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Trial record 32 of 120 for:    severe preeclampsia AND delivery

Melatonin in Pregnancy (MEL-P2)

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ClinicalTrials.gov Identifier: NCT03609086
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:
Melatonin is well known for its role in the sleep-wake cycle and is synthesised in response to low light levels from the pineal gland. In our previous study it was found that serum melatonin levels increased dramatically during pregnancy, such that levels were up to 100 fold higher in the third trimester compared to healthy non-pregnant women. The placenta contains the enzymes which are involved in synthesising melatonin but it is unclear if this is the source of the high levels in pregnancy. Severe pre-eclampsia has been reported to be associated with low levels of melatonin. In this study its is proposed to measure serum melatonin immediately before and after delivery and in cord blood and relate the levels to those in the placenta itself. This will contribute to the potential role for melatonin as a biomarker for obstetric disease and potentially as a therapeutic agent in future. This observational pilot study aims to measure serum and placental melatonin levels (as the major metabolite 6-hydroxymelatonin sulphate) in pregnant women undergoing elective Caesarean section.

Condition or disease Intervention/treatment
Pregnancy Other: Melatonin analysis

Detailed Description:

Background Melatonin, a substance produced by the pineal gland, is well known for its role in the sleep-wake cycle but it is less well known as an effective antioxidant. It is able to access all parts of the cell, and can cross the blood-brain and placental barrier.

Melatonin has been reported to be synthesised in the placenta and may have both receptor mediated and non-receptor mediated protective functions during pregnancy. Severe pre-eclampsia has been reported to be associated with low levels of melatonin in the placenta although it is not known if the placental melatonin contributes to circulating levels.1,2 Despite this, melatonin levels have been proposed as a biomarker of pre-eclampsia. More information on the role of melatonin and metabolism of melatonin in pregnancy would inform planning of larger research studies to investigate the potential role for melatonin as a bio-marker for obstetric disease and potentially as a therapeutic agent in future.

Melatonin is synthesized endogenously from serotonin via two steps; the first, rate limiting step is arylalkylamine N-acetyltransferase mediated acetylation of serotonin to N-acetyl serotonin. The second step is methylation of N-acetyl serotonin via the enzyme hydroxyindole O-methyltransferase (also called N-acetylserotonin O-methyl-transferase).3,4 Interrogation of our database of next generation sequencing analysis of 80 human foetal livers revealed that the genes encoding these enzymes were not present although those encoding related acetyltransferases were. We can conclude that the human foetal liver is not a site of melatonin synthesis.

Our previous work found melatonin levels do however increase markedly during pregnancy and are up to 50-100 times higher than non-pregnant women in the third trimester (Figure). The physiological role of these elevated melatonin levels remains a supposition and the relationship of melatonin levels in the placenta with the maternal and foetal circulations at different stages of pregnancy are unclear. Melatonin synthesizing enzymes have been found in human placental tissue, however it is not clear whether placental production of melatonin is directly related to the elevated circulating maternal melatonin levels.

The production of melatonin is catalysed by specific enzymes and although these enzymes have been found in placental tissue, it is not known if the high melatonin levels in pregnancy come from the placenta and what the role of this melatonin is. It is proposed to measure melatonin in placentas and maternal/cord blood from women undergoing planned Caesarean section. The results should enable defining as to whether the placenta is a major source of melatonin and how the pattern of production changes in pregnancy. The blood samples taken from women having a Caesarean section and the umbilical cord will provide information about the role of melatonin at delivery.

If melatonin levels in the maternal circulation falls after delivery and placental tissue melatonin levels are well above limits of detection, then a firm conclusion that the placenta is the source of elevated maternal melatonin would be justified. This observational pilot study aims to measure 6-hydroxymelatonin sulphate levels in blood from women undergoing Caesarean section and umbilical cords, and from placental tissue.

This is an observational pilot study to investigate 6-hydroxymelatonin sulphate levels in blood from pregnant women immediately before and after delivery, from umbilical cord blood at the time of delivery and in samples of placental tissue.

Healthy pregnant women will be recruited at the pre-Caesarean section pre-assessment clinic.


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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation of Melatonin Production in Pregnancy: a Pilot Study to Define the Contribution of the Placenta
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin


Intervention Details:
  • Other: Melatonin analysis
    Measurement of 6-hydroxymelatonin


Primary Outcome Measures :
  1. 6-hydroxymelatonin sulphate in serum [ Time Frame: 24 hours after delivery ]
    Change in serum 6-hydroxymelatonin sulphate levels after delivery


Secondary Outcome Measures :
  1. 6-hydroxymelatonin sulphate in serum [ Time Frame: Immediately after delivery ]
    Serum 6-hydroxymelatonin sulphate levels in umbilical cord blood after delivery

  2. 6-hydroxymelatonin sulphate in placental tissue [ Time Frame: Immediately after delivery ]
    Serum 6-hydroxymelatonin sulphate levels in placental tissue after delivery


Biospecimen Retention:   Samples Without DNA
Serum and placenta


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy pregnant women scheduled for elective Caesarean section
Criteria

Inclusion Criteria:

  • Scheduled for elective caesarian section
  • Singleton pregnancy
  • Aged 16-45
  • Taking no regular medication other than pregnancy related vitamins or supplements

Exclusion Criteria:

  • Pregnancy non-viable
  • Twins or higher multiple pregnancies
  • Outside age range
  • Diabetes or pre-existing hypertension, chronic kidney disease or autoimmune disorders

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): NCT03609086


Contacts
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Contact: Helen F Galley, phD +441224437363 h.f.galley@abdn.ac.uk
Contact: Andrea Woolner, MBChB +447900603649 a.woolner@abdn.ac.uk

Locations
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United Kingdom
University of Aberdeen/NHS Grampian Recruiting
Aberdeen, If Already Stated Select NOT Listed, United Kingdom, AB25 2ZD
Contact: Helen o Galley, PhD    01224437363    h.f.galley@abdn.ac.uk   
Contact: Helen F Galley    07900603649    h.f.galley@abdn.ac.uk   
Principal Investigator: Helen Galley, PhD         
Aberdeen Maternity Hospital Recruiting
Ellon, Lowland Scotland, United Kingdom, AB25 2ZB
Contact: Andrea MF Woolner, PhD FRCA    07900603649    a.woolner@abdn.ac.uk   
Principal Investigator: Helen Galley, PhD FRCA         
Sponsors and Collaborators
University of Aberdeen
NHS Grampian

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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03609086     History of Changes
Other Study ID Numbers: 2-020-18
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Reasonable requests for access to anonymous IPD (biochemical data) will be considered

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants