Testing Effects of Melatonin on Uterine Contractions in Women

NCT05358834 | Recruiting

• 2 other identifiers: 2021P002926R01HD107064
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Daytime: Total number of uterine contractions

  Daytime: Total number of uterine contractions

  10 hours

• Nighttime: Total number of uterine contractions

  Nighttime: Total number of uterine contractions

  4 hours

Study Arms (5)

Daytime melatonin 0.0 mg

PLACEBO COMPARATOR

Daytime melatonin 0.0 mg

Dietary Supplement: Placebo

Daytime melatonin 0.5 mg

EXPERIMENTAL

Daytime melatonin 0.5 mg

Dietary Supplement: Melatonin

Daytime melatonin 3.0 mg

EXPERIMENTAL

Daytime melatonin 3.0 mg

Dietary Supplement: Melatonin

Nighttime melatonin 0.0 mg

PLACEBO COMPARATOR

Nighttime melatonin 0.0 mg

Dietary Supplement: Placebo

Nighttime melatonin 0.5 mg

EXPERIMENTAL

Nighttime melatonin 0.5 mg

Dietary Supplement: Melatonin

Interventions

Melatonin DIETARY_SUPPLEMENT

Oral melatonin administered as a single pill.

Daytime melatonin 0.5 mg; Daytime melatonin 3.0 mg; Nighttime melatonin 0.5 mg

Placebo DIETARY_SUPPLEMENT

Oral placebo administered as a single pill.

Daytime melatonin 0.0 mg; Nighttime melatonin 0.0 mg

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• nulliparity, age between 18 and 35,
• BMI\<36 pre-pregnancy,
• ≥38 weeks of pregnancy with a single fetus at time of study.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts General Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Elizabeth B Klerman, MD PhD

  MGH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth B Klerman, MD PhD

CONTACT

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

Shadab A Rahman, PhD

CONTACT

617-525-8830; sarahman@rics.bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request and following publication of the final study results
• Access Criteria: Outside investigators should submit their request in writing to the PI. A data-sharing agreement will be required. The request must be in accordance with MGB Policies and Harvard Medical School (HMS) guidelines. Such datasets will not contain identifying information per the regulations outlined in HIPAA, and permission will be obtained from study participants to share their data with researchers outside MGB. Per standard MGB policies, we will require a data-sharing agreement from any investigator or entity requesting the data; this agreement will include: (i) a commitment to using the data only for research purposes and not to identify any individual participant; (ii) a commitment to securing the data using appropriate computer technology; and (iii) a commitment to destroying or returning the data after analyses are completed.

Locations

US (1)