N/A
Completed N=152
Sleep Disruption in New Mothers: An Intervention Trial
Pregnancy · Postpartum Period · Sleep Disturbances
Source: ClinicalTrials.gov NCT01321710 ↗
Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Feb 2012
Primary outcomePrimary: Maternal Sleep Quantity (Objective) — 6.1; 6.6 hours
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Sleep Quantity (Objective) |
6.1; 6.6 | — |
| PRIMARY Maternal Sleep Quality (Objective) |
68; 71 | — |
| PRIMARY Change in Infant Sleep Quantity (Objective) |
47.4; 73.1 | — |
| SECONDARY Maternal Sleep Disturbance (Subjective) |
49.9; 49.4 | — |
| SECONDARY Maternal Well-being |
13.3; 13.0 | — |
Eligibility Criteria
Inclusion Criteria
- pregnant women expecting first singleton birth
- able to speak, read, and write in English
- willing to participate for 3 consecutive days and nights during 36-39 weeks gestation and at 4, 8, and 12 weeks postpartum
- willing to have their infant participate in ankle actigraphy recording of their sleep/wake patterns for 96 hrs at the time of their first immunization
Exclusion Criteria
- history of affective illness prior to pregnancy
- current use of medications that may alter sleep
- history of a diagnosed sleep disorder such as sleep apnea, nocturnal myoclonus, or narcolepsy
- plan to employ live-in help with child care
- working the night-shift
- multiple pregnancy with twins or more
Data sourced from ClinicalTrials.gov (NCT01321710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.