Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term? (RE-DINO)

NCT02888041 Phase 3 TERMINATED

According perinatal surveys, induction of labor is performed at more than 20% of pregnant women. According to a survey on the trigger practices in France, prostaglandins are widely used to initiate cervical ripening, usually by laying intravaginal dinoprostone (Propess®). The overall work-up rate due to the use of a single Propess® is 74.6% with 80% of vaginal deliveries. Currently, 25.4% of patients who was not put in work after 24 hours are triggered by oxytocin (Syntocinon®) or directly caesarean. The initial installation of intravaginal dinoprostone limits the use of oxytocin (Syntocinon®) or in lower doses. Using a second Propess® is carried out in several maternity hospitals, as reported by the survey on the cervical ripening practices in France. This second administration could be the solution to reduce the rate of caesarean in France which amounted to 20.8%.

Details

Lead sponsor	University Hospital, Limoges
Phase	Phase 3
Status	TERMINATED
Enrolment	160
Start date	2016-12
Completion	2022-04-23

Conditions

• Cervical Ripening
• Pregnancy

Interventions

• Dinoprostone
• Oxytocine

Primary outcomes

• Rate of deliveries vaginally — At delivery
  The rate of births vaginally in each arm

Countries

France