CompletedNot Applicable

Melatonin in Pregnancy Compared to Non-pregnant

United Kingdom60 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range

16 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in melatonin and 6-hydroxymelatonin levels during pregnancy

Timeframe: Values up to 40 weeks

Trial details

NCT IDNCT03014245

SponsorUniversity of Aberdeen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-04

View on ClinicalTrials.gov More Pregnancy Transient Hypertension trials