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)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Bishop Score After 24 Hours of Maturation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cervical ripening balloon
Prospective
干预措施: Cervical ripening balloon (Device)
Dinoprostone
Retrospective
干预措施: Dinoprostone (Drug)
结局指标
主要结局
Bishop Score After 24 Hours of Maturation
时间窗: 24 hours
次要结局
未报告次要终点