Effects of Light on Melatonin and Contractions in Pregnant Women

NCT01863446 | Completed Results

• 2 other identifiers: 2012P0025681R21HD086392-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

Pregnancy; Melatonin; Contractions; Light

Outcome Measures

Primary Outcomes (1)

• Melatonin Area Under the Curve (AUC)

  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 Outcomes (1)

• Uterine Contractions

  4 hours of light exposure

Other Outcomes (1)

• Subjective Assessment of Uterine Contractions

  4 hours of light exposure

Study Arms (4)

Lighting1

EXPERIMENTAL

Ocular light exposure of a red wavelength light for one night

Device: Lighting1

Lighting2

EXPERIMENTAL

Ocular light exposure of a blue-green wavelength light for one night

Device: Lighting2

Lighting3

EXPERIMENTAL

Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2

Device: Lighting1

Lighting4

EXPERIMENTAL

Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2

Device: Lighting1; Device: Lighting2

Interventions

Lighting1 DEVICE

Ocular light exposure to a red wavelength light

Lighting1; Lighting3; Lighting4

Lighting2 DEVICE

Ocular light exposure to a blue/green wavelength light

Lighting2; Lighting4

Eligibility Criteria

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

You may qualify if:

• pregnant at 35-40 weeks
• first pregnancy

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard University: collaborator
• National Institutes of Health (NIH): 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

Location

Results Point of Contact

• Title: Elizabeth Klerman
• Organization: Mass General Hospital

ebklerman@hms.harvard.edu

617-643-2424

Study Officials

• Elizabeth B Klerman, MD PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 29, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2023
• Last Updated: August 27, 2024
• Results First Posted: November 13, 2023

Record last verified: 2024-08

Locations

US (1)