Sleep Disruption in New Mothers: An Intervention Trial (MOMS)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Sleep Disturbance; Postpartum Period; Pregnancy

Treatments: Behavioral: Sleep hygiene; Drug: Acetaminophen; Behavioral: Dietary information

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01321710

MOMS Sleep

2R01NR005345 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 152 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 3 patient groups

Dietary information & standard care

Active Comparator group

Description:

Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive no intervention beyond standard immunization care.

Treatment:

Behavioral: Dietary information

Sleep hygiene & standard care

Experimental group

Description:

Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep. Infants in this arm receive standard immunization care.

Treatment:

Behavioral: Sleep hygiene

Sleep hygiene & acetaminophen

Experimental group

Description:

Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep. Infants in this arm receive an acetaminophen intervention (12.5mg per kg infant weight, 1 dose 30 minutes prior to immunization and q4-6h thereafter, for a total of 5 doses) to minimize sleep disturbance following immunization.

Treatment:

Drug: Acetaminophen

Behavioral: Sleep hygiene