Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies

PHASE3CompletedINTERVENTIONAL
Enrollment

1,224

Participants

Timeline

Start Date

January 27, 2017

Primary Completion Date

December 12, 2018

Study Completion Date

December 12, 2018

Conditions
Prolonged Pregnancy
Interventions
DEVICE

Mechanical cervical ripening

"The mechanical cervical ripening is a double transcervical balloon. The device used in the study is the Cook® Cervical Ripening Balloon with CE marked (commercialized by the Cook® laboratory, ref JCRBS-184000). It is a silicone double balloon catheter. Maximum balloon inflation is 80 mL/balloon.~It will be used in accordance with user manual"

DRUG

Pharmacological cervical ripening

"The comparative pharmacological procedure is a vaginal slow releasing system of dinoprostone. The form used in the study is Propess (Ferring pharmaceuticals) containing 10mg of dinoprostone (prostaglandin E2).~It will be used in accordance with Summary of Product Characteristics"

Trial Locations (14)

13008

Hopital Saint Joseph, Marseille

14033

CHU CAEN, Caen

37044

Chru Tours, Tours

42270

Chu Saint Etienne, Saint-Priest-en-Jarez

44093

Chu Nantes, Nantes

51092

Chu Reims, Reims

63001

Chu Clermont-Ferrand, Clermont-Ferrand

85925

Ch Departemental Vendee, La Roche-sur-Yon

95303

Ch Pontoise, Cergy-Pontoise

Unknown

Chu Brest, Brest

Ch Chartres, Chartres

Chi Poissy, Poissy

Chu Rennes, Rennes

Chu Toulouse, Toulouse

All Listed Sponsors
lead

University Hospital, Tours

OTHER

NCT02907060 - Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies | Biotech Hunter | Biotech Hunter