Sleep Apnea in Pregnancy Screening Study (SAPSS)

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Judette Louis, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01585844
First received: April 23, 2012
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further information may help improve maternal/fetal outcome. One reason why women and in particular pregnant women are under diagnosed is the lack of an effective, reliable screening tool. Validated questionnaires used in the general population may not be effective in screening pregnant women. The investigators hypothesize that sleep apnea will have 20% prevalence in the obese pregnant population and that it is associated with increased maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their prenatal care clinics and they will be screened for OSA using validated sleep questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea detection device. Women who meet clinical criteria for OSA will be referred for overnight polysomnogram and management by the Pulmonary and Critical Care Division of the Internal Medicine Department. For all enrolled patients the remainder of prenatal care will be per routine. Data will be collected regarding the pregnancy course and outcomes.

The primary outcome of interest is the prevalence of sleep apnea in obese women and the associated maternal and neonatal morbidity. The secondary outcome measures will be molecular measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep apnea.


Condition
Sleep Apnea
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • The prevalence of sleep apnea in obese pregnant women [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alterations in biomarkers of inflammation and oxidative stress [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ] [ Designated as safety issue: No ]
  • The prevalence of maternal and neonatal morbidity [ Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

urine serum


Enrollment: 182
Study Start Date: August 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women with sleep apnea
Women without sleep apnea

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Obstetric care clinic at a tertiary care hospital

Criteria

Inclusion Criteria:

  • Prepregnancy BMI of 30kg/m2 or greater
  • Singleton pregnancy
  • 18 years or older

Exclusion Criteria:

  • Chronic use of narcotics or other CNS drugs
  • Inability to sleep beyond 2 hours
  • 3 or more missed prenatal visits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585844

Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Judette Louis, MD, MPH MetroHealth Medical Center
  More Information

Publications:
Responsible Party: Judette Louis, Assistant Professor, Reproductive Biology, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01585844     History of Changes
Other Study ID Numbers: RWJ64323
Study First Received: April 23, 2012
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
sleep apnea
pregnancy
obesity

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Disorders
Obesity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Dyssomnias
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014