Clinical trial NCT00462306: Incidence of Obstructive Sleep Apnea in Pregnancy
Official title: Incidence of Obstructive Sleep Apnea in Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Pregnancy
Keywords: Obstructive Sleep Apnea
Pregnancy
Berlin Questionnaire
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2007-04-19
Enrollment: 4577
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing
timeFrame: 1-2 minutes
Secondary outcomes:
measure: Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires
timeFrame: 1-2minutes
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Cynthia A Wong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1164/rccm.2109080.
citation: 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.
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. doi: 10.7326/0003-4819-131-7-199910050-00002.