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 Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Delivery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cervical ripening balloon

Prospective

Group Type EXPERIMENTAL

Cervical ripening balloon

Intervention Type DEVICE

Dinoprostone

Retrospective

Group Type ACTIVE_COMPARATOR

Dinoprostone

Intervention Type DRUG

Interventions

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Cervical ripening balloon

Intervention Type DEVICE

Dinoprostone

Intervention Type DRUG

Other Intervention Names

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Cook Propess

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No