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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O990||Anemia complicating pregnancy, childbirth and the puerperium, |
|
Intervention / Comparator Agent
|
|
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 |
|
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. |