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临床试验/NCT06403059
NCT06403059已完成不适用

Cervical Length and Uterocervical Angle as Predictors of Spontaneous Preterm Birth

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2023年10月15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
263
试验地点
1
主要终点
uterocervical angle

研究概览

简要总结

This prospective study was carried out on 263 pregnant females aged from 19 to 35 years old carrying singleton, and uncomplicated pregnancy. TVS examination was performed in all cases at 28 and 32 weeks of gestation. The pregnant women recruited in the study closely followed up to delivery. Maternal progesterone was given to all women with short CL (<20mm and more than 10mm) to support pregnancy.

详细描述

#Patients and Methods: This prospective cohort study was performed on 263 pregnant females aged from 19 to 35 years old carrying singleton, and uncomplicated pregnancy.

The study was done after approval from ethical committee. An informed written consent was obtained from the patient.

With aseptic measures and a high-frequency endo-vaginal 7.5 Hz. probe (GE Logiq P6), TVS examinations were done to all pregnant women. Dorsal lithotomy posture was applied to pregnant women who were instructed to evacuate their bladders. Without applying excessive pressure, the vaginal probe was inserted into the anterior fornix. At maximum magnification, a sagittal image of the cervix and anterior uterine wall was obtained. We identified the echogenic endocervical canal with the surrounded less echogenic cervical mucosa zone. The external os was noted at the junction of the cervix both anterior and posterior lips within the vaginal canal, but the internal os was situated at the end of the cervical mucosa in the lower uterine segment. CL and UCA were measured using the ultrasound's built-in angle caliper. The anterior UCA measurement involved calculating the angle formed by a line running through the cervix and another line along the lower front segment of the uterus, starting from the internal os. This was achieved by manually drawing two lines with the angle caliper: one connecting the internal and external os, and another extending from the internal os along the lower anterior uterine wall, up to a point 3 cm from the internal os.

The research involved close monitoring of pregnant participants up to the time of delivery. Demographics and pregnancy outcomes were collected and recorded. PTB was defined as delivery occurring before 37 complete weeks of gestation [9]. To support pregnancy, maternal progesterone was administered to all women with a short CL (less than 20mm but more than 10mm). In this study, cervical cerclage was not used in any case.

Sample Size Calculation:

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant 28 to 32 weeks

排除标准

  • additional signs of preterm labour in the mother
  • foetus, polyhydramnios,
  • multiple pregnancies,
  • a previous cervix operation,

结局指标

主要结局

uterocervical angle

时间窗: 28 and 32 weeks of gestation

TVS examination

cervical length

时间窗: 28 and 32 weeks of gestation

TVS examination

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

Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Beni-Suef University

研究点 (1)

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