Uterine Contractions Under Blue Light

Preterm Contractions Clinical Trial

Official title:

Nightly Suppression of Contractions in At-Risk Pregnancies by the Infusion of Defused Blue Light

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03691740
• Other study ID #: Pro00031969
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: June 2019

Study information

• Verified date: September 2018
• Source: University of South Florida
• Contact: Judette M Louis, MD
• Phone: 8132598500
• Email: jlouis1[@]health.usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Preterm Contractions

Intervention

Device:
• Ocular 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

Locations

Country	Name	City	State
United States	Tampa General Hospital	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Kyndermed

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

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