Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
Study NCT ID:
NCT05087160
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2021-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Socioeconomic Inequalities Exacerbated by Mitigation Measures to COVID-19 and Differences in Prematurity Prevalence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37323}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of incidence of preterm births, low birth weight and intrauterine growth restriction', 'timeFrame': 'March 15 to September 30, 2019 and March 15 to September 30, 2020', 'description': 'number of birth in total birth with these conditions en two periods time in the two subsectors of health care'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'preterm', 'low birth weight'], 'conditions': ['COVID-19 Pandemic', 'Preterm', 'Low Birth-weight']}, 'referencesModule': {'references': [{'pmid': '37052316', 'type': 'DERIVED', 'citation': 'Briozzo L, Tomasso G, Trujillo J, Viroga S, Pintos J, Nozar F, Aleman A, Buekens P. COVID-19 mitigation measures increase preterm birth and low birth weight in the public healthcare system in Uruguay. Int J Gynaecol Obstet. 2023 Aug;162(2):718-724. doi: 10.1002/ijgo.14778. Epub 2023 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'Objective: to assess the perinatal results in Uruguay during the semester of successful control of the COVID 19 pandemic to evaluate the impact of the crises in the public and private sub sectors of the Health System.\n\nMethodology: An analytical observational study was carried out, comparing the semesters from March 15 to September 30, 2019 (year prior to the COVID 19 pandemic) with the same period 2020 (year of the COVID 19 pandemic), in the 2 sub sectors of public and private health care.', 'detailedDescription': 'An analytical observational study was carried out, comparing the semesters from March 15 to September 30, 2019 with the same period 2020, in the 2 sub sectors of public health care of the private sub sector throughout the country, taking all births in that period of time.\n\nThe semester selected is based on the fact that the first months of the pandemic were the ones with the greatest mitigation measures with drastic socio-economic consequences, but it was also a period of almost zero COVID infection in pregnancy, this being an opportune moment not to have as confounding factor to the maternal and fetal biological complications of this infection.\n\nThe situation will be analyzed in the 2 sub sectors of public health care, made up of the State Health Services Administration (ASSE), police health and military health, and the UDELAR Clinic Hospital, on the one hand, and the private sub-sector. made up of the Institutions of Collectivized Medical Assistance (IAMC) of Montevideo and the Interior (FEPREMI) and the private health care insurance.\n\nThe primary variable to be analyzed in both periods and in both subsectors of the national integrated system health was the incidence of preterm births (less than 37 weeks gestational age), low birth weight (newborns with a birth weight less than 2,500 grams) and intrauterine growth restriction (marked by doctor attending the birth, as a clinical diagnosis of the current pregnancy)\n\nFor the analysis of the national data, of the study periods, the database was requested from the Ministry of Public Health. This database is provided to researchers anonymously'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all live births in the 2 sub sectors of public health care of the private sub sector in the selected period of time', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all live birth\n\nExclusion Criteria:\n\n* stillbirth'}, 'identificationModule': {'nctId': 'NCT05087160', 'briefTitle': 'Socioeconomic Inequalities Exacerbated by Mitigation Measures to COVID-19 and Differences in Prematurity Prevalence', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de la Republica'}, 'officialTitle': 'Socioeconomic Inequalities Exacerbates by Mitigation Measures Against COVID-19 in the Differential Prevalence of Prematurity and Low Weight in Uruguay', 'orgStudyIdInfo': {'id': 'COVID-19 and perinatal results'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'semester pre pandemia in sub sectors of public health care in Uruguay', 'description': 'all birth in sub sectors of public health care between march 15 and September 30 of 2019, pre pandemia'}, {'label': 'semester pre pandemia in sub sectors of private health care in Uruguay', 'description': 'all birth in sub sectors of private health care between march 15 and September 30 of 2019, pre pandemia'}, {'label': 'semester with mitigation measures against COVID 19 in sub sectors of public health care in Uruguay', 'description': 'all birth in sub sectors of public health care between march 15 and September 30 of 2020, with mitigation measures against COVID- 19', 'interventionNames': ['Other: mitigation measures against COVID 19']}, {'label': 'semester with mitigation measures against COVID 19 in sub sectors of private health care in Uruguay', 'description': 'all birth in sub sectors of private health care between march 15 and September 30 of 2020, with mitigation measures against COVID- 19', 'interventionNames': ['Other: mitigation measures against COVID 19']}], 'interventions': [{'name': 'mitigation measures against COVID 19', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['semester with mitigation measures against COVID 19 in sub sectors of private health care in Uruguay', 'semester with mitigation measures against COVID 19 in sub sectors of public health care in Uruguay']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11300', 'city': 'Montevideo', 'country': 'Uruguay', 'facility': 'Stephanie Viroga', 'geoPoint': {'lat': -34.90328, 'lon': -56.18816}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de la Republica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Stephanie Viroga', 'investigatorAffiliation': 'Universidad de la Republica'}}}}