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Melatonin in Pregnancy Compared to Non-pregnant (MEL-P)

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ClinicalTrials.gov Identifier: NCT03014245
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : May 23, 2017
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 but it is less well known as an effective antioxidant. It 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. There is little reported on the circulating levels of melatonin or oxidative stress at different stages of normal pregnancy. More information on the role of melatonin and metabolism of melatonin in pregnancy as well as any significant association with adverse pregnancy outcomes would inform planning of larger research studies to investigate 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 melatonin levels and 6-hydroxymelatonin sulphate (the major metabolite of melatonin) during each trimester of pregnancy.


Condition or disease
Pregnancy Transient Hypertension

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Circulating Melatonin and 6-hydroxymelatonin Levels During Pregnancy
Actual Study Start Date : November 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : May 18, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Group/Cohort
Pregnant
Normal pregnant women (first baby) singleton
Control
Non pregnant healthy women



Primary Outcome Measures :
  1. Change in melatonin and 6-hydroxymelatonin levels during pregnancy [ Time Frame: Values up to 40 weeks ]
    Do serum melatonin and 6-hydroxymelatonin sulphate levels differ in each trimester of pregnancy? Levels during each trimester will be compared.


Secondary Outcome Measures :
  1. Change in lipid peroxide levels during pregnancy [ Time Frame: Values up to 40 weeks ]
    Does oxidative stress (lipid peroxide levels) vary in each trimester. Levels during each trimester will be compared.

  2. Relationship between melatonin and 6-hydroxymelatonin levels and duration of pregnancy. [ Time Frame: Up to 40 weeks ]
    What is melatonin status in women who deliver at different gestation (in weeks).

  3. Relationship between melatonin and 6-hydroxymelatonin levels with different types of delivery. [ Time Frame: Up to 40 weeks ]
    What is melatonin status in women with different labours (induced, spontaneous or planned caesarean section)

  4. Relationship between melatonin and 6-hydroxymelatonin levels and pre-eclampsia [ Time Frame: Up to 40 weeks ]
    What is melatonin status in women who had pre-eclampsia ( as yes/no) and those who did not.

  5. Relationship between melatonin and 6-hydroxymelatonin levels and gestational diabetes [ Time Frame: Up to 40 weeks ]
    What is melatonin status in women who had gestational diabetes ( as yes/no) compared to those who did not.

  6. Melatonin and 6-hydroxymelatonin levels in pregnancy compared to non pregnant [ Time Frame: Up to 40 weeks ]
    Is melatonin status at any time during pregnancy different to that in healthy non pregnant women? :Levels of melatonin and 6-hydroxymelatonin in non-pregnant women will be compared with levels in pregnant women.


Biospecimen Retention:   Samples Without DNA
Blood


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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy women pregnant with first baby (singleton) presenting for first trimester scan and healthy non-pregnant women of child bearing age.
Criteria

Inclusion Criteria:

Pregnant subjects

  • Primigravid women (in their first pregnancy)
  • Singleton pregnancy
  • Aged 16-45
  • Taking no regular medication other than pregnancy related vitamins or supplements
  • First trimester (FVS) ultrasound scan reported as normal

Non pregnant subjects

  • Non pregnant women
  • Aged 16-45
  • No chronic health issues and not taking any medication

Exclusion Criteria:

Pregnant subjects

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

Non pregnant subjects

  • Male
  • Outside age range
  • Chronic health complaint/taking medication
  • Recent blood donation over 1 unit

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): NCT03014245


Locations
United Kingdom
Aberdeen Maternity Hospital (NHS Grampian)
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZB
Sponsors and Collaborators
University of Aberdeen
NHS Grampian

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT03014245     History of Changes
Other Study ID Numbers: 2/08/16
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Hypertension
Vascular Diseases
Cardiovascular Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants