Effects of Light on Melatonin and Contractions in Pregnant Women

NCT ID: NCT01863446

Last Updated: 2024-08-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Lighting1

Ocular light exposure of a red wavelength light for one night

Group Type EXPERIMENTAL

Lighting1

Intervention Type DEVICE

Ocular light exposure to a red wavelength light

Lighting2

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

Group Type EXPERIMENTAL

Lighting2

Intervention Type DEVICE

Ocular light exposure to a blue/green wavelength light

Lighting3

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

Group Type EXPERIMENTAL

Lighting1

Intervention Type DEVICE

Ocular light exposure to a red wavelength light

Lighting4

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

Group Type EXPERIMENTAL

Lighting1

Intervention Type DEVICE

Ocular light exposure to a red wavelength light

Lighting2

Intervention Type DEVICE

Ocular light exposure to a blue/green wavelength light

Interventions

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Lighting1

Ocular light exposure to a red wavelength light

Intervention Type DEVICE

Lighting2

Ocular light exposure to a blue/green wavelength light

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Harvard University

OTHER

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Klerman MD PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth B Klerman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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1R21HD086392-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012P002568

Identifier Type: -

Identifier Source: org_study_id

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