PregnancyNCT01863446
Effects of Light on Melatonin and Contractions in Pregnant Women
A study testing Lighting1 and Lighting2 in people with Pregnancy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin secretion and reduce uterine contractions in women at late term pregnancies. Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported uterine contractions in women at late term pregnancies. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Lighting1 and Lighting2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant at 35-40 weeks
- first pregnancy
Who cannot join
- pregnancy-related complications
- twin or higher pregnancy
- using medication that affects the sympathetic nervous system
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin secretion and reduce uterine contractions in women at late term pregnancies.
Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported uterine contractions in women at late term pregnancies.
- Conditions
- Pregnancy
- Being tested
- Lighting1, Lighting2
- Keywords
- Pregnancy, Melatonin, Contractions, Light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lighting1Device
Ocular light exposure to a red wavelength light
Lighting2Device
Ocular light exposure to a blue/green wavelength light
| Study group | Role | What they receive |
|---|---|---|
| Lighting1 | Experimental | Ocular light exposure of a red wavelength light for one night Receives: Device: Lighting1 |
| Lighting2 | Experimental | Ocular light exposure of a blue-green wavelength light for one night Receives: Device: Lighting2 |
| Lighting3 | Experimental | Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2 Receives: Device: Lighting1 |
| Lighting4 | Experimental | Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2 Receives: Device: Lighting1; Device: Lighting2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin Area Under the Curve (AUC)
Melatonin will be assessed using concentrations in saliva or blood. AUC will be calculated using melatonin concentrations during the Outcome Measure Time Frame.
(1) for Lighting1 and Lighting2, the AUC for night 1; (2) for Lighting3 and Lighting4, the AUC for Night 2
Measured: 4 hours of light exposure.
Secondary outcomes (1)
Uterine Contractions
Uterine contractions will be measured using a uterine tocometer device
(1) for Lighting1 and Lighting2, the sum for night 1; (2) for Lighting3 and Lighting4, the sum for Night 2
Measured: 4 hours of light exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2021
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elizabeth Klerman MD PhD, Brigham and Women's Hospital
- Investigators
- Elizabeth B Klerman, MD PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863446
- Sponsor's protocol ID
- 2012P002568
- Other IDs
- 1R21HD086392-01
- Status last verified
- Aug 2024
- First submitted
- 23 May 2013
- Last updated
- 27 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Light on Melatonin and Contractions in Pregnant Women
- ClinicalTrials.gov ID
- NCT01863446
- Acronym / sponsor ID
- 2012P002568
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Melatonin, Contractions, Light
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Harvard University, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2013
- Primary completion
- Jun 2021 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 29 May 2013 (estimated)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aim: Test the hypothesis that ocular light exposure will suppress melatonin secretion and reduce uterine contractions in women at late term pregnancies.
Secondary aim. Test the hypothesis that ocular light exposure will reduce self-reported uterine contractions in women at late term pregnancies.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lighting1 | Experimental | Device: Lighting1Ocular light exposure of a red wavelength light for one night |
| Lighting2 | Experimental | Device: Lighting2Ocular light exposure of a blue-green wavelength light for one night |
| Lighting3 | Experimental | Device: Lighting1Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2 |
| Lighting4 | Experimental | Device: Lighting1, Device: Lighting2Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant at 35-40 weeks
- first pregnancy
Key exclusion criteria (3 listed)
- pregnancy-related complications
- twin or higher pregnancy
- using medication that affects the sympathetic nervous system
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 |
|---|---|---|
| Lighting1Ocular light exposure to a red wavelength light | Device | Lighting1, Lighting3, Lighting4 |
| Lighting2Ocular light exposure to a blue/green wavelength light | Device | Lighting2, Lighting4 |
Primary outcome
Melatonin Area Under the Curve (AUC)
Time frame: 4 hours of light exposure.
Melatonin will be assessed using concentrations in saliva or blood. AUC will be calculated using melatonin concentrations during the Outcome Measure Time Frame. (1) for Lighting1 and Lighting2, the AUC for night 1; (2) for Lighting3 and Lighting4, the AUC for Night 2
1 secondary outcome
Uterine Contractions
Time frame: 4 hours of light exposure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elizabeth B Klerman, MD PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lighting1 and Lighting2 in people with Pregnancy, run by Brigham and Women's Hospital 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 27 Aug 2024. 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. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin Area Under the Curve (AUC) (time frame: 4 hours of light exposure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2024.