NCT01321710

Sleep Disruption in New Mothers: An Intervention Trial

Sleep Disruption in New Parents: An Intervention Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. This study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.

Conditions

• Pregnancy
• Postpartum Period
• Sleep Disturbance

Interventions

Type	Name	Description
BEHAVIORAL	Sleep hygiene	This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation. It is administered to women during their last month of pregnancy.
BEHAVIORAL	Dietary information	This intervention consists of dietary information aimed at improving postpartum sleep. The recommendations include avoiding alcohol, caffeine, and heavy meals before bed, as well as eating healthy foods.
DRUG	Acetaminophen	51-90mg depending on infant weight (12.5mg per kg infant weight). Administered 30 minutes prior to immunization and q4-6h for a total of 5 doses.

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2011-03-23
• Last updated: 2012-02-29
• Results posted: 2012-02-29

Locations

1 site across 1 country: United States