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)

Not Applicable

Terminated

• Conditions: Delivery
• Interventions: Drug: Dinoprostone; Device: Cervical ripening balloon

• Registration Number: NCT02649920
• Lead Sponsor: Centre Hospitalier Departemental Vendee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-08
• Study Start: 2016-06
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Results First Submitted: 2022-09-15
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Results First Posted: 2024-08-15
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dinoprostone	Dinoprostone	Retrospective
Cervical ripening balloon	Cervical ripening balloon	Prospective

Primary Outcome Measures

Name	Time	Method
Bishop Score After 24 Hours of Maturation	24 hours

Trial Locations

Locations (2)

Centre Hospitalier Vendée; 🇫🇷 La Roche sur Yon, France

Centre Hospitalier; 🇫🇷 Le Mans, France