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临床试验/CTRI/2025/04/085021
CTRI/2025/04/085021尚未招募不适用

Severe and very severe anaemia in pregnancy and fetomaternal outcome in third trimester: An Observational study

Rohilkhand Medical College and Hospital, Bareilly1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2025年4月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
126
试验地点
1
主要终点
•To correlate the signs and symptoms of severe and very severe anaemia with laboratory findings.

研究概览

简要总结

Pregnancy-related anaemia is a serious public health issue all over the world, but it is especially problematic in developing nations like India .WHO’s most recent study states that the prevalence of anaemia among females aged 15-49 who are pregnant and those who are not rose between 2012 & 2016 in majority of countries. One of the main variables affecting both the newborn’s health and the morbidity and mortality of the mother is anaemia. It is a worldwide health concern that over half of expectant mothers experience.

World health organization defines anaemia as haemoglobin less than 11gm/dl in first and third trimester and less than 10.5 gm/dl in second trimester. Anaemia is divided into three categories according to haemoglobin level: mild (9.1 to 11gm%), moderate (7.1 to 9 gm%), severe (4.1-7 gm%)[2], very severe ( <4 gm%).

Physiological anaemia is a common ailment during pregnancy. Erythroid hyperplasia of the marrow occurs during pregnancy and in a singleton pregnancy, the mass of RBCs increase by 15-20%. However 40-50% increase in plasma volume causes hemodilution also known as “pregnancy associated hydremia” which raises the need for iron. An average haematocrit drops from 38-45% in healthy non pregnant women to roughly 34% in singleton pregnancy and to 30% in multifetal pregnancy, indicating physiological anaemia. Throughout pregnancy oxygen carrying capacity is normal despite hemodilution. Due to fetal and placental growth and larger amount of circulatory blood there is increased demand for nutrients, especially iron and folic acid as their stores are already low. There are numerous causes of pathological anaemia in pregnancy. Mild anaemia is mostly due to nutritional deficiency i.e., dietary deficiency of iron, folic acid and vitamin B12 and presence of inhibitors of iron absorption. Moderate anaemia is due to hemoglobinopathies like Beta Thalassemia minor, Sickle cell trait, nutritional deficiency. Severe anaemia in pregnancy can occur due to infections (like Malaria, hook work infestation), chronic diseases like chronic kidney disease, heart failure, autoimmune diseases like Rheumatoid arthritis, vasculitis, Crohn’s disease and Ulcerative colitis. In patients with chronic blood loss, Beta Thalassemia major, Sickle cell disease also presents with severe anaemia. Due to recent advancement in medical sciences, and improvement in management of these haemoglobinopathies these patients can now experience uneventful pregnancy.

The majority of the severely anaemic women belong to low socioeconomic status who are uneducated and are un booked pregnancies who have not taken iron and folic acid supplementation during pregnancy. Other risk factors include multiple pregnancies, teenage pregnancy, iron deficiency, lack of appropriate spacing between pregnancies, parasitic infestation (e.g. malaria, hookworm infestation), poor environmental and personal hygiene.

Severe anaemia in pregnancy have adverse outcomes in mother and fetus leading to maternal and fetal morbidity and mortality. It is associated with multiple spontaneous abortions, pre-term labour, pre-eclampsia, recurrent infections, antepartum haemorrhage and postpartum haemorrhage in mother. It is important to timely diagnose the cause and to treat it to prevent the adverse effects on fetus such as intrauterine growth restriction, intrauterine fetal death, birth asphyxia, low birth weight babies.

Anaemia being an important concern during pregnancy, the current study is aimed to find out various risk factors, causes , different pathological findings and management of severe anaemia. Inspite of all the Government policies implemented to decrease anaemia in pregnancy, the problem is still very much prevalent. At our region, it has been noticed that the number of patient affected by severe and very severe anaemia are more. Also the number of studies on severe anaemia and very severe anaemia are less, hence the need of study.

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

  • Pregnant females with hemoglobin less than or equal to 7 g/dl and gestational age more than or equal to 28 weeks.

排除标准

  • Bleeding placenta previa.
  • Bleeding due to non obstructive causes like haemorrhoids.

结局指标

主要结局

•To correlate the signs and symptoms of severe and very severe anaemia with laboratory findings.

时间窗: Outcome will be assessed during anc visit , 1 week after intervention (if any) , during labour and one week postpartum

•To detect the morphological and etiological types of severe and very severe anaemia in pregnant women.

时间窗: Outcome will be assessed during anc visit , 1 week after intervention (if any) , during labour and one week postpartum

次要结局

  • To assess maternal outcome in terms of maternal morbidity and mortality.(To assess fetal outcome in terms of APGAR score, low birth weight, IUGR and IUD.)

研究者

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

Dr Wadaskar Apeksha Satish

Rohilkhand Medical College and Hospital, Bareilly

研究点 (1)

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