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Recruiting

NCT Number: NCT05358834

Testing Effects of Melatonin on Uterine Contractions in Women

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).

Recruiting

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Elizabeth B Klerman, MD PhD

CONTACT

[email protected]

617-732-5500 ext. 33948

Elizabeth Klerman, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

melatonin

Dietary Supplement

Oral melatonin administered as a single pill.

Placebo

Dietary Supplement

Oral placebo administered as a single pill.

Primary outcomes

  1. Daytime: Total number of uterine contractions

    Time frame: 10 hours

    Daytime: Total number of uterine contractions

  2. Nighttime: Total number of uterine contractions

    Time frame: 4 hours

    Nighttime: Total number of uterine contractions

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth B Klerman, MD PhD

CONTACT

[email protected]

617-643-2424

Shadab A Rahman, PhD

CONTACT

[email protected]

617-525-8830

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Massachusetts General Hospital

Registry information

Acronym: MelPreg

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 3, 2022
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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