Melatonin in Pregnancy Compared to Non-pregnant
MEL-P
Circulating Melatonin and 6-hydroxymelatonin Levels During Pregnancy
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2017
CompletedMay 8, 2026
January 1, 2017
5 months
December 12, 2016
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in melatonin and 6-hydroxymelatonin levels during pregnancy
Do serum melatonin and 6-hydroxymelatonin sulphate levels differ in each trimester of pregnancy? Levels during each trimester will be compared.
Values up to 40 weeks
Secondary Outcomes (6)
Change in lipid peroxide levels during pregnancy
Values up to 40 weeks
Relationship between melatonin and 6-hydroxymelatonin levels and duration of pregnancy.
Up to 40 weeks
Relationship between melatonin and 6-hydroxymelatonin levels with different types of delivery.
Up to 40 weeks
Relationship between melatonin and 6-hydroxymelatonin levels and pre-eclampsia
Up to 40 weeks
Relationship between melatonin and 6-hydroxymelatonin levels and gestational diabetes
Up to 40 weeks
- +1 more secondary outcomes
Study Arms (2)
Pregnant
Normal pregnant women (first baby) singleton
Control
Non pregnant healthy women
Eligibility Criteria
Healthy women pregnant with first baby (singleton) presenting for first trimester scan and healthy non-pregnant women of child bearing age.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- NHS Grampiancollaborator
Study Sites (1)
Aberdeen Maternity Hospital (NHS Grampian)
Aberdeen, Aberdeenshire, AB25 2ZB, United Kingdom
Related Links
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2016
First Posted
January 9, 2017
Study Start
November 1, 2016
Primary Completion
April 1, 2017
Study Completion
May 18, 2017
Last Updated
May 8, 2026
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share