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

Phase 3

Terminated

• Conditions: Cervical Ripening; Pregnancy
• Interventions: Drug: Oxytocine; Drug: Dinoprostone

• Registration Number: NCT02888041
• Lead Sponsor: University Hospital, Limoges

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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Study Start: 2016-12
• Primary Completion: 2022-04-23
• Study Completion: 2022-04-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocine	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.
Dinoprostone	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.

Primary Outcome Measures

Name	Time	Method
Rate of deliveries vaginally	At delivery	The rate of births vaginally in each arm

Secondary Outcome Measures

Name	Time	Method
Transfer in Intensive Care Unit	10 Days	The transfer in Intensive Care Unit
Maternal death	10 Days	Maternal death
Apgar score	3 Min, 5 Min and 10 Min	Determination of Apgar score
Hospital stay of mother	10 Days	Hospital stay of mother
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.
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.
Caesarean indications	At delivery	Caesarean indications
Fetal / neonatal death	At the birth	Fetal / neonatal death
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.
Proportion of complete uterine rupture	At delivery	The proportion of complete uterine rupture
Proportion of transfer neonatal or newborn intensive care unit	At the birth	The proportion of transfer neonatal or newborn intensive care unit
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

Trial Locations

Locations (7)

CH de Blois; 🇫🇷 Blois, France

CH de BRIVE; 🇫🇷 Brive La Gaillarde, France

CHU de LIMOGES; 🇫🇷 Limoges, France

CH Metropole Savoie; 🇫🇷 Chambéry, France

Hôpital d'Estaing - CHU de Clermont-Ferrand; 🇫🇷 Clermont-ferrand, France

Hôpital Nord - APHM; 🇫🇷 Marseille, France

CH de TULLE; 🇫🇷 Tulle, France