Uterine Contractions Under Blue Light

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Preterm Contractions

Intervention / Treatment
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* Device: Ocular light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Ocular light will be applied via a mask. The participants allocated to the experimental group will receive blue light | Device: Ocular light<br>* 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<br>|
| Placebo Comparator: Control<br>Ocular light will be applied via a mask. The participants allocated to the control group will receive red light | Device: Ocular light<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of contractions per hour | 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 | Compare proportion proportions among each treatment group | Immediately upon completion of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circadian, melatonin, preterm labor