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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

RecruitingNAAges 18 Years - anyFemaleNantes University Hospital
NCT07265518 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 w

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📋 Eligibility rules (as published)
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
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What it tests

  • Outpatient
  • Inpatient
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Where

2 sites
CHU de Nantes
Nantes, France
CHD Vendée
La Roche-sur-Yon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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