Effects of melatonin on uterine contractions in pregnant women
Testing Effects of Melatonin on Uterine Contractions in Women
This study tests whether taking melatonin can change the frequency of uterine contractions in full-term pregnant women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05358834 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are nulliparous women aged 18 to 35, with a BMI under 36, who are at least 38 weeks pregnant with a single fetus.
Not a fit: Patients with medical conditions or medications that contraindicate melatonin use or affect uterine contractions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into managing uterine contractions during labor, potentially improving outcomes for mothers and infants.
How similar studies have performed: While this approach is based on recent physiological discoveries, it is relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.