CONSCIENCE: 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)

Sponsor
Hospital San Juan de Dios, Santiago (Other)
Overall Status
Completed
CT.gov ID
NCT04551690
Collaborator
(none)
720
1
3
240.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    720 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    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
    Actual Study Start Date :
    Apr 15, 2020
    Actual Primary Completion Date :
    Jul 15, 2020
    Actual Study Completion Date :
    Jul 15, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    Secondary Outcome Measures

    1. Neonatal hospitalization [Through study completion, an average of 4 months]

      Number of days requiring hospitalization in the neonatal unit.

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital San Juan de Dios Santiago Chile 8350488

    Sponsors and Collaborators

    • Hospital San Juan de Dios, Santiago

    Investigators

    • Study Chair: Helga Vera von Bargen, physician, Hospital San Juan de Dios AND Universidad de Chile

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helga Vera, Principal investigator: Helga Vera von Bargen, Hospital San Juan de Dios, Santiago
    ClinicalTrials.gov Identifier:
    NCT04551690
    Other Study ID Numbers:
    • COVID 19 Pregnancy HSJD Chile
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Oct 14, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Helga Vera, Principal investigator: Helga Vera von Bargen, Hospital San Juan de Dios, Santiago
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 14, 2021