Effects of Light on Melatonin and Contractions in Pregnant Women

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Device: Lighting2; Device: Lighting1

• Registration Number: NCT01863446
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-29
• Primary Completion: 2021-06
• Results First Submitted: 2023-08-30
• Results First Submitted QC: 2023-10-19
• Results First Posted: 2023-11-13
• Study Completion: 2023-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lighting2	Lighting2	Ocular light exposure of a blue-green wavelength light for one night
Lighting4	Lighting1	Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2
Lighting1	Lighting1	Ocular light exposure of a red wavelength light for one night
Lighting3	Lighting1	Ocular light exposure to a red wavelength light on night 1 and to a red wavelength light on night 2
Lighting4	Lighting2	Ocular light exposure to a red wavelength light on night 1 and to a blue-green wavelength light on night 2

Primary Outcome Measures

Name	Time	Method
Melatonin Area Under the Curve (AUC)	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

Secondary Outcome Measures

Name	Time	Method
Uterine Contractions	4 hours of light exposure	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

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States