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Uterine Contractions Under Blue Light

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691740
Recruitment Status : Unknown
Verified September 2018 by University of South Florida.
Recruitment status was:  Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
Kyndermed
Information provided by (Responsible Party):
University of South Florida

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Preterm Contractions Device: Ocular light Not Applicable

Detailed 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Study group assignments will be placed in an opaque envelope which will be kept in the designated research area on Labor and Delivery. After informed consent is obtained, the coordinator will take one of the envelopes to determine the study group. The coordinator will not communicate with the care provide or the investigator regarding study group assignment.
Primary Purpose: Treatment
Official Title: Nightly Suppression of Contractions in At-Risk Pregnancies by the Infusion of Defused Blue Light
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
Ocular light will be applied via a mask. The participants allocated to the experimental group will receive blue light
 Device: Ocular light
A light mask to which small light emitting diode(LED) lights emitting a blue or red color light will be used to deliver ocular light
Placebo Comparator: Control
Ocular light will be applied via a mask. The participants allocated to the control group will receive red light
 Device: Ocular light
A light mask to which small light emitting diode(LED) lights emitting a blue or red color light will be used to deliver ocular light


Outcome Measures
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Primary Outcome Measures :
  1. Number of contractions per hour [ Time Frame: Immediately upon completion of intervention ]
    Number of contractions per hour


Secondary Outcome Measures :
  1. Binary proportion of 4 or less compared to 5+ contractions per hour [ Time Frame: Immediately upon completion of intervention ]
    Compare proportion proportions among each treatment group


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • Gestational age: 24 to 31 (+6 days) week of pregnancy
  • Uterine contractions
  • First episode of preterm labor

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691740


Contacts
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Contact: Judette M Louis, MD 8132598500 jlouis1@health.usf.edu
Contact: Linda Odibo, RN, BSc, MN (813) 259-0655 lodibo@health.usf.edu

Locations
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United States, Florida
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Contact: Linda Odibo       lodibo@health.usf.edu   
Contact: Judette M Louis, MD    8132598500    jlouis1@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Kyndermed
Investigators
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Principal Investigator: Judette M Louis, MD University of South Florida
More Information
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Publications:

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03691740    
Other Study ID Numbers: Pro00031969
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of South Florida:
circadian, melatonin, preterm labor
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications