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临床试验/CTRI/2024/03/064501
CTRI/2024/03/064501尚未招募不适用

COMPARISON OF FOETAL MYOCARDIAL PERFORMANCE INDEX IN WOMEN WITH AND WITHOUT GESTATIONAL DIABETES MELLITUS

Vasudha Singal1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Myocardial performance index in gestational diabetes group and euglycemia group

研究概览

简要总结

The research will take place on pregnant women between 32-36 weeks of gestation.Foetal myocardial performance index shall be compared between women with and without gestational diabetes mellitus. The pregnancy will be managed as per established hospital protocols. The study will continue till the discharge of mother and baby from hospital.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Maternal age between 18-35 years Singleton live fetus Between 32-36 period of gestation.

排除标准

  • Maternal hypertensive disease Any chronic disease Known structural or chromosomal anomaly in the fetus.
  • Cardiac heart rate abnormalities Foetal growth restriction Tocolytic therapy Betamethasone administration.

结局指标

主要结局

Myocardial performance index in gestational diabetes group and euglycemia group

时间窗: At 32-36 weeks of gestation

次要结局

  • Neonatal hypoglycemia(During hospital stay of neonate)
  • 5 min Apgar less than 7(At the time of birth of baby)
  • Cord pH less than 7.2(At the time of birth of baby)
  • Neonatal polycythemia(During hospital stay of neonate)
  • Neonatal hyperbilirubinemia(During hospital stay of neonate)
  • Need for neonatal resuscitation(At time of birth of baby)
  • NICU stay(During hospital stay of baby)

研究者

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

Vasudha Singal

ABVIMS and Dr RML Hospital

研究点 (1)

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