Uterine Contractions Under Blue Light

Not Applicable

• Conditions: Preterm Contractions
• Interventions: Device: Ocular light

• Registration Number: NCT03691740
• Lead Sponsor: University of South Florida

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 Timeline

• Status Verified: 2018-09
• Study Start: 2018-09-06
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-01
• Last Update Submitted: 2018-10-01
• Study First Posted: 2018-10-02
• Last Update Posted: 2018-10-02
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Ocular light	Ocular light will be applied via a mask. The participants allocated to the control group will receive red light
Experimental	Ocular light	Ocular light will be applied via a mask. The participants allocated to the experimental group will receive blue light

Primary Outcome Measures

Name	Time	Method
Number of contractions per hour	Immediately upon completion of intervention	Number of contractions per hour

Secondary Outcome Measures

Name	Time	Method
Binary proportion of 4 or less compared to 5+ contractions per hour	Immediately upon completion of intervention	Compare proportion proportions among each treatment group

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States