NCT05087160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37,323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

29 days

First QC Date

October 6, 2021

Last Update Submit

October 20, 2021

Conditions

Keywords

COVID-19pretermlow birth weight

Outcome Measures

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

    March 15 to September 30, 2019 and March 15 to September 30, 2020

Study Arms (4)

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

no intervention

semester with mitigation measures against COVID 19 in sub sectors of private health care in Uruguaysemester with mitigation measures against COVID 19 in sub sectors of public health care in Uruguay

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • all live birth

You may not qualify if:

  • stillbirth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephanie Viroga

Montevideo, 11300, Uruguay

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Premature Birth

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

October 6, 2021

First Posted

October 21, 2021

Study Start

August 1, 2021

Primary Completion

August 30, 2021

Study Completion

September 30, 2021

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations