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

Poitiers University Hospital

Status

Completed

Conditions

Scarred Uterus

Treatments

Drug: oxytocin

Procedure: balloon catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT01711060

CICATAC

Details and patient eligibility

About

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.

Enrollment

204 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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