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Clinical Trials/NCT04883801
NCT04883801
Completed
Not Applicable

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

Kahramanmaras Sutcu Imam University1 site in 1 country202 target enrollmentMarch 11, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Kahramanmaras Sutcu Imam University
Enrollment
202
Locations
1
Primary Endpoint
Vertical transmission
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 11, 2020
End Date
May 5, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Kahramanmaras Sutcu Imam University
Responsible Party
Principal Investigator
Principal Investigator

Deniz Akyıldız

Assistant professor

Kahramanmaras Sutcu Imam University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Vertical transmission

Time Frame: 48 hours after birth

Determine the prevalence of COVID-19 in newborns born to pregnant women with COVID-19 with PCR from a nasopharyngeal swab.

Neonatal birth outcomes

Time Frame: At birth

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.

Neonatal postnatal outcomes

Time Frame: Within 48 hours after birth

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.

Study Sites (1)

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