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Uterine Contractions Under Blue Light

Primary Purpose

Preterm Contractions

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ocular light
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Contractions focused on measuring circadian, melatonin, preterm labor

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tampa General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

Ocular light will be applied via a mask. The participants allocated to the experimental group will receive blue light

Ocular light will be applied via a mask. The participants allocated to the control group will receive red light

Outcomes

Primary Outcome Measures

Number of contractions per hour
Number of contractions per hour

Secondary Outcome Measures

Binary proportion of 4 or less compared to 5+ contractions per hour
Compare proportion proportions among each treatment group

Full Information

First Posted
September 28, 2018
Last Updated
October 1, 2018
Sponsor
University of South Florida
Collaborators
Kyndermed
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1. Study Identification

Unique Protocol Identification Number
NCT03691740
Brief Title
Uterine Contractions Under Blue Light
Official Title
Nightly Suppression of Contractions in At-Risk Pregnancies by the Infusion of Defused Blue Light
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 6, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
Kyndermed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Contractions
Keywords
circadian, melatonin, preterm labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Ocular light will be applied via a mask. The participants allocated to the experimental group will receive blue light
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Ocular light will be applied via a mask. The participants allocated to the control group will receive red light
Intervention Type
Device
Intervention Name(s)
Ocular light
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of contractions per hour
Description
Number of contractions per hour
Time Frame
Immediately upon completion of intervention
Secondary Outcome Measure Information:
Title
Binary proportion of 4 or less compared to 5+ contractions per hour
Description
Compare proportion proportions among each treatment group
Time Frame
Immediately upon completion of intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Judette M Louis, MD
Phone
8132598500
Email
jlouis1@health.usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Odibo, RN, BSc, MN
Phone
(813) 259-0655
Email
lodibo@health.usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judette M Louis, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Odibo
Email
lodibo@health.usf.edu
First Name & Middle Initial & Last Name & Degree
Judette M Louis, MD
Phone
8132598500
Email
jlouis1@health.usf.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
19001515
Citation
Sharkey JT, Puttaramu R, Word RA, Olcese J. Melatonin synergizes with oxytocin to enhance contractility of human myometrial smooth muscle cells. J Clin Endocrinol Metab. 2009 Feb;94(2):421-7. doi: 10.1210/jc.2008-1723. Epub 2008 Nov 11.
Results Reference
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PubMed Identifier
25015556
Citation
Olcese J, Beesley S. Clinical significance of melatonin receptors in the human myometrium. Fertil Steril. 2014 Aug;102(2):329-35. doi: 10.1016/j.fertnstert.2014.06.020. Epub 2014 Jul 9.
Results Reference
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PubMed Identifier
22556015
Citation
Olcese J, Lozier S, Paradise C. Melatonin and the circadian timing of human parturition. Reprod Sci. 2013 Feb;20(2):168-74. doi: 10.1177/1933719112442244. Epub 2012 May 3.
Results Reference
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PubMed Identifier
20382690
Citation
Sharkey JT, Cable C, Olcese J. Melatonin sensitizes human myometrial cells to oxytocin in a protein kinase C alpha/extracellular-signal regulated kinase-dependent manner. J Clin Endocrinol Metab. 2010 Jun;95(6):2902-8. doi: 10.1210/jc.2009-2137. Epub 2010 Apr 9.
Results Reference
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Uterine Contractions Under Blue Light

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