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

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ClinicalTrials.gov Identifier: NCT01321710
Recruitment Status : Completed
First Posted : March 23, 2011
Results First Posted : February 29, 2012
Last Update Posted : February 29, 2012
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Pregnancy
Postpartum Period
Sleep Disturbance
Interventions: Behavioral: Sleep hygiene
Behavioral: Dietary information
Drug: Acetaminophen

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dietary Information & Standard Care

Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.

Infants in this arm receive standard immunization care.

Sleep Hygiene & Standard Care

Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.

Infants in this arm receive standard immunization care.

Sleep Hygiene & Acetaminophen

Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.

Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization.


Participant Flow:   Overall Study
    Dietary Information & Standard Care   Sleep Hygiene & Standard Care   Sleep Hygiene & Acetaminophen
STARTED   50   58   44 
COMPLETED   46   53   44 
NOT COMPLETED   4   5   0 
Lost to Follow-up                4                5                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dietary Information & Standard Care

Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.

Infants in this arm receive standard immunization care.

Sleep Hygiene & Standard Care

Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.

Infants in this arm receive standard immunization care.

Sleep Hygiene & Acetaminophen

Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.

Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization.

Total Total of all reporting groups

Baseline Measures
   Dietary Information & Standard Care   Sleep Hygiene & Standard Care   Sleep Hygiene & Acetaminophen   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   58   44   152 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   50   58   44   152 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.8  (6.5)   26.4  (6.4)   26.5  (7.1)   26.6  (6.6) 
Gender 
[Units: Participants]
       
Female   50   58   44   152 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   50   58   44   152 


  Outcome Measures

1.  Primary:   Maternal Sleep Quantity (Objective)   [ Time Frame: 1-month postpartum (approximately) ]

2.  Primary:   Maternal Sleep Quality (Objective)   [ Time Frame: 1 month postpartum (approximately) ]

3.  Primary:   Change in Infant Sleep Quantity (Objective)   [ Time Frame: 24 hours before and 24 hours after immunizations at approximately 2 months of age ]

4.  Secondary:   Maternal Sleep Disturbance (Subjective)   [ Time Frame: 1 month postpartum (approximately) ]

5.  Secondary:   Maternal Well-being   [ Time Frame: 1 month postpartum (approximately) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kathryn Lee, RN, PhD
Organization: University of California, San Francisco
phone: 415-476-4442
e-mail: kathryn.lee@nursing.ucsf.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01321710     History of Changes
Other Study ID Numbers: MOMS Sleep
2R01NR005345 ( U.S. NIH Grant/Contract )
First Submitted: March 22, 2011
First Posted: March 23, 2011
Results First Submitted: August 22, 2011
Results First Posted: February 29, 2012
Last Update Posted: February 29, 2012