Testing Effects of Melatonin on Uterine Contractions in Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorBrigham and Women's Hospital

About 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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

nulliparity, age between 18 and 35,

BMI<36 pre-pregnancy,

≥38 weeks of pregnancy with a single fetus at time of study.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Melatonin

    Dietary supplement

    Oral melatonin administered as a single pill.

  • Placebo

    Dietary supplement

    Oral placebo administered as a single pill.

Treatment groups

120 Participants
are divided into 5 treatment groups
Group A: Daytime melatonin 0.0 mgPlacebo comparator 1 intervention
Group B: Daytime melatonin 0.5 mgExperimental treatment 1 intervention
Group C: Daytime melatonin 3.0 mgExperimental treatment 1 intervention
Group D: Nighttime melatonin 0.0 mgPlacebo comparator 1 intervention
Group E: Nighttime melatonin 0.5 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Daytime: Total number of uterine contractions

Daytime: Total number of uterine contractions

Time frame
10 hours
2

Nighttime: Total number of uterine contractions

Nighttime: Total number of uterine contractions

Time frame
4 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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Brigham and Women's Hospital

Lead sponsor

Massachusetts General Hospital

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator