Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05087160 |
| Other study ID # |
COVID-19 and perinatal results |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Universidad de la Republica |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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
