Uterine Contractions Under Blue Light

Last updated: October 1, 2018
Sponsor: University of South Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03691740
Pro00031969
  • Ages 18-55
  • Female
  • Accepts Healthy Volunteers

Study Summary

The objective in the current study is to test the hypothesis that nocturnal uterine contractions in preterm women can be suppressed by brief ocular exposure to blue light.The Olcese lab at Florida State University identified a novel interaction between the myometrial melatonin receptors and OT receptors in human myometrial cells (Sharkey et al. 2009), which may ultimately help to resolve certain issues surrounding idiopathic preterm labor. Their results consistently indicate that melatonin at physiological concentration sensitizes human myometrial smooth muscle cells to the contractile effects of OT (Sharkey et al. 2010).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant

  • Gestational age: 24 to 31 (+6 days) week of pregnancy

  • Uterine contractions

  • First episode of preterm labor

Exclusion

Exclusion Criteria:

  • Visual impairment (legally blind)

  • Multiple pregnancy

  • Current progesterone treatment

  • Preeclampsia

  • Renal disease

  • Current chlamydia or gonorrhea infections

  • Cocaine or opiate use

  • Nightshift work in the past week

Study Design

Total Participants: 30
Study Start date:
September 06, 2018
Estimated Completion Date:
June 30, 2019

Study Description

Study participants will be pregnant women (gestational weeks 24 to 31+6 days) who present with preterm contractions. In the triage room, the study participant will be connected to the external tocometer from at least 19:00h (7 PM) to the following morning at 07:00h. Room lighting will be kept dim.

Participants meeting inclusion criteria will be randomly allocated to blue light or red light. Baseline contractions will be measured. The allocated light mask will be applied for 2 intervals of 60 minutes each.There will be a 60 minute rest period after every 60 minute intervention period for comparison.

Other than the application of the light mask, all routine standards of care deemed warranted by the obstetric provider for proper treatment of preterm labor will be followed. (ie antenatal steroids, tocolytics).

Connect with a study center

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

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