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临床试验/NCT03151915
NCT03151915已完成不适用

Neonatales Outcome Nach Intrauteriner Laserablation Mit 1.0mm-Optik Bei Fetofetalem Transfusionssyndrom

Michael Tchirikov MD, PhD1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Gestational Age at delivery

研究概览

简要总结

Twin-twin transfusion syndrome is one of the most severe complication in monochorionic twin pregnancies and can cause severe impairment of fetal and neonatal outcome. In severe TTTS the fetoscopic laser coagulation is the treatment of choice. Fetoscopic laser coagulation is associated with a morbidity and mortality due to iatronic rupture of membranes as well as iatrogenic placenta insufficiency. This can cause preterm delivery as well as intrauterine fetal demise. An adaption of the fetoscopic tools to reduce the lesions of the amniotic membrane can decrease the risk of PPROM and increase the overall survival.

详细描述

Twin-twin transfusion syndrome (TTTS) occurs in approximately 15% of monochorionic pregnancies. The disease is thought to result from unbalanced intertwin blood flow between the donor and the recipient twin through placental vascular anastomoses. Untreated, TTTS is associated with high perinatal mortality and morbidity.

Fetoscopic laser photocoagulation of the vascular anastomoses is currently the best treatment option for TTTS. The aim of laser surgery is to separate completely both fetal circulations by occluding all placental vascular anastomoses.

However, at the same time the fetoscopic procedure can cause injury to the amniotic membrane. This injury will last until childbirth, as the fetal membrane's capability to repair is restricted. This can lead to preterm premature rupture of membranes (PPROM) and in some cases even to fetal loss.

Decreasing the diameter of fetoscopic instruments can reduce injury to the amniotic membrane. At University Hospital Halle/Saale a new ultrathin fetoscpoes with 1.0/1.2 mm optic is used to reduce sheath sectional area from 3.8/4.3 mm (13F) to 2.3mm (7F).

In 2011 the author published a retrospective cohort study of the first results of laser coagulation using 1.0/1.2 mm optic on 27 female patients. The data was compared to the results using 2.0 mm optic on 53 female patients. The comparison brought to light that the survival rate of at least one twin was 97% (compared to 94.4% using classic optic) and 83.3% (75.5%) for both twins surviving. At the same time the use of the ultrathin optic increased the length of pregnancy by 21.3 days, increased the recipient's weight by 389g and also the donor's Apgar score.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Clinical diagnosis of TTTS
  • Ability to give informed consent in german or english

排除标准

  • Missing informed consent

结局指标

主要结局

Gestational Age at delivery

时间窗: at delivery

average gestational Age at delivery

postoperative neonatal survival

时间窗: 48 hours after fetoscopic surgery

rate of intrauterine demise until demission

Long term neonatal survival

时间窗: fetoscopic surgery until delivery

rate of fetal demise until delivery

次要结局

  • Premature rupture of membranes(48 hours after fetoscopic surgery)
  • Child's survival after fetoscopic laser coagulation(one minute after delivery)
  • Reoccurrence of TTTS after the procedure(48 hours after fetoscopic surgery)

研究者

发起方
Michael Tchirikov MD, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michael Tchirikov MD, PhD

Professor Dr. med.

Martin-Luther-Universität Halle-Wittenberg

研究点 (1)

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