| 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
|
|
|
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
|
|
|
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. |