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Completed

NCT Number: NCT05832840

Survey Tool for Screening of Anemia in Women Before Pregnancy

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.

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Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Observational

Primary location

Jawaharlal Nehru Medical College

Belagavi, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Validation of survey instrument

    Time frame: Up to four weeks following pre-pregnancy administration of PREPSA scale

    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.

Sponsors and collaborators

Lead sponsor

NICHD Global Network for Women's and Children's Health

Network

Collaborators

  • Global Network for Women's and Children's Health Research
  • Jawaharlal Nehru Medical College
  • RTI International
  • Thomas Jefferson University

Registry information

Official study title

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

Acronym: PREPSA

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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