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

Study Overview
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Brief Summary
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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%.

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

Conditions
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Cervical Ripening, Pregnancy

Intervention / Treatment
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* Drug: Dinoprostone
* Drug: Oxytocine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dinoprostone<br>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. | Drug: Dinoprostone<br>* 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.<br>|
| Active Comparator: Oxytocine<br>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. | Drug: Oxytocine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of deliveries vaginally | The rate of births vaginally in each arm | At delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of induction of labor | The failure of induction of labor correspond to cervical dilation remaining <3cm despite 6 hours of Syntocinon (or 1 syringe) and regular uterine contractions and amniotomy. The success of the trigger is defined by regular uterine contractions and cervical dilatation ≥ 3 cm. | At delivery | 
| Time of work | Time in minutes between the start of work defined by the onset of regular uterine contractions and cervical dilation ≥3 cm and delivery. | delivery time | 
| Caesarean indications | Caesarean indications | At delivery | 
| Proportion of instrumental delivery | The proportion of instrumental delivery | At delivery | 
| Proportion of complications of delivery and various care. | The proportion of complications of delivery and various care. | Day 1 | 
| Proportion of complete uterine rupture | The proportion of complete uterine rupture | At delivery | 
| Transfer in Intensive Care Unit | The transfer in Intensive Care Unit | 10 Days | 
| Maternal death | Maternal death | 10 Days | 
| Hospital stay of mother | Hospital stay of mother | 10 Days | 
| Apgar score | Determination of Apgar score | 3 Min, 5 Min and 10 Min | 
| Visual estimation of presence of amniotic fluid meconium | Visual estimation of presence of meconium in amniotic fluid. Absence of meconium if transparent and presence if colored. | At the birth | 
| Proportion of transfer neonatal or newborn intensive care unit | The proportion of transfer neonatal or newborn intensive care unit | At the birth | 
| Fetal / neonatal death | Fetal / neonatal death | At the birth | 
| Assessment of fetal acidosis by measuring of pH, lactates and base excess | Assessment of fetal acidosis by measuring of pH, lactates and base excess | At the birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical ripening, Vaginal Administration, Pregnancy