RE-DINO: Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?
Study Details
Study Description
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%.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dinoprostone 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
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.
|
| Active Comparator: Oxytocine 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
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.
|
Outcome Measures
Primary Outcome Measures
- Rate of deliveries vaginally [At delivery]
The rate of births vaginally in each arm
Secondary Outcome Measures
- Failure of induction of labor [At delivery]
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.
- Time of work [delivery time]
Time in minutes between the start of work defined by the onset of regular uterine contractions and cervical dilation ≥3 cm and delivery.
- Caesarean indications [At delivery]
Caesarean indications
- Proportion of instrumental delivery [At delivery]
The proportion of instrumental delivery
- Proportion of complications of delivery and various care. [Day 1]
The proportion of complications of delivery and various care.
- Proportion of complete uterine rupture [At delivery]
The proportion of complete uterine rupture
- Transfer in Intensive Care Unit [10 Days]
The transfer in Intensive Care Unit
- Maternal death [10 Days]
Maternal death
- Hospital stay of mother [10 Days]
Hospital stay of mother
- Apgar score [3 Min, 5 Min and 10 Min]
Determination of Apgar score
- Visual estimation of presence of amniotic fluid meconium [At the birth]
Visual estimation of presence of meconium in amniotic fluid. Absence of meconium if transparent and presence if colored.
- Proportion of transfer neonatal or newborn intensive care unit [At the birth]
The proportion of transfer neonatal or newborn intensive care unit
- Fetal / neonatal death [At the birth]
Fetal / neonatal death
- Assessment of fetal acidosis by measuring of pH, lactates and base excess [At the birth]
Assessment of fetal acidosis by measuring of pH, lactates and base excess
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient who is >=18 years.
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Term pregnancy > 37 weeks
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Induction of labor in progress, medically indicated
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Patients who have had the establishment of a first Propess®, within 24 to 36 hours (before signing the consent)
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Cephalic presentation
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Unfavorable cervical conditions (Bishop score <6) 1 hour prior to inclusion
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Intact Membranes
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Affiliated with a social security system
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Having signed the consent form.
Exclusion Criteria:
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Multiple pregnancy
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Uterus scar
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Contraindications to epidural anesthesia
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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).
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Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
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Contraindications to vaginal delivery (placenta previa, previa obstacle ...)
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Premature Rupture of Membranes (PROM)
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Intra Uterine Growth Retardation (IUGR) <3rd percentile
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Macrosomia> 97th percentile
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Severe Impaired fetal heart rate
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In Utero Fetal Death (IUFD)
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Medical Termination of pregnancy or lethal fetal pathology
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Patient under guardianship or trusteeship safeguard justice
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CH de Blois | Blois | France | 41250 | |
| 2 | CH de BRIVE | Brive La Gaillarde | France | 19100 | |
| 3 | CH Metropole Savoie | Chambéry | France | 73011 | |
| 4 | Hôpital d'Estaing - CHU de Clermont-Ferrand | Clermont-ferrand | France | 63100 | |
| 5 | CHU de LIMOGES | Limoges | France | 87045 | |
| 6 | Hôpital Nord - APHM | Marseille | France | 13015 | |
| 7 | CH de TULLE | Tulle | France | 19012 |
Sponsors and Collaborators
- University Hospital, Limoges
Investigators
- Principal Investigator: Perrine COSTE-MAZEAU, MD, University Hospital, Limoges
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I15014 (RE-DINO)