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

University of Limoges (UL)

Status and phase: Terminated; Phase 3

Conditions: Cervical Ripening; Pregnancy

Treatments: Drug: Oxytocine; Drug: Dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT02888041

I15014 (RE-DINO)

Details and patient eligibility

About

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%.

Enrollment: 160 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient who is >=18 years.
• Term pregnancy > 37 weeks
• Induction of labor in progress, medically indicated
• Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent)
• Cephalic presentation
• Unfavorable cervical conditions (Bishop score <6) 1 hour prior to inclusion
• Intact Membranes
• Affiliated with a social security system
• Having signed the consent form.

Exclusion criteria

• Multiple pregnancy
• Uterus scar
• Contraindications to epidural anesthesia
• Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins Adverse effects appeared in the first Propess®: anaphylactic shock, disseminated intravascular coagulation (DIC).
• Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
• Contraindications to vaginal delivery (placenta previa, previa obstacle ...)
• Premature Rupture of Membranes (PROM)
• Intra Uterine Growth Retardation (IUGR) <3rd percentile
• Macrosomia> 97th percentile
• Severe Impaired fetal heart rate
• In Utero Fetal Death (IUFD)
• Medical Termination of pregnancy or lethal fetal pathology
• Patient under guardianship or trusteeship safeguard justice

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Dinoprostone

Experimental group

Description:

In case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10 mg), patients receive a second Propess®, followed by Oxytocin 5U.I/ml (Syntocinon®) (if necessary) and epidural analgesia if desired by the patient.

Treatment:

Drug: Dinoprostone

Oxytocine

Active Comparator group

Description:

In case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10mg), patients receive directly Oxytocin 5U.I/ml (Syntocinon®) and epidural analgesia if desired by the patient.

Treatment:

Drug: Oxytocine