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)

Delivery Clinical Trial

— BALLODINO  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02649920
• Other study ID #: CHD019-15
• Status: Terminated
• Phase: N/A
• First received: January 4, 2016
• Last updated: January 10, 2017
• Start date: June 2016
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delivery

Intervention

Device:
• Cervical ripening balloon

Drug:
• Dinoprostone

Locations

Country	Name	City	State
France	Centre Hospitalier Vendée	La Roche sur Yon
France	Centre Hospitalier	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bishop score after 24 hours of maturation		24 hours	No