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

NCT02888041 | Terminated Phase 3 DMC

• 1 other identifier: I15014 (RE-DINO)
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 7

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%.

Conditions

Cervical Ripening; Pregnancy

Keywords

Cervical ripening; Pregnancy; Vaginal Administration

Outcome Measures

Primary Outcomes (1)

• Rate of deliveries vaginally

  The rate of births vaginally in each arm

  At delivery

Secondary Outcomes (14)

• Failure of induction of labor

  At delivery

• Time of work

  delivery time

• Caesarean indications

  At delivery

• Proportion of instrumental delivery

  At delivery

• Proportion of complications of delivery and various care.

  Day 1

Study Arms (2)

Dinoprostone

EXPERIMENTAL

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

Oxytocine

ACTIVE COMPARATOR

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

Interventions

Dinoprostone DRUG

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.

Dinoprostone

Oxytocine DRUG

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.

Oxytocine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Intact Membranes
• Affiliated with a social security system
• Having signed the consent form.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (7)

CH de Blois

Blois, 41250, France

Location

CH de BRIVE

Brive-la-Gaillarde, 19100, France

Location

CH Metropole Savoie

Chambéry, 73011, France

Location

Hôpital d'Estaing - CHU de Clermont-Ferrand

Clermont-Ferrand, 63100, France

Location

CHU de LIMOGES

Limoges, 87045, France

Location

Hôpital Nord - APHM

Marseille, 13015, France

Location

CH de TULLE

Tulle, 19012, France

Location

Related Publications (1)

• 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.

  PMID: 31915047 DERIVED

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Perrine COSTE-MAZEAU, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 2, 2016
• Study Start: December 1, 2016
• Primary Completion: April 23, 2022
• Study Completion: April 23, 2022
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)