COVID-19 PandemicNCT05087160
Socioeconomic Inequalities Exacerbated by Mitigation Measures to COVID-19 and Differences in Prematurity Prevalence
An observational study of COVID-19 Pandemic and Preterm, run by Universidad de la Republica at 1 site in Uruguay.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- COVID-19 Pandemic, Preterm, Low Birth-weight
- What is being tested?
- mitigation measures against COVID 19
- How many people
- 37,323 participants
- Where
- 1 siteUruguay
- Study dates
- 1 Aug 2021to 30 Sep 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Child, Adult, Older adult
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
Who may be able to join
- all live birth
Who cannot join
- stillbirth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- COVID-19 Pandemic, Preterm, Low Birth-weight
- Being tested
- mitigation measures against COVID 19
- Keywords
- COVID-19, preterm, low birth weight
- Medical subject headings
- COVID-19, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitigation measures against COVID 19Other
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: mitigation measures against COVID 19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: March 15 to September 30, 2019 and March 15 to September 30, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Aug 2021
- Primary completion30 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 37,323 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universidad de la Republica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Viroga, Universidad de la Republica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087160
- Sponsor's protocol ID
- COVID-19 and perinatal results
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37052316
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioeconomic Inequalities Exacerbates by Mitigation Measures Against COVID-19 in the Differential Prevalence of Prematurity and Low Weight in Uruguay
- ClinicalTrials.gov ID
- NCT05087160
- Acronym / sponsor ID
- COVID-19 and perinatal results
- Conditions
- COVID-19 Pandemic, Preterm, Low Birth-weight
- Keywords
- COVID-19, preterm, low birth weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,323 participants (actual)
- Lead sponsor
- Universidad de la RepublicaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: mitigation measures against COVID 19all birth in sub sectors of public health care between march 15 and September 30 of 2020, with mitigation measures against COVID- 19 |
| semester with mitigation measures against COVID 19 in sub sectors of private health care in Uruguay | – | Other: mitigation measures against COVID 19all birth in sub sectors of private health care between march 15 and September 30 of 2020, with mitigation measures against COVID- 19 |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- all live birth
Key exclusion criteria (1 listed)
- stillbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mitigation measures against COVID 19no intervention | Other | semester with mitigation measures against COVID 19 in sub sectors of private health care in Uruguay, semester with mitigation measures against COVID 19 in sub sectors of public health care in Uruguay |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 37052316Briozzo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic and Preterm, run by Universidad de la Republica at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05087160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021.