Comparing the Efficiency of Cervical Ripening BALLoon (Cook) to the DINOprostone (Propess) for the Cervical Maturation in Case of Unfavorable Cervix (Bishop <6) in the Population of Obese Pregnant Women (BMI >= 30 kg/m²)

NCT02649920 | Terminated Results

• 1 other identifier: CHD019-15
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

At the moment in France, one delivery on four is induced for a medical indication. In this context, the practitioners are exposed to an additional difficulty when the clinical examination of the patient reveals a unfavorable cervix because the main drug used for the releases cannot be used and the cervix must be previously mature. There is a pharmacological method used and estimated in these indications of cervical maturation: the dinoprostone (Propess®). Other methods using a mechanical process, are under development and of evaluation as it is the case of the probe of dilation with double balloon (Cook®). The population of the obese women is a population in constant increase in France and presenting deliveries to higher risks of maternal and foetal complications. At these patients, the medicinal releases seem also more difficult and at greater risks of failures. The investigators wish compared the efficiency of the cervical ripening balloon to the dinoprostone within the framework of a medical indication in a release with a unfavorable cervix in obese pregnant women.

Conditions

Delivery

Keywords

unfavorable cervix; obese pregnant women

Outcome Measures

Primary Outcomes (1)

• Bishop Score After 24 Hours of Maturation

  24 hours

Study Arms (2)

Cervical ripening balloon

EXPERIMENTAL

Prospective

Device: Cervical ripening balloon

Dinoprostone

ACTIVE COMPARATOR

Retrospective

Drug: Dinoprostone

Interventions

Cervical ripening balloon DEVICE

Also known as: Cook

Cervical ripening balloon

Dinoprostone DRUG

Also known as: Propess

Dinoprostone

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Term ≥ 37 weeks of amenorrhea
• Singleton pregnancy
• Cephalic presentation
• Medical indication of release and unfavorable cervix (Bishop \<6)
• BM pre-pregnancy ≥ 30 kg/m2
• Having given their agreement for the participation of the study
• Patient receiving social coverage

You may not qualify if:

• Age \< 18 years
• Term \< 37 weeks of amenorrhea
• Multiple pregnancy
• Favorable cervix (Bishop ≥ 6)
• Contraindication of vaginal delivery: praevia placenta, transverse presentation, cord prolapse
• Evolutive urinary tract infection (positive urine dip: leukocytes/ nitrites)
• Not affiliated with a legal protection regime
• Patient trust, guardianship, under legal protection measure, deprived of freedom
• Balloon's contraindications:
• Abnormal pelvis structure
• Evolutive genital herpes
• Invasive cervical cancer
• Anomaly of foetal heart rate
• Breech presentation
• Maternal heart disorder

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (2)

Centre Hospitalier Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier

Le Mans, France

Location

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Guillaume DUCARME
• Organization: Centre Hospitalier Départemental Vendée

guillaume.ducarme@ght85.fr

02 51 44 61 61

Study Officials

• Guillaume DUCARME, PH

  Centre Hospitalier Departemental Vendee

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 8, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2024-03

Locations

FR (2)