Testing Effects of Melatonin on Uterine Contractions in Women

NCT ID: NCT05358834

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2027-06-30

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).

Conditions

Pregnant Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Daytime melatonin 0.0 mg

Daytime melatonin 0.0 mg

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral placebo administered as a single pill.

Daytime melatonin 0.5 mg

Daytime melatonin 0.5 mg

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Oral melatonin administered as a single pill.

Daytime melatonin 3.0 mg

Daytime melatonin 3.0 mg

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Oral melatonin administered as a single pill.

Nighttime melatonin 0.0 mg

Nighttime melatonin 0.0 mg

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral placebo administered as a single pill.

Nighttime melatonin 0.5 mg

Nighttime melatonin 0.5 mg

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Oral melatonin administered as a single pill.

Interventions

Melatonin

Oral melatonin administered as a single pill.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oral placebo administered as a single pill.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Klerman MD PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth B Klerman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth B Klerman, MD PhD

Role: CONTACT

ebklerman@hms.harvard.edu

617-643-2424

Shadab A Rahman, PhD

Role: CONTACT

sarahman@rics.bwh.harvard.edu

617-525-8830

Facility Contacts

Elizabeth B Klerman, MD PhD

Role: primary

ebklerman@hms.harvard.edu

617-732-5500 ext. 33948

Other Identifiers

R01HD107064

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021P002926

Identifier Type: -

Identifier Source: org_study_id