跳至主要内容
临床试验/NCT04512820
NCT04512820已完成不适用

Embryoscopic Evacuation of Early Missed Abortion Using the TRUCLEAR Hysteroscopic Morcellator System a Feasibility Study

Assuta Ashdod Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年3月5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
10
试验地点
1
主要终点
Number of cases with retained products of conception following the procedure

研究概览

简要总结

the Aim of this study is to prospectively study the feasibility of evacuation of products of conception (POC) in missed miscarriages up to 10 weeks using the TRUCLEAR tissue removal system in order to achieve targeted treatment under direct vision of the POC and thus potentially reducing the risk of complications and intrauterine adhesions

详细描述

Embryoscopy and fetoscopy had been used increasingly in the treatment of missed abortions in the last two decades. This is done simply by transcervical hysteroscopy during pregnancy. The fact that we can directly view the embryo in the gestational sack allows us to document and describe the fetal morphology and to note different anatomical malformations. Phillips et al. described in 2001 the use of embryoscopy prior to evacuation of the uterus in early missed abortions in order to diagnose anatomical malformations and to allow sampling of the fetal tissues for genetic testing. This group also demonstrated that patients with repeated pregnancy loss are more likely to have morphologically normal embryos and less aneuploidy in cytogenetic analysis. The use of fetal tissue obtained in embryoscopy allows for more accurate genetic testing and diagnosis and reduces the number of maternal cells in the specimen.

Hysteroscopic morcellation had been used for intrauterine tissue extraction for over 20 years. Hysteroscopic morcellators have been shown to allow for rapid and complete resection of polyps, fibroids, uterine septa, and retained products of conception. These instruments use a rotating blade and a suction system that allows for the removal of the specimen under direct hysteroscopic visualization. When compared with standard resectoscopic technique, the use of hysteroscopic morcellators probably saves time and allows for more complete removal of the specimen.

Use of the hysteroscopic morcellator for resection of the fetal tissue in early missed abortions might prove beneficial over the standard blind Dilatation and curettage currently used to treat this condition. This technique might allow selective targeting of the fetal tissue thus decreasing the damage caused by trauma to the entire uterine cavity. In a recent systematic review the rate of intrauterine adhesions following D&C for missed abortions ranged between 16 to 21 percent. This technique was assessed in one case for a woman with previous Ashreman's syndrome and was found to be feasible although the authors state that visibility was poor while resecting the implantation site due to high vascularization.

The primary aim of the current study is to assess the feasibility of embryolysis - resection of an early missed abortion with the Truclear 8 mm hysteroscopic morcellator.

Secondary aims include the rate of complications, incomplete removal and intrauterine adhesions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Patients with missed miscarriage up to 10 weeks from the last menstrual period
  • Patients are able to provide written consent
  • Patients with no underlying medical conditions

排除标准

  • Inability to consent due to cognitive or language barrier
  • Any underlying medical condition requiring medical treatment
  • Documented failed hysteroscopy prior to the current referral
  • Inability to consent due to cognitive or language barrier
  • Uterine malformations or fibroids
  • Previous cesarean section

结局指标

主要结局

Number of cases with retained products of conception following the procedure

时间窗: immediate - during the procedure

Number of cases in which the procedure could not be completed using under vision hysteroscopic morcellation

次要结局

  • number of complications according to Dindo-Clavien scale(within six weeks from the procedure)
  • incomplete removal(within 8 weeks)

研究者

发起方
Assuta Ashdod Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验