Skip to main content
This repository is under review for potential modification in compliance with Administration directives.
Study Information

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 Information
Total Variables: 200
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_educationWhat is the highest level of education you have achieved outside or in the United States?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_disabilityDo you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities?
nih_vape_freqVaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all?
nih_cig_smoke_freqNicotine Frequency: Do you now smoke cigarettes?
nih_smoking_ynDo you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)?
nih_history_smokingHistory of Smoking
nih_lifetime_use_alcoholIn 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_asthmaAsthma
nih_cancer_past_yrCancer diagnosis and/or treatment within the past 12 months
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_mental_health_disorderMental health disorder
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_immunocompromisedImmunocompromised condition
nih_autoimmAutoimmune disease
nih_copdChronic obstructive pulmonary disease (COPD)
nih_chronic_lungOther chronic lung disease
nih_depressionDepression
nih_alc_sub_abuseAlcohol or substance use disorder
nih_iv_drug_useIntravenous drug use
nih_other_chronic_condOther chronic condition
nih_coughCough
nih_fever_chillsFever or Chills
nih_diff_breathShortness of breath or difficulty breathing
nih_headacheHeadache
nih_muscle_acheMuscle ache
nih_olfactoryNew loss of taste or smell
nih_nausea_vomiting_diarrheaNausea, vomiting, or diarrhea
nih_abdom_painAbdominal pain
nih_throat_congestion_noseSore throat, congestion or runny nose
nih_other_sympOther
nih_health_statusWould you say that (your) health in general is excellent, very good, good, fair, or poor?
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
age_yrsAge For babies less than 1 year old, do not write the age in months. Write 0 as the age. (Years)
bio_sex_birth_2What was your sex assigned at birth on your birth certificate?
cc_asthma_2Asthma
cc_asud_2Alcohol or substance use disorder
cc_autoimm_2Autoimmune disease
cc_cancer_2Cancer diagnosis and/or treatment within the past 12 months
cc_chronickd_2Chronic kidney disease (CKD)
cc_clung_2Other chronic lung disease
cc_copd_2Chronic obstructive pulmonary disease (COPD)
cc_cvd_2Cardiovascular disease (CVD or heart disease)
cc_depression_2Depression
cc_diabetes_2Diabetes
cc_hypertension_2Hypertension (HTN, high blood pressure)
cc_imm_2Immunocompromised condition
cc_intrav_2Intravenous drug use
cc_otherchroniccond_2Other chronic condition
cc_othermh_2Other mental health disorder
cc_sickle_2Sickle Cell Anemia
covid_abpain_2Abdominal Pain
covid_cough_2Cough
covid_diffbreath_2Shortness of breath or difficulty breathing
covid_fever_2Fever or chills
covid_headache_2Headache
covid_myalgia_2Muscle or body aches
covid_nausea_2Feeling sick to your stomach or vomiting, diarrhea
covid_olfactory_2New loss of taste or smell
covid_other_2Other
covid_runnynose_2Sore throat, congestion or runny nose
current_employment_statusWe 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_typeWhat 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_alcoholIn your entire life, have you had at least 1 drink of any kind of alcohol, not counting small tastes or sips?
pregnancy_statusAre you currently pregnant?
race_ethn_hispanicAre you of Hispanic, Latino, or Spanish origin?
self_reported_disabilityDo 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_centimetersCentimeters
self_reported_height_feetFeet
self_reported_height_inchesInches
self_reported_height_metersMeters
self_reported_weight_kgsHow much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy?
self_reported_weight_lbsHow much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy?
smoker_cur_stat_2Do you now smoke cigarettes?
vaper_cur_statDo 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-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
READMEproject59_README.html274.67 KB
Study Documentationphs002905_6-Weeks Postpartum Survey.pdf176.18 KB
Study Documentationphs002905_Data Collection Forms_Delivery Hospitalization.pdf300.85 KB
Study Documentationphs002905_Project 59_COVID-19 Related Stress Survey.pdf146.22 KB
Study Documentationphs002905_Project 59_Data Collection Forms_Enrollment.pdf416.50 KB
Study Documentationphs002905_Project 59_Data Collection Forms_Follow-Up Visits.pdf365.04 KB
Study Documentationphs002905_Project 59_Distress Protocol.pdf118.82 KB
Study Documentationphs002905_Project 59_Enrollment Questionnaire.pdf204.45 KB
Study Documentationphs002905_Project 59_Everyday Events Survey.pdf216.53 KB
Study Documentationphs002905_Project 59_Impact of COVID-19 Pandemic Survey.pdf270.71 KB
Study Documentationphs002905_Project 59_Interview Guides.pdf287.82 KB
Study Documentationphs002905_Project 59_Postnatal Depression Survey.pdf219.59 KB
Study Documentationphs002905_Project 59_Social Support and Social Network Survey.pdf234.25 KB
Study Documentationphs002905_Project 59_Protocol_11DEC2020.pdf730.52 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project59_DATA_origcopy.csvTabular Data - Non-harmonizedcsv399
project59_DATA_transformcopy.csvTabular Data - Harmonizedcsv399