Incidence of Obstructive Sleep Apnea in Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incidence of Obstructive Sleep Apnea in Pregnancy

Conditions
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Obstructive Sleep Apnea, Pregnancy

Intervention / Treatment
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* Procedure: Survey: Berlin questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant Females 18 years of age and older scheduled induction of labor spontaneously laboring scheduled cesarean delivery Nonpregnant Females 18 years of age or older presenting to the PWH OR for gynecologic surgery 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant population<br>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<br>* Completion of questionnaire<br>|
| Non-Pregnant Population<br>The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery | Procedure: Survey: Berlin questionnaire<br>* Completion of questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Pregnancy, Berlin Questionnaire