Clinical trial NCT04551690: 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)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Covid19
Labor (Obstetrics)--Complications
Demography
Keywords: Pregnancy
Labor
COVID-19
SARS-Cov2
sociodemographic
Lead sponsor: Hospital San Juan de Dios, Santiago
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 720
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Prevalence of SARS-CoV-2 in pregnant patients on labor
timeFrame: Through study completion, an average of 4 months
measure: Characterization of clinical features of patients who tested positive for COVID 19.
timeFrame: Through study completion, an average of 4 months
measure: Characterization of living conditions of pregnant women with COVID 19
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
measure: Neonatal hospitalization
timeFrame: Through study completion, an average of 4 months
measure: Neonatal weight
timeFrame: Through study completion, an average of 4 months
measure: Perinatal outcomes
timeFrame: Through study completion, an average of 4 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital San Juan de Dios
Study officials:
affiliation: Hospital San Juan de Dios AND Universidad de Chile
name: Helga Vera von Bargen, physician
role: STUDY_CHAIR
References: