Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-06 @ 1:42 PM
Study NCT ID:
NCT05883761
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2023-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}], 'ancestors': [{'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-26', 'size': 955025, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-22T16:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50075}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on DTG at conception.', 'timeFrame': '24 months', 'description': 'Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-positive women on DTG at conception'}, {'measure': 'Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-negative women', 'timeFrame': '24 months', 'description': 'Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-negative women'}, {'measure': 'Proportion of neural tube defects (NTDs) among live and stillborn infants delivered by HIV-positive women on non-DTG ARV at conception', 'timeFrame': '24 months', 'description': 'Number of live and stillborn infants with NTDs divided by the total number of live and stillborn infants of HIV-positive women on non-DTG ARV at conception'}], 'secondaryOutcomes': [{'measure': 'Prevalence of major external birth defects among all live and stillborn infants regardless of maternal HIV or ART status.', 'timeFrame': '24 months', 'description': 'Number of live and stillborn infants with major external birth defects divided by the total number of live and stillborn infants among all women regardless of HIV or ART status'}, {'measure': 'Proportion of other pregnancy outcomes', 'timeFrame': '24 months', 'description': 'Number of live and stillborn infants with low birthweight and pre-term delivery divided by the total number of live infants among women (overall and by HIV/ART status); number of stillborn infants among all pregnancies, including miscarriages'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neural Tube Defects', 'Congenital Abnormalities', 'Teratogens']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to assess the birth outcomes of HIV-positive women delivering in hospitals in Eswatini who are receiving dolutegravir (DTG) or other anti-retroviral (ARV) drug regimens. The main question the study aims to answer is, what is the proportion of neural tube defects among live and stillborn infants delivered by:\n\n* HIV-positive women on DTG at conception\n* HIV-negative women\n* HIV-positive women on non-DTG ARV at conception\n\nParticipants will be interviewed for information on HIV testing and antiretroviral therapy history, other medical history of selected conditions (e.g., diabetes, malaria, TB) and potential birth defect exposures. Photographs will be taken of the infants. Data on mothers' pregnancy history, birth outcomes, and HIV and ARV information (as applicable) will be collected from patient records.", 'detailedDescription': "This is an observational study conducted at five high volume hospitals in Eswatini, in which birth defect and other data will be collected at the time of delivery (or hospital admission for miscarriages and medical abortions) for all women. The overall aim of this study is to evaluate the birth outcomes of HIV-positive women who are receiving DTG or other ARV drug regimens. The primary research objectives are to: 1) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-positive women on DTG at conception; 2) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-negative women; and 3) determine the proportion of neural tube defects among live and stillborn infants delivered by HIV-positive women on non-DTG ART at conception. Secondary objectives are to determine overall general prevalence of major external birth defects and other pregnancy outcomes and any associations with other factors (e.g., maternal age, gravida). Data on mothers' pregnancy history, birth outcomes, and HIV and ARV information (as applicable) are collected from patient charts, registers, reporting forms and databases for all women. Women of live or stillborn infants with birth defects are consented for interviews capturing detailed history and exposure data and photographs of newborns' birth defects. Data collection will be for approximately 24 months. Blinded interview data and photographs are reviewed by a medical geneticist for confirmatory defect diagnosis. We will describe rates and 95% confidence intervals (CI) for birth defects among infants by maternal HIV and ART status."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women delivering infants at selected hospitals in Eswatini, including women delivering stillborn infants and those admitted for miscarriages or medical abortions due to identified congenital defects via diagnostic imaging', 'healthyVolunteers': True, 'eligibilityCriteria': 'Surveillance component includes all deliveries/admissions as defined in study population description. For a subset of the population recruited for additional data collection:\n\nInclusion Criteria:\n\n* women whose live or stillborn infant has birth defect as identified by a midwife or other clinician at the study hospital\n* willing to provide informed consent\n\nExclusion Criteria:\n\n* unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05883761', 'briefTitle': 'Birth Outcomes In Eswatini After Transition To Dolutegravir-Based Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Elizabeth Glaser Pediatric AIDS Foundation'}, 'officialTitle': 'Assessment of Birth Outcomes in Eswatini After Transition to Dolutegravir-based Treatment', 'orgStudyIdInfo': {'id': 'EG0259'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-positive DTG preconception', 'description': 'HIV status defined as a documented positive result in the perinatal and/or maternity register or other clinical source record. Preconception drug exposure determined using date of DTG initiation and LMP date or gestational age at delivery (if LMP not available). ART at conception is defined as maternal ART that started up to 8 weeks after the calculated LMP date, which would be up to 6 weeks after the estimated date of conception. As this is the group of interest, sample size target was determined as 10,000.'}, {'label': 'HIV-negative', 'description': 'Women with the last HIV test result recorded during pregnancy or labor and delivery as negative.'}, {'label': 'HIV-positive on non-DTG ARV preconception', 'description': 'HIV status defined as a documented positive result in the perinatal and/or maternity register or other clinical source record. Preconception drug exposure determined using date of ARV initiation (e.g., efavirenz) and LMP date or gestational age at delivery (if LMP not available). ART at conception is defined as maternal ART that started up to 8 weeks after the calculated LMP date, which would be up to 6 weeks after the estimated date of conception. Other groups to be included as informed by the data (e.g., HIV+ not on ART a conception, unknown ART at conception, etc).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lubombo', 'state': 'Lubombo Region', 'country': 'Eswatini', 'facility': 'Good Shepherd Hospital'}, {'city': 'Shiselweni', 'state': 'Shiselweni District', 'country': 'Eswatini', 'facility': 'Hlathikhulu Hospital'}, {'city': 'Manzini', 'country': 'Eswatini', 'facility': 'Mankayane Government Hospital', 'geoPoint': {'lat': -26.49884, 'lon': 31.38004}}, {'city': 'Manzini', 'country': 'Eswatini', 'facility': 'Raleigh Fitkin Memorial Hospital', 'geoPoint': {'lat': -26.49884, 'lon': 31.38004}}, {'city': 'Mbabane', 'country': 'Eswatini', 'facility': 'Mbabane Government Hospital', 'geoPoint': {'lat': -26.31667, 'lon': 31.13333}}], 'overallOfficials': [{'name': 'Michelle Gill, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elizabeth Glaser Pediatric AIDS Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health Eswatini', 'class': 'UNKNOWN'}, {'name': 'George Washington University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}