Effects of Light on Melatonin and Contractions in Pregnant Women

Pregnancy Clinical Trial

Official title:

Effects of Light on Melatonin and Contractions in Pregnant Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01863446
• Other study ID #: 2012P002568
• Secondary ID: 1R21HD086392-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2013
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: December 2023
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• pregnant at 35-40 weeks
• first pregnancy

Exclusion Criteria:

• pregnancy-related complications
• twin or higher pregnancy
• using medication that affects the sympathetic nervous system

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Lighting1
Ocular light exposure to a red wavelength light
• Lighting2
Ocular light exposure to a blue/green wavelength light

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Harvard University, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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	4 hours of light exposure.
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	4 hours of light exposure