Melatonin Levels on COVID-19 Positive Pregnant Women

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318144
• Other study ID #: COVID-19 and pregnancy
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2022
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: February 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Pregnancy Complications
• Pregnancy Related
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Turkey	Samsun Training and Research Hospital	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Nazan Yurtcu MD

Country where clinical trial is conducted

Turkey, 

References & Publications (16)

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Di Mascio D, Khalil A, Saccone G, Rizzo G, Buca D, Liberati M, Vecchiet J, Nappi L, Scambia G, Berghella V, D'Antonio F. Outcome of coronavirus spectrum infections (SARS, MERS, COVID-19) during pregnancy: a systematic review and meta-analysis. Am J Obstet — View Citation

Farnoosh G, Akbariqomi M, Badri T, Bagheri M, Izadi M, Saeedi-Boroujeni A, Rezaie E, Ghaleh HEG, Aghamollaei H, Fasihi-Ramandi M, Hassanpour K, Alishiri G. Efficacy of a Low Dose of Melatonin as an Adjunctive Therapy in Hospitalized Patients with COVID-19 — View Citation

Huntley BJF, Huntley ES, Di Mascio D, Chen T, Berghella V, Chauhan SP. Rates of Maternal and Perinatal Mortality and Vertical Transmission in Pregnancies Complicated by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Co-V-2) Infection: A Systematic Review. Obstet Gynecol. 2020 Aug;136(2):303-312. doi: 10.1097/AOG.0000000000004010. — View Citation

Liset R, Grønli J, Henriksen RE, Henriksen TEG, Nilsen RM, Pallesen S. A randomized controlled trial on the effect of blue-blocking glasses compared to partial blue-blockers on melatonin profile among nulliparous women in third trimester of the pregnancy. — View Citation

Nehme PA, Amaral FG, Middleton B, Lowden A, Marqueze E, França-Junior I, Antunes JLF, Cipolla-Neto J, Skene DJ, Moreno CRC. Melatonin profiles during the third trimester of pregnancy and health status in the offspring among day and night workers: A case s — View Citation

Salles C. Correspondence COVID-19: Melatonin as a potential adjuvant treatment. Life Sci. 2020 Jul 15;253:117716. doi: 10.1016/j.lfs.2020.117716. Epub 2020 Apr 22. — View Citation

Uzun M, Gencer M, Turkon H, Oztopuz RO, Demir U, Ovali MA. Effects of Melatonin on Blood Pressure, Oxidative Stress and Placental Expressions of TNFa, IL-6, VEGF and sFlt-1 in RUPP Rat Model of Preeclampsia. Arch Med Res. 2017 Oct;48(7):592-598. doi: 10.1 — View Citation

Voiculescu SE, Zygouropoulos N, Zahiu CD, Zagrean AM. Role of melatonin in embryo fetal development. J Med Life. 2014 Oct-Dec;7(4):488-92. Review. — View Citation

Wastnedge EAN, Reynolds RM, van Boeckel SR, Stock SJ, Denison FC, Maybin JA, Critchley HOD. Pregnancy and COVID-19. Physiol Rev. 2021 Jan 1;101(1):303-318. doi: 10.1152/physrev.00024.2020. Epub 2020 Sep 24. Review. — View Citation

Wong SF, Chow KM, Leung TN, Ng WF, Ng TK, Shek CC, Ng PC, Lam PW, Ho LC, To WW, Lai ST, Yan WW, Tan PY. Pregnancy and perinatal outcomes of women with severe acute respiratory syndrome. Am J Obstet Gynecol. 2004 Jul;191(1):292-7. — View Citation

Yurtcu N, Çaliskan C, Çelik S. Serum Melatonin as a Biomarker for Assessment of Late-term and Postterm Pregnancies in Women without Spontaneous Onset of Labor. Z Geburtshilfe Neonatol. 2021 Dec;225(6):499-505. doi: 10.1055/a-1479-3220. Epub 2021 May 31. — View Citation

Zauche LH, Wallace B, Smoots AN, Olson CK, Oduyebo T, Kim SY, Peterson EE, Ju J, Beauregard J, Wilcox AJ, Rose CE, Meaney-Delman D, Ellington SR. Receipt of mRNA COVID-19 vaccines preconception and during pregnancy and risk of self-reported spontaneous ab — View Citation

Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melatonin level	Melatonin level of pregnant women with COVID-19	6 year