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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 35 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • nulliparity, age between 18 and 35, - BMI<36 pre-pregnancy, - ≥38 weeks of pregnancy with a single fetus at time of study.

Exclusion Criteria

  • color blind; - prescription drugs affecting sleep, melatonin, and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs); - a health or pregnancy related condition that might affect melatonin or uterine contractions; - medical conditions or medications for which melatonin might be contraindicated or there may be a drug interactions (e.g., Central Nervous System depressants/sedatives, Fluvoxamin (Luvox), medications for diabetes, immunosuppressants, anti-coagulants, Nifedipine, Verapamil). Note: We cannot list all possible exclusionary criteria. Dr. Carolina Bibbo (co-I), our Obstetrics Investigator at Brigham and Women's Hospital (BWH), will make final determination of suitability including any safety concerns for each potential participant.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Daytime melatonin 0.0 mg 		Daytime melatonin 0.0 mg
  • Dietary Supplement: Placebo
    Oral placebo administered as a single pill.
Experimental
Daytime melatonin 0.5 mg 		Daytime melatonin 0.5 mg
  • Dietary Supplement: Melatonin
    Oral melatonin administered as a single pill.
Experimental
Daytime melatonin 3.0 mg 		Daytime melatonin 3.0 mg
  • Dietary Supplement: Melatonin
    Oral melatonin administered as a single pill.
Placebo Comparator
Nighttime melatonin 0.0 mg 		Nighttime melatonin 0.0 mg
  • Dietary Supplement: Placebo
    Oral placebo administered as a single pill.
Experimental
Nighttime melatonin 0.5 mg 		Nighttime melatonin 0.5 mg
  • Dietary Supplement: Melatonin
    Oral melatonin administered as a single pill.

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Elizabeth B Klerman, MD PhD
617-732-5500
ebklerman@hms.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Elizabeth B Klerman, MD PhD
617-643-2424
ebklerman@hms.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.