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Melatonin Levels on COVID-19 Positive Pregnant Women

N

Nazan Yurtcu MD

Status

Completed

Conditions

Pregnancy Complications
COVID-19 Acute Respiratory Distress Syndrome
Pregnancy Related

Study type

Observational

Funder types

Other

Identifiers

NCT05318144
COVID-19 and pregnancy

Details and patient eligibility

About

This study aimed to investigate the prognostic value of serum melatonin as a biomarker for the determination of severe COVID-19 infection in pregnant women.

Four study groups were formed, including pregnant women with a positive COVID-19 PCR test, severe symptoms, and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints, but had a PCR test due to the surveillance program and negative test results were included in the control group.

Methods and Main Outcome measure: Laboratory values of the cases at the time of diagnosis parameters were collected.

Melatonin levels decrease in pregnant women with COVID-19 symptoms, the severity of symptoms increases. In addition, patients with low melatonin levels have an increase in infection parameters and an increase in the hospital stay.

Full description

A total of 228 pregnant women included in this prospective controlled study between June 20021 and June 2022 at Gynecology and Obstetrics Department of Health Sciences University Samsun Training and Research Hospital.

Enrollment

228 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • pregnant women with a positive COVID-19 PCR test and severe symptoms and inpatient treatment. Pregnant women who had complaints similar to COVID-19 infection or had no complaints but had a PCR test due to the surveillance program and negative test results were included in the control group. Pregnant women who had contact with people with COVID-19 infection and had a PCR test due to the surveillance program and had positive results, but no complaints were included in the other study group. The PCR test of pregnant women who had complaints and needed inpatient treatment during the COVID-19 infection was confirmed, and the COVID-19 infection was graded according to WHO's criteria. Pregnant women with viral infection with symptoms compatible with infection and virus isolation in any culture samples collected at admission were included in the patient group with PCR positive mild-moderate and severe COVID-19 infection.

Trial design

228 participants in 4 patient groups

PCR (-) symptomatic
Description:
control group, pregnant women with negative COVID-19 Polymerase Chain Reaction (PCR) test
PCR (+) asymptomatic
Description:
Pregnant women who have a positive COVID-19 PCR test and have had the infection without symptoms
PCR (+) mild-moderate
Description:
Pregnant women with positive COVID-19 PCR test and mild to moderate symptoms and inpatient treatment
PCR (+) severe COVID-19
Description:
Pregnant women with positive COVID-19 PCR test and severe symptoms

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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