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Clinical Trials/NCT04551690
NCT04551690
Completed
Not Applicable

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

Hospital San Juan de Dios, Santiago1 site in 1 country720 target enrollmentApril 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Hospital San Juan de Dios, Santiago
Enrollment
720
Locations
1
Primary Endpoint
Characterization of living conditions of pregnant women with COVID 19
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2020
End Date
July 15, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Hospital San Juan de Dios, Santiago
Responsible Party
Principal Investigator
Principal Investigator

Helga Vera

Principal investigator: Helga Vera von Bargen

Hospital San Juan de Dios, Santiago

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Neonatal hospitalization(Through study completion, an average of 4 months)
  • Neonatal weight(Through study completion, an average of 4 months)
  • Perinatal outcomes(Through study completion, an average of 4 months)

Study Sites (1)

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