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临床试验/NCT04399174
NCT04399174已完成不适用

3DPD of the Placenta in Fetal Growth Restriction

Benha University0 个研究点目标入组 200 人开始时间: 2016年12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
200
主要终点
vascularization index (VI)

研究概览

简要总结

: In this Prospective longitudinal observational study, two hundred pregnant women with singleton pregnancy from 11 up to 13 weeks with history of intrauterine growth restriction in a previous pregnancy underwent ultrasound assessment of gestational age , ultrasound assessment of uterine artery pulsatility index, placental volume by 3D ultrasound and placental vascularization by 3D power Doppler (3DPD).

详细描述

This Prospective longitudinal observational study was conducted at Benha University hospital starting from December 2016 to May 2019 after approval of faculty Research Ethics Board. Two hundred pregnant women with history of IUGR in previous pregnancy were recruited for the study after full explanation of the method, aim of work and obtaining consent. Inclusion criteria: singleton pregnancy from 11 up to 13 weeks. History of intrauterine growth restriction in previous pregnancy Exclusion criteria: Multiple pregnancies, Smoking women, and pre-existing medical disorders which may affect fetal growth e.g. hypertension, diabetes mellitus, thyroid dysfunction or renal impairment. Ultrasound evidence of congenital anomalies.

All women underwent ultrasound study which was performed by a member of ultra-sound unit (Volsun 730 pro V; G.E medical system), for assessment of: Gestational age confirmed by crown-rump length assessment, Uterine artery pulsatility index (angle of insonation is<50°, the sampling gate set at 2mm), 3D ultrasound assessment of Placental volume, 3DPD for assessment of placental vascularization. The examination was done with the patient in lithotomy position with slight left lateral tilting to avoid supine hypotension.

After visualization of the placental vasculature, 3D static power Doppler scanning was performed. After scanning the region of interest, placental volume was measured using the VOCAL rotational technique and VOCAL software (3D Sono View, GE Medical Systems, Milwaukee, WI, USA). After completing a full rotation, another analysis was performed using VOCAL Software (3D Sono View, GE Medical Systems, Milwaukee, WI, USA), which automatically calculates placental volume, vascularization index (VI), flow index (FI) and vascularization flow index(VFI). Low dose aspirin 75mg was described for all cases with the beginning of 2nd trimester.

All cases were having a second (between 20 to 24 weeks) and a third ultrasound assessment for exclusion of congenital malformation and assessment of fetal growth parameter and identification of IUGR cases (according to fetal growth curves). (Nicolaides KH et al., 2018). In order to avoid including healthy, yet constitutionally small for gestational age fetuses to the IUGR group, patients' data were included in the study only in cases of IUGR diagnosis confirmed after delivery.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • singleton pregnancy from 11 up to 13 weeks.
  • History of intrauterine growth restriction in previous pregnancy

排除标准

  • Multiple pregnancies,
  • Smoking women, and
  • pre-existing medical disorders which may affect fetal growth e.g. hypertension, diabetes mellitus, thyroid dysfunction or renal impairment.
  • Ultrasound evidence of congenital anomalies.

结局指标

主要结局

vascularization index (VI)

时间窗: 11-13 week

expressed as percentage, measures the number of colour voxels in the studied volume, representing the blood vessels within the tissue

placental volume

时间窗: 11-13 week

Assessment of placental volume.

uterine doppler

时间窗: 11-13 week

uterine artery pulsatility index

flow index (FI)

时间窗: 11-13 week

the average colour value of all colour voxels, representing average colour intensity.

vascularization flow index (VFI)

时间窗: 11-13 week

the average colour value of all grey and colour voxels, which represents both blood flow and vascularization

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

khalid mohammed salama

principal investigator

Benha University

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