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

NCT04883801 | Completed

• 1 other identifier: Newborns outcomes
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Vertical Transmission of Infectious Disease; Neonatal Infection; Pregnancy Related

Keywords

Childbirth; COVID-19; Neonatal outcomes; Newborn; Pregnant women; Vertical transmission

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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

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

Interventions

Reviewed clinical records and laboratory results DIAGNOSTIC_TEST

Retrospectively reviewed clinical records and laboratory results

COVID-19 case group; Control group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pregnant women on labor or preterm labor. Pregnant women who underwent programmed or emergence cesarean

You may not qualify if:

• Those who were transferred to another hospital without or within a short period of delivery

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Denizli State Hospital

Denizli, 4600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 9, 2021
• First Posted: May 12, 2021
• Study Start: March 11, 2020
• Primary Completion: March 11, 2021
• Study Completion: May 5, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)