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

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%.

Study Overview

• Status: Terminated
• Conditions: Pregnancy; Cervical Ripening
• Intervention / Treatment: Drug: Dinoprostone; Drug: Oxytocine

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Blois, France, 41250
    • CH de Blois
  • Brive La Gaillarde, France, 19100
    • CH de Brive
  • Chambéry, France, 73011
    • CH Metropole Savoie
  • Clermont-ferrand, France, 63100
    • Hôpital d'Estaing - CHU de Clermont-Ferrand
  • Limoges, France, 87045
    • CHU de Limoges
  • Marseille, France, 13015
    • Hôpital Nord - APHM
  • Tulle, France, 19012
    • CH de Tulle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Perrine COSTE-MAZEAU, MD, University Hospital, Limoges

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): April 23, 2022
• Study Completion (Actual): April 23, 2022

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Cervical ripening; Vaginal Administration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: I15014 (RE-DINO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No