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临床试验/NCT05832840
NCT05832840已完成不适用

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

NICHD Global Network for Women's and Children's Health1 个研究点 分布在 1 个国家目标入组 503 人开始时间: 2023年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
503
试验地点
1
主要终点
Validation of survey instrument

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Currently using any form of contraception other than barrier methods

结局指标

主要结局

Validation of survey instrument

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
NICHD Global Network for Women's and Children's Health
申办方类型
Network
责任方
Sponsor

研究点 (1)

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