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BALLODINO: 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)

Sponsor
Centre Hospitalier Departemental Vendee (Other)
Overall Status
Terminated
CT.gov ID
NCT02649920
Collaborator
(none)
2
Enrollment
2
Locations
2
Arms
5
Duration (Months)
1
Patient Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot, Comparative, Not Randomized, Two Centers Study 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)
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cervical ripening balloon

Prospective

Device: Cervical ripening balloon
Other Names:
  • Cook

    		•
    Active Comparator: Dinoprostone

    Retrospective

    Drug: Dinoprostone
    Other Names:
  • Propess

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bishop score after 24 hours of maturation [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    • Hydramnios

    • Serious and uncontrolled arterial high blood pressure

    • Rupture of membranes

    • Medical histories of hysterotomy, classic uterine section, myomectomy or quite different uterine section of full thickness

    • Presentation above superior pelvic strait

    Dinoprostone's contraindications:

    • Scarred uterus

    • Prostaglandin's hypersensitivity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Vendée La Roche sur Yon France 85925
    2 Centre Hospitalier Le Mans France

    Sponsors and Collaborators

    • Centre Hospitalier Departemental Vendee

    Investigators

    • Study Director: Guillaume DUCARME, PH, Centre Hospitalier Departemental Vendee

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Departemental Vendee
    ClinicalTrials.gov Identifier:
    NCT02649920
    Other Study ID Numbers:
    • CHD019-15
    First Posted:
    Jan 8, 2016
    Last Update Posted:
    Jan 11, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by Centre Hospitalier Departemental Vendee
    unfavorable cervix
    obese pregnant women
    Additional relevant MeSH terms:
    Dinoprostone

    Study Results

    No Results Posted as of Jan 11, 2017