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Completed

NCT Number: NCT05318144

Melatonin Levels on COVID-19 Positive Pregnant Women

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.

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Key information

Conditions

COVID-19 Acute Respiratory Distress Syndrome COVID-19 Coronaviridae Infections Coronavirus Infections Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Pregnancy Complications Pregnancy Related RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Virus Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Samsun Training and Research Hospital

Samsun, 58153, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Melatonin level

    Time frame: 6 year

    Melatonin level of pregnant women with COVID-19

Sponsors and collaborators

Lead sponsor

Nazan Yurtcu MD

Other

Registry information

Official study title

Prognostic Value of Serum Melatonin as a Biomarker for the Determination of Severe COVID-19 Infection in Pregnant Women

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Apr 8, 2022

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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