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临床试验/NCT06452017
NCT06452017已完成不适用

Effects of Telerehabilitation Exercise Program on Maternal Antenatal Glycemic Control in Women With Gestational Diabetes.

Riphah International University4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月10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
70
试验地点
4
主要终点
HbA1c: Glycated hemoglobin

研究概览

简要总结

Gestational diabetes is in which high blood glucose concentration results from body's inability to create enough insulin to fulfil the needs of pregnancy. It appears in week between 24 to 28 and and raises the mothers and Childs risk of problems. It is thought to affect about 1 in 7 pregnancies worldwide. Through these remote exercise sessions the study evaluates the effectiveness of tele rehabilitation in improving glycemic management during pregnancy.The results will help clarify how telehealth intervention can best support GDM patient's maternal health outcomes.

详细描述

Literature suggests that hormonal changes during pregnancy can interfere with insulin, the hormone that regulates blood glucose.This excess glucose can cross the placenta, affecting the developing fetus and increasing risks for both mother and child. The rising trends in obesity and advanced maternal age suggest that the prevalence of GDM will continue to increase.Approximately 7-10% of pregnancies worldwide are affected by gestational diabetes.Managing glucose levels is critical for women with gestational diabetes to ensure a healthy pregnancy and reduce the risk of complications for both mother and baby. Developing a positive attitude towards exercise is important for helping people with gestational diabetes manage their condition effectively through physical activity. The use of telerehabilitation may improve blood glucose levels in participants with GDM.

The control group will receive routine medical care and the experimental group will receive structured telerehabilitation exercise protocol. The results of both groups will be recorded and compared to assess the effectiveness of using telerehabilitation in the treatment of women with GDM in improving maternal blood glucose level.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 20 to 35 years
  • Gestational age between 20-28weeks
  • diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT)
  • Primigravida and multigravida
  • able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness.
  • Patients or caregivers have and able to use an electronic device (PC, tablet or smartphone)
  • Who signed informed consent

排除标准

  • Previously diagnosed T1DM or T2DM
  • High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines
  • Patients taking insulin regularly.
  • Patients with fetal anomalies diagnosed at 20 th week.
  • Multiple gestation (twin or triplets)

结局指标

主要结局

HbA1c: Glycated hemoglobin

时间窗: Baseline to 12th week

This test provides an estimate over average blood glucose level over past two to three months. It is a critical clinical marker used to assess long-term blood sugar control in individuals with diabetes. It measures the percentage of hemoglobin in the blood that has glucose attached to it.

Blood sugar fasting

时间窗: Baseline to 2nd,4th,6th and 8th week

It is a diagnostic tool to assess person bloods sugar control and screen for diabetes and pre diabetes, is a fundamental measure of blood glucose levels in a fasting state, typically measured after an overnight fast. It provides insights into a person's current blood sugar status and is often used for diagnosing and monitoring diabetes.

Blood sugar random

时间窗: Baseline to 2nd,4th,6th and 8th week

Random blood sugar, is a fundamental measure of blood glucose levels after a meal, it will be done 2 hours postprandial.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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