Outpatient induction of labour with a double‑balloon transcervical catheter for low‑risk pregnant women
Official title: Outpatient Induction of Labour Using a Double Balloon Transcervical Catheter in Low-risk Pregnant Women: a Two-centre Open Prospective Randomised Controlled Trial - OutCRIB
Run by Nantes University Hospital · NCT07265518 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 258 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 2 sites (Nantes, Loire Atlantique and 1 other locations) |
| Status | Recruiting |
| Started | April 30, 2026 |
| Main results expected | January 15, 2028 |
| Study ends | January 15, 2028 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07265518 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.