Delivery
Conditions
Keywords
unfavorable cervix, obese pregnant women
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.
Interventions
DRUGDinoprostone
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bishop Score After 24 Hours of Maturation | 24 hours |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervical Ripening Balloon Prospective
Cervical ripening balloon | 2 |
| Dinoprostone Retrospective
Dinoprostone | 0 |
| Total | 2 |
Baseline characteristics
| Characteristic | Cervical Ripening Balloon | Total |
|---|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 2.12 | 26.5 years STANDARD_DEVIATION 2.12 |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Bishop Score After 24 Hours of Maturation
Time frame: 24 hours
Population: Data were not collected.