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CTRI Number  CTRI/2022/05/042722 [Registered on: 23/05/2022] Trial Registered Prospectively
Last Modified On: 19/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal 
Study Design  Other 
Public Title of Study   Causes of severe anemia in pregnancy and its outcome for mother and child 
Scientific Title of Study   “Clinico-Laboratory profile and pregnancy outcome among women with severe anemia - An observational study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeti Sharma 
Designation  JUNIOR RESIDENT 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Obstetrics and Gynecology JIPMER, Dhanvantri nagar,Puducherry INDIA
Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Road Dhanvantari Nagar, Puducherry, 605006 India
Pondicherry
PONDICHERRY
605006
India 
Phone  9418421264  
Fax    
Email  drpreetisharmapp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yavana Suriya Venkatesh 
Designation  Assistant professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Obstetrics and Gynecology JIPMER, Dhanvantri nagar,Puducherry
Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Road Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India 
Phone  8903479912  
Fax    
Email  venkateshyavana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yavana Suriya Venkatesh 
Designation  Assistant professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Obstetrics and Gynecology JIPMER, Dhanvantri nagar,Puducherry
Jawaharlal Institute of Postgraduate Medical Education and Research, JIPMER Campus Road Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India 
Phone  8903479912  
Fax    
Email  venkateshyavana@gmail.com  
 
Source of Monetary or Material Support  
Intramural research fund committee Research Department JIPMER Puducherry 
 
Primary Sponsor  
Name  JIPMER 
Address  Department of obstetrics and gynecology, JIPMER Dhanvantri nagar Puducherry 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Preeti Sharma  JIPMER  Department of Obstetrics and Gynecology 1st floor ICMR research lab JIPMER dhanvantri nagar Puducherry 605006
Pondicherry
PONDICHERRY 
9418421264

drpreetisharmapp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Pregnant women with severe anemia (<7g/dl) at any trimester 
 
ExclusionCriteria 
Details  nil 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Biochemical and hematological
1.Complete blood count with indices
2.Serum Vitamin B12 levels
3.Serum Folate
4.Serum Iron
5.Serum Ferritin
6.Total iron binding capacity (TIBC)
7.Transferrin saturation
8.Blood variants by High performance liquid chromatography
 
Time from conception till delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Maternal Outcome:
1.Post-partum hemorrhage
2.Congestive heart failure
3.Preterm labor
4.Puerperal Sepsis

Perinatal Outcome :
1.Preterm birth
2.Low birth weight
3.IUGR
4.Intrauterine death

 
Time from conception till puerperium 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/05/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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