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CTRI Number  CTRI/2024/11/076494 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of simple testing devices for anemia in pregnant women 
Scientific Title of Study   Evaluation of a non-invasive hemoglobin and a minimally invasive ferritin point of care device for screening for anemia in pregnant women in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Uma Chandra Mouli Natchu 
Designation  Deputy Director and Senior Scientist 
Affiliation  Society for Applied Studies 
Address  680 Gali No. 5 Nai Basti Ground Floor Infectious Diseases Department
Devli Gaon Devli New Delhi
South
DELHI
110080
India 
Phone  01146043751  
Fax  01146043756  
Email  unatchu@sas.org.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Uma Chandra Mouli Natchu 
Designation  Deputy Director and Senior Scientist 
Affiliation  Society for Applied Studies 
Address  680 Gali No. 5 Nai Basti Ground Floor Infectious Diseases Department
Devli Gaon Devli New Delhi
South
DELHI
110080
India 
Phone  01146043751  
Fax  01146043756  
Email  unatchu@sas.org.in  
 
Details of Contact Person
Public Query
 
Name  Dr Nidhi Goyal 
Designation  Deputy Director and Scientist 
Affiliation  Society for Applied Studies 
Address  680 Gali No. 5 Nai Basti Ground Floor Infectious Diseases Department
Devli Gaon Devli New Delhi
South
DELHI
110080
India 
Phone  01146043751  
Fax  01146043756  
Email  nidhi.goyal@sas.org.in  
 
Source of Monetary or Material Support  
Bill and Melinda Gates Foundation, 500 5th Ave N, Seattle, Washington, WA 98109, United States of America 
 
Primary Sponsor  
Name  Society For Applied Studies 
Address  45, Kalu Sarai, New Delhi-110016 
Type of Sponsor  Research institution 
 
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 
Dr Uma Chandra Mouli Natchu  Society for Applied Studies   680, Gali No. 5, Nai Basti, Ground Floor, Infectious Diseases Department, New Delhi
South
DELHI 
01146043751
01146043756
unatchu@sas.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Society for Applied Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  Pregnant women with any period of gestation, consenting for participation 
 
ExclusionCriteria 
Details  Known cyanotic cardiac condition at the time of enrolment.
Known jaundice at the time of enrolment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Agreement between hemoglobin estimation using a non-invasive point of care device and laboratory estimation of hemoglobin during pregnancy  24 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Agreement between ferritin estimation using a minimally-invasive point of care ferritin measurement device and laboratory estimation of serum ferritin during pregnancy   24 months 
2. Stakeholder perceptions on acceptability of non-invasive hemoglobin measurement and anemia management  24 months 
3. Appropriate screening ranges for use of point-of-care non-invasive hemoglobin and minimally invasive ferritin assays as a screening tool for anemia during pregnancy  24 months 
4. Estimation of potential cost saving from point-of-care non-invasive hemoglobin and minimally invasive ferritin assays as a screening tool for anemia during pregnancy  24 months 
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="450" 
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)   01/01/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Anemia remains one of the commonest problems during pregnancy in the world. The highest burden of anemia in pregnancy is in low resource settings, where measuring hemoglobin and appropriately treating anemia remains a challenge.

In settings where antenatal care is delivered at home or in small facilities, a point of care device capable of non-invasive estimation of hemoglobin could have great utility.

Point of care ferritin measurement devices when used in combination with hemoglobin measurement could help to understand whether iron deficiency is the underlying cause of anemia.

Pregnant women residing in low middle income urban resettlement neighborhood in South district of Delhi will be identified and approached for participation in the study. 450 pregnant women from all gestational ages across pregnancy (up to term prior to onset of labour) will be enrolled.

The following activities will be conducted on the day of enrolment for all pregnant women who give consent for participation:

  • Collection of baseline demographic and health data
  • Point of care hemoglobin estimation using EzeCheckTM non-invasive instrument
  • Point of care serum ferritin estimated from capillary blood (finger-prick) using ferritin lateral flow assay device from Huwel Lifesciences, India.
  • Venous blood sample collection for hemoglobin and serum ferritin estimation at a nationally accredited laboratory

Study staff will follow-up with the participants monthly to collect information on their subsequent ANC visits, treatment and any investigations advised, reports of any other investigations related to anemia, compliance to advised medication and outcome of pregnancy. Pregnancies will be tracked until delivery to identify outcomes. These outcomes will be used to estimate the benefit from

 point of care tests.

The total duration of the study will be 24 months. Participation of each pregnant woman will be till ascertainment of the outcome of her pregnancy.

Qualitative analysis of stakeholder perceptions about the acceptability of non-invasive measurements and point-of-care methods and anemia management will be done through interviews and focus group discussions with pregnant women, health care personnel and physicians.

Evaluation of point of care test devices for their accuracy and error ranges for use as screening test in pregnant women will be done.

Data on the hemoglobin and ferritin levels, treatment decision, pregnancy outcomes and costs involved, that is collected at the different stages of pregnancy, will be used to build model to estimate the potential cost saving and benefits from the use of non-invasive and minimally invasive screening tests for anemia during pregnancy.

 
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