Uterine Contractions Under Blue Light

October 1, 2018 updated by: University of South Florida

Nightly Suppression of Contractions in At-Risk Pregnancies by the Infusion of Defused Blue Light

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of contractions per hour
Time Frame: Immediately upon completion of intervention
Number of contractions per hour
Immediately upon completion of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately upon completion of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

Kyndermed

Investigators

  • Principal Investigator: Judette M Louis, MD, University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2018

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00031969

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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