跳至主要内容
临床试验/NCT01297439
NCT01297439终止不适用

CONTRADYS : A Randomized Controlled Trial of a New Prophylactic Maneuver, the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 1,538 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1,538
试验地点
2
主要终点
occurrence of shoulder dystocia

研究概览

简要总结

Shoulder dystocia is a major obstetric emergency defined as a delivery requiring maneuver in addition to downward traction on the fetal head for delivery of the shoulders. Shoulder dystocia is a major obstetrical complication, occurring in approximately 0.2 to 3% of deliveries, principally due to fetal macrosomia. The obstetrical and neonatal complications associated with shoulder dystocia include newborn mortality occurring in 21 to 290 per 1000 deliveries, generalized asphyxia, fractures, neurological damages (brachial plexus injury) and hematoma. The objective of this study was to evaluate the "pushing" maneuver, that is performed gently on the fetal head since the crowning of the head (appearance of the fetal scalp at the introitus between pushes), aiming to facilitate the anterior shoulder to slip off behind the symphysis pubis, reducing thus the risk of shoulder dystocia. This preventive maneuver may reduce the power (energy/time unit) exerted on the perineal tissues and give the shoulders time to enter the pelvic cavity. The "pushing" maneuver will be evaluated in comparison with either an expectative attitude or a suctioning of fetal nose and mouth.

详细描述

Hypothesis: the "pushing" maneuver reduces of 50% the risk of shoulder dystocia in comparison with either an expectative attitude or a suctioning of fetal nose and mouth.

Main objective: to assess whether prophylactic use of the "pushing on the fetal head" maneuver decreases the prevalence of shoulder dystocia, in comparison with an expectative attitude or a suctioning of fetal nose and mouth.

Secondary objective: to compare the occurrence of neonatal complications including brachial plexus injury, clavicle and humerus fracture, hematoma and generalized asphyxia.

Main criterion: occurrence of shoulder dystocia, defined by a necessity of requiring a specific obstetrical maneuver (McRoberts' maneuver).

Secondary criterion: neonatal complications including neurological damages (brachial plexus injury), generalized asphyxia, hematoma, clavicle and humerus fractures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women having completed 37 or more gestational weeks with singleton vertex fetus, delivering vaginally

排除标准

  • patients with caesarean section are excluded

结局指标

主要结局

occurrence of shoulder dystocia

时间窗: during delivery

shoulder dystocia is defined as a necessity of requiring a specific obstetrical maneuver (McRoberts' maneuver).

次要结局

  • complications(5 days after delivery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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