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临床试验/NCT03081754
NCT03081754已完成不适用

Study of Placental Bed of Growth Restricted Fetuses: Correlation of Doppler Velocimetries of Uterine and Umbilical Arteries With Placental Pathology

Ahmed Maged1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Doppler correlation with placental pathology

研究概览

简要总结

When indicated, a conservative management plan of IUGR was undertaken. Doppler studies were performed within the last week before delivery The results of Umbilical artery (UA) Doppler velocimetry were categorized as normal , increased , absent, and reversed . Patients were admitted for close surveillance in the case of worsening of maternal or fetal conditions (e.g. absent or reversed UA blood flow, and severe preeclampsia).

Tissue samples The general shapes of placentas were assessed. The collected placentas were weighed by trimming the membranes and umbilical cord. Then the diameters and thickness of placentas were noted. The position of insertion of umbilical cord on the fetal surface of placenta was observed. Transverse cuts were made through the maternal surface at a distance of 1-2 cm in bread loaf manner and examined for the pale areas. All placentas were immersed in 10% formalin overnight and examined on the next day. For each placenta, blocks containing cord, membrane and full thickness of villous tissue were prepared. Whole thickness villous tissue blocks were obtained from three zones, i)central zone ii) peripheral zone and iii) intermediate zone between the first two zones, so as to include all areas of placenta.

Placental bed biopsies were obtained at Caesarean sections with direct visualization of the placental site. Biopsies of at least 1cm were taken. The specimens were fixed in buffered formalin. The tissues were processed and stained with Haematoxlyin and Eosin. Microscopic study of placenta was carried out utilizing a set of standard criteria for villous and intervillous lesions

Immunohistochemistry Expression of VEGF and CD34 was analyzed in 75 (50 placenta of IUGR and 25 of control) placental villous tissues.

Immunostaining was performed by the streptavidin-biotin-peroxidase method. Evaluation of immunohistochemical staining To determine the MVD, the stained placental vasculature. Tissue sections were initially screened microscopically at low power (100×) to identify the areas of highest vascularization ("hot spots").

Evaluation of immunohistochemical staining of VEGF:

详细描述

When indicated, a conservative management plan of IUGR was undertaken according to a defined protocol including antenatal visits, ultrasound surveillance. The frequency of fetal surveillance was assessed at each visit according to the maternal and fetal conditions.

Doppler studies were performed within the last week before delivery using a 3.5-Mhz transducer, color-flow mapping, and a 50-Hz high-pass filter; all measurements were performed with the mothers in a semi recumbent position. Color-flow imaging was used to visualize the ascending branch of the uterine arteries. Pulsed Doppler velocimetry was performed with a sample volume of 5 mm.

A minimum of three separate recordings was taken for each examination. The wave contour of the uterine arteries was studied for the presence of a diastolic notch from which the systolic/end-diastolic (S/ D) ratio was calculated. Abnormal uterine velocimetry was defined as an average of (left and right) S/ D ratio and by the bilateral presence of diastolic notching. Umbilical artery waveform was measured from free-floating loop of cord during fetal quiescence. The pulsatility index (PI) (maximum velocity - minimum velocity/ mean velocity) was calculated and the average of three measurements was used. An abnormal umbilical artery PI was defined as standard deviations above the mean for gestational age based reference standards (Chitty and Altman, 1999).

The results of Umbilical artery (UA) Doppler velocimetry were categorized as normal (end-diastolic velocity <90th percentile of our reference curve), increased (end-diastolic velocity ≥90th percentile), absent, and reversed (Madazil R et al., 2002) Patients were admitted for close surveillance in the case of worsening of maternal or fetal conditions (e.g. absent or reversed UA blood flow, and severe preeclampsia). Preeclampsia was defined according to standard criteria (Arduini D et al, 2002).

Tissue samples The general shapes of placentas were assessed. The collected placentas were weighed by trimming the membranes and umbilical cord. Then the diameters and thickness of placentas were noted. The position of insertion of umbilical cord on the fetal surface of placenta was observed. Transverse cuts were made through the maternal surface at a distance of 1-2 cm in bread loaf manner and examined for the pale areas. All placentas were immersed in 10% formalin overnight and examined on the next day. For each placenta, blocks containing cord, membrane and full thickness of villous tissue were prepared. Whole thickness villous tissue blocks were obtained from three zones, i)central zone ii) peripheral zone and iii) intermediate zone between the first two zones, so as to include all areas of placenta.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Pregnant women with gestational age 28-34 weeks fetal growth below 5th percentile

排除标准

  • Pregnancies with known vascular maternal disease (chronic hypertension, autoimmune diseases, and diabetes) fetuses with structural abnormalities twins

结局指标

主要结局

Doppler correlation with placental pathology

时间窗: at delivery

次要结局

未报告次要终点

研究者

发起方
Ahmed Maged
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Maged

Assistant professor

Cairo University

研究点 (1)

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