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Completed

NCT Number: NCT04551690

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)

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.

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Key information

Conditions

Pregnancy COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Demography Infections Labor (Obstetrics)--Complications Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital San Juan de Dios

Santiago, 8350488, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Stillbirth
  • Refusal to participate in the study

Treatment and study plan

Primary outcomes

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

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

    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.

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

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

    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.

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

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

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

Secondary outcomes

  1. Neonatal hospitalization

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

    Number of days requiring hospitalization in the neonatal unit.

  2. Neonatal weight

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

    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.

  3. Perinatal outcomes

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

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

Sponsors and collaborators

Lead sponsor

Hospital San Juan de Dios, Santiago

Other

Registry information

Official study 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

Acronym: CONSCIENCE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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