Preterm ContractionsNCT03691740
Uterine Contractions Under Blue Light
A study testing Ocular light in people with Preterm Contractions, run by University of South Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Contractions
- What is being tested?
- Ocular light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2018to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant
- Gestational age: 24 to 31 (+6 days) week of pregnancy
- Uterine contractions
- First episode of preterm labor
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Linda Odibo, lodibo@health.usf.edu
Judette M Louis, MD, 8132598500, jlouis1@health.usf.edu
About this study
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).
Read the detailed 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).
- Conditions
- Preterm Contractions
- Being tested
- Ocular light
- Keywords
- circadian, melatonin, preterm labor
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Ocular light will be applied via a mask. The participants allocated to the experimental group will receive blue light Receives: 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 Receives: Device: Ocular light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of contractions per hour
Number of contractions per hour
Measured: Immediately upon completion of intervention
Secondary outcomes (1)
Binary proportion of 4 or less compared to 5+ contractions per hour
Compare proportion proportions among each treatment group
Measured: Immediately upon completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start6 Sep 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm ContractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Kyndermed
- Responsible party
- Sponsor
- Investigators
- Judette M Louis, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691740
- Sponsor's protocol ID
- Pro00031969
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19001515Olcese 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.
PubMed 25015556Olcese 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.
PubMed 22556015Sharkey 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.
PubMed 20382690
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nightly Suppression of Contractions in At-Risk Pregnancies by the Infusion of Defused Blue Light
- ClinicalTrials.gov ID
- NCT03691740
- Acronym / sponsor ID
- Pro00031969
- Conditions
- Preterm Contractions
- Keywords
- circadian, melatonin, preterm labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Kyndermed
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Ocular lightOcular light will be applied via a mask. The participants allocated to the experimental group will receive blue light |
| Control | Placebo comparator | Device: Ocular lightOcular light will be applied via a mask. The participants allocated to the control group will receive red light |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant
- Gestational age: 24 to 31 (+6 days) week of pregnancy
- Uterine contractions
- First episode of preterm labor
Key exclusion criteria (8 listed)
- Visual impairment (legally blind)
- Multiple pregnancy
- Current progesterone treatment
- Preeclampsia
- Renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular lightA light mask to which small light emitting diode(LED) lights emitting a blue or red color light will be used to deliver ocular light | Device | Control, Experimental |
Primary outcome
Number of contractions per hour
Time frame: Immediately upon completion of intervention
Number of contractions per hour
1 secondary outcome
Binary proportion of 4 or less compared to 5+ contractions per hour
Time frame: Immediately upon completion of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Background: PubMed 19001515Sharkey 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.
- Background: PubMed 25015556Olcese 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.
- Background: PubMed 22556015Olcese 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.
- Background: PubMed 20382690Sharkey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judette M Louis, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular light in people with Preterm Contractions, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judette M Louis, MD (8132598500, jlouis1@health.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of contractions per hour (time frame: Immediately upon completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691740, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.