Melatonin in Pregnancy
MEL-P2
Investigation of Melatonin Production in Pregnancy: a Pilot Study to Define the Contribution of the Placenta
1 other identifier
observational
15
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2018
Shorter than P25 for all trials
2 active sites
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
June 6, 2018
CompletedFirst Submitted
Initial submission to the registry
July 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedFebruary 18, 2021
February 1, 2021
3 months
July 10, 2018
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
6-hydroxymelatonin sulphate in serum
Change in serum 6-hydroxymelatonin sulphate levels after delivery
24 hours after delivery
Secondary Outcomes (2)
6-hydroxymelatonin sulphate in serum
Immediately after delivery
6-hydroxymelatonin sulphate in placental tissue
Immediately after delivery
Interventions
Measurement of 6-hydroxymelatonin
Eligibility Criteria
Healthy pregnant women scheduled for elective Caesarean section
You may qualify if:
- Scheduled for elective caesarian section
- Singleton pregnancy
- Aged 16-45
- Taking no regular medication other than pregnancy related vitamins or supplements
You may not qualify if:
- Pregnancy non-viable
- Twins or higher multiple pregnancies
- Outside age range
- Diabetes or pre-existing hypertension, chronic kidney disease or autoimmune disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aberdeenlead
- NHS Grampiancollaborator
Study Sites (2)
University of Aberdeen/NHS Grampian
Aberdeen, If Already Stated Select NOT Listed, AB25 2ZD, United Kingdom
Aberdeen Maternity Hospital
Ellon, Lowland Scotland, AB25 2ZB, United Kingdom
Biospecimen
Serum and placenta
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2018
First Posted
August 1, 2018
Study Start
June 6, 2018
Primary Completion
August 31, 2018
Study Completion
March 30, 2019
Last Updated
February 18, 2021
Record last verified: 2021-02