Testing Effects of Melatonin on Uterine Contractions in Women

Pregnant Women Clinical Trial

— MelPreg  

Official title:

Testing Effects of Melatonin on Uterine Contractions in Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05358834
• Other study ID #: 2021P002926
• Secondary ID: R01HD107064
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: Elizabeth B Klerman, MD PhD
• Phone: 617-643-2424
• Email: ebklerman[@]hms.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• nulliparity, age between 18 and 35,

• BMI<36 pre-pregnancy,

• =40 weeks of pregnancy with a single fetus at time of study.

• pregnancy-associated obstetrical care by nurse midwife or physician associated with MassGeneralBrigham (MGB) (including hospital and community health centers)

• planned admission for delivery at a MGB affiliated institution.

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.

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Dietary Supplement:
• Melatonin
Oral melatonin administered as a single pill.
• Placebo
Oral placebo administered as a single pill.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daytime: Total number of uterine contractions	Daytime: Total number of uterine contractions	10 hours
Primary	Nighttime: Total number of uterine contractions	Nighttime: Total number of uterine contractions	4 hours