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Testing Effects of Melatonin on Uterine Contractions in Women

Brigham and Women's Hospital · with Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT05358834

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–35 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
120
US sites recruiting
1
Study start
January 1, 2023
Record last updated
May 18, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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).

Being studied: Melatonin; Placebo

Conditions: Pregnant Women

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Brigham and Women's Hospital

    Boston, MA 02115

    Site contact: Elizabeth B Klerman, MD PhD · 617-732-5500 · ebklerman@hms.harvard.edu

Study contacts (from the official record)

  • Elizabeth B Klerman, MD PhD · 617-643-2424 · ebklerman@hms.harvard.edu
  • Shadab A Rahman, PhD · 617-525-8830 · sarahman@rics.bwh.harvard.edu
All pregnancy studies in Massachusetts →
Testing Effects of Melatonin on Uterine Contractions in Women (NCT05358834) | Bored Studies