Testing Effects of Melatonin on Uterine Contractions in Women

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Apr 28, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of melatonin, a hormone that helps regulate sleep, on uterine contractions in pregnant women who are at or near their due date. Researchers want to understand how changing melatonin levels can affect contractions during labor. The study will involve giving melatonin to participants at different times of the day to see how it influences their uterine contractions.

To be eligible for this trial, women must be between 18 and 35 years old, be pregnant with only one baby, and be at least 40 weeks along in their pregnancy. They should not have any health issues or take medications that could interfere with melatonin or uterine contractions. If you participate, you can expect to be monitored closely while receiving melatonin and to provide information about your contractions. This study is being conducted by healthcare professionals at MassGeneralBrigham, ensuring that safety is a top priority for all participants.

Gender

FEMALE

Eligibility 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.