COVID-19 PCR Test Results in Asymptomatic Pregnants

COVID-19 PCR Test Results in Asymptomatic Pregnants Admitted for Birth and Other Interventions in Our Clinic

In order to prevent contamination from the pregnant women hospitalized in this clinic, the RT-PCR test is performed from the oropharyngeal and nasal swab sample taken before hospitalization. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant women who undergo intervention.

Study Overview

• Status: Completed
• Conditions: COVID-19; Asymptomatic Pregnant
• Intervention / Treatment: Diagnostic test: Reverse transcription polymerase chain reaction

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • İstanbul Medipol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients who apply to Istanbul Medipol University Hospital

Description

Inclusion Criteria:

• Asymptomatic pregnant women who will give birth in this clinic, dilatation and curettage due to missed abortion, cerclage due to cervical insufficiency, medical evacuation due to fetal anomaly, and routine PCR test taken for service for some treatments.

Exclusion Criteria:

• Having any COVID-19 infection symptoms (fever, cough, weakness, shortness of breath, sore throat, etc.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of positive COVID-19 cases in asymptomatic pregnant women	1 day

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Publications and helpful links

General Publications

• Sutton D, Fuchs K, D'Alton M, Goffman D. Universal Screening for SARS-CoV-2 in Women Admitted for Delivery. N Engl J Med. 2020 May 28;382(22):2163-2164. doi: 10.1056/NEJMc2009316. Epub 2020 Apr 13. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2020
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): May 21, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Gpolat1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No