Testing Effects of Melatonin on Uterine Contractions in Women

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05358834
Status
Recruiting
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Conditions

  • Pregnant Women

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Melatonin — DIETARY_SUPPLEMENT
    Oral melatonin administered as a single pill.
  • Placebo — DIETARY_SUPPLEMENT
    Oral placebo administered as a single pill.

Study Details

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).

Key Dates

Start date
Jan 1, 2023
Status verified
May 2026
Primary completion
May 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: Daytime melatonin 0.0 mg
    Daytime melatonin 0.0 mg
  • Experimental: Daytime melatonin 0.5 mg
    Daytime melatonin 0.5 mg
  • Experimental: Daytime melatonin 3.0 mg
    Daytime melatonin 3.0 mg
  • Placebo Comparator: Nighttime melatonin 0.0 mg
    Nighttime melatonin 0.0 mg
  • Experimental: Nighttime melatonin 0.5 mg
    Nighttime melatonin 0.5 mg

Primary Outcome Measure

Daytime: Total number of uterine contractions [ Time Frame: 10 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Elizabeth B Klerman, MD PhD
[email protected]
617-732-5500
Elizabeth Klerman, MD PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MA

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