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临床试验/NCT02969447
NCT02969447已完成4 期

Effect of Intra-venous Oxytocin Injection After Fetal Expulsion in Management of Third-stage of Labor After Second Trimester Medical Pregnancy Termination

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2016年10月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
27
试验地点
2
主要终点
Incidence of placental retention

研究概览

简要总结

Prospective randomized trail which compare 2 regimens for third-stage management after second trimester medical pregnancy termination : 10UI intra venous oxytocin or no additional medication after fetal expulsion. Primary outcome was the incidence of placental retention.

详细描述

Complication of third stage of labor in second trimester medical pregnancy termination is not well studied. Accord to publications, the placental retention rate is 30 to 40% in these situations. Placental retention may be associated with increased blood loss, increased requirement for blood transfusion anesthetic and operative complications, and infectious morbidity. The high incidence of retained placenta is an area of clinical concern. Publications reveal a wide variation in practices but there are only few studies about third stage of labor in second trimester medical pregnancy termination. The study is a prospective randomized trial. Two third stage management strategies are compared: 10 units of intra venous oxytocin (group 1) and no additional medication (group 2) after fetal expulsion. It concerns pregnancies between 14 and 28 weeks gestation.

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
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

入选标准

  • 18 years old and older
  • medical pregnancy termination between 14 and 28 weeks gestation
  • informed consent obtained

排除标准

  • less than 18 years old
  • refusal to consent
  • in utero fetal death

研究组 & 干预措施

Oxytocin administration after fetal expulsion

Experimental

Administration of 10 units of intra venous oxytocin after fetal expulsion

干预措施: Administration of 10 units of intra venous oxytocin after fetal expulsion (Drug)

结局指标

主要结局

Incidence of placental retention

时间窗: Up to 30 minutes after fetal expulsion

次要结局

  • Incidence of partial placental retention(Up to 1 hour after fetal expulsion)
  • Incidence of digital exploration(Up to 1 hour after fetal expulsion)
  • Incidence of blunt curettage(Up to 1 hour after fetal expulsion)
  • Incidence of post-partum hemorrhage(Up to 1 hour after fetal expulsion)
  • Blood loss(Up to 1 hour after fetal expulsion)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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