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)

NCT04551690 | Completed

• 1 other identifier: COVID 19 Pregnancy HSJD Chile
• Study Type: observational
• Target: 720
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pregnancy; Labor; COVID-19; SARS-Cov2; sociodemographic

Outcome Measures

Primary Outcomes (3)

• 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.

  Through study completion, an average of 4 months

• 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.

  Through study completion, an average of 4 months

• Characterization of living conditions of pregnant women with COVID 19

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

  Through study completion, an average of 4 months

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Stillbirth
• Refusal to participate in the study

Sponsors & Collaborators

• Hospital San Juan de Dios, Santiago: lead

Study Sites (1)

Hospital San Juan de Dios

Santiago, 8350488, Chile

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Helga Vera von Bargen, physician

  Hospital San Juan de Dios AND Universidad de Chile

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator: Helga Vera von Bargen

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: September 16, 2020
• Study Start: April 15, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

CL (1)