Survey Tool for Screening of Anemia in Women Before Pregnancy

Last updated: November 16, 2023
Sponsor: NICHD Global Network for Women's and Children's Health
Overall Status: Completed

Phase

N/A

Condition

Anemia

Pregnancy Complications

Treatment

N/A

Clinical Study ID

NCT05832840
GN08 PREPSA
  • Ages 18-25
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Currently using any form of contraception other than barrier methods

Study Design

Total Participants: 503
Study Start date:
April 17, 2023
Estimated Completion Date:
July 04, 2023

Study 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.

Connect with a study center

  • Jawaharlal Nehru Medical College

    Belgaum,
    India

    Site Not Available

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