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临床试验/NCT05355038
NCT05355038已完成不适用

Effect of Lifestyle Modification on Pregnancy Outcomes for Pregnant Women With Gestational Diabetes: an Evidence Based.

Cairo University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年11月11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
150
试验地点
2
主要终点
effect of lifestyle modification among GDM on pregnancy outcome

研究概览

简要总结

Effect of lifestyle modification on pregnancy outcome for pregnant women with GDM

详细描述

evaluate the effect of lifestyle modification on pregnancy outcome among GDM women.

Primary outcomes: excessive gestational weight gain, uncontrolled blood glucose level, PIH, polyhydromnios, oligohydrominos, recurrent monilia infection and urinary tract infection , intra uterine fetal death (IUFD), intra uterine growth restriction (IUGR), premature preterm rupture of membrane and Diabetic ketoacidosis.

Secondary outcomes: preterm labor, caesarian section, neonatal hypoglycemia, stillbirth, respiratory distress syndrome, small for gestational age (SGA), large for gestational age (LGA) ,neonatal intensive care unit (NICU) and failure to initiate or maintain breast feeding.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

control group were in the first 3 day of week (saturday ,sunday ,monday) study group were in the 2nd three day of week(tuesday, wednsday,thursday)

入排标准

年龄范围
19 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women diagnosed with GDM

排除标准

  • pre-gestational diabetes type 1 or type 2 diabetes mellitus, diagnosed as pregnancy induced hypertension before GDM

结局指标

主要结局

effect of lifestyle modification among GDM on pregnancy outcome

时间窗: from 28 weeks of gestational until the first 24hours postpartum

change blood glucose level (fasting blood sugar (FBS) and random blood sugar (RBS) measured with digital blood glucose monitoring by using test strips; HA1C and urine analysis done in the laboratory and get the result)

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

Basma Said Mahmoud Elgamasy

assistant lecture in maternal and newborn health nursing

Cairo University

研究点 (2)

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