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OpenTrials
Completed

NCT Number: NCT01863446

Effects of Light on Melatonin and Contractions in Pregnant Women

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.

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Key information

Conditions

Pregnancy

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lighting1

Device

Ocular light exposure to a red wavelength light

Lighting2

Device

Ocular light exposure to a blue/green wavelength light

Primary outcomes

  1. 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 outcomes

  1. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2013
Primary completion
2021
Study completion
2023
First posted
May 29, 2013
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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