Survey Tool for Screening of Anemia in Women Before Pregnancy

Completed

• Conditions: Anemia Complicating the Puerperium; Anemia Complicating Pregnancy; Anemia Complicating Childbirth

• Registration Number: NCT05832840
• Lead Sponsor: NICHD Global Network for Women's and Children's Health

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.

Study Timeline

• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-16
• Study Start: 2023-04-17
• Study First Posted: 2023-04-27
• Primary Completion: 2023-06-13
• Study Completion: 2023-07-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 503

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of survey instrument	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.

Trial Locations

Locations (1)

Jawaharlal Nehru Medical College; 🇮🇳 Belgaum, India