- ICH GCP
- US Clinical Trials Registry
- 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) (BALLODINO)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
La Roche sur Yon, France, 85925
- Centre Hospitalier Vendée
-
Le Mans, France
- Centre Hospitalier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
Active Comparator: Dinoprostone
Retrospective
|
Other Names:
|
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
Investigators
- Study Director: Guillaume DUCARME, PH, Centre Hospitalier Départemental Vendée
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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.
Clinical Trials on Delivery
-
Rambam Health Care CampusRecruitingCesarean Delivery Affecting Fetus | Delivery ComplicationIsrael
-
Alzahraa Ismail Ragheb GodaUnknownDelivery ,Complications,Maternal | Delivery,Complication,FetalEgypt
-
The Reading Hospital and Medical CenterRecruitingPregnancy Related | Cesarean Delivery Affecting Fetus | Delivery ComplicationUnited States
-
Charite University, Berlin, GermanyCompletedCesarean Section Complications | Cesarean Delivery Affecting Newborn | Cesarean Delivery Affecting FetusGermany
-
Centre Hospitalier René DubosCompleted
-
University Hospital, CaenCompleted
-
Hadassah Medical OrganizationUnknown
-
Oslo University HospitalVestre Viken Hospital Trust; Helse Stavanger HF; Haukeland University Hospital; Sorlandet Hospital HF and other collaboratorsCompletedDelivery Complication | Induced; Birth | Indications for Care in Pregnancy; Labor; and DeliveryNorway
-
Kayseri Education and Research HospitalCompletedInflammation | Delivery | Cesarean Delivery
Clinical Trials on Dinoprostone
-
Cairo UniversityCompletedDinoprostone TimingEgypt
-
Seoul National University HospitalCompletedNulliparous Women Who Scheduled for Labor InductionKorea, Republic of
-
Università degli Studi di BresciaCompletedLabor, Induced | Cervical RipeningItaly
-
Intermountain Health Care, Inc.Ferring PharmaceuticalsTerminatedInduction of Labor Affected Fetus / NewbornUnited States
-
Hospital Universitario 12 de OctubreInstituto de Salud Carlos III; Spanish Clinical Research Network - SCReNRecruitingFetal Growth RetardationSpain
-
Mednax Center for Research, Education, Quality...Completed
-
Weill Medical College of Cornell UniversityCompletedCervical Ripening | Labor InductionUnited States
-
Zeynep Kamil Maternity and Pediatric Research and...CompletedEarly Amniotomy, Unfavorable CervixTurkey
-
Cairo UniversityCompletedIntrauterine DeviceEgypt
-
Cairo UniversityUnknown