Survey Tool for Screening of Anemia in Women Before Pregnancy (PREPSA)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 503

Contacts and Locations

Study Locations

• India
  • Belgaum, India
    • Jawaharlal Nehru Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Currently married pre-pregnant women (n=500), ages 18-25 years, in Belagavi, Karnataka, India

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of survey instrument	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.	Up to four weeks following pre-pregnancy administration of PREPSA scale

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): June 13, 2023
• Study Completion (Actual): July 4, 2023

Study Registration Dates

• First Submitted: April 16, 2023
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Anemia
• Additional Relevant MeSH Terms: Hematologic Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Anemia; Pregnancy Complications
• Other Study ID Numbers: GN08 PREPSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified participant data will be made available through the NICHD Data and Specimen Hub (N-DASH system, a publicly accessible online archive, following publication of the primary paper.
• IPD Sharing Time Frame: No more than one year after publication of the primary paper. No end date.
• IPD Sharing Access Criteria: Access will follow procedures in accordance with those outlined by the NICHD Data and Specimen Hub (N-DASH).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No