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)

Study 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.

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

Conditions
-----------------
Pregnancy, Covid19, Labor (Obstetrics)--Complications, Demography

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal hospitalization | Number of days requiring hospitalization in the neonatal unit. | Through study completion, an average of 4 months | 
| 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. | Through study completion, an average of 4 months | 
| Perinatal outcomes | Describe the perinatal outcomes of the newborn specifying the Apgar score at delivery.Apgar scores goes form 0 to 10. | Through study completion, an average of 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Labor, Pregnancy, COVID-19, SARS-Cov2, sociodemographic