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临床试验/NCT05672563
NCT05672563尚未招募不适用

Cesarean Scar Evaluation Using Saline Infusion Sonography in Women With Previous Pregnancy in Scar

Assaf-Harofeh Medical Center0 个研究点目标入组 40 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Uterine niche

研究概览

简要总结

Evaluation of cesarean scar using saline-infused sonography in women with history of cesarean scar pregnancy.

详细描述

Over the past few decades, cesarean delivery rates worldwide have risen considerably. The surgery may lead to deficient uterine scar healing, thinning of the myometrium and formation of cesarean scar defects or uterine scar niche. The prevalence of clinically relevant cesarean scar defects is unclear and has been reported between 20-88%, it is identified by using transvaginal ultrasound or saline-infused sonography in non-pregnant patients. Women may be asymptomatic or present a wide gynecologic sequela including cesarean scar pregnancy, abnormal uterine bleeding, dysmenorrhea, chronic pelvic pain, infertility, and increased risk of complications during gynecologic procedures such as uterine evacuation and insertion of intrauterine device.

Cesarean scar pregnancy (CSP) is defined as an early pregnancy implantation in the scar from a prior cesarean delivery. This pregnancy is implanted in a fibrous scar tissue and may lead to substantial risk for severe maternal morbidity such as adherent placenta, second or third trimester uterine dehiscence or rupture, severe maternal bleeding, and adherence to adjacent tissues. The prevalence of scar pregnancy is reported to be between 1:1800-2500 pregnancies, with increasing diagnosis in the last decade due to increasing use of transvaginal ultrasound early in pregnancy and possible increased physician awareness of this condition.

The ultrasound criteria for CSP have been redefined recently, and now propose transvaginal ultrasound as the imaging technique of choice at this early stage. In 2022, the Niche Task-force convened a Delphi consensus to develop a standardized sonographic evaluation and reporting system for a CSP in the first trimester. According to this consensus, CSPs were classified into three subgroups, Subgroup A in which the largest part of the gestational sac protruded towards the uterine cavity, subgroup B in which the largest part of the gestational sac was embedded in the myometrium, and subgroup C in which the gestational was partially located outside the outer contour of the cervix or uterus. This sonographic classification has yet to be validated clinically.

In the present report the investigators aim to evaluate the uterine cavity and potential cesarean scar defects or niche in women with history of CSP using saline infused sonography. In the second stage of the research, we will classify the past cesarean pregnancies according to the new Delphi criteria and examine correlation between the different CSP subgroups and presence of cesarean scar defects.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with history of cesarean scar pregnancy

排除标准

  • ongoing pregnancy
  • vaginal bleeding
  • active or suspected inflammation of genital tract including pelvic inflammatory disease
  • women engaged in unprotected intercourse
  • presence of intra-uterine device contraception

研究组 & 干预措施

women with previous CSP

Experimental

experimental: women with previous cesarean scar pregnancy that are invited to our unit for sonographic evaluation.

干预措施: Saline infusion sonography for evaluation of cesarean scar (Drug)

结局指标

主要结局

Uterine niche

时间窗: through study completion, an average of 6 months

Number of participants who underwent saline infused sonography and have evidence of cesarean scar defects/ uterine niche.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

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