dbGaP Study Accession: phs002905
NIH Institute/Center: NICHD
RADx Data Program: RADx-UP
Release Date: 08/30/2023
DOI: 10.60773/geyp-w645
Study Description: Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk of preterm birth, cesarean section, and maternal intensive care. The objectives of this study were to: (a) evaluate the full impact of SARS-CoV-2 in pregnancy to inform testing strategies, (b) examine the factors that impede testing during pregnancy, and (c) use study data to devise implementation strategies that improve SARS-CoV-2 testing in pregnancy and prenatal care during the pandemic. To do so, this study proposed to prospectively enroll two cohorts of pregnant women: 1) exposed (SARS-CoV-2 positive), and 2) unexposed (SARS-CoV-2 negative as defined by antibody testing at the beginning of pregnancy, every trimester, and at delivery). Women who initially enroll as unexposed but later test positive for SARS-CoV-2 antibodies crossed over to the exposed cohort. In total, an estimated 179 pregnant women were followed per cohort. In Aim 1, the study evaluated patients' and providers' perceptions of SARS-CoV-2 testing during pregnancy and the influence of COVID-19 on maternal care-seeking behavior and anxiety via surveys and semi-structured interviews. The study hypothesized suboptimal uptake of testing among pregnant women due to the fear of repercussions from a positive test. In Aim 2, the study determined the effect of SARS-CoV-2 infection during pregnancy on the risk of preterm birth and other adverse pregnancy outcomes in symptomatic and asymptomatic disease. The study hypothesized that SARS-CoV-2 infection will increase the risk of preterm birth by 12%, regardless of disease severity. In Aim 3, the study estimated the risk of mother-to-fetus SARS-CoV-2 transmission and viral presence in umbilical cord blood, placenta, and amniotic fluid by assaying for viral RNA in the neonate, cord blood, and placenta. The study hypothesized that SARS-CoV-2 can be transmitted from mother to fetus. Collectively, Aims 1-3 were interpreted by investigators, a Scientific Advisory Board (experts in obstetrics, infectious disease, implementation science, disparities) and Community Advisory Board (an obstetric social worker, pregnant women, and a director of a community obstetrics clinic) who applied data to devising targeted implementation strategies designed for rapid community dissemination to improve testing and prenatal care. In sum, this study filled knowledge gaps on the impact of SARS-CoV-2 infection and current utilization of diagnostic testing in pregnancy. Further, it created implementation strategies to overcome barriers to testing, increase uptake, and promote acceptance and sustainability of testing. Lastly, this study helped determine optimal testing strategies by examining the necessity of testing for asymptomatic disease, informed prenatal care plans by assessing the full impact of infection, and contributed to the ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.
Updated Date: 04/17/2024
Principal Investigator: Foeller, Megan
Has Data Files: Yes
Study Domain: Health Behaviors; Mental Health; Pandemic Perceptions or Decision-Making; Serological or Antibody Testing; Testing Rate or Uptake
Data Collection Method: Interview or Focus Group; Survey
Keywords: Asymptomatic Population; Individual-Level Data; Mother-to-fetus SARS-CoV-2 Transmission; Symptomatic Population; Testing in Pregnancy and Prenatal Care
Study Design: Longitudinal Cohort
Multi-Center Study: Yes
Study Sites: Barnes Jewish Hospital; Mercy Hospital St. Louis
Data Types: Behavioral; Biologic Specimens; Clinical; Electronic Medical Records; Imaging; Psychological; Questionnaire or Survey; Social
Study Start Date: 11/01/2020
Study End Date: 10/31/2022
Species: Human
Estimated Cohort Size: 420
Study Population Focus: Adults; Pregnant or Nursing Women
Publication URL: https://pubmed.ncbi.nlm.nih.gov/33870242/; https://pubmed.ncbi.nlm.nih.gov/34171317/; https://pubmed.ncbi.nlm.nih.gov/34809458/; https://pubmed.ncbi.nlm.nih.gov/35523141/; https://pubmed.ncbi.nlm.nih.gov/35970470/
Acknowledgement Statement: This study was supported through funding, 3R01HD091218-04S1, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. We would also like to acknowledge the many patients and staff from Washington University, Mercy Hospital, and the St. Louis community who contributed their time to this project. Approved users should acknowledge the provision of data access by dbGaP for accession phs002905.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.
Funding Opportunity Announcement (FOA) Number: PA-20-135
NIH Grant or Contract Number(s): 3R01HD091218-04S1
Consent/Data Use Limitations: General Research Use
Variable Name | Label |
---|---|
nih_record_id | User ID |
nih_race | What is your race? |
nih_ethnicity | Are you of Hispanic or Latino origin? May include Spanish origin. |
nih_age | What is your age? |
nih_sex | What is your biological sex assigned at birth? |
nih_education | What is the highest level of education you have achieved outside or in the United States? |
nih_employment | Please specify your employment status. |
nih_insurance | What kind of health insurance do you have? |
nih_disability | Do you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities? |
nih_vape_freq | Vaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all? |
nih_cig_smoke_freq | Nicotine Frequency: Do you now smoke cigarettes? |
nih_smoking_yn | Do you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)? |
nih_history_smoking | History of Smoking |
nih_lifetime_use_alcohol | In your entire life, have you had at least 1 drink of any kind of alcohol, not counting small tastes or sips? (Yes or No) |
nih_asthma | Asthma |
nih_cancer_past_yr | Cancer diagnosis and/or treatment within the past 12 months |
nih_cardiovascular_disease | Cardiovascular disease |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_diabetes | Diabetes |
nih_hypertension | Hypertension |
nih_mental_health_disorder | Mental health disorder |
nih_sickle_cell_disease | Sickle cell disease |
nih_pregnancy | Pregnancy status |
nih_immunocompromised | Immunocompromised condition |
nih_autoimm | Autoimmune disease |
nih_copd | Chronic obstructive pulmonary disease (COPD) |
nih_chronic_lung | Other chronic lung disease |
nih_depression | Depression |
nih_alc_sub_abuse | Alcohol or substance use disorder |
nih_iv_drug_use | Intravenous drug use |
nih_other_chronic_cond | Other chronic condition |
nih_cough | Cough |
nih_fever_chills | Fever or Chills |
nih_diff_breath | Shortness of breath or difficulty breathing |
nih_headache | Headache |
nih_muscle_ache | Muscle ache |
nih_olfactory | New loss of taste or smell |
nih_nausea_vomiting_diarrhea | Nausea, vomiting, or diarrhea |
nih_abdom_pain | Abdominal pain |
nih_throat_congestion_nose | Sore throat, congestion or runny nose |
nih_other_symp | Other |
nih_health_status | Would you say that (your) health in general is excellent, very good, good, fair, or poor? |
nih_height | What is your height in inches? |
nih_weight | What is your weight in pounds? |
age_yrs | Age For babies less than 1 year old, do not write the age in months. Write 0 as the age. (Years) |
bio_sex_birth_2 | What was your sex assigned at birth on your birth certificate? |
cc_asthma_2 | Asthma |
cc_asud_2 | Alcohol or substance use disorder |
cc_autoimm_2 | Autoimmune disease |
cc_cancer_2 | Cancer diagnosis and/or treatment within the past 12 months |
cc_chronickd_2 | Chronic kidney disease (CKD) |
cc_clung_2 | Other chronic lung disease |
cc_copd_2 | Chronic obstructive pulmonary disease (COPD) |
cc_cvd_2 | Cardiovascular disease (CVD or heart disease) |
cc_depression_2 | Depression |
cc_diabetes_2 | Diabetes |
cc_hypertension_2 | Hypertension (HTN, high blood pressure) |
cc_imm_2 | Immunocompromised condition |
cc_intrav_2 | Intravenous drug use |
cc_otherchroniccond_2 | Other chronic condition |
cc_othermh_2 | Other mental health disorder |
cc_sickle_2 | Sickle Cell Anemia |
covid_abpain_2 | Abdominal Pain |
covid_cough_2 | Cough |
covid_diffbreath_2 | Shortness of breath or difficulty breathing |
covid_fever_2 | Fever or chills |
covid_headache_2 | Headache |
covid_myalgia_2 | Muscle or body aches |
covid_nausea_2 | Feeling sick to your stomach or vomiting, diarrhea |
covid_olfactory_2 | New loss of taste or smell |
covid_other_2 | Other |
covid_runnynose_2 | Sore throat, congestion or runny nose |
current_employment_status | We would like to know about what you do -- are you working now, looking for work, retired, keeping house, a student, or something else? |
hi_coverage_type | What is the primary kind of health insurance or health care plan that you have now? (Exclude plans that pay for only one type of Service (such as, nursing home care, accidents, family planning, or dental care) and plans that only provide extra cash when hospitalized. ) |
lifetime_use_alcohol | In your entire life, have you had at least 1 drink of any kind of alcohol, not counting small tastes or sips? |
pregnancy_status | Are you currently pregnant? |
race_ethn_hispanic | Are you of Hispanic, Latino, or Spanish origin? |
self_reported_disability | Do you have a disability that interferes with your ability to carry out daily activities? Examples of daily activities include walking, climbing stairs, shopping, balancing a checkbook, bathing or dressing. |
self_reported_height_centimeters | Centimeters |
self_reported_height_feet | Feet |
self_reported_height_inches | Inches |
self_reported_height_meters | Meters |
self_reported_weight_kgs | How much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy? |
self_reported_weight_lbs | How much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy? |
smoker_cur_stat_2 | Do you now smoke cigarettes? |
vaper_cur_stat | Do you now use electronic cigarettes every day, some days, rarely, or not at all? |
consent_given | - |
consent_ident | - |
consent_recontact | - |
consent_ssn | - |
consent_zip_2 | - |
covid_pandemic_challenges_abod_2 | - |
covid_pandemic_challenges_food_2 | - |
covid_pandemic_challenges_wate_2 | - |
covid_vaccine | - |
cov_pan_chal_hlth_2 | - |
cov_pan_chal_med_2 | - |
cov_pan_chlng_trans_2 | - |
cov_tst_mthd_2 | - |
edu_years_of_school | - |
employed_ew | - |
employed_healthcare_2 | - |
family_income | - |
flu_vaccinehistind_2 | - |
flu_vaccine_season_3 | - |
gender_identity_term_2 | - |
hi_loss_covid | - |
household_famgen_3 | - |
household_homeless | - |
jobloss_covid19_2 | - |
language_english | - |
language_home___1 | - |
language_home___2 | - |
language_home___3 | - |
language_home___4 | - |
language_home___5 | - |
language_home___6 | - |
language_home___7 | - |
language_home___8 | - |
language_home___9 | - |
language_home___90 | - |
language_home___99 | - |
positiveyear_covidtest_3 | - |
race_ethn_asian_detail_3___1 | - |
race_ethn_asian_detail_3___2 | - |
race_ethn_asian_detail_3___3 | - |
race_ethn_asian_detail_3___4 | - |
race_ethn_asian_detail_3___5 | - |
race_ethn_asian_detail_3___99 | - |
race_ethn_hispanic_detail_2___1 | - |
race_ethn_hispanic_detail_2___2 | - |
race_ethn_hispanic_detail_2___3 | - |
race_ethn_hispanic_detail_2___4 | - |
race_ethn_hispanic_detail_2___5 | - |
race_ethn_hispanic_detail_2___6 | - |
race_ethn_hispanic_detail_2___7 | - |
race_ethn_hispanic_detail_2___99 | - |
race_ethn_islander_detail_2___1 | - |
race_ethn_islander_detail_2___10 | - |
race_ethn_islander_detail_2___11 | - |
race_ethn_islander_detail_2___12 | - |
race_ethn_islander_detail_2___13 | - |
race_ethn_islander_detail_2___14 | - |
race_ethn_islander_detail_2___2 | - |
race_ethn_islander_detail_2___3 | - |
race_ethn_islander_detail_2___4 | - |
race_ethn_islander_detail_2___5 | - |
race_ethn_islander_detail_2___6 | - |
race_ethn_islander_detail_2___7 | - |
race_ethn_islander_detail_2___8 | - |
race_ethn_islander_detail_2___9 | - |
race_ethn_islander_detail_2___99 | - |
race_ethn_race___1 | - |
race_ethn_race___15 | - |
race_ethn_race___2 | - |
race_ethn_race___3 | - |
race_ethn_race___4 | - |
race_ethn_race___5 | - |
race_ethn_race___99 | - |
recentresult_covidtest | - |
recentyear_covidtest_3 | - |
redcap_event_name | - |
redcap_repeat_instance | - |
redcap_repeat_instrument | - |
self_reported_health_status_assessment | - |
self_reported_height_coded | - |
self_reported_weight_units_2 | - |
sex_orient_id | - |
smoker_number | - |
test_accesseasy_2 | - |
test_accesswhere_2 | - |
tested_for_covid | - |
tested_positive_for_covid | - |
vaccine_avail | - |
vaccine_concerns_3___1 | - |
vaccine_concerns_3___10 | - |
vaccine_concerns_3___2 | - |
vaccine_concerns_3___3 | - |
vaccine_concerns_3___4 | - |
vaccine_concerns_3___5 | - |
vaccine_concerns_3___6 | - |
vaccine_concerns_3___7 | - |
vaccine_concerns_3___8 | - |
vaccine_concerns_3___9 | - |
vaccine_concerns_3___96 | - |
vaccine_reasons_3___1 | - |
vaccine_reasons_3___10 | - |
vaccine_reasons_3___11 | - |
vaccine_reasons_3___2 | - |
vaccine_reasons_3___3 | - |
vaccine_reasons_3___4 | - |
vaccine_reasons_3___5 | - |
vaccine_reasons_3___6 | - |
vaccine_reasons_3___7 | - |
vaccine_reasons_3___8 | - |
vaccine_reasons_3___9 | - |
vaccine_reasons_3___96 | - |
work_closecont_2 | - |
work_ppe_2 | - |
work_wash_2 | - |