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

NCT07265518 | Not Yet Recruiting

• 2 other identifiers: RC24_00362024-A02122-45
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnant Women

Keywords

outpatient labor induction; low-risk pregnant women; transcervical catheter

Outcome Measures

Primary Outcomes (1)

• compare the duration of induction and labor between outpatient and inpatient care.

  72 hours

Secondary Outcomes (5)

• 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 Outcomes (2)

• 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

Study Arms (3)

Outpatient

EXPERIMENTAL

patients randomized to this arm will go home until labour or 24 hours after balloon insertion

Other: Outpatient

Inpatient

ACTIVE COMPARATOR

patients randomized to this arm will stay at hospital

Other: Inpatient

observationnal study

NO INTERVENTION

patients refusing to be randomized will be able to enter this cohort without their care affecting the site's usual clinical practice

Interventions

Outpatient OTHER

Women return at home

Outpatient

Inpatient OTHER

Women stay at hospital

Inpatient

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female gender
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU de Nantes

Nantes, Loire Atlantique, 44093, France

Location

CHD Vendée

La Roche-sur-Yon, vendée, 85000, France

Location

MeSH Terms

Interventions

Inosine Monophosphate

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Vincent DOCHEZ, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MARION GAUTIER

CONTACT

+33253526204; marion.gautier@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: December 4, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-10

Locations

FR (2)