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

Pregnancy Clinical Trial

— RE-DINO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02888041
• Other study ID #: I15014 (RE-DINO)
• Status: Terminated
• Phase: Phase 3
• Start date: December 2016
• Est. completion date: April 23, 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 161
• Est. completion date: April 23, 2022
• Est. primary completion date: April 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Ripening
• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CH de Blois	Blois
France	CH de BRIVE	Brive La Gaillarde
France	CH Metropole Savoie	Chambéry
France	Hôpital d'Estaing - CHU de Clermont-Ferrand	Clermont-ferrand
France	CHU de LIMOGES	Limoges
France	Hôpital Nord - APHM	Marseille
France	CH de TULLE	Tulle

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of deliveries vaginally	The rate of births vaginally in each arm	At delivery
Secondary	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
Secondary	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
Secondary	Caesarean indications	Caesarean indications	At delivery
Secondary	Proportion of instrumental delivery	The proportion of instrumental delivery	At delivery
Secondary	Proportion of complications of delivery and various care.	The proportion of complications of delivery and various care.	Day 1
Secondary	Proportion of complete uterine rupture	The proportion of complete uterine rupture	At delivery
Secondary	Transfer in Intensive Care Unit	The transfer in Intensive Care Unit	10 Days
Secondary	Maternal death	Maternal death	10 Days
Secondary	Hospital stay of mother	Hospital stay of mother	10 Days
Secondary	Apgar score	Determination of Apgar score	3 Min, 5 Min and 10 Min
Secondary	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
Secondary	Proportion of transfer neonatal or newborn intensive care unit	The proportion of transfer neonatal or newborn intensive care unit	At the birth
Secondary	Fetal / neonatal death	Fetal / neonatal death	At the birth
Secondary	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