临床试验/CTRI/2025/09/094131

CTRI/2025/09/094131尚未招募不适用

EFFECT OF ANTENATAL CORTICOSTEROIDS FOR FETAL LUNG MATURITY ON GLYCEMIC STATUS IN PREGNANT WOMEN- AN OBSERVATIONAL STUDY

NIL SPONSOR1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2025年10月9日最近更新: 2025年9月1日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 80
试验地点: 1
主要终点: 1 Change in maternal glycemic levels after ACS

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

In my study i will be including antenatal mothers including both Gestational diabetic and Non diabetic and are receiving corticosteroids indicated for development of fetal lung maturity and will monitor their CBG values at regular intervals to evaluate the impact of steroids in maternal glycemic variations and also effectively manage the rise in blood glucose values

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: Female

入选标准

•1 Age 18-45 yrs.
•2 Gestational age between 28 – 36 weeks.
•3 Planned for administration of antenatal corticosteroids.
•4 Willing to undergo Glycemic monitoring and provide informed consent.

排除标准

•1 Diabetic ketoacidosis 2 Women for whom the prescribed course of corticosteroid cannot be completed ( eg active labour).
•3 Suspected chorioamnionitis .
•4 Chronic steroid therapy or conditions requiring long-term steroid use.
•5 Severe maternal comorbidities (e.g., renal or hepatic dysfunction.

结局指标

主要结局

1 Change in maternal glycemic levels after ACS

时间窗: BASELINE | DAY 1 | DAY 3

2 Duration and persistence of hyperglycemia

时间窗: BASELINE | DAY 1 | DAY 3

3 Comparison between diabetic and non diabetic women

时间窗: BASELINE | DAY 1 | DAY 3

次要结局

1 Proportion of diabetic AND non diabetic women requiring insulin or OHA post ACS(2 Risk factors associated with persistent or severe hyperglycemia)

研究者

发起方

NIL SPONSOR

申办方类型

Private medical college

责任方

Principal Investigator

主要研究者

UMAPRIYA C

MGMCRI

研究点 (1)

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