Trial Outcomes & Findings for Effects of Light on Melatonin and Contractions in Pregnant Women (NCT NCT01863446)
NCT ID: NCT01863446
Last Updated: 2024-08-27
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
4 hours of light exposure.
Results posted on
2024-08-27
Participant Flow
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
Participant milestones
| Measure |
Lighting1
Ocular light exposure of a red wavelength light for one night
Lighting1: Ocular light exposure to a red wavelength light
|
Lighting2
Ocular light exposure of a blue-green wavelength light for one night
Lighting2: Ocular light exposure to a blue/green wavelength light
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
12
|
12
|
|
Overall Study
COMPLETED
|
4
|
4
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Lighting1
Ocular light exposure of a red wavelength light for one night
Lighting1: Ocular light exposure to a red wavelength light
|
Lighting2
Ocular light exposure of a blue-green wavelength light for one night
Lighting2: Ocular light exposure to a blue/green wavelength light
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
Baseline Characteristics
data are missing about gestational age for three participants
Baseline characteristics by cohort
| Measure |
Lighting1
n=4 Participants
Ocular light exposure of a red wavelength light for one night
Lighting1: Ocular light exposure to a red wavelength light
|
Lighting2
n=4 Participants
Ocular light exposure of a blue-green wavelength light for one night
Lighting2: Ocular light exposure to a blue/green wavelength light
|
Lighting3
n=8 Participants
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
|
Lighting4
n=9 Participants
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
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24.8 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
23.0 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
27.5 years
STANDARD_DEVIATION 4.9 • n=8 Participants
|
30.4 years
STANDARD_DEVIATION 3.2 • n=9 Participants
|
27.4 years
STANDARD_DEVIATION 4.9 • n=25 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=8 Participants
|
9 Participants
n=9 Participants
|
25 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=9 Participants
|
19 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=9 Participants
|
7 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=9 Participants
|
15 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=25 Participants
|
|
Gestational age
|
37.9 weeks
STANDARD_DEVIATION 1.2 • n=4 Participants • data are missing about gestational age for three participants
|
37.6 weeks
STANDARD_DEVIATION 1.2 • n=4 Participants • data are missing about gestational age for three participants
|
38.3 weeks
STANDARD_DEVIATION 0.4 • n=6 Participants • data are missing about gestational age for three participants
|
37.7 weeks
STANDARD_DEVIATION 1.1 • n=8 Participants • data are missing about gestational age for three participants
|
37.9 weeks
STANDARD_DEVIATION 0.9 • n=22 Participants • data are missing about gestational age for three participants
|
PRIMARY outcome
Timeframe: 4 hours of light exposure.Population: Healthy pregnant women. In Lighting3, there were missing data from 2 participants; in Lighting4, there were missing data from 1 participant
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
Outcome measures
| Measure |
Lighting1
n=4 Participants
Ocular light exposure of a red wavelength light for one night
Lighting1: Ocular light exposure to a red wavelength light
|
Lighting2
n=4 Participants
Ocular light exposure of a blue-green wavelength light for one night
Lighting2: Ocular light exposure to a blue/green wavelength light
|
Lighting3
n=8 Participants
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
|
Lighting4
n=9 Participants
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
|
|---|---|---|---|---|
|
Melatonin Area Under the Curve (AUC)
|
42.1 area under curve (h*pg/mL)
Standard Deviation 23.0
|
24.3 area under curve (h*pg/mL)
Standard Deviation 24.8
|
38.5 area under curve (h*pg/mL)
Standard Deviation 14.6
|
26.3 area under curve (h*pg/mL)
Standard Deviation 39.8
|
SECONDARY outcome
Timeframe: 4 hours of light exposurePopulation: Healthy pregnant women. In Lighting3, there were missing data from 2 participants; in Lighting4, there were missing data from 1 participant
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
Outcome measures
| Measure |
Lighting1
n=4 Participants
Ocular light exposure of a red wavelength light for one night
Lighting1: Ocular light exposure to a red wavelength light
|
Lighting2
n=4 Participants
Ocular light exposure of a blue-green wavelength light for one night
Lighting2: Ocular light exposure to a blue/green wavelength light
|
Lighting3
n=8 Participants
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
|
Lighting4
n=9 Participants
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
|
|---|---|---|---|---|
|
Uterine Contractions
|
16.8 number of uterine contractions
Standard Deviation 10.9
|
13.8 number of uterine contractions
Standard Deviation 17.3
|
14.5 number of uterine contractions
Standard Deviation 9.1
|
13.0 number of uterine contractions
Standard Deviation 12.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 hours of light exposurePopulation: Healthy pregnant women. In Lighting3, there were missing data from 2 participants; in Lighting4, there were missing data from 1 participant.
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
Outcome measures
| Measure |
Lighting1
n=4 Participants
Ocular light exposure of a red wavelength light for one night
Lighting1: Ocular light exposure to a red wavelength light
|
Lighting2
n=4 Participants
Ocular light exposure of a blue-green wavelength light for one night
Lighting2: Ocular light exposure to a blue/green wavelength light
|
Lighting3
n=8 Participants
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
|
Lighting4
n=9 Participants
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
|
|---|---|---|---|---|
|
Subjective Assessment of Uterine Contractions
|
4.0 number of uterine contractions
Standard Deviation 6.1
|
3.5 number of uterine contractions
Standard Deviation 2.4
|
5.5 number of uterine contractions
Standard Deviation 4.9
|
2.9 number of uterine contractions
Standard Deviation 4.5
|
Adverse Events
Lighting1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lighting2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lighting3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lighting4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place