Preterm Contractions
Conditions
Keywords
circadian, melatonin, preterm labor
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).
Interventions
DEVICEOcular 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
Sponsors
Kyndermed
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
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.
Intervention model description
Randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of contractions per hour | Immediately upon completion of intervention | Number of contractions per hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binary proportion of 4 or less compared to 5+ contractions per hour | Immediately upon completion of intervention | Compare proportion proportions among each treatment group |
Countries
United States
Contacts
Primary ContactJudette M Louis, MD
Backup ContactLinda Odibo, RN, BSc, MN
Outcome results
None listed