Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Location contact
Elizabeth B Klerman, MD PhD
CONTACT
617-732-5500 ext. 33948
Elizabeth Klerman, MD PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05358834
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).
Interested in participating?
Request Info18 year–35 year
Female
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Elizabeth B Klerman, MD PhD
CONTACT
617-732-5500 ext. 33948
Elizabeth Klerman, MD PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Oral melatonin administered as a single pill.
Oral placebo administered as a single pill.
Time frame: 10 hours
Daytime: Total number of uterine contractions
Time frame: 4 hours
Nighttime: Total number of uterine contractions
Contact information is provided by the study sponsor or research team.
Elizabeth B Klerman, MD PhD
CONTACT
Shadab A Rahman, PhD
CONTACT
Brigham and Women's Hospital
Other
Acronym: MelPreg
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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