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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04883801
Enrollment
202
Registered
2021-05-12
Start date
2020-03-11
Completion date
2021-05-05
Last updated
2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTReviewed clinical records and laboratory results

Retrospectively reviewed clinical records and laboratory results

Sponsors

Kahramanmaras Sutcu Imam University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vertical transmission48 hours after birthDetermine the prevalence of COVID-19 in newborns born to pregnant women with COVID-19 with PCR from a nasopharyngeal swab.
Neonatal birth outcomesAt birthDetermine 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 outcomesWithin 48 hours after birthDetermine 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026