Recruiting

Observational Study

Sponsor:

University of South Florida

Code:

NCT03691740

Conditions

Preterm Contractions

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Ocular light

Study Details

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).

Conditions

Preterm Contractions

Study ID

NCT03691740

Start date

Sep 6, 2018

Status verified date

Sep, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

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

placebo comparator: Control

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

Interventions

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

Primary outcome measure

  • Number of contractions per hour [ Time Frame: Immediately upon completion of intervention ]

Central Contacts and Locations

Central contacts

Judette M Louis, MD

8132598500jlouis1@health.usf.edu

Linda Odibo, RN, BSc, MN

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

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Linda Odibo

lodibo@health.usf.edu

Judette M Louis, MD

8132598500jlouis1@health.usf.edu

More Information

Sponsor

University of South Florida

Last update posted

Oct 2, 2018

Last verified

Sep, 2018

Keywords

  • circadian, melatonin, preterm labor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2018-10-02.