NCT02100943

Brief Summary

This study will evaluate the presence or absence of Obstructive Sleep Apnea (OSA) in the third trimester of pregnancy and again postpartum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2016

Completed
Last Updated

April 20, 2017

Status Verified

June 1, 2016

Enrollment Period

2.7 years

First QC Date

March 27, 2014

Last Update Submit

April 18, 2017

Conditions

PregnancyOSA

Keywords

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Difference in incidence of Obstructive Sleep Apnea (OSA)

    The difference in incidence of OSA during the third trimester and postpartum. We assumed an incidence of 25% during the third trimester, reducing to 6% postpartum. Comparison will be made with McNemar's test on proportions at an α level of 0.05.

    6-8 weeks postpartum

Study Arms (1)

OSA in Pregnancy

Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women between 32 0/7 prior to 35 6/7 weeks gestation

You may qualify if:

  • Female (\> or equal 18 year of age)
  • Pregnant between 32 0/7 prior to 35 6/7 weeks gestation
  • Anticipated delivery at Forsyth Medical Center: Winston Salem, North Carolina

You may not qualify if:

  • Illicit drug/Alcohol abuse
  • Current treatment for obstructive sleep apnea
  • Age \<18 years
  • Inability to speak/read English proficiently enough to give informed consent
  • Usage of alpha blockers or short acting nitrates
  • Permanent pacemaker
  • Sustained non-sinus cardiac arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest School of Medicine, Forsyth Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • Street LM, Aschenbrenner CA, Houle TT, Pinyan CW, Eisenach JC. Gestational Obstructive Sleep Apnea: Biomarker Screening Models and Lack of Postpartum Resolution. J Clin Sleep Med. 2018 Apr 15;14(4):549-555. doi: 10.5664/jcsm.7042.

    PMID: 29609706DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Linda M Street, M.D.

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

March 1, 2014

Primary Completion

November 14, 2016

Study Completion

November 14, 2016

Last Updated

April 20, 2017

Record last verified: 2016-06

Locations

US(1)