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Recommendations for Common Data Elements for Post-Acute Sequelae of SARS-CoV-2 infection (PASC) Studies Including Pregnant Participants

Publicly Available, No Cost
Yes (CDEs for COVID-19 Studies Including Pregnant Participants)
We present a battery of recommended biomedical and psychosocial common data elements (CDEs) and measures that, when combined across datasets, can improve our collective understanding of Post-Acute Sequelae of SARS-CoV-2 infection (PASC) in pregnant and lactating women and their neonates. Experts across eight large pregnancy cohort studies developed these recommendations for use by any planned or upcoming PASC study that includes women of reproductive age or pregnant women. We encourage researchers to include some or all of these measures—which cover key medical and psychosocial domains relevant to pregnancy and childbirth—into their studies to maximize the potential for data harmonization while continuing to advance their own study goals. Common biomedical data elements and measures aim to accelerate our understanding of the clinical course of PASC and its effects on pregnant women and their neonates, which will continue to evolve as treatments and vaccines become available. Here we highlight CDEs and measures across four domains, which include: COVID-19 Vaccination History, Vaccine Attitudes, Postpartum, and Contraception Use. Recommendations assume that information from all patient visits (e.g., prenatal visits, COVID-19 testing, and delivery) can be collected via medical chart or downloaded data from electronic health records. Common psychosocial data elements and measures aim to advance our understanding of the psychological, behavioral, and social effects of the virus and the pandemic on pregnant women and their neonates. Here we highlight CDEs and measures across seven domains, including: Postpartum Outcomes, Pregnancy and Postpartum Function, Infant Care Practices, Childcare and Education, Attribution of Symptoms, Domestic Violence, and Access to Care.
Project 5 Draft CDEs/FDA, DR2 Vaccine Questions, Martin Mother Third Trimester Questionnaire, Kaiser Family Foundation COVID-19 Vaccine Monitor, Pew Research Center, WERF EPHect Questionnaire – Standard (EPQ-S), NORC Teen Sexual Health Survey Student_Survey.pdf (, Phenx Contraception Use, Vachkova – Qol-Grav Questionnaire , Inventory of Functional Status After Childbirth (IFSAC) , Infant Feeding Practices Survey (IFPS – 3 Months)  PRAMS Standard Questionnaire  PRAMS Core Questionnaire  Infant Feeding Practices Survey (IFPS – 3 Months) , Brief Infant Sleep Questionnaire (BISQ) , Postpartum Bonding Questionnaire, 2020 COVID-19 Household Pulse Survey , NICHD CDEs | Disaster Information Management Research Center | NLM (, Robbins 1991 | Attributions of common somatic symptoms - PubMed (, PRAMS Standard Questionnaire

Additional Descriptors

  • Medical Professional, Researcher or Professional Interviewer, Self, Trained Non-Expert
  • In-Person Interview, Online or Mobile App, Paper, Phone Interview
    • 16-30
      • Easy
      • RedCap
        • 50.0–30.0 (College)
        • English
          • 75-99
          • Guideline
            • Age, Sex or Gender
              • Age: Adult, Child
                • Children: Infant
              • Sex or Gender: Female or Women
                • Female or Women: Pregnant or Lactating Women
            • Infectious Disease Outbreak, Other
              • Other (write in): Research related to Pregnant and Lactating women and COVID-19
            • Biological or Infectious Agent
              • Biological or Infectious Agent: Virus
                • Virus: SARS-CoV-2, SARS-CoV-1, MERS
                  • SARS-CoV-2, SARS-CoV-1, MERS: Long COVID/Post-Acute Sequelae of COVID (PASC)
            • Circulatory, Cardiovascular, Developmental, Diabetes or Obesity, Endocrine, Immune or Lymphatic, Mental Health or Well-Being, Morbidity or Mortality, Neurological or Nervous System, Pregnancy, Reproductive, Respiratory
              • Diagnosis or Status or Treatment or Recovery, Domestic Violence or Family Impacts, Lifestyle or Quality of Life, Risk Reduction Behaviors, Social Determinants of Health, Symptoms
                • Risk Reduction Behaviors: Vaccine-related
              • National Institues of Health

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