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Study identifier: NCT07265518 Synced from ClinicalTrials.gov · July 29, 2026
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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

Condition: Pregnant Women  ·  Sponsor: Nantes University Hospital

PhaseNA
Planned participants258
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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. T…

This description comes directly from the study's public registry record.

Talk to the study team

MARION GAUTIER  ·  +33253526204  ·  marion.gautier@chu-nantes.fr

Always discuss trial participation with your own doctor first.

Locations (2)

CHU de NantesNantes, Loire Atlantique, FranceRecruiting
CHD VendéeLa Roche-sur-Yon, vendée, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT07265518