Jawaharlal Nehru Medical College
Belagavi, India
NCT Number: NCT05832840
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.
Looking for future studies?
Notify Me18 year–25 year
Female
Observational
Belagavi, India
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
NICHD Global Network for Women's and Children's Health
Network
Validation of a Survey Instrument for Screening of Pre-Pregnant Women - The PREPSA SCALE
Acronym: PREPSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07135635
Anemia, Anemia Complicating Pregnancy
Sohag, Egypt
View Trial DetailsNCT07485023
Anemia Complicating Pregnancy
View Trial DetailsNCT07356258
Anemia Complicating Pregnancy, Iron Adverse Reaction
Haifa, Israel
View Trial DetailsNCT02075970
Anemia, Anemia, Neonatal
Iowa City, Iowa, United States
View Trial Details