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临床试验/NCT02445261
NCT02445261已完成不适用

The Effects of Mobile Phone on Umbilical Artery Doppler and Fetal Cardiotogogrphy in Normal and Gowth Restricted Fetuses

Cairo University4 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
4
主要终点
umbilical artery doppler

研究概览

简要总结

Women were instructed not to use the mobile phones for 24 hours before carrying out the initial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG trace recording was done followed by umbilical artery Doppler ultrasound using high resolution ultrasound unit with 3-5 MHz transabdominal transducers (General Electric logic a500, logic a200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on the mother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. The umbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interference with the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetal heart rate (FHR) strips before and after the mobile phone use were blindly analyzed with respect to umbilical artery resistance indices (RI) and CTG parameters in terms of number of fetal kicks, absence of beat to beat variability, loss of accelerations and the appearance of spontaneous decelerations.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • aged 18 to 40 years pregnant between
  • singleton fetus
  • 32-38 weeks' gestation . They were classified into two groups. Group (A) included 120 women with normally growing fetuses. Group (B) included 70 women with growth-restricted fetuses.

排除标准

  • presence of medical disorders or obstetric complications (in group A), anomalous fetus and non-reactive fetal CTG in initial CTG trace severe oligohydramnios

研究组 & 干预措施

normal growth

Active Comparator

120 woman with normal fetal growth will be subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes. Umbilical artery (UA) Doppler ultrasound will be done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone. UA resistance indices, number of fetal kicks, the loss of acceleration and variability, and the appearance of decelerations were assessed

干预措施: mobile phone (Radiation)

growth restricted group

Active Comparator

70 woman with l growth restricted fetus will be subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes. Umbilical artery (UA) Doppler ultrasound will be done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone. UA resistance indices, number of fetal kicks, the loss of acceleration and variability, and the appearance of decelerations

干预措施: mobile phone (Radiation)

结局指标

主要结局

umbilical artery doppler

时间窗: 5 minutes after hanging up the mobile phone

次要结局

  • fetal heart rate tracing(10 minutes after phone is in the dialing mode for)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Assistant professor

Cairo University

研究点 (4)

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