Uterine Contractions Under Blue Light

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

September 6, 2018

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of contractions per hour[ Time Frame: Immediately upon completion of intervention ]

Number of contractions per hour

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Uterine Contractions Under Blue Light

Official Title ^ICMJE

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

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).

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Interventional
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

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Experimental: Experimental
Ocular light will be applied via a mask. The participants allocated to the experimental group will receive blue light
Placebo Comparator: Control
Ocular light will be applied via a mask. The participants allocated to the control group will receive red light

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 2019

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of South Florida

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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