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临床试验/NCT03178682
NCT03178682已完成不适用

Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 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
入组人数
90
试验地点
1
主要终点
number of patients develops 1st trimester pregnancy loss

研究概览

简要总结

evaluation of the role of ultrasonographic parameters (mean gestational sac diameter, yolk sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in predicting early pregnancy failure in patients with recurrent pregnancy loss

详细描述

  1. Mean gestational sac diameter (MSD) is determined by measuring the mean of 3 diameters (longitudinal, antero-posterior and transverse) which are measured from inside of the sac excluding the decidual reaction from the measurement. It is normally eccentric in location embedded in endometrium, and has a smooth; round or oval shape.
  2. Yolk sac is measured by placing calipers on the inner limits of the longer diameter. It usually appears at the periphery of the gestational sac and should not be floating within the sac. Size of the sac, shape, echogenicity of the rim and center of sac, its number and degenerative changes such as calcification will be evaluated. YS having diameter between 3-7mm, rounded shape, absence of degenerative changes, presence of echogenic rim and hypoechoic center are considered normal. Any deviation from above parameters is considered abnormal.
  3. Crown-rump length (CRL) is the length of the embryo from the top of its head to bottom of torso excluding the yolk sac and the extremities, to be measured in sagittal plane of the embryo and recorded as an average of three measurements.
  4. The MGSD-CRL ratio was calculated as the difference between the MGSD and the CRL if less than 5 mm are prone to first trimester miscarriage.
  5. Embryonic heart rate by M-mode calculated as beat per minute using software of ultrasound machine after measuring by electronic calibers of distance between 2 heart waves on frozen M-mode image.
  6. Uterine artery Doppler with measurement of systolic/diastolic (S/D) ratio, resistance index (RI) and pulsatility index (PI) of uterine arteries.

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • A positive pregnancy test result.
  • Single intrauterine pregnancy.
  • Gestational age by last menstrual period of 6-10 weeks in patients with regular cycles and sure of her last menstrual period date.
  • History of recurrent pregnancy loss which is defined as three or more consecutive pregnancy losses.

排除标准

  • Women who are uncertain of her last menstrual period date.
  • Women with irregular menstrual cycles.
  • Multiple pregnancies

结局指标

主要结局

number of patients develops 1st trimester pregnancy loss

时间窗: within the first 13 weeks of pregnancy.

defined as a non-viable intrauterine pregnancy with either empty gestational sac or gestational sac containing embryo or fetus without fetal heart activity

次要结局

未报告次要终点

研究者

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

Radwa Rasheedy Ali

lecturer of obstetrics and gynecology

Ain Shams University

研究点 (1)

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