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NCT04883801 Clinical Trial

Clinical Outcomes of Newborns Born to Pregnant Women With and Without COVID-19

Covid19 Clinical Trial

Official title:
Comparison of Early Postnatal Clinical Outcomes of Newborns Born to Pregnant Women With COVID-19: A Case-control Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04883801
Other study ID # Newborns outcomes
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 11, 2020
Est. completion date May 5, 2021

Study information
Verified date May 2021
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A case-control trial was conducted to test the early postpartum period clinical outcomes of newborns born to pregnant women with and without COVID-19.

Recruitment information / eligibility
Status Completed
Enrollment 202
Est. completion date May 5, 2021
Est. primary completion date March 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 45 Years
Eligibility Inclusion Criteria: Pregnant women on labor or preterm labor. Pregnant women who underwent programmed or emergence cesarean Exclusion Criteria: Those who were transferred to another hospital without or within a short period of delivery

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Reviewed clinical records and laboratory results
Retrospectively reviewed clinical records and laboratory results

Locations
Country Name City State
Turkey Denizli State Hospital Denizli

Sponsors (1)
Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vertical transmission Determine the prevalence of COVID-19 in newborns born to pregnant women with COVID-19 with PCR from a nasopharyngeal swab. 48 hours after birth
Primary Neonatal birth outcomes Determine the neonatal outcomes of the newborn specifying the birth week of the newborn, delivery type (vaginal or cesarean), birth weight (g), APGAR scores in the first and fifth minutes after birth. At birth
Primary Neonatal postnatal outcomes Determine the prevalence of neonatal postnatal outcomes of the newborn specifying the respiratory system illness, intensive care need, oxygen need, neonatal mortality, general health status, and breastfeeding status. Within 48 hours after birth
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