NCT05832840

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
• Phase: —
• Study type: Observational
• Enrollment: 503 (actual)
• Sponsor: NICHD Global Network for Women's and Children's Health · Network
• Sex: Female
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anemia Complicating Pregnancy
• Anemia Complicating Childbirth
• Anemia Complicating the Puerperium

Timeline

• Start date: 2023-04-17
• Primary completion: 2023-06-13
• Completion: 2023-07-04
• First posted: 2023-04-27
• Last updated: 2023-11-18

Locations

1 site across 1 country: India