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临床试验/CTRI/2024/04/065269
CTRI/2024/04/065269尚未招募2 期

Effect of artificial intelligence-based mobile application for lifestyle modification in prevention of Gestational diabetes mellitus among the high risk primigravida women in Central Referral Hospital of Gangtok, Sikkim

Binita Khati1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年12月2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
142
试验地点
1
主要终点
To find out the incidence of gestational diabetes mellitus.

研究概览

简要总结

The study "**Effect of artificial intelligence-based mobile application for lifestyle modification in prevention of Gestational diabetes mellitus among the high risk primigravida women in Central Referral Hospital of Gangtok, Sikkim"**is aimed to find out the incidence of gestational diabetes mellitus among high risk primigravida women. With GDM, the pregnancy results are obviously worse for both the mother and the newborn. Mothers’ knowledge of GDM and its potential morbid consequences is extremely low and could be a target area to enhance the result. Thus, this study will help in prevention of GDM using artificial intelligence based mobile application leading to decrease in adverse pregnancy outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
19.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Phase 1 ⮚ Women who are registered case in Central Referral hospital of Gangtok, Sikkim ⮚ Women who are primigravida.
  • ⮚ Primigravida women who are at 7weeks+ days of gestation.
  • ⮚ Primigravida who can speak, understand and write English, Nepali or Hindi ⮚ Primigravida women who can use android phone with mobile application.
  • Phase 2 ⮚ Primi gravida women who are at risk of gestational diabetes mellitus.

排除标准

  • Phase 1 ⮚ Primigravida women with any pre-existing medical condition ⮚ Primigravida women any Medical Legal Cases (MLC).
  • ⮚ Primigravida women not willing to give consent for the participation in the study.
  • Phase 2 ⮚ Antenatal women with any pre-existing medical condition.

结局指标

主要结局

To find out the incidence of gestational diabetes mellitus.

时间窗: 4 years

次要结局

  • maternal outcome:mode of delivery, nature of labour, postpartum haemorrhage. Fetal outcome: APGAR score, gestational age at birth, birth weight, levels of neonatal unit admission, neonatal glucose level, congenital malformation.(4 years)

研究者

发起方
Binita Khati
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Binita Khati

Sikkim Manipal College of Nursing

研究点 (1)

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