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临床试验/NCT03473158
NCT03473158已完成不适用

Early Fetal Reduction Through a Transvaginal Ultrasound Guided Approach in Multifetal Pregnancies: Mechanical Disruption Against Potassium Chloride Injection. A Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Success of the procedure

研究概览

简要总结

In this study multifetal pregnancy reduction (to twins) will be carried out through a transvaginal route, at an early gestational age (6 weeks - 9weeks + 6days) using 2 methods: mere mechanical disruption against potassium chloride injection. The 2 methods will be compared regarding the efficacy, complications and pregnancy outcome.

详细描述

The incidence of multifetal gestations has increased dramatically over the past several decades. Multiple pregnancies are frequently complicated by maternal and fetal morbidities and mortalities. Data show that the incidence of morbidity and mortality correlate with fetal number. In the United Kingdom, the single embryo transfer policy has reduced the incidence of multifetal gestation. Also, in the United States the ASRM (American society of reproductive medicine) has revised the guidelines to optimize the number of transferred embryos during IVF. However in Egypt, transfer of 3 to 4 embryos is still practiced. The procedure of fetal reduction aims to decrease the occurrence of maternal and perinatal morbidities related to multifetal gestations. It can be carried out transvaginally or transabdominally under ultrasound guidance. It may be done by potassium chloride injection through needle injection, mere mechanical disruption by a needle, or by radiofrequency ablation. In this study multifetal pregnancy reduction will be carried out through transvaginal route, at an early gestational age (6 weeks - 9weeks + 6days), and compare the efficacy, complications and pregnancy outcome using mere mechanical disruption against potassium chloride injection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Pregnant women with multifetal pregnancy (3 fetuses or more)
  • Pregnant women from 6 weeks to 9 weeks + 6 days

排除标准

  • Pregnant women with singleton or twin pregnancy
  • Pregnant women before 6 weeks (higher incidence of spontaneous vanishing twin)
  • Pregnant women after 9 weeks + 6 days (the technique is difficult to apply)
  • Pelvic or genital infection
  • Hemorrhagic blood disease

结局指标

主要结局

Success of the procedure

时间窗: 5 minutes after the end of fetal reduction

Number of gestational sacs in which fetal heart activity will stop

次要结局

  • Fetal birth weight(On the same day of delivery)
  • Duration of the fetal reduction procedure(5 minutes after the end of the procedure when cessation of fetal heart is confirmed)
  • Gestational age at birth(On the same day of delivery)
  • Post-operative vaginal spotting or bleeding(within the first week of the procedure i.e. from the end of the procedure till 7 days after the procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed AA Wali, MD

Lecturer of Obstetrics and Gynecology

Cairo University

研究点 (2)

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