Testing Effects of Melatonin on Uterine Contractions in Women

Not Applicable

Recruiting

• Conditions: Pregnant Women
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Melatonin

• Registration Number: NCT05358834
• Lead Sponsor: Brigham and Women's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-03
• Study Start: 2023-01-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nighttime melatonin 0.0 mg	Placebo	Nighttime melatonin 0.0 mg
Daytime melatonin 0.0 mg	Placebo	Daytime melatonin 0.0 mg
Daytime melatonin 0.5 mg	Melatonin	Daytime melatonin 0.5 mg
Daytime melatonin 3.0 mg	Melatonin	Daytime melatonin 3.0 mg
Nighttime melatonin 0.5 mg	Melatonin	Nighttime melatonin 0.5 mg

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States