Clinical trial NCT02888041: Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?
Official title: Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cervical Ripening
Pregnancy
Keywords: Cervical ripening
Pregnancy
Vaginal Administration
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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%.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of deliveries vaginally
timeFrame: At delivery
Secondary outcomes:
measure: Failure of induction of labor
timeFrame: At delivery
measure: Time of work
timeFrame: delivery time
measure: Caesarean indications
timeFrame: At delivery
measure: Proportion of instrumental delivery
timeFrame: At delivery
measure: Proportion of complications of delivery and various care.
timeFrame: Day 1
measure: Proportion of complete uterine rupture
timeFrame: At delivery
measure: Transfer in Intensive Care Unit
timeFrame: 10 Days
measure: Maternal death
timeFrame: 10 Days
measure: Hospital stay of mother
timeFrame: 10 Days
measure: Apgar score
timeFrame: 3 Min, 5 Min and 10 Min
measure: Visual estimation of presence of amniotic fluid meconium
timeFrame: At the birth
measure: Proportion of transfer neonatal or newborn intensive care unit
timeFrame: At the birth
measure: Fetal / neonatal death
timeFrame: At the birth
measure: Assessment of fetal acidosis by measuring of pH, lactates and base excess
timeFrame: At the birth
Other outcomes:
Locations:
city: Blois
country: France
facility: CH de Blois
city: Brive La Gaillarde
country: France
facility: CH de BRIVE
city: Chambéry
country: France
facility: CH Metropole Savoie
city: Clermont-ferrand
country: France
facility: Hôpital d'Estaing - CHU de Clermont-Ferrand
city: Limoges
country: France
facility: CHU de LIMOGES
city: Marseille
country: France
facility: Hôpital Nord - APHM
city: Tulle
country: France
facility: CH de TULLE
Study officials:
affiliation: University Hospital, Limoges
name: Perrine COSTE-MAZEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coste Mazeau P, Hessas M, Martin R, Eyraud JL, Margueritte F, Aubard Y, Sallee C, Sire F, Gauthier T. Is there an interest in repeating the vaginal administration of dinoprostone (Propess(R)), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial. Trials. 2020 Jan 8;21(1):51. doi: 10.1186/s13063-019-3985-0.