NCT05358834 Testing Effects of Melatonin on Uterine Contractions in Women
| NCT ID | NCT05358834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Pregnant Women |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-01-01 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
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.
Contact & Investigator
Elizabeth B Klerman, MD PhD
PRINCIPAL INVESTIGATOR
MGH
Frequently Asked Questions
Who can join the NCT05358834 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 35 Years, studying Pregnant Women. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05358834 currently recruiting?
Yes, NCT05358834 is actively recruiting participants. Contact the research team at ebklerman@hms.harvard.edu for enrollment information.
Where is the NCT05358834 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05358834 clinical trial?
NCT05358834 is sponsored by Brigham and Women's Hospital. The principal investigator is Elizabeth B Klerman, MD PhD at MGH. The trial plans to enroll 120 participants.