Melatonin in Pregnancy Compared to Non-pregnant (MEL-P)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03014245|
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : May 23, 2017
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|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|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|
Normal pregnant women (first baby) singleton
Non pregnant healthy women
- 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.
- 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.
- 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).
- 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)
- 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.
- 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.
- 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
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
|Aberdeen Maternity Hospital (NHS Grampian)|
|Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZB|