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临床试验/NCT00120042
NCT00120042已完成不适用

Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption

The University of Western Australia1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2005年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
251
试验地点
1
主要终点
Placental Retention Rate

研究概览

简要总结

Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness. This process is usually conducted medically in Australia, using the prostaglandin E1 analogue misoprostol. This prostaglandin, although not specifically licensed for use in pregnancy termination, is now a common abortifacient with a lot of accumulated experience both within Australia and internationally.

Since 1996, misoprostol, a synthetic prostaglandin, has been used at King Edward Memorial Hospital as the principal agent for second trimester pregnancy termination. This agent is administered vaginally, and in its current form and dosage regimen results in 75-80% of women delivering within 24 hours. As experience with this agent has grown, it has been observed that in approximately 40% of women the placenta is either completely retained or incompletely delivered, necessitating operative removal and an increased potential for maternal blood loss. In this study, it is planned, in a randomized controlled clinical trial, to evaluate three regimens for the management of placental delivery in women undergoing second trimester pregnancy interruption. The primary intention of this study is to develop a third stage management protocol to reduce the incidence of placental retention in second trimester medical pregnancy termination.

The secondary aim of this study is to assess the ultrasound appearance of the uterus and its cavity within 24 hours of second trimester pregnancy termination. The ultrasound appearances of the uterus following second trimester pregnancy loss have not been previously investigated in detail. Previous ultrasound studies of the term postpartum uterus have demonstrated a high incidence of echogenic material within the uterine cavity soon after an uncomplicated vaginal delivery. These findings have been of concern as the ultrasound appearances may erroneously imply a need for operative intervention. The investigators wish to ascertain if this high incidence of echogenic tissue presence is also true in the second trimester. Ultrasound is frequently used by clinicians to define placental completeness and the potential requirement for surgical curettage. The data from this single sonographic examination of the uterus will provide baseline data for a planned longitudinal study of uterine appearances following second trimester pregnancy loss and their correlation with clinical symptoms.

详细描述

Methods:

All women who are admitted to King Edward Memorial Hospital for Women for pregnancy interruption for severe fetal anomaly or maternal pregnancy complications between 14 and 24 weeks gestation will be invited to participate in the study. No women with an intrauterine fetal demise will be recruited due to the potential confounding effects of the fetal death on the placental separation process.

Once consent has been obtained, the women will be randomised to three placental management strategy groups:

Group 1: Standard management protocol; Group 2: Oxytocin protocol; Group 3: Oral misoprostol protocol.

Group 1:

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
16 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Abortion at 14-24 weeks gestation
  • Live fetus
  • Medical termination with vaginal misoprostol

排除标准

  • Surgical termination
  • Gestation less than 14 weeks or greater than 24 weeks

研究组 & 干预措施

2

Active Comparator

Intramuscular oxytocin injection

干预措施: Oxytocin (Drug)

3

Active Comparator

Oral misoprostol to assist in placental delivery

干预措施: Misoprostol (Drug)

结局指标

主要结局

Placental Retention Rate

时间窗: 3 years

If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.

次要结局

  • Post-Delivery Blood Loss(3 years)
  • Endometrial Appearances Postpartum(3 years)

研究者

申办方类型
Other

研究点 (1)

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