Is there an interest in repeating the vaginal administration of dinoprostone ( Propess® ) , to promote cervical ripening of pregnant women at term?

Phase 1

• Conditions: cervix ripening; MedDRA version: 19.0Level: PTClassification code 10073175Term: Induction of cervix ripeningSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2016-000147-13-FR
• Lead Sponsor: CHU de LIMOGES

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-22
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

- Age = 18 years.
- Term pregnancy> 37 weeks
- Current Trigger 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), one hour before inclusion
- Intact membranes
- Affiliated with the French social security system
- Having signed the consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Multiple pregnancy
- Uterus scar
- Contraindications to epidural anesthesia
- Contraindications to Propess®: recent history of pelvic inflammatory disease; hypersensitivity to prostaglandins
- Contraindications to Syntocinon: Hypersensitivity to oxytocin, cardiovascular disorders and severe toxemia of pregnancy.
- Contraindications to vaginal delivery
- Premature Rupture of Membranes (PROM)
- Intra Uterine Growth retardation (IUGR) < 3rd percentile
- Macrosomia > 97th percentile
- Impaired fetal heart rate
- Fetal Death In Utéro (IUFD)
- Patient under guardianship, curatorship or safeguard justice

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate, if cervical ripening failure by a first Propess®, the laying of a second Propess® (followed if necessary by oxytocin (Syntocinon®)) increases the rate of births vaginally by compared to the direct injection of oxytocin (Syntocinon®).;Secondary Objective: 1. Comparison of the proportion trigger failure<br>2. Assessment and comparison of maternal morbidity and mortality <br>3. Assessment and comparison of fetal morbidity and mortality;Primary end point(s): The rate of vaginal deliveries.;Timepoint(s) of evaluation of this end point: At the delivery