Clinical trial NCT05087160: Socioeconomic Inequalities Exacerbated by Mitigation Measures to COVID-19 and Differences in Prematurity Prevalence
Official title: Socioeconomic Inequalities Exacerbates by Mitigation Measures Against COVID-19 in the Differential Prevalence of Prematurity and Low Weight in Uruguay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Preterm
Low Birth-weight
Keywords: COVID-19
preterm
low birth weight
Lead sponsor: Universidad de la Republica
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 37323
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all live births in the 2 sub sectors of public health care of the private sub sector in the selected period of time

Brief summary: 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.

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

Eligibility criteria: Inclusion Criteria:

* all live birth

Exclusion Criteria:

* stillbirth

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
city: Montevideo
country: Uruguay
facility: Stephanie Viroga
Study officials:
References: