Testing Effects of Melatonin on Uterine Contractions in Women (MelPreg)

Mass General Brigham

Status: Enrolling

Conditions: Pregnant Women

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Melatonin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05358834

R01HD107064 (U.S. NIH Grant/Contract)

2021P002926

Details and patient eligibility

About

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).

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 5 patient groups, including a placebo group

Daytime melatonin 0.0 mg

Placebo Comparator group

Description:

Daytime melatonin 0.0 mg

Treatment:

Dietary Supplement: Placebo

Daytime melatonin 0.5 mg

Experimental group

Description:

Daytime melatonin 0.5 mg

Treatment:

Dietary Supplement: Melatonin

Daytime melatonin 3.0 mg

Experimental group

Description:

Daytime melatonin 3.0 mg

Treatment:

Dietary Supplement: Melatonin

Nighttime melatonin 0.0 mg

Placebo Comparator group

Description:

Nighttime melatonin 0.0 mg

Treatment:

Dietary Supplement: Placebo

Nighttime melatonin 0.5 mg

Experimental group

Description:

Nighttime melatonin 0.5 mg

Treatment:

Dietary Supplement: Melatonin