Clinical trial NCT02649920: 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)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Delivery
Keywords: unfavorable cervix
obese pregnant women
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bishop Score After 24 Hours of Maturation
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Vendée
city: Le Mans
country: France
facility: Centre Hospitalier
Study officials:
affiliation: Centre Hospitalier Departemental Vendee
name: Guillaume DUCARME, PH
role: STUDY_DIRECTOR
References: