COVID-19 PCR Test Results in Asymptomatic Pregnants

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04410939
• Other study ID #: Gpolat1
• Status: Completed
• Start date: April 10, 2020
• Est. completion date: May 21, 2020

Study information

• Verified date: May 2020
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: May 21, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.)

Related Conditions & MeSH terms

• Asymptomatic Pregnant
• COVID-19

Intervention

Diagnostic Test:
• Reverse transcription polymerase chain reaction
PCR test is performed from the oropharyngeal and nasal swab samples taken before admission to each pregnant to prevent contamination from the pregnant women hospitalized in this clinic. 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 and undergoing pregnant women.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 Apr 13. doi: 10.1056/NEJMc2009316. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of positive COVID-19 cases in asymptomatic pregnant women		1 day