CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 152 enrolled
Drug / intervention
Acetaminophen +2 moredrug
Likely dose
Acetaminophen 90mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01321710
NCT01321710N/ACompleted
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Sleep Disruption in New Parents: An Intervention Trial

University of California, San Francisco·interventional·Posted Mar 23, 2011·Updated Feb 29, 2012

In Brief

A clinical study evaluating Sleep hygiene, Dietary information, and 1 other intervention for Pregnancy and 2 related conditions. Completed, enrolled 152 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Postpartum Period, Sleep Disturbance
CountriesUnited States
CollaboratorsNational Institute of Nursing Research (NINR)

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 23, 2011
Enrollment StartDec 1, 2004
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.3 years ago

Interventions

Sleep hygienebehavioral

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.

Dietary informationbehavioral

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.

Acetaminophendrug

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.