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A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01711060
Enrollment
204
Registered
2012-10-22
Start date
2010-12-31
Completion date
Unknown
Last updated
2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scarred Uterus

Brief summary

Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended. Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women. But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score \<4). The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method). The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.

Interventions

DRUGoxytocin

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years

Inclusion criteria

* Pregnancy over 37 weeks * Singleton pregnancy * Vertex presentation * Previous caesarean section with unique Transversal segmentary incision * Medical indication of induction of labor * Unfavorable cervix with Bishop score \< 4 * No Premature Rupture Of Membranes * Informed consent

Exclusion criteria

* Before 18 years old * Placenta Praevia * Premature Rupture Of Membranes * Uterine scar other than transversal segmentary incision * Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis * Multiple pregnancy * Fetal malpresentation * Cesarean indication * Latex allergy * No informed consent

Design outcomes

Primary

MeasureTime frameDescription
Rate of childbirth by low wayThe childbirth by low way being considered as a success of the treatment

Secondary

MeasureTime frameDescription
Rate of incidence of materno-fœtales morbiditynumber

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026