Clinical trial NCT05832840: Survey Tool for Screening of Anemia in Women Before Pregnancy
Official title: Validation of a Survey Instrument for Screening of Pre-Pregnant Women - The PREPSA SCALE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia Complicating Pregnancy
Anemia Complicating Childbirth
Anemia Complicating the Puerperium
Keywords: Anemia
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Global Network for Women's and Children's Health Research
name: Thomas Jefferson University
name: Jawaharlal Nehru Medical College
name: RTI International
First posted: 2023-04-27
Enrollment: 503
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Currently married pre-pregnant women (n=500), ages 18-25 years, in Belagavi, Karnataka, India

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.

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

Primary outcomes:
measure: Validation of survey instrument
timeFrame: Up to four weeks following pre-pregnancy administration of PREPSA scale
Secondary outcomes:
Other outcomes:
Locations:
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College
Study officials:
References: