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OpenTrials
Completed

NCT Number: NCT04883801

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neonatal Infection Nidovirales Infections Pneumonia Pneumonia, Viral Pregnancy Related RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vertical Transmission of Infectious Disease Virus Diseases

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Denizli State Hospital

Denizli, 4600, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reviewed clinical records and laboratory results

Diagnostic Test

Retrospectively reviewed clinical records and laboratory results

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2021
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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