Pregnant Women
Conditions
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).
Interventions
DIETARY_SUPPLEMENTMelatonin
Oral melatonin administered as a single pill.
DIETARY_SUPPLEMENTPlacebo
Oral placebo administered as a single pill.
Sponsors
Brigham and Women's Hospital
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daytime: Total number of uterine contractions | 10 hours | Daytime: Total number of uterine contractions |
| Nighttime: Total number of uterine contractions | 4 hours | Nighttime: Total number of uterine contractions |
Countries
United States
Contacts
CONTACTElizabeth B Klerman, MD PhD
CONTACTShadab A Rahman, PhD
PRINCIPAL_INVESTIGATORElizabeth B Klerman, MD PhD
MGH
Outcome results
None listed