Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT02649920
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02649920
Study Brief:
Protocol Section:
NCT02649920