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

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).

Study Overview

• Status: Recruiting
• Conditions: Pregnant Women
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Melatonin

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth B Klerman, MD PhD; Phone Number: 617-643-2424; Email: ebklerman@hms.harvard.edu
• Study Contact Backup: Name: Shadab A Rahman, PhD; Phone Number: 617-525-8830; Email: sarahman@rics.bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Elizabeth B Klerman, MD PhD; Phone Number: 33948 617-732-5500; Email: ebklerman@hms.harvard.edu
      • Principal Investigator: Elizabeth Klerman, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Daytime melatonin 0.0 mg	Dietary supplement: Placebo; Oral placebo administered as a single pill.
Experimental: Daytime melatonin 0.5 mg	Dietary supplement: Melatonin; Oral melatonin administered as a single pill.
Experimental: Daytime melatonin 3.0 mg	Dietary supplement: Melatonin; Oral melatonin administered as a single pill.
Placebo Comparator: Nighttime melatonin 0.0 mg	Dietary supplement: Placebo; Oral placebo administered as a single pill.
Experimental: Nighttime melatonin 0.5 mg	Dietary supplement: Melatonin; Oral melatonin administered as a single pill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Massachusetts General Hospital
• Investigators: Principal Investigator: Elizabeth B Klerman, MD PhD, MGH

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Tryptamines; Melatonin
• Other Study ID Numbers: 2021P002926; R01HD107064 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Per the NIH Policy on Data Sharing, we will make the datasets available to other investigators following publication of the final study results. We will make data available on a public database, such as the NIH-supported National Sleep Research Resource (NSRR; sleepdata.org). Outside investigators should submit their request in writing to the PI. Additional details below in Access Criteria
• IPD Sharing Time Frame: Upon request and following publication of the final study results
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No