NCT03691740

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

September 28, 2018

Last Update Submit

October 1, 2018

Conditions

Preterm Contractions

Keywords

circadian, melatonin, preterm labor

Outcome Measures

Primary Outcomes (1)

  • Number of contractions per hour

    Number of contractions per hour

    Immediately upon completion of intervention

Secondary Outcomes (1)

  • Binary proportion of 4 or less compared to 5+ contractions per hour

    Immediately upon completion of intervention

Study Arms (2)

Experimental

EXPERIMENTAL

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

Device: Ocular light

Control

PLACEBO COMPARATOR

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

Device: Ocular light

Interventions

Ocular lightDEVICE

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

ControlExperimental

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant
  • Gestational age: 24 to 31 (+6 days) week of pregnancy
  • Uterine contractions
  • First episode of preterm labor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 19001515BACKGROUND

  • 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.

    PMID: 25015556BACKGROUND

  • 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.

    PMID: 22556015BACKGROUND

  • 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.

    PMID: 20382690BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Judette M Louis, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judette M Louis, MD

CONTACT

8132598500jlouis1@health.usf.edu

Linda Odibo, RN, BSc, MN

CONTACT

(813) 259-0655lodibo@health.usf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 2, 2018

Study Start

September 6, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 2, 2018

Record last verified: 2018-09

Locations

US(1)