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OpenTrials
Completed

NCT Number: NCT01711060

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

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.

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Key information

Conditions

Scarred Uterus

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service Gynécologie Obstétrique, Angoulême, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

balloon catheter

Procedure

Primary outcomes

  1. Rate of childbirth by low way

    The childbirth by low way being considered as a success of the treatment

Secondary outcomes

  1. Rate of incidence of materno-fœtales morbidity

    number

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
First posted
Oct 22, 2012
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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