Survey Tool for Screening of Anemia in Women Before Pregnancy
PREPSA
Validation of a Survey Instrument for Screening of Pre-Pregnant Women - The PREPSA SCALE
1 other identifier
observational
503
1 country
1
Brief Summary
The goal of this observational and cross-sectional study is to develop and validate a survey that can be used to identify anemia, and its severity, among pre-pregnant women allowing for the timely implementation of focused public health and personalized interventions. Participants will be asked 26 survey questions about menstrual history and provide a 5 ml venous blood sample to measure hemoglobin, ferritin, and transferrin saturation levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2023
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedFirst Posted
Study publicly available on registry
April 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2023
CompletedNovember 18, 2023
November 1, 2023
2 months
April 16, 2023
November 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validation of survey instrument
The PREPSA Scale will be administered to pre-pregnant women and a blood draw within four weeks will be used to assess anemia status and support validation of the PREPSA Scale. The minimum value on the scale is a score of zero. The maximum value on the scale is a score of forty. This is based on the number of items plus the value of the highest coded category on items with more than one category. A higher score means a worse outcome and is associated with higher levels of iron deficient anemia.
Up to four weeks following pre-pregnancy administration of PREPSA scale
Eligibility Criteria
Currently married pre-pregnant women (n=500), ages 18-25 years, in Belagavi, Karnataka, India
You may qualify if:
- year old women
- Not currently pregnant and have never been pregnant
- Currently married
- If last menstrual period \>6 weeks ago, exclude pregnancy via pregnancy test
You may not qualify if:
- Currently using any form of contraception other than barrier methods
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NICHD Global Network for Women's and Children's Healthlead
- Global Network for Women's and Children's Health Researchcollaborator
- Thomas Jefferson Universitycollaborator
- Jawaharlal Nehru Medical Collegecollaborator
- RTI Internationalcollaborator
Study Sites (1)
Jawaharlal Nehru Medical College
Belagavi, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2023
First Posted
April 27, 2023
Study Start
April 17, 2023
Primary Completion
June 13, 2023
Study Completion
July 4, 2023
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- No more than one year after publication of the primary paper. No end date.
- Access Criteria
- Access will follow procedures in accordance with those outlined by the NICHD Data and Specimen Hub (N-DASH).
Deidentified participant data will be made available through the NICHD Data and Specimen Hub (N-DASH system, a publicly accessible online archive, following publication of the primary paper.