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)

Covid19 Clinical Trial

— CONSCIENCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551690
• Other study ID #: COVID 19 Pregnancy HSJD Chile
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: October 2021
• Source: Hospital San Juan de Dios, Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• Covid19
• Demography
• Labor (Obstetrics)--Complications
• Pregnancy

Locations

Country	Name	City	State
Chile	Hospital San Juan de Dios	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Juan de Dios, Santiago

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Neonatal hospitalization	Number of days requiring hospitalization in the neonatal unit.	Through study completion, an average of 4 months
Secondary	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
Secondary	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