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临床试验/NCT07336173
NCT07336173已完成不适用

Role of Uterine Artery Doppler Indices and Sonographic Measurement of Uterocervical Angle in Predicting Preterm Labor

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
Sensitivity, specificity and accuracy performance of uterine artery Doppler indices and uterocervical angle assed by ultrasound for prediction of preterm labor

研究概览

简要总结

The goal of this observational study is to evaluate the role of uterine artery doppler indices and uterocervical angle measurement in prediction of preterm labor .The main question it aims to answer is:

Does combination of both uterine artery doppler indices and uterocervical angle measurement increase sensitivity and specificity for prediction of established preterm labor ? Participants already performing uterine artery doppler as part of their regular antenatal care .measurement of anterior uterocervical angle will be added between 24 to 34 weeks gestation to predict preterm labor in candidates .

详细描述

In this study the aim is to evaluate the combined predictive value of both uterine artery doppler and uterocervical angle measurement in a prospective cohort study design to predict preterm labor . The abnormal mid-trimester uterine artery resistance, pulsatility index and diastolic notching measured with Doppler sonography is known to be predictive for preeclampsia and, hence, for iatrogenic Preterm labor. It will be measured via trans abdominal approach.

The measurement of UCA in the second trimester of pregnancy is strongly associated with the occurrence of spontaneous Preterm labor and will be measured via transvaginal approach .

Both measurement will be conducted between 24 to 34 weeks gestational .

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient who will give verbal & written will informed consent.
  • Pregnant women between 18 and 40 years old of age
  • Singleton pregnancy
  • Gestational age will be confirmed by first trimester ultrasound scan (<14 weeks).
  • Gestational age between 24 and 34 weeks .
  • Threatened preterm labor which is defined as:
  • Presence of at least one uterine contraction every 10 minutes lasting ≥30 seconds . Cervical dilatation ≤3 cm . Cervical effacement <80%.

排除标准

  • Ruptured membranes
  • Clinical evidence of Chorioamnionitis.
  • Fetal compromise on evaluation.
  • Severe obstetric complications (e.g., severe Preeclampsia, Eclampsia).
  • Diagnosed intrauterine growth restriction (IUGR).
  • Congenital fetal anomalies.
  • Multiple pregnancies.
  • Prior cervical surgery (e.g., cone biopsy, cerclage).
  • Non-Obstetric:
  • Significant maternal medical disorders (e.g., chronic hypertension, diabetes mellitus, liver dysfunction).
  • Severe non-obstetric complications (e.g., acute abdomen).

结局指标

主要结局

Sensitivity, specificity and accuracy performance of uterine artery Doppler indices and uterocervical angle assed by ultrasound for prediction of preterm labor

时间窗: From 24 to 34 weeks gestation

Its hypothesized that: Abnormal uterine artery Doppler indices and an abnormal (acute) uterocervical angle (\< 95°) are significant predictors of preterm labor. The combination of these two parameters will enhance the sensitivity and specificity of preterm labor prediction.

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

Nourhan Moustafa Elsayed Shalaby

Resident physician doctor

Kafrelsheikh University

研究点 (1)

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