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临床试验/CTRI/2025/07/090915
CTRI/2025/07/090915尚未招募不适用

Correlation of HbA1C and fasting blood sugar with birth weight in non diabetic pregnancy

Department of Obsterics and Gynaecology Dr RML Hospital Rachna1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2025年7月27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
175
试验地点
1
主要终点
To find out the correlation between maternal HbA1c and fasting blood sugar with birth weight in non-diabetic pregnant women.

研究概览

简要总结

All consecutively registered in the antenatal clinic at <12 weeks , non diabetic women will be evaluated  by detailed  history taking and examination as per attached  proforma. The patients will be recruited according to the inclusion and exclusion criteria after obtaining their written informed consent . After 8 hours of fasting , 4 mL blood will be drawn from the antecubital vein. Of which , 2 mL will be collected into a EDTA vial for HbA1c  and  2ml will be collected into a grey vial (Sodium fluoride ) for fasting blood sugar . The women will be followed up in the antenatal clinic till delivery as per the hospital protocol. At  20-24 weeks and 32-36 weeks, 4 mL blood will be drawn from the antecubital vein for for HbA1c and for fasting blood sugars . At  the time of delivery, pregnancy outcome including neonatal birth weight will be recorded as follows :

Primary Outcome – Birth weight

Secondary Outcome – Gestational age at delivery, mode of delivery, APGAR, admission in NICU.

The collected data will be entered in Microsoft Excel and then will be analysed and statistically evaluated using SPSS-v23 version. Normality of each variable will be assessed by using the Kolmogorov-Simirnov test. Quantitative data will be expressed by mean, standard deviation or median with interquartile range and depends on normal distribution, groups will be tested by student t test or Mann Whitney U test. Qualitative data will be expressed in percentage and difference between the proportions will be tested by chi square test or Fisher’s exact test.

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

  • Singleton, primigravida, low risk females , 18-35 years of age.

排除标准

  • 未提供

结局指标

主要结局

To find out the correlation between maternal HbA1c and fasting blood sugar with birth weight in non-diabetic pregnant women.

时间窗: At delivery .

次要结局

  • To find out the association between maternal HbA1c & fasting blood sugar with mode of delivery , APGAR , gestational age at delivery & NICU admission of baby in pregnant women.

研究者

发起方
Department of Obsterics and Gynaecology Dr RML Hospital Rachna
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rachna

Dr. Ram Manohar Lohia Hospital

研究点 (1)

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