NCT07265518 Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB
| NCT ID | NCT07265518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Pregnant Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2028-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 258 participants in total. It began in 2026-04-30 with a primary completion date of 2028-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Vincent DOCHEZ, Dr
PRINCIPAL INVESTIGATOR
Nantes University Hospital
Frequently Asked Questions
Who can join the NCT07265518 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnant Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07265518 currently recruiting?
Yes, NCT07265518 is actively recruiting participants. Contact the research team at marion.gautier@chu-nantes.fr for enrollment information.
Where is the NCT07265518 trial being conducted?
This trial is being conducted at Nantes, France, La Roche-sur-Yon, France.
Who is sponsoring the NCT07265518 clinical trial?
NCT07265518 is sponsored by Nantes University Hospital. The principal investigator is Vincent DOCHEZ, Dr at Nantes University Hospital. The trial plans to enroll 258 participants.