Melatonin for Uterine Contractions in Pregnancy
(MelPreg Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The planned experiments will test a causal link between circulating melatonin levels and uterine contractions in full-term pregnant women by manipulating melatonin levels using exogenous melatonin (i) during the day when endogenous levels of melatonin are very low (Experiment 1), and (ii) during the evening under conditions with lighting that would be expected to suppress the higher evening and nighttime levels of endogenous melatonin (Experiment 2).
Will I have to stop taking my current medications?
If you are taking prescription drugs that affect sleep, melatonin, or circadian rhythms, or medications that might interact with melatonin, you may need to stop them to participate in this trial. It's best to discuss your specific medications with the study team to determine eligibility.
Is melatonin safe for use in humans?
How does the drug melatonin differ from other treatments for uterine contractions in pregnancy?
Melatonin is unique because it is a hormone that naturally increases at night and may influence uterine contractions by interacting with melatonin receptors in the uterus, potentially affecting the timing of labor. Unlike other treatments, melatonin also acts as an antioxidant and can cross the placenta, providing benefits to both the mother and fetus.13567
What evidence supports the effectiveness of the drug melatonin for uterine contractions in pregnancy?
Research suggests that melatonin may play a role in the timing of labor, as it can influence uterine contractions, especially when combined with another hormone, noradrenaline. Melatonin levels naturally rise at night, which is when labor often begins, indicating it might help regulate the timing of birth.13468
Who Is on the Research Team?
Elizabeth B Klerman, MD PhD
Principal Investigator
MGH
Are You a Good Fit for This Trial?
This trial is for first-time pregnant women aged 18-35, with a BMI under 36 before pregnancy, and at least 40 weeks into a single-fetus pregnancy. They must be receiving care from MassGeneralBrigham and planning to deliver at an MGB-affiliated institution. Women taking certain medications or with conditions affecting sleep, melatonin levels, or uterine contractions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Daytime Treatment
Participants receive exogenous melatonin during the day when endogenous levels are low
Nighttime Treatment
Participants receive exogenous melatonin during the evening under lighting conditions expected to suppress endogenous melatonin
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Melatonin
- Placebo
Melatonin is already approved in European Union, United States for the following indications:
- Insomnia in adults aged 55 and over
- Sleep disorders in children with autism spectrum disorder
- Insomnia in children and adolescents aged 2-18 with autism spectrum disorder
- Sleep disorders in children with autism spectrum disorder
- Insomnia in adults
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Massachusetts General Hospital
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator