Effects of Light on Melatonin and Contractions in Pregnant Women

Overview

Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin secretion and reduce uterine contractions in women at late term pregnancies. Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported uterine contractions in women at late term pregnancies.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2021

Interventions

  • Device: Lighting1
    • Ocular light exposure to a red wavelength light
  • Device: Lighting2
    • Ocular light exposure to a blue/green wavelength light

Arms, Groups and Cohorts

  • Experimental: Lighting1
    • Ocular light exposure of a red wavelength light for one night
  • Experimental: Lighting2
    • Ocular light exposure of a blue-green wavelength light for one night
  • Experimental: Lighting3
    • Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2
  • Experimental: Lighting4
    • Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2

Clinical Trial Outcome Measures

Primary Measures

  • Melatonin Area Under the Curve (AUC)
    • Time Frame: 4 hours of light exposure.
    • Melatonin will be assessed using concentrations in saliva or blood. AUC will be calculated using melatonin concentrations during the Outcome Measure Time Frame. (1) for Lighting1 and Lighting2, the AUC for night 1; (2) for Lighting3 and Lighting4, the AUC for Night 2

Secondary Measures

  • Uterine Contractions
    • Time Frame: 4 hours of light exposure
    • Uterine contractions will be measured using a uterine tocometer device (1) for Lighting1 and Lighting2, the sum for night 1; (2) for Lighting3 and Lighting4, the sum for Night 2

Participating in This Clinical Trial

Inclusion Criteria

  • pregnant at 35-40 weeks – first pregnancy Exclusion Criteria:

  • pregnancy-related complications – twin or higher pregnancy – using medication that affects the sympathetic nervous system

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Collaborator
    • Harvard University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elizabeth Klerman MD PhD, Associate Professor – Brigham and Women’s Hospital
  • Overall Official(s)
    • Elizabeth B Klerman, MD PhD, Principal Investigator, Brigham and Women’s Hospital

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