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临床试验/CTRI/2022/05/042722
CTRI/2022/05/042722尚未招募不适用

“Clinico-Laboratory profile and pregnancy outcome among women withsevere anemia - An observational studyâ€

JIPMER1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年5月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
JIPMER
入组人数
160
试验地点
1
主要终点
Biochemical and hematological

研究概览

简要总结

Anemia is one of the most common nutritional deficiency disorders affecting the pregnant women in the developing countries. The causes of anemia are broadly attributed to nutritional deficiencies, infections (malaria, HIV and hookworm infestation) and genetic disorders, particularly the hemoglobinopathies, beta thalassemia and sickle cell anemia.Globally, iron deficiency accounts for the highest cause of anemia (63%), followed by thalassemia trait (5.4%), malaria (4%) and sickle cell trait (2.2%). India has a dual burden of nutritional anemia and haemoglobinopathies.

Although anemia is highly prevalent in our country, the schematic evaluation, investigation and typing of anemia is not routinely practiced.  The pregnant women are covered with iron supplements still the prevalence of anemia is higher. This warrants the need for identification of the other underlying nutritional deficiencies, prevalent inherited or acquired causes of anemia.

The study will aim at analyzing the various causes of severe anemia in the Southern part of India and thereby aid in the prompt evaluation, prevention and treatment of the disease condition.The pregnant women diagnosed with severe anemia presenting to antenatal OPD or ward in JIPMER fulfilling the inclusion criteria and willing to participate will be enrolled in the study.  Detailed history will be noted down in pre-designed clinical proforma including personal details, sociodemographic details, menstrual, obstetric history, relevant past and family history, dietary history, intake of oral iron, folate, multivitamins, medical comorbidities, treatment details of severe anemia in JIPMER or outside i.e., parenteral iron supplementation and blood transfusions. General examination including vitals, pallor, edema, Jugular venous pressure (JVP) assessment will be done with cardiovascular and obstetric examination.

10 ml (5ml for biochemistry tests +CBC with peripheral smear and 5 ml for HPLC) blood sample will be taken at first point of contact with the patient in the WCH OPD/ Casualty/labor room  and submitted at Biochemistry (TIBC, Transferrin saturation, serum ferritin, serum folate, serum vitaminB12) & Pathology laboratory of JIPMER (CBC with peripheral smear and HPLC for hemoglobin variants in blood picture showing microcytic and dimorphic anemia if indicated based on the CBC and peripheral smear findings) for analysis. Diagnosis will be made based on clinical and laboratory details. Further work-up if indicated and treatment will be instituted as per the existing departmental protocols.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Pregnant women with severe anemia (<7g/dl) at any trimester.

排除标准

  • 未提供

结局指标

主要结局

Biochemical and hematological

时间窗: Time from conception till delivery

1.Complete blood count with indices

时间窗: Time from conception till delivery

2.Serum Vitamin B12 levels

时间窗: Time from conception till delivery

3.Serum Folate

时间窗: Time from conception till delivery

4.Serum Iron

时间窗: Time from conception till delivery

5.Serum Ferritin

时间窗: Time from conception till delivery

6.Total iron binding capacity (TIBC)

时间窗: Time from conception till delivery

7.Transferrin saturation

时间窗: Time from conception till delivery

8.Blood variants by High performance liquid chromatography

时间窗: Time from conception till delivery

次要结局

  • Maternal Outcome:(1.Post-partum hemorrhage)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital

研究点 (1)

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