Uterine Contractions Under Blue Light

University of South Florida

Status: Unknown

Conditions: Preterm Contractions

Treatments: Device: Ocular light

Study type: Interventional

Funder types: Other

Identifiers

NCT03691740

Pro00031969

Details and patient eligibility

About

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).

Full 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).

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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

Treatment:

Device: Ocular light

Control

Placebo Comparator group

Description:

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

Treatment:

Device: Ocular light