Survey Tool for Screening of Anemia in Women Before Pregnancy

NCT ID: NCT05832840

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 503 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2023-07-04

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.

Conditions

Anemia Complicating Pregnancy; Anemia Complicating Childbirth; Anemia Complicating the Puerperium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

Jawaharlal Nehru Medical College

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: collaborator

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

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jawaharlal Nehru Medical College

Belagavi, , India

Countries

India

Other Identifiers

GN08 PREPSA

Identifier Type: -

Identifier Source: org_study_id