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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2026-05-07

No results posted yet for this study

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

Interventions

OTHER

Outpatient

Women return at home

OTHER

Inpatient

Women stay at hospital

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Vincent DOCHEZ, Dr · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-01-15
Completion
2028-01-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07265518 on ClinicalTrials.gov