Testing Effects of Melatonin on Uterine Contractions in Women

Brigham and Women's Hospital120 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

120

Conditions

Pregnant Women

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Daytime: Total number of uterine contractions

Time frame: 10 hours

Nighttime: Total number of uterine contractions

Time frame: 4 hours

Central Contacts

Elizabeth B Klerman, MD PhD

CONTACT

617-643-2424 ebklerman@hms.harvard.edu

Shadab A Rahman, PhD