Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-03 @ 4:52 AM
Study NCT ID:
NCT04388605
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2020-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'At-home blood spot kits will be used for serology surveillance. Tests will occur weekly during the first trimester and monthly during the second and third trimesters of pregnancy. Covid-19 antibody serology and cytokine testing will be assayed using these blood spot cars.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7965}, 'targetDuration': '20 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of SARS-CoV-2 infection throughout pregnancy in women', 'timeFrame': 'Up to 9 months', 'description': 'Determine the prevalence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.'}, {'measure': 'Incidence of SARS-CoV-2 infection throughout pregnancy in women', 'timeFrame': 'Up to 9 months', 'description': 'Determine the incidence of SARS-CoV-2 infection throughout pregnancy in women whose pregnancy was documented at a SART member clinic in the United States between November 2019-December 2020. The investigators will use patient-reported information on infection symptoms as well as serological testing to capture both symptomatic and asymptomatic infections. Deliverable: By instituting the first prospectively tracked U.S.-based pregnancy cohort with precisely timed conception, the investigators will provide foundational, urgent data regarding the epidemiology of SARS-CoV-2 infection at varying gestational ages, across the real-time evolution of the COVID-19 pandemic and in the setting of various public health measures to reduce infection spread.'}], 'secondaryOutcomes': [{'measure': 'Risk ratios of adverse obstetric in women infect with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women', 'timeFrame': 'Up to 9 months', 'description': 'Determine risk ratios of adverse obstetric outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women. The investigators will focus on timing of infection (gestational month) and extent of COVID-19 symptoms as potential predictors of risk. Deliverable: The investigators will provide critical information about the maternal and fetal implications of SARS-CoV-2 infection at specific time points in pregnancy, compared to non-exposed pregnancies, and enable evidence-based obstetric surveillance protocols.'}, {'measure': 'Risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women', 'timeFrame': 'Up to 1.5 years', 'description': 'Determine risk ratios of adverse neonatal outcomes in women infected with SARS-CoV-2 during early pregnancy onward compared to non-infected pregnant women. The investigators will focus on timing of infection (gestational month) and extent of COVID-19 symptoms as potential predictors of risk. Deliverable: The investigators will provide critical information about the maternal and fetal implications of SARS-CoV-2 infection at specific time points in pregnancy, compared to non-exposed pregnancies, and enable evidence-based obstetric surveillance protocols.'}, {'measure': 'Clinical, behavioral, and sociodemographic determinants', 'timeFrame': 'Up to 27 months', 'description': 'Identify clinical, behavioral and sociodemographic determinants that predict risk of (a) maternal infection during pregnancy and (b) severe infection symptomatology (hospitalization, ICU admission). Deliverable: The investigators will provide novel findings that identify high-risk groups warranting more aggressive social avoidance measures during pregnancy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Pregnancy', 'Coronavirus'], 'conditions': ['Corona Virus Infection', 'COVID', 'Pregnancy Related', 'Early Pregnancy']}, 'referencesModule': {'references': [{'pmid': '34649015', 'type': 'DERIVED', 'citation': 'Huddleston HG, Jaswa EG, Lindquist KJ, Kaing A, Morris JR, Hariton E, Corley J, Hoskin E, Gaw SL, Cedars MI. COVID-19 vaccination patterns and attitudes among American pregnant individuals. Am J Obstet Gynecol MFM. 2022 Jan;4(1):100507. doi: 10.1016/j.ajogmf.2021.100507. Epub 2021 Oct 11. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for Covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.', 'detailedDescription': "ASPIRE is focused on the first trimester, a critical and vulnerable period when all of a baby's organ systems form and the placenta - the crucial connection between mom and baby - develops.\n\nCurrently, there are no data about the effects of COVID-19 infections in the first trimester. The study will provide critical information to:\n\n1. Guide the care of pregnant women\n2. Protect the safety of their babies and families\n3. Help those considering pregnancy in the future understand what it means to be pregnant in this new era\n\nThe investigators are recruiting 10,000 women from the start of pregnancy and will track COVID-19 exposures using frequent serology testing. The investigators will collect information during and after the pregnancy to try to determine the effects of COVID 19 for mom and baby.\n\nParticipants will be asked to do the following throughout pregnancy:\n\n* Submit frequent, quick (\\<1 minute each) symptom tracking reports using your mobile phone and/or computer.\n* Collect finger-stick blood samples from home at several points throughout your pregnancy.\n* Give permission to review medical records related to your pregnancy, delivery and baby's development.\n* Complete questionnaires online about your health during your pregnancy and after delivery of your baby."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators are recruiting 10,000 women from the start of pregnancy (4-10 weeks gestation) and will track COVID-19 exposures using frequent serology testing. The investigators will collect information during and after the pregnancy to try to determine the effects of COVID 19 for mom and baby.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over age 18\n* Participant is 4-10 weeks pregnant (gestation)\n\nExclusion Criteria:\n\n\\- Male (biologically unable to achieve pregnancy)'}, 'identificationModule': {'nctId': 'NCT04388605', 'acronym': 'ASPIRE', 'briefTitle': 'Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study', 'orgStudyIdInfo': {'id': '20-30559'}}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Heather Huddleston, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}