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临床试验/NCT03399006
NCT03399006Unknown不适用

Combined 3D Power Doppler Placental Volume and Vascular Flow Indices In the First Trimester of Pregnancy Could be a Specific Screening Toll in the Early Prediction Of Preeclampsia?.

Cairo University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Development of preeclampsia

研究概览

简要总结

200 women at risk factor for preeclampsia will be subjected to transabdominal Doppler ultrasonography for assessment of placental volume measurements, pulasatility index (PI) and resistivity index (RI) in both uterine arteries, and assessment of the placental volume and its vascular indices (VI, FI, VFI)

详细描述

Ultrasonography assessment: Woman underwent an abdominal ultrasonographic examination including color-Doppler techniques at the period of 11-14 weeks of gestations to assess the following data:

  • Gestational age was determined from the onset of the last normal menstrual period; measurements of fetal crown-rump length (CRL) were done to confirm the fetal gestational age.
  • The fetal viability and careful search for any fetal abnormalities present.
  • The measurement of the pulsatility index (PI), the resistance index (RI) in the uterine arteries both on the left and right side, detection for the presence of notch and determine whether it is unilateral or bilateral.
  • The time of examination was approximately 20 minutes.
  • The ultrasound equipment used for both abdominal sonography and color Doppler technique was GE ultrasound machine (model?? ) equipped with pulsed and color Doppler options was used with the probe frequency of 7 MHz.

Trans-abdominal ultrasound examination was performed with the woman placed in a recumbent or semi recumbent position & carried out for measurement of fetal CRL and diagnosis of any major fetal defects and measurement of UtA-PI & UtA-RI. A sagittal section of the uterus was obtained For the Doppler studies, and the cervical canal and internal cervical os were identified. The transducer was gently tilted from side to side and color flow mapping was used to identify each UtA along the side of the cervix and uterus at the level of the internal os.

the sampling gate set at 2mm to cover the whole vessel and care was taken to ensure that the angle of insonation was less than 60◦. When three similar consecutive waveforms had been obtained the UtA-PI and UtA-RI were measured, and the mean UtA-PI and UtA-RI of the left and right arteries were calculated.

Uterine artery Doppler was obtained with the patient in a semirecumbent position following a previously described technique [14]. A sagittal view of the uterus and of the cervical canal was obtained and color flow mapping was used to identify the uterine arteries coursing along the side of the cervix and uterus. The pulsed Doppler sample volume was placed on the ascending branch of the uterine artery closest to the internal os. The pulsatility index (PI = S _ D/M) was measured on three consecutive waveforms and the mean value between the left and right arteries was calculated. The presence of an early diastolic notch in the waveforms was recorded. An abnormal value was considered a mean PI greater than 2.36 corresponding to the 95th centile of a cross-sectional study on 3045 pregnancies

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 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy.
  • Familial history of preeclampsia as it has agenetic predisposition.
  • Regular menstrual cycles before pregnancy.
  • Females had preeclampsia in a previous pregnancy.
  • Gestational diabetes or essential hypertension or chronic nephritis with pregnancy" they will be seen between 11 - 14 weeks' of gestation

排除标准

  • Cases with fetal anomalies.
  • Dead fetuses

结局指标

主要结局

Development of preeclampsia

时间窗: 28 to 38 weeks of gestational age

Preeclampsia was defined as a blood pressure 140/90 mmHg and proteinuria of 300 mg in 24 hours, or two readings of at least 2+ on dipstick analysis of midstream urine specimens if no 24-hour urine collection was available in absence of urinary tract infection

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

Ahmed Maged

professor

Cairo University

研究点 (1)

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