Effects of Light on Melatonin and Contractions in Pregnant Women

August 6, 2024 updated by: Elizabeth Klerman MD PhD, Brigham and Women's Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lighting1
Ocular light exposure of a red wavelength light for one night
Device: Lighting1
Ocular light exposure to a red wavelength light
Experimental: Lighting2
Ocular light exposure of a blue-green wavelength light for one night
Device: Lighting2
Ocular light exposure to a blue/green wavelength light
Experimental: Lighting3
Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2
Device: Lighting1
Ocular light exposure to a red wavelength light
Experimental: Lighting4
Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2
Device: Lighting1
Ocular light exposure to a red wavelength light
Device: Lighting2
Ocular light exposure to a blue/green wavelength light

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 hours of light exposure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 hours of light exposure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Assessment of Uterine Contractions
Time Frame: 4 hours of light exposure

Self-reported uterine contractions will be assessed by asking the women how many contractions they felt.

(1) for Lighting1 and Lighting2, the sum for night 1; (2) for Lighting3 and Lighting4, the sum for Night 2
4 hours of light exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Harvard University

Investigators

  • Principal Investigator: Elizabeth B Klerman, MD PhD, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimated)

May 29, 2013

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012P002568
  • 1R21HD086392-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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