Effects of melatonin on uterine contractions in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between melatonin levels and uterine contractions in full-term pregnant women. It builds on previous research that explored how melatonin affects the human myometrium and uterine activity. The study will manipulate melatonin levels using exogenous melatonin during different times of the day to observe its effects on uterine contractions. Participants will be monitored to establish a causal link between melatonin and contraction frequency.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Elizabeth B Klerman, MD PhD — Mgh
• Study coordinator: Elizabeth B Klerman, MD PhD
• Email: ebklerman@hms.harvard.edu
• Phone: 617-643-2424

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.