- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05087160
Socioeconomic Inequalities Exacerbated by Mitigation Measures to COVID-19 and Differences in Prematurity Prevalence
Socioeconomic Inequalities Exacerbates by Mitigation Measures Against COVID-19 in the Differential Prevalence of Prematurity and Low Weight in Uruguay
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.
Methodology: 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
The 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.
The 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.
The 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)
For 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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Montevideo, Uruguay, 11300
- Stephanie Viroga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- all live birth
Exclusion Criteria:
- stillbirth
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
semester pre pandemia in sub sectors of public health care in Uruguay
all birth in sub sectors of public health care between march 15 and September 30 of 2019, pre pandemia
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semester pre pandemia in sub sectors of private health care in Uruguay
all birth in sub sectors of private health care between march 15 and September 30 of 2019, pre pandemia
|
|
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semester with mitigation measures against COVID 19 in sub sectors of public health care in Uruguay
all birth in sub sectors of public health care between march 15 and September 30 of 2020, with mitigation measures against COVID- 19
|
no intervention
|
|
semester with mitigation measures against COVID 19 in sub sectors of private health care in Uruguay
all birth in sub sectors of private health care between march 15 and September 30 of 2020, with mitigation measures against COVID- 19
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
incidence of incidence of preterm births, low birth weight and intrauterine growth restriction
Time Frame: March 15 to September 30, 2019 and March 15 to September 30, 2020
|
number of birth in total birth with these conditions en two periods time in the two subsectors of health care
|
March 15 to September 30, 2019 and March 15 to September 30, 2020
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID-19 and perinatal results
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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