MelPreg: Testing Effects of Melatonin on Uterine Contractions in Women

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05358834
Collaborator
Massachusetts General Hospital (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
120
5
58.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Melatonin
  • Dietary Supplement: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Testing Effects of Melatonin on Uterine Contractions in Women
Anticipated Study Start Date :
Aug 20, 2022
Anticipated Primary Completion Date :
Jun 30, 2026
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Daytime: Total number of uterine contractions [10 hours]

    Daytime: Total number of uterine contractions

  2. Nighttime: Total number of uterine contractions [4 hours]

    Nighttime: Total number of uterine contractions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Elizabeth B Klerman, MD PhD, MGH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elizabeth Klerman MD PhD, Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05358834
Other Study ID Numbers:
  • 2021P002926
  • R01HD107064
First Posted:
May 3, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022