Causes of severe anemia in pregnancy and its outcome for mother and child

Not yet recruiting

Conditions: Anemia complicating pregnancy, childbirth and the puerperium,

Registration Number: CTRI/2022/05/042722

Lead Sponsor: JIPMER

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical and hematological	Time from conception till delivery
1.Complete blood count with indices	Time from conception till delivery
2.Serum Vitamin B12 levels	Time from conception till delivery
3.Serum Folate	Time from conception till delivery
4.Serum Iron	Time from conception till delivery
5.Serum Ferritin	Time from conception till delivery
6.Total iron binding capacity (TIBC)	Time from conception till delivery
7.Transferrin saturation	Time from conception till delivery
8.Blood variants by High performance liquid chromatography	Time from conception till delivery

Secondary Outcome Measures

Name	Time	Method
Maternal Outcome:	1.Post-partum hemorrhage

Trial Locations

Locations (1): JIPMER
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Preeti Sharma
Principal investigator
9418421264
drpreetisharmapp@gmail.com