Incidence of Obstructive Sleep Apnea in Pregnancy

Pregnancy Clinical Trial

— OSA  

Official title:

Incidence of Obstructive Sleep Apnea in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462306
• Other study ID #: 0524-026
• Status: Completed
• Phase: N/A
• First received: April 17, 2007
• Last updated: March 17, 2014
• Start date: September 2005
• Est. completion date: June 2008

Study information

• Verified date: March 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

All patients presenting to the Prentice Women's Hospital's (PWH) Labor and Delivery Unit for spontaneous labor, induction of labor and scheduled cesarean delivery are routinely interviewed by a member of the anesthesia team to obtain a detailed history and physical examination and to discuss labor analgesia options. Immediately following this usual and customary preanesthetic evaluation the member of the anesthesia team performing the preanesthetic consultation (anesthesiology attending, resident physician, or nurse) used a standard verbal consent script to obtain verbal consent from the subject for study participation. Study participants were asked to complete a written validated survey, the Berlin Questionnaire, evaluating self-reported snoring and daytime sleepiness as well as basic demographic data (age, height, current weight and pregnancy weight gain). Survey completion time was 1 to 2 minutes.

The survey was available in English and Spanish. It did not contain any subject personal health information. The survey sheet remained in the labor and delivery room with the subject's usual anesthesia medical record paperwork until the patient was discharged from the unit. At the time of discharge, the infant's birthweight and APGAR scores were recorded on the survey and the survey collected.

All female patients, ages 18 - 45, presenting to the PWH Operating Room for elective gynecologic surgery, and all female patients, ages 18 - 45, presenting to the Northwestern Memorial Hospital (NMH) Ambulatory Surgery Center were interviewed by a member of the anesthesia team to obtain a routine preoperative history and physical examination and to discuss the anesthesia options. Immediately following this usual and customary preanesthetic evaluation the member of the anesthesia team performing the preanesthetic consultation (anesthesiology attending, resident physician, or certified registered nurse anesthetist) used a standard verbal consent script to obtain verbal consent from the subject for study participation. Study participants were asked to complete a written validated survey, the Berlin Questionnaire, evaluating self-reported snoring and daytime sleepiness as well as basic demographic data (age, height, and weight). The survey was available in English and Spanish. Survey completion time was 1-2 minutes. The survey did not contain any patient identifying information and was collected after completion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4577
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant Females

1. 18 years of age and older

2. scheduled induction of labor

3. spontaneously laboring

4. scheduled cesarean delivery

• Nonpregnant Females

1. 18 years of age or older

2. presenting to the PWH OR for gynecologic surgery

3. presenting to the NMH Ambulatory Surgery Center for ambulatory surgery

Exclusion Criteria:

• patient refusal

• patient age > 45 years old

• inability to understand the English language

• patient presenting for an emergency procedure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Pregnancy
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Survey: Berlin questionnaire
Completion of questionnaire

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

Roush SF, Bell L. Obstructive sleep apnea in pregnancy. J Am Board Fam Pract. 2004 Jul-Aug;17(4):292-4. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires	Number of subjects with obstetrician diagnosis of pregnancy induced hypertension (pre-eclampsia) among subjects with a positive compared to a negative Berlin questionnaire. The Berlin Questionnaire consists of three categories. 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 Positive Berlin Questionnaire if 2 or more categories are positive.	1-2minutes	No