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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05358834
Other study ID # 2021P002926
Secondary ID R01HD107064
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date June 30, 2027

Study information

Verified date February 2023
Source Brigham and Women's Hospital
Contact Elizabeth B Klerman, MD PhD
Phone 617-643-2424
Email ebklerman@hms.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 30, 2027
Est. primary completion date June 30, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - nulliparity, age between 18 and 35, - BMI<36 pre-pregnancy, - =40 weeks of pregnancy with a single fetus at time of study. - pregnancy-associated obstetrical care by nurse midwife or physician associated with MassGeneralBrigham (MGB) (including hospital and community health centers) - planned admission for delivery at a MGB affiliated institution. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Melatonin
Oral melatonin administered as a single pill.
Placebo
Oral placebo administered as a single pill.

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Brigham and Women's Hospital Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daytime: Total number of uterine contractions Daytime: Total number of uterine contractions 10 hours
Primary Nighttime: Total number of uterine contractions Nighttime: Total number of uterine contractions 4 hours
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