Status:
RECRUITING
Testing Effects of Melatonin on Uterine Contractions in Women
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnant Women
Eligibility:
FEMALE
18-35 years
Phase:
NA
Brief Summary
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 physiolog...
Eligibility Criteria
Inclusion
- nulliparity, age between 18 and 35,
- BMI\<36 pre-pregnancy,
- ≥38 weeks of pregnancy with a single fetus at time of study.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05358834
Start Date
January 1 2023
End Date
June 30 2027
Last Update
February 10 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115