Preterm Contractions Clinical Trial
Official title:
Nightly Suppression of Contractions in At-Risk Pregnancies by the Infusion of Defused Blue Light
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).
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00163579 -
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|
Phase 4 | |
| Completed |
NCT01868308 -
Screening To Obviate Preterm Birth
|
N/A |