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)

Completed

• Conditions: Labor (Obstetrics)--Complications; Demography; Pregnancy; Covid19

• Registration Number: NCT04551690
• Lead Sponsor: Hospital San Juan de Dios, Santiago

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.

Study Timeline

• Study Start: 2020-04-15
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-15
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-16
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 720

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of living conditions of pregnant women with COVID 19	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	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.	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 Outcome Measures

Name	Time	Method
Neonatal hospitalization	Through study completion, an average of 4 months	Number of days requiring hospitalization in the neonatal unit.
Neonatal weight	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.
Perinatal outcomes	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.

Trial Locations

Locations (1)

Hospital San Juan de Dios; 🇨🇱 Santiago, Chile