Skip to content

Survey Tool for Screening of Anemia in Women Before Pregnancy

Validation of a Survey Instrument for Screening of Pre-Pregnant Women - The PREPSA SCALE

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05832840
Acronym
PREPSA
Enrollment
503
Registered
2023-04-27
Start date
2023-04-17
Completion date
2023-07-04
Last updated
2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia Complicating Childbirth, Anemia Complicating Pregnancy, Anemia Complicating the Puerperium

Keywords

Anemia

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.

Detailed description

Despite a variety of governmental campaigns and funded programs, anemia rates among reproductive age women in low- and middle-income countries (LMICs) have not decreased over the past few decades. Iron deficiency is associated with increases in morbidity and mortality in both non-pregnant and pregnant women, as well as their offspring. Up to 500 currently married women between 18 and 25 years old who are not pregnant, have never been pregnant, and are not using any type of contraception other than barrier methods will be recruited for this study from primary health centres (PHCs) in Belagavi , Karnataka, India. Accredited Social Health Activists (ASHAs) will identify potentially eligible participants and bring them to participating primary healthcare centers (PHCs) for screening, consent, and enrollment. Once enrolled, trained female interviewers will administer the PREPSA survey to the participant and a laboratory technician will draw a blood sample (upon completion of the survey or within four weeks) to analyze hemoglobin, ferritin, and transferrin saturation values. The survey responses that most closely align with low iron indices will be identified and become the basis of a scored, validated instrument which may be weighted based upon the strength of the associations found. Results will inform future health outcome trials.

Interventions

None listed

Sponsors

Global Network for Women's and Children's Health Research
CollaboratorOTHER
Thomas Jefferson University
CollaboratorOTHER
Jawaharlal Nehru Medical College
CollaboratorOTHER
RTI International
CollaboratorOTHER
NICHD Global Network for Women's and Children's Health
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 - 25 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

Exclusion criteria

* Currently using any form of contraception other than barrier methods

Design outcomes

Primary

MeasureTime frameDescription
Validation of survey instrumentUp to four weeks following pre-pregnancy administration of PREPSA scaleThe 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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026