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CompletedNCT04551690CONSCIENCEUpdated Oct 14, 2021

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 in Pregnancy, Covid19 and Labor (Obstetrics)--Complications, sponsored by Hospital San Juan de Dios, Santiago. Completed at 1 site in Chile. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-14.

Sponsored by Hospital San Juan de Dios, Santiago · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
720
Ages
18 Years to 45 Years
Sex
Female
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Study 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 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.

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Conditions studied

  • Pregnancy
  • Covid19
  • Labor (Obstetrics)--Complications
  • Demography

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Keywords

  • Pregnancy
  • Labor
  • COVID-19
  • SARS-Cov2
  • sociodemographic
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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 720 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Hospital San Juan de Dios, Santiago is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

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

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

Exclusion criteria

Exclusion Criteria:

  • Stillbirth
  • Refusal to participate in the study
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
720 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Through study completion, an average of 4 months

Secondary outcomes

  1. Neonatal hospitalization

    Number of days requiring hospitalization in the neonatal unit.

    Time frame: 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.

    Time frame: 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.

    Time frame: Through study completion, an average of 4 months

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Study locations

1 site
  • Hospital San Juan de Dios
    Santiago, 8350488, Chile
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2020 to primary completion in Jul 2020, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2020
First posted
Sep 16, 2020
StartActual
Apr 15, 2020
Primary completionActual
Jul 15, 2020
CompletionActual
Jul 15, 2020
Last update
Oct 14, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04551690
Lead sponsor
Hospital San Juan de Dios, Santiago
Responsible party
Helga Vera (Principal investigator: Helga Vera von Bargen, Hospital San Juan de Dios, Santiago) — Principal investigator
First posted
Sep 16, 2020
Start date
Apr 15, 2020
Primary completion
Jul 15, 2020
Completion
Jul 15, 2020
Last update
Oct 14, 2021

Study contacts

Helga Vera von Bargen, physician
study chair · Hospital San Juan de Dios AND Universidad de Chile

Oversight

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

Not currently enrolling

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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Discussion

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