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CompletedNCT05087160Updated Oct 21, 2021

Socioeconomic Inequalities Exacerbated by Mitigation Measures to COVID-19 and Differences in Prematurity Prevalence

An observational study in COVID-19 Pandemic, Preterm and Low Birth-weight, sponsored by Universidad de la Republica. Completed at 1 site in Uruguay. Open to female participants. Per ClinicalTrials.gov, last updated 2021-10-21.

Sponsored by Universidad de la Republica · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
37,323
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • COVID-19 Pandemic
  • Preterm
  • Low Birth-weight

Keywords

  • COVID-19
  • preterm
  • low birth weight
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's enrollment of 37,323 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Universidad de la Republica is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all live birth

Exclusion criteria

Exclusion Criteria:

  • stillbirth
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
37,323 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • 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

  • 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

    Other: mitigation measures against COVID 19

  • 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

    Other: mitigation measures against COVID 19

Interventions

  • Othermitigation measures against COVID 19

    no intervention

06

What researchers measure

Primary outcomes

  1. incidence of incidence of preterm births, low birth weight and intrauterine growth restriction

    number of birth in total birth with these conditions en two periods time in the two subsectors of health care

    Time frame: March 15 to September 30, 2019 and March 15 to September 30, 2020

07

Study locations

1 site
  • Stephanie Viroga
    Montevideo, 11300, Uruguay
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05087160
Lead sponsor
Universidad de la Republica
Responsible party
Stephanie Viroga (Clinical professor, Universidad de la Republica) — Principal investigator
First posted
Oct 21, 2021
Start date
Aug 1, 2021
Primary completion
Aug 30, 2021
Completion
Sep 30, 2021
Last update
Oct 21, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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