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Melatonin Levels on COVID-19 Positive Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05318144
Recruitment Status : Completed
First Posted : April 8, 2022
Last Update Posted : April 8, 2022
Sponsor:
Information provided by (Responsible Party):
Nazan Yurtcu MD, Cumhuriyet University

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.


Condition or disease
COVID-19 Acute Respiratory Distress Syndrome Pregnancy Related Pregnancy Complications

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 228 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Prognostic Value of Serum Melatonin as a Biomarker for the Determination of Severe COVID-19 Infection in Pregnant Women
Actual Study Start Date : June 1, 2021
Actual Primary Completion Date : December 1, 2021
Actual Study Completion Date : February 1, 2022


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



Primary Outcome Measures :
  1. Melatonin level [ Time Frame: 6 year ]
    Melatonin level of pregnant women with COVID-19



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women with COVID-19 and control groups
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05318144


Locations
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Turkey
Samsun Training and Research Hospital
Samsun, Turkey, 58153
Sponsors and Collaborators
Nazan Yurtcu MD
Investigators
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Study Chair: Serkan Oral Halic University Faculty of Medicine, Department of Obstetrics and Gynecology
Publications of Results:

Other Publications:
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Responsible Party: Nazan Yurtcu MD, Assistant Professor, Cumhuriyet University
ClinicalTrials.gov Identifier: NCT05318144    
Other Study ID Numbers: COVID-19 and pregnancy
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: April 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: June 2021- December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nazan Yurtcu MD, Cumhuriyet University:
COVID-19
SARS-CoV-2
Melatonine
pregnancy
pregnancy outcomes
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pregnancy Complications
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury