Outpatient induction of labour with a double‑balloon transcervical catheter for low‑risk pregnant women
Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB
This trial will test whether starting cervical ripening at home with a double‑balloon catheter is as safe, acceptable, and time‑efficient as staying in hospital for low‑risk pregnant women due for induction of labour.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 2 sites (Nantes, Loire Atlantique and 1 other locations) |
| Trial ID | NCT07265518 on ClinicalTrials.gov |
What this trial studies
This is a two‑centre, open, randomized controlled trial comparing outpatient versus inpatient induction using a double‑balloon transcervical catheter in term, low‑risk singleton pregnancies. Participants are randomized to return home after catheter placement with planned follow‑up at the hospital, or to remain admitted for conventional inpatient induction. Primary outcome is duration of induction and labour; secondary outcomes include maternal satisfaction, maternal and neonatal morbidity and mortality, service organization impact, and a one‑month cost‑consequence analysis. Women who decline randomization are invited to an observational cohort to record reasons for refusal and measure maternal satisfaction.
Who should consider this trial
Good fit: Ideal candidates are term (≥37 weeks) low‑risk pregnant women with a singleton cephalic fetus, Bishop score <6, aged ≥18, with no major maternal or fetal pathology, who live within a 30‑minute drive and have a family member available at home.
Not a fit: Women with prior uterine surgery, ruptured membranes, fetal heart abnormalities, placenta previa/accreta, major maternal illness, or who live too far or lack home support are unlikely to benefit from outpatient induction.
Why it matters
Potential benefit: If successful, this approach could let eligible women start cervical ripening at home, reducing hospital time, improving comfort, and lowering costs without increasing harm.
How similar studies have performed: Previous trials and observational series have shown that outpatient cervical ripening with catheters can be feasible and have similar short‑term safety and patient satisfaction, but evidence is still limited and heterogeneous.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes, Loire Atlantique and 1 other locations
- CHU de Nantes — Nantes, Loire Atlantique, France (Recruiting)
- CHD Vendée — La Roche-sur-Yon, vendée, France (Recruiting)
Study contacts
- Principal investigator: Vincent DOCHEZ, Dr — Nantes University Hospital
- Study coordinator: Marion Gautier
- Email: marion.gautier@chu-nantes.fr
- Phone: +33253526204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.