Incidence of Obstructive Sleep Apnea in Pregnancy

NCT00462306 | Completed Results

• 1 other identifier: 0524-026
• Study Type: observational
• Target: 4,577
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea is a condition characterized by obstruction of the upper airways and episodes of apnea and hypopnea during sleep. It is associated with significant adverse health effects. The incidence of obstructive sleep apnea in the general female population is approximately 2% but the incidence of obstructive sleep apnea in pregnancy is unknown. There is some evidence that pregnancy precipitates or at least exacerbates this condition and that there may be a relationship between intrauterine fetal growth retardation and maternal preeclampsia. In addition, there are several anesthetic implications that are concern for the patient with obstructive sleep apnea. These include: exquisite sensitivity to all central nervous system depressant drugs and the potential for upper airway obstruction or apnea with even minimal drug doses; difficult mask ventilation; difficult intubation; arterial hypoxemia; arterial hypercarbia; polycythemia; hypertension; pulmonary hypertension and cardiac failure. All of these conditions pose significant anesthetic risk for the patient, and this risk may be increased further by pregnancy.

Conditions

Obstructive Sleep Apnea; Pregnancy

Keywords

Obstructive Sleep Apnea; Pregnancy; Berlin Questionnaire

Outcome Measures

Primary Outcomes (1)

• Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing

  The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive.

  1-2 minutes

Secondary Outcomes (1)

• Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires

  1-2minutes

Study Arms (2)

Pregnant population

The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.

Procedure: Survey: Berlin questionnaire

Non-Pregnant Population

The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery

Procedure: Survey: Berlin questionnaire

Interventions

Survey: Berlin questionnaire PROCEDURE

Completion of questionnaire

Non-Pregnant Population; Pregnant population

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant females spontaneously laboring, scheduled for induction of labor or scheduled for a cesarean delivery, and non-pregnant females presenting for outpatient surgery between the ages of 18-45.

You may qualify if:

• Pregnant Females
• years of age and older
• scheduled induction of labor
• spontaneously laboring
• scheduled cesarean delivery
• Nonpregnant Females
• years of age or older
• presenting to the PWH OR for gynecologic surgery
• presenting to the NMH Ambulatory Surgery Center for ambulatory surgery

You may not qualify if:

• patient refusal
• patient age \> 45 years old
• inability to understand the English language
• patient presenting for an emergency procedure

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (4)

• Roush SF, Bell L. Obstructive sleep apnea in pregnancy. J Am Board Fam Pract. 2004 Jul-Aug;17(4):292-4. doi: 10.3122/jabfm.17.4.292.

  PMID: 15243018 BACKGROUND

• Young T, Peppard PE, Gottlieb DJ. Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med. 2002 May 1;165(9):1217-39. doi: 10.1164/rccm.2109080.

  PMID: 11991871 BACKGROUND

• Guilleminault C, Kreutzer M, Chang JL. Pregnancy, sleep disordered breathing and treatment with nasal continuous positive airway pressure. Sleep Med. 2004 Jan;5(1):43-51. doi: 10.1016/j.sleep.2003.07.001.

  PMID: 14725826 BACKGROUND

• Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.

  PMID: 10507956 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

The Berlin questionnaire has not been validated as a screening tool in pregnancy.

Results Point of Contact

• Title: Dr. Robert J. McCarthy
• Organization: Northwestern University Feinberg School of Medicine

r-mccarthy@northwestern.edu

312-926-9015

Study Officials

• Cynthia A Wong, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 19, 2007
• Study Start: September 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 14, 2014
• Results First Posted: May 25, 2011

Record last verified: 2014-03

Locations

US (1)