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临床试验/CTRI/2024/04/066137
CTRI/2024/04/066137尚未招募不适用

Association of severity of Anemia with 5 min Heart Rate Variability in pregnant females of second trimester at tertiary care hospital of West India

Government Medical College1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
To correlate heart rate variability with severity of anemia in second trimester pregnant participants having anemia.

研究概览

简要总结

q  Previous study show reduced HRV in all three trimester of pregnancy compared to normal starting from first trimester itself.

q Anemia can also call for sympathetic overactivity to meet circulatory demand and severity of Anemia can have graded worsening of HRV.

q  In light of this, we intend to study HRV in second trimester pregnant female in relation to anemia and its severity.

q It can suggest whether cardiac Autonomic Imbalance is linked with severity of anaemia or not.

●Study design:  A cross-sectional study

●Study Population : Pregnant (13-28 weeks of gestation) Women with a Singleton , Live fetus with recent hemogram coming to Ob-Gy OPD

●Study setting: Department of Ob-Gy.

●Study Duration : 6 months (4+2)

●Duration of Data collection : 4 months

●Sample size: 80 Case and  40 Control (Raosoft sample size calculator)

●Sampling method: convenient sampling

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

  • Case : Pregnant (13-28 weeks of gestation) Women with a Singleton , Live fetus with anaemia Control : Non-Anaemic Pregnant (13-28 weeks of gestation) women with a Singleton , Live fetus.

排除标准

  • Any medical condition (such as hypertension , gestational diabetes mellitus, or any other chronic medical illness) complicating pregnancy ECG showing Irregular rhythm Participant with pacemaker Participant with Cardio-vascular intervention.

结局指标

主要结局

To correlate heart rate variability with severity of anemia in second trimester pregnant participants having anemia.

时间窗: At baseline

次要结局

  • To compare heart rate variability among second trimester pregnant participants with anemia & normal second trimester pregnant females.(At baseline)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rinkal Chavda

Government Medical College Bhavnagar

研究点 (1)

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