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PregnancyCONSCIENCENCT04551690

Prevalence of COVID-19 (Coronavirus Disease 19) in Pregnant Women on Labor in a Public Hospital in Chile (COroNavirus diSease Covid-19 pandEmic iN ChilE)

An observational study of Pregnancy and Covid19, run by Hospital San Juan de Dios, Santiago at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aim is to assess the prevalence of SARS-COV-2 in unselected pregnant women on labour (or a predictable delivery during next 24 hours), their outcome and sociodemographic conditions. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
How many people
720 participants
Where
1 siteChile
Study dates
15 Apr 2020to 15 Jul 2020
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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Pregnant women on labor or preterm labor or who will require interruption of their preg-nancy during the next 24 hours in the Hospital San Juan de Dios in Santiago de Chile between 15 April 2020 and 15 July 2020.

Who may be able to join

  • Pregnant women on labor or preterm labor.
  • Pregnant women who underwent programmed or emergence cesarean

Who cannot join

  • Stillbirth
  • Refusal to participate in the study

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Hospital San Juan de Dios

    Santiago, 8350488

Other trials in Chile

About this study

Official title: Analysis of Prevalence, Pregnancy Outcomes and Sociodemographic Conditions in Women at Labour With and Without Coronavirus 19 Disease COVID-19 in a Public Hospital in Chile

This study aim is to assess the prevalence of SARS-COV-2 in unselected pregnant women on labour (or a predictable delivery during next 24 hours), their outcome and sociodemographic conditions.

Read the detailed description

This is a cross sectional study conducted in Hospital San Juan de Dios, Santiago of Chile. This Hospital attends nearly 4500 births every year. When the COVID-19 pandemia came to Chile, there was no possibility to assess the seroconversion for SARS-Cov2. Currently, it remains unclear the seroprevalence of SARS-Cov-2 in pregnant near to delivery in our country, also its correlation with clinical, perinatal outcomes and sociodemographic characteristics. The project will evaluate these features, collecting nasopharyngeal swab serology in a systematic manner in unselected pregnant women on labor (or a predictable delivery during next 24 hours). Maternal information including clinical data, obstetric history, comorbidities and sociodemographic characteristics acquired from medical records will be correlated to the seroconversion.

Keywords
Pregnancy, Labor, COVID-19, SARS-Cov2, sociodemographic
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of SARS-CoV-2 in pregnant patients on labor

    Determine the prevalence of SARS-CoV-2 in pregnant patients on labor (or a predictable delivery during next 24 hours) with PCR form oropharyngeal swab.

    Measured: Through study completion, an average of 4 months

  2. Characterization of clinical features of patients who tested positive for COVID 19.

    A questionaire was elaborated to quote all of the following symptoms and were checked at the moment of labour by the residents at charge. The questionaire include following symptoms : presence of fever, cough, dyspnea , headache, myalgia, rhinorrhea, odynophagia and anosmia.

    Measured: Through study completion, an average of 4 months

  3. Characterization of living conditions of pregnant women with COVID 19

    Number of bedrooms and number of persons that sleep in that bedroom.

    Measured: Through study completion, an average of 4 months

Secondary outcomes (3)

  1. Neonatal hospitalization

    Number of days requiring hospitalization in the neonatal unit.

    Measured: Through study completion, an average of 4 months

  2. Neonatal weight

    Evaluate the neonatal outcome classifying the newborn in adequate for the gestational age, large for gestational age or growth restriction for Parkin. Birth weigt is in grams. We use the Neonatal Growth Charts from Chile.

    Measured: Through study completion, an average of 4 months

  3. Perinatal outcomes

    Describe the perinatal outcomes of the newborn specifying the Apgar score at delivery.Apgar scores goes form 0 to 10.

    Measured: Through study completion, an average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start15 Apr 2020
  3. Primary completion15 Jul 2020
  4. Study completion15 Jul 2020

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551690
Sponsor's protocol ID
COVID 19 Pregnancy HSJD Chile
Acronym
CONSCIENCE
Status last verified
Oct 2021
First submitted
28 Jul 2020
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Covid19, run by Hospital San Juan de Dios, Santiago at 1 site in Chile.

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 2 inclusion and 2 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 14 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 Chile. 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?

Prevalence of SARS-CoV-2 in pregnant patients on labor (time frame: Through study completion, an average of 4 months). The study lists 3 primary outcomes in all. 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 NCT04551690.

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 14 Oct 2021.

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