AzTrials
AzTrials

PregnancyMOMSNCT01321710

Sleep Disruption in New Mothers: An Intervention Trial

A study testing Sleep hygiene, Dietary information and Acetaminophen in people with Pregnancy and Postpartum Period, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, Postpartum Period, Sleep Disturbance
What is being tested?
Sleep hygiene, Dietary information and Acetaminophen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteUnited States
Study dates
Dec 2004to May 2008
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • University of California

    San Francisco, California, 94143-0606

Other trials in United States

About this study

Official title: Sleep Disruption in New Parents: An Intervention Trial

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.

Being tested
Sleep hygiene, Dietary information, Acetaminophen
Keywords
sleep hygiene, actigraphy, maternal, infant, postpartum period, immunization, acetaminophen
Medical subject headings
Parasomnias, Sleep Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep hygieneBehavioural

    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 informationBehavioural

    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.

Study groups in NCT01321710
Study groupRoleWhat they receive
Dietary information & standard careActive comparatorMothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance. Infants in this arm receive no intervention beyond standard immunization care.
Receives: Behavioral: Dietary information
Sleep hygiene & standard careExperimentalMothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep. Infants in this arm receive standard immunization care.
Receives: Behavioral: Sleep hygiene
Sleep hygiene & acetaminophenExperimentalMothers 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.
Receives: Behavioral: Sleep hygiene; Drug: Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal Sleep Quantity (Objective)

    Maternal sleep quantity is defined as total night-time sleep in hours as measured by wrist actigraphy over 3 nights.

    Measured: 1-month postpartum (approximately)

  2. Maternal Sleep Quality (Objective)

    Maternal sleep quality is defined as sleep efficiency (percent sleep per time in bed averaged across 3 nights) as measured by wrist actigraphy.

    Measured: 1 month postpartum (approximately)

  3. Change in Infant Sleep Quantity (Objective)

    Change in infant sleep quantity is defined as the difference between the number of hours slept in the 24 hours prior to immunization and the the number of hours slept after immunization (positive numbers indicate more sleep following immunization). Infant sleep was measured by ankle actigraphy.

    Measured: 24 hours before and 24 hours after immunizations at approximately 2 months of age

Secondary outcomes (2)

  1. Maternal Sleep Disturbance (Subjective)

    Maternal sleep disturbance is measured by the total score on the General Sleep Disturbance Scale (GSDS). The GSDS is a self-report questionnaire that measures perceived sleep disturbance in the past week. GSDS scores range from 0 to 147, with higher scores indicating more sleep disturbance.

    Measured: 1 month postpartum (approximately)

  2. Maternal Well-being

    Maternal well-being was measured by the total score on the Center for Epidemiologic Studies - Depression Scale (CES-D). The CES-D measures depressive symptoms in the past week. CES-D scores can range 0 to 60, with higher scores indicating more symptoms of depression.

    Measured: 1 month postpartum (approximately)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2011 (estimated)
  2. Study startDec 2004
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01321710
Sponsor's protocol ID
MOMS Sleep
Other IDs
2R01NR005345
Acronym
MOMS
Status last verified
Jan 2012
First submitted
22 Mar 2011
Last updated
29 Feb 2012
Data monitoring committee
Yes

Publications

  • Lee KA, Gay CL. Can modifications to the bedroom environment improve the sleep of new parents? Two randomized controlled trials. Res Nurs Health. 2011 Feb;34(1):7-19. doi: 10.1002/nur.20413. Epub 2010 Nov 17.

    PubMed 21243655

  • Goyal D, Gay C, Lee KA. How much does low socioeconomic status increase the risk of prenatal and postpartum depressive symptoms in first-time mothers? Womens Health Issues. 2010 Mar-Apr;20(2):96-104. doi: 10.1016/j.whi.2009.11.003. Epub 2010 Feb 4.

    PubMed 20133153

  • Kennedy HP, Gardiner A, Gay C, Lee KA. Negotiating sleep: a qualitative study of new mothers. J Perinat Neonatal Nurs. 2007 Apr-Jun;21(2):114-22. doi: 10.1097/01.JPN.0000270628.51122.1d.

    PubMed 17505231

  • Franck L, Gay CL, Lynch M, Lee KA. Infant sleep after immunization: randomized controlled trial of prophylactic acetaminophen. Pediatrics. 2011 Dec;128(6):1100-8. doi: 10.1542/peds.2011-1712. Epub 2011 Nov 28.

    PubMed 22123869

Questions about this trial

What is this clinical trial studying?

A study testing Sleep hygiene, Dietary information and Acetaminophen in people with Pregnancy and Postpartum Period, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal Sleep Quantity (Objective) (time frame: 1-month postpartum (approximately)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01321710, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in