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临床试验/CTRI/2024/07/071107
CTRI/2024/07/071107尚未招募2 期

Effect Of High Intensity Breastfeeding Practices With Structured Exercise On Blood Glucose For Postpartum Mothers With Gestational Diabetes Mellitus

Sharulatha N1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年8月6日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Blood glucose level glucose tolerance test

研究概览

简要总结

Individuals will be selected for the study based on the inclusion and exclusion criteria

The study will be clearly explained in patient words and an informed consent will be obtained

The sociodemographic details such as name, age, occupation, education status, menstrual history, comorbidities, medical history, BMI, etc. will be collected.

The Gestational diabetes postpartum mothers are selected by doing a pre test of glucose tolerance test (GTT) to check the sugar level and noted.

Then, high intensity breast feeding assessment was done by interviewing using breastfeeding stages and the first 3 stages are considered as high intensity breastfeeding mothers.

The mothers are differentiated by high intensity breast feeding and non high intensity breastfeeding both mothers are included and then separated.

A structured exercise program for GDM postpartum mother was done, then 2 Intervention group and 1 control group

According to randomized control trail, participant 1 will be in first group, 2 will be in second group and 3 will be in third group

This procedure will be continued for all the 90 participants.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Diagnosed case of gestational diabetes mellites in postpartum Age– above 18 Early postpartum 6 to 12 weeks High intensity breast feeding mother included on self-reported breastfeeding stages Both high intensity breastfeeding and non high intensity breastfeeding are included.

排除标准

  • chronic diseases like heart disease, respiratory disease Pelvic disease and infection Subjects with neuromuscular disease- myasthenia gravis, inherited neuropathies and myopathies chronic autoimmune diseases Non breastfeeding mothers Participant not willing to participate.

结局指标

主要结局

Blood glucose level glucose tolerance test

时间窗: pre test | post test after the duration of 4th week | post test after the duration of 8th week

次要结局

  • Edinburgh postnatal depression scale
  • Pittsburg Sleep Quality Index questionnaire(pretest)

研究者

发起方
Sharulatha N
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sharulatha N

SRM College Of Physiotherapy, SRM Institute of Science and Technology

研究点 (1)

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