      • Contact: Vincent DOCHEZ, Dr; Phone Number: 0240083177; Email: vincent.dochez@chu-nantes.fr
  • vendée
    • La Roche-sur-Yon, vendée, France, 85000
      • Recruiting
      • CHD Vendee
      • Contact: Emelyne Dr LEFIZELIER; Phone Number: 0251446161; Email: Emelyne.lefizelier@ght85.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant woman with singleton pregnancy in cephalic presentation
• Term ≥ 37SA+0d
• Age ≥ 18 years
• Affiliated or beneficiary of a social security scheme
• No severe maternal/neonatal pathology (severe pre-eclampsia, intra-uterine growth retardation, etc.)
• Indication for balloon induction
• Bishop score <6
• Home-hospital distance ≤ 30 minutes' drive
• Presence of a family member at the woman's side to help her return home

Exclusion Criteria:

• Scarred uterus
• Fetal heart rhythm abnormalities
• Rupture of membranes
• Death in utero
• Placenta previa or adherent placenta (accreta or percreta)
• Maternal respiratory, cardiac, hepatic, renal, digestive or decompensated psychiatric pathology
• Anamnios
• Patient under guardianship, curatorship and/or safeguard of justice

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient; patients randomized to this arm will go home until labour or 24 hours after balloon insertion	Other: Outpatient; Women return at home
Active Comparator: Inpatient; patients randomized to this arm will stay at hospital	Other: Inpatient; Women stay at hospital
No Intervention: observationnal study; patients refusing to be randomized will be able to enter this cohort without their care affecting the site's usual clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
compare the duration of induction and labor between outpatient and inpatient care.	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare maternal satisfaction from induction to delivery between the two groups outpatient and inpatient via EXIT questionnaire	48 hours
Compare maternal morbidity and mortality between the two groups outpatient and inpatient	48 hours
Compare neonatal morbidity and mortality between the two groups outpatient and inpatient	48 hours
Compare the number of hospital beds freed up and the number of concurrent induction in the department	24 hours
Compare medico-economic evaluation (cost-consequence analysis) from a collective perspective and with a time horizon of one month between the two groups outpatient and inpatient	1 month

Other Outcome Measures

Outcome Measure	Time Frame
Observational study: Determine patients' reasons for refusing to participate in the randomized study via an internal questionnaire	72 hours
8. Observational study: Compare maternal satisfaction with induction between the "patients randomized to hospitalization" and "non-randomized patients (hospitalized)" groups via EXIT questionnaire	72 hours

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Vincent DOCHEZ, Dr, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: outpatient labor induction; low-risk pregnant women; transcervical catheter
• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleic Acids, Nucleotides, and Nucleosides; Purines; Ribonucleotides; Nucleotides; Purine Nucleotides; Inosine Nucleotides; Inosine Monophosphate
• Other Study ID Numbers: RC24_0036; 2024-A02122-45 (Registry Identifier: RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No