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

May 10, 2021 updated by: Deniz Akyıldız, Kahramanmaras Sutcu Imam University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 4600
        • Denizli State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns born to pregnant women with and without COVID-19 at Denizli State Hospital between March 11, 2020 - March 11, 2021.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 case group
Newborns born to pregnant women diagnosed with COVID-19 during hospitalization for delivery
Diagnostic test: Reviewed clinical records and laboratory results
Retrospectively reviewed clinical records and laboratory results
Control group
Newborns born to pregnant women who were not diagnosed with COVID-19 in their medical history and hospitalization for delivery
Diagnostic test: Reviewed clinical records and laboratory results
Retrospectively reviewed clinical records and laboratory results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours after birth
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.
At 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.
Within 48 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2020

Primary Completion (Actual)

March 11, 2021

Study Completion (Actual)

May 5, 2021

Study Registration Dates

First Submitted

May 9, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Newborns outcomes

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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