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临床试验/NCT04548102
NCT04548102已完成不适用

Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman: A Randomized Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月30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
100
试验地点
2
主要终点
Decreased fetal movement count

研究概览

简要总结

Up till now, there is insufficient evidence that daily fetal movement counting for pregnant women who are already have a history of high risk pregnancy is beneficial or not in term of early detection and preventing adverse pregnancy outcomes.

Aim The aim of the current study is to evaluate the effect of fetal movement counting on maternal and fetal outcome

详细描述

The researchers met the pregnant women in antenatal clinics during their routine follow up. Woman who was eligible to be recruited in the study signed the consent after description of the study's purpose. Pregnant women in the study group received verbal information regarding normal fetal movements (i.e. description of the changing pattern of movement as the fetus develops, normal sleep/wake cycles, and factors which may modify the mother's perception of movements such as maternal weight and placental position), and its importance to be followed during the third trimester. Further, each pregnant woman in the study group was trained how to count the fetal movement (i.e.lying down on her left side after taking her meal, and concentrating on fetal movements, calculate it three times per day, half an hour/ one time and record it in the chart). As a rule, if there are less than 10 movements felt in 2 hours, women should contact her health care provider immediately (Royal college of obstetrician & gynecologists, 2011). Fetal movements counting chart was provided and women telephoned once a week in order to ensure proper recording. They also asked to present the fetal movements' chart to the researcher and thier health care providers in each antenatal follow up visit. Pregnant women in both groups; the study and the control groups followed according to thier antenatal visits schedule till delivery. Women in the control group received the antenatal hospital standard care. The maternal and neonatal outcomes had been assessed at delivery unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Second gravida
  • Singleton
  • 28 weeks gestation
  • History of pregnancy induced hypertension (PIH)
  • History of premature rupture of membrane (PROM)
  • History of preterm labor
  • History of gestational diabetes
  • History of antepartum hemorrhage
  • History of stillbirth
  • History of fetal growth restriction

排除标准

  • History of psychological problems
  • Drugs abuse
  • Experience any terrible life events during the past 6 months
  • Oligohydramnios
  • Multi-fetal pregnancy
  • Fetal abnormalities

结局指标

主要结局

Decreased fetal movement count

时间窗: 37 weeks gestation

Mothers' self report

Intrauterine fetal death

时间窗: 37 weeks gestation

Antenatal follow up and examination

Still birth

时间窗: Within 24 hoursafter delivery

Deliver died fetus or died within 24hrs. after delivery

NICU admission

时间窗: 10 minutes after delivery

Newborn Apgar at fifth minutes less than 6

次要结局

  • Pregnancy complications(37 weeks gestation)
  • Delivery outcome(Immediatly after delivery)

研究者

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

Rania Mahmoud Abdel Ghani

Assisstant professor

Cairo University

研究点 (2)

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