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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Tampa General Hospital | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Kyndermed |
United States,
Olcese J, Beesley S. Clinical significance of melatonin receptors in the human myometrium. Fertil Steril. 2014 Aug;102(2):329-35. doi: 10.1016/j.fertnstert.2014.06.020. Epub 2014 Jul 9. Review. — View Citation
Olcese J, Lozier S, Paradise C. Melatonin and the circadian timing of human parturition. Reprod Sci. 2013 Feb;20(2):168-74. doi: 10.1177/1933719112442244. Epub 2012 May 3. Review. — View Citation
Sharkey JT, Cable C, Olcese J. Melatonin sensitizes human myometrial cells to oxytocin in a protein kinase C alpha/extracellular-signal regulated kinase-dependent manner. J Clin Endocrinol Metab. 2010 Jun;95(6):2902-8. doi: 10.1210/jc.2009-2137. Epub 2010 Apr 9. — View Citation
Sharkey JT, Puttaramu R, Word RA, Olcese J. Melatonin synergizes with oxytocin to enhance contractility of human myometrial smooth muscle cells. J Clin Endocrinol Metab. 2009 Feb;94(2):421-7. doi: 10.1210/jc.2008-1723. Epub 2008 Nov 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of contractions per hour | Number of contractions per hour | Immediately upon completion of intervention | |
Secondary | Binary proportion of 4 or less compared to 5+ contractions per hour | Compare proportion proportions among each treatment group | Immediately upon completion of intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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