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) (BALLODINO)

January 10, 2017 updated by: Centre Hospitalier Departemental Vendee

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)

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.

Study Overview

Status

Terminated

Conditions

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Vendée
      • Le Mans, France
        • Centre Hospitalier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervical ripening balloon
Prospective
Other Names:
  • Cook
Active Comparator: Dinoprostone
Retrospective
Other Names:
  • Propess

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bishop score after 24 hours of maturation
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Guillaume DUCARME, PH, Centre Hospitalier Départemental Vendée

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CHD019-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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