Melatonin Levels on COVID-19 Positive Pregnant Women

NCT05318144 | Completed

• 1 other identifier: COVID-19 and pregnancy
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Pregnancy Related; Pregnancy Complications

Keywords

COVID-19; SARS-CoV-2; Melatonine; pregnancy; pregnancy outcomes

Outcome Measures

Primary Outcomes (1)

• Melatonin level

  Melatonin level of pregnant women with COVID-19

  6 year

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women with COVID-19 and control groups

You may qualify if:

• 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.

Sponsors & Collaborators

• Nazan Yurtcu MD: lead

Study Sites (1)

Samsun Training and Research Hospital

Samsun, 58153, Turkey (Türkiye)

Location

Related Publications (16)

• Di Mascio D, Buca D, Berghella V, Khalil A, Rizzo G, Odibo A, Saccone G, Galindo A, Liberati M, D'Antonio F. Counseling in maternal-fetal medicine: SARS-CoV-2 infection in pregnancy. Ultrasound Obstet Gynecol. 2021 May;57(5):687-697. doi: 10.1002/uog.23628.

  PMID: 33724545 BACKGROUND

• 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.

  PMID: 32171076 BACKGROUND

• 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.

  PMID: 32516273 BACKGROUND

• Yurtcu N, Caliskan C, Celik 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.

  PMID: 34058776 RESULT

• Head Zauche L, 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 abortions, CDC v-safe COVID-19 Vaccine Pregnancy Registry 2020-21. Res Sq [Preprint]. 2021 Aug 9:rs.3.rs-798175. doi: 10.21203/rs.3.rs-798175/v1.

  PMID: 34401872 RESULT

• 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.

  PMID: 32969772 RESULT

• 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. doi: 10.1016/j.ajog.2003.11.019.

  PMID: 15295381 RESULT

• 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 Gynecol MFM. 2020 May;2(2):100107. doi: 10.1016/j.ajogmf.2020.100107. Epub 2020 Mar 25.

  PMID: 32292902 RESULT

• 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.

  PMID: 25713608 RESULT

• Uzun M, Gencer M, Turkon H, Oztopuz RO, Demir U, Ovali MA. Effects of Melatonin on Blood Pressure, Oxidative Stress and Placental Expressions of TNFalpha, IL-6, VEGF and sFlt-1 in RUPP Rat Model of Preeclampsia. Arch Med Res. 2017 Oct;48(7):592-598. doi: 10.1016/j.arcmed.2017.08.007. Epub 2018 Feb 1. No abstract available.

  PMID: 29397206 RESULT

• Anderson G, Maes M, Markus RP, Rodriguez M. Ebola virus: melatonin as a readily available treatment option. J Med Virol. 2015 Apr;87(4):537-43. doi: 10.1002/jmv.24130. Epub 2015 Jan 21.

  PMID: 25611054 RESULT

• Anderson G, Reiter RJ. Melatonin: Roles in influenza, Covid-19, and other viral infections. Rev Med Virol. 2020 May;30(3):e2109. doi: 10.1002/rmv.2109. Epub 2020 Apr 21.

  PMID: 32314850 RESULT

• Nehme PA, Amaral FG, Middleton B, Lowden A, Marqueze E, Franca-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 series. Neurobiol Sleep Circadian Rhythms. 2019 Apr 13;6:70-76. doi: 10.1016/j.nbscr.2019.04.001. eCollection 2019 Jan.

  PMID: 31236522 RESULT

• 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: A Randomized, Double-blind Clinical Trial. Arch Med Res. 2022 Jan;53(1):79-85. doi: 10.1016/j.arcmed.2021.06.006. Epub 2021 Jun 23.

  PMID: 34229896 RESULT

• 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. No abstract available.

  PMID: 32334009 RESULT

• Liset R, Gronli 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. Neurobiol Sleep Circadian Rhythms. 2021 Dec 29;12:100074. doi: 10.1016/j.nbscr.2021.100074. eCollection 2022 May.

  PMID: 35024497 RESULT

MeSH Terms

Conditions

Pregnancy Complications; COVID-19

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Serkan Oral

  Halic University Faculty of Medicine, Department of Obstetrics and Gynecology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 8, 2022
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)