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

Scarred Uterus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711060
• Other study ID #: CICATAC
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: October 10, 2016
• Start date: December 2010

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. primary completion date: January 2014
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Cicatrix
• Scarred Uterus

Intervention

Drug:
• oxytocin

Procedure:
• balloon catheter

Locations

Country	Name	City	State
France	Service Gynécologie Obstétrique	Angouleme
France	Service Gynécologie Obstétrique	Bressuire
France	Service Gynécologie Obstétrique	Chatellerault
France	Service Gynécologie Obstétrique	Nancy
France	Service Gynécologie Obstétrique et médecine de la reproduction	Poitiers
France	Service Gynécologie Obstétrique	Rennes
France	Service Gynécologie Obstétrique	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of childbirth by low way	The childbirth by low way being considered as a success of the treatment
Secondary	Rate of incidence of materno-fœtales morbidity	number