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

Completed

• Conditions: Vertical Transmission of Infectious Disease; Covid19; Pregnancy Related; Neonatal Infection
• Interventions: Diagnostic Test: Reviewed clinical records and laboratory results

• Registration Number: NCT04883801
• Lead Sponsor: Kahramanmaras Sutcu Imam University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-11
• Primary Completion: 2021-03-11
• Status Verified: 2021-05
• Study Completion: 2021-05-05
• Study First Submitted: 2021-05-09
• Study First Submitted QC: 2021-05-10
• Last Update Submitted: 2021-05-10
• Study First Posted: 2021-05-12
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Reviewed clinical records and laboratory results	Newborns born to pregnant women who were not diagnosed with COVID-19 in their medical history and hospitalization for delivery
COVID-19 case group	Reviewed clinical records and laboratory results	Newborns born to pregnant women diagnosed with COVID-19 during hospitalization for delivery

Primary Outcome Measures

Name	Time	Method
Vertical transmission	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	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	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.

Trial Locations

Locations (1)

Denizli State Hospital; 🇹🇷 Denizli, Turkey