Actively Recruiting
Testing Effects of Melatonin on Uterine Contractions in Women
Led by Brigham and Women's Hospital · Updated on 2025-02-10
120
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Testing Effects of Melatonin on Uterine Contractions in Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Nulliparous women aged between 18 and 35 years
- Pre-pregnancy body mass index (BMI) less than 36
- Currently at least 38 weeks pregnant with a single fetus at the time of the study
You will not qualify if you...
- Color blindness
- Use of prescription drugs affecting sleep, melatonin, or circadian rhythms such as beta blockers or non-steroidal anti-inflammatory drugs
- Any health or pregnancy-related condition that might alter melatonin levels or uterine contractions
- Medical conditions or medications for which melatonin is contraindicated or may interact, including central nervous system depressants, sedatives, Fluvoxamin (Luvox), diabetes medications, immunosuppressants, anti-coagulants, Nifedipine, or Verapamil
- Final eligibility and safety determination made by the study obstetrics investigator at Brigham and Women's Hospital
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
E
Elizabeth B Klerman, MD PhD
CONTACT
S
Shadab A Rahman, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
5
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