Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT01653392
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2012-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioThrax® (Anthrax) Vaccine in Pregnancy Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D063130', 'term': 'Maternal Death'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D004461', 'term': 'Eclampsia'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D011271', 'term': 'Pregnancy, Ectopic'}, {'id': 'D006828', 'term': 'Hydatidiform Mole'}, {'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001724', 'term': 'Birth Weight'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D063129', 'term': 'Parental Death'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D031901', 'term': 'Gestational Trophoblastic Disease'}, {'id': 'D014328', 'term': 'Trophoblastic Neoplasms'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011252', 'term': 'Pregnancy Complications, Neoplastic'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2012-07-16', 'studyFirstSubmitQcDate': '2012-07-30', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy Outcomes', 'timeFrame': 'Up to 44 weeks', 'description': 'Pregnancy outcomes measured include live birth, still birth, spontaneous abortion, elective termination, ectopic pregnancy, or molar pregnancy Note: Twin or higher order multiple pregnancies may have more than one outcome.'}, {'measure': 'Maternal Outcomes', 'timeFrame': 'Up to 44 weeks', 'description': 'Maternal outcomes measured include maternal death, pre-eclampsia/eclampsia, preterm labor, and gestational diabetes.'}, {'measure': 'Infant Outcomes', 'timeFrame': 'Up to 1 year of age', 'description': 'Infant outcomes measured include birth defects, infant sex ratios, preterm birth, and birth weight.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Maternal Mortality', 'Obstetric Labor, Premature', 'Eclampsia', 'Pre-Eclampsia', 'Abortion, Spontaneous', 'Diabetes, Gestational', 'Pregnancy, Ectopic', 'Hydatidiform Mole', 'Fetal death', 'Live birth', 'Still birth', 'Premature Birth', 'Sex ratio', 'Birth weight'], 'conditions': ['Pregnancy Complications', 'Pregnancy Outcome', 'Congenital Abnormalities']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.', 'detailedDescription': 'This study will use a convenience sample and passive referral to enroll participants.\n\nFor the maternal outcome portion of the study, pregnant active duty women who consent to join the registry are expected to complete several surveys over the course of their pregnancy, including an initial enrollment survey, a follow-up survey at or after the 20th week of pregnancy, and a post-delivery survey at two weeks after their delivery due date (unless a pregnancy loss is reported in the 20 week survey).\n\nOutcomes among infants born to women enrolled in the Registry whose pregnancies result in a livebirth will be assessed with a survey during the post-delivery contact, again at 4 months of age, with a final follow-up when the infant reaches one year of age.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Active duty female service members who received one or more doses of BioThrax® while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period (LMP) All live born infants born to women who join the registry.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female active duty service member\n* Received one or more dose of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period.\n\nExclusion Criteria:\n\n* Non-service member, non-active duty pregnant female.'}, 'identificationModule': {'nctId': 'NCT01653392', 'briefTitle': 'BioThrax® (Anthrax) Vaccine in Pregnancy Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Emergent BioSolutions'}, 'officialTitle': 'BioThrax® (Anthrax) Vaccine in Pregnancy Registry', 'orgStudyIdInfo': {'id': 'EBS.AVA.010 / NHRC.2012.0003'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anthrax Vaccine Adsorbed', 'description': 'Active duty women who received one or more doses of BioThrax while pregnant, with the onset of pregnancy defined as the first day of the last menstrual period, and all live born infants born to women who join the registry.', 'interventionNames': ['Biological: Observational Intervention']}], 'interventions': [{'name': 'Observational Intervention', 'type': 'BIOLOGICAL', 'description': 'This is an observational study, therefore no interventions are specified.', 'armGroupLabels': ['Anthrax Vaccine Adsorbed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92106', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Health Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Natalie Wells, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Naval Health Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emergent BioSolutions', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Naval Health Research Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}