Clinical trial NCT05318144: Melatonin Levels on COVID-19 Positive Pregnant Women
Official title: Prognostic Value of Serum Melatonin as a Biomarker for the Determination of Severe COVID-19 Infection in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Pregnancy Related
Pregnancy Complications
Keywords: COVID-19
SARS-CoV-2
Melatonine
pregnancy
pregnancy outcomes
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women with COVID-19 and control groups

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Melatonin level
timeFrame: 6 year
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun Training and Research Hospital
Study officials:
affiliation: Halic University Faculty of Medicine, Department of Obstetrics and Gynecology
name: Serkan Oral
role: STUDY_CHAIR
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