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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD086392-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Harvard University | OTHER |
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lighting1 | Experimental | Ocular light exposure of a red wavelength light for one night |
|
| Lighting2 | Experimental | Ocular light exposure of a blue-green wavelength light for one night |
|
| Lighting3 | Experimental | Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2 |
|
| Lighting4 | Experimental | Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lighting1 | Device | Ocular light exposure to a red wavelength light |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 hours of light exposure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 hours of light exposure |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Assessment of Uterine Contractions | Self-reported uterine contractions will be assessed by asking the women how many contractions they felt. (1) for Lighting1 and Lighting2, the sum for night 1; (2) for Lighting3 and Lighting4, the sum for Night 2 | 4 hours of light exposure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth B Klerman, MD PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
51 people total enrolled 33 started study; 18 were not studied. 18 people who signed informed consent were not studied: 3 had a new medical reason for ineligibility 5 delivered the baby before their scheduled study date 8 signed consent forms but were not studied because study enrollment was complete before their scheduled study data 2 were lost to follow-up
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| ID | Title | Description |
|---|---|---|
| FG000 | Lighting1 | Ocular light exposure of a red wavelength light for one night Lighting1: Ocular light exposure to a red wavelength light |
| FG001 | Lighting2 | Ocular light exposure of a blue-green wavelength light for one night Lighting2: Ocular light exposure to a blue/green wavelength light |
| FG002 | Lighting3 | Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2 Lighting1: Ocular light exposure to a red wavelength light |
| FG003 | Lighting4 | Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2 Lighting1: Ocular light exposure to a red wavelength light Lighting 2: Ocular light exposure to a blue/green wavelength light |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Incomplete data (problem with data collection) in 2 participants in Lighting 3 and 1participant in Lighting4
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| ID | Title | Description |
|---|---|---|
| BG000 | Lighting1 | Ocular light exposure of a red wavelength light for one night Lighting1: Ocular light exposure to a red wavelength light |
| BG001 | Lighting2 | Ocular light exposure of a blue-green wavelength light for one night Lighting2: Ocular light exposure to a blue/green wavelength light |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, Continuous in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Healthy pregnant women. In Lighting3, there were missing data from 2 participants; in Lighting4, there were missing data from 1 participant | Posted | Mean | Standard Deviation | area under curve (h*pg/mL) | 4 hours of light exposure. |
|
Inpatient 1 or 2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lighting1 | Ocular light exposure of a red wavelength light for one night Lighting1: Ocular light exposure to a red wavelength light |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Klerman | Mass General Hospital | 617-643-2424 | ebklerman@hms.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 18, 2023 | Oct 18, 2023 | Prot_SAP_ICF_000.pdf |
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| Lighting2 | Device | Ocular light exposure to a blue/green wavelength light |
|
| Physician Decision |
|
| BG002 | Lighting3 | Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2 Lighting1: Ocular light exposure to a red wavelength light |
| BG003 | Lighting4 | Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2 Lighting1: Ocular light exposure to a red wavelength light Lighting2: Ocular light exposure to a blue/green wavelength light |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gestational age | data are missing about gestational age for three participants | Mean | Standard Deviation | weeks |
|
Ocular light exposure of a blue-green wavelength light for one night Lighting2: Ocular light exposure to a blue/green wavelength light |
| OG002 | Lighting3 | Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2 Lighting1: Ocular light exposure to a red wavelength light |
| OG003 | Lighting4 | Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2 Lighting1: Ocular light exposure to a red wavelength light Lighting 2: Ocular light exposure to a blue/green wavelength light |
|
|
|
| Secondary | 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 | Healthy pregnant women. In Lighting3, there were missing data from 2 participants; in Lighting4, there were missing data from 1 participant | Posted | Mean | Standard Deviation | number of uterine contractions | 4 hours of light exposure |
|
|
|
|
| Other Pre-specified | Subjective Assessment of Uterine Contractions | Self-reported uterine contractions will be assessed by asking the women how many contractions they felt. (1) for Lighting1 and Lighting2, the sum for night 1; (2) for Lighting3 and Lighting4, the sum for Night 2 | Healthy pregnant women. In Lighting3, there were missing data from 2 participants; in Lighting4, there were missing data from 1 participant. | Posted | Mean | Standard Deviation | number of uterine contractions | 4 hours of light exposure |
|
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Lighting2 | Ocular light exposure of a blue-green wavelength light for one night Lighting2: Ocular light exposure to a blue/green wavelength light | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Lighting3 | Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2 Lighting1: Ocular light exposure to a red wavelength light | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Lighting4 | Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2 Lighting1: Ocular light exposure to a red wavelength light Lighting 2: Ocular light exposure to a blue/green wavelength light | 0 | 10 | 0 | 10 | 0 | 10 |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
Unpaired t-test of Lighting3 vs Lighting4 |
| Superiority |
Unpaired t-test |