Obstructive Sleep Apnea, Pregnancy
Conditions
Keywords
Obstructive Sleep Apnea, Pregnancy, Berlin Questionnaire
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.
Interventions
PROCEDURESurvey: Berlin questionnaire
Completion of questionnaire
Sponsors
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing | 1-2 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires | 1-2minutes | 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. |
Countries
United States
Participant flow
Recruitment details
We compared Berlin Questionnaire scores between pregnant and nonpregnant females between October 2005 through September 2007. The study group consisted of pregnant women presenting to Prentice Women's Hospital and non-pregnant females (control group) presenting to Northwestern Memorial Hospital for ambulatory surgery.
Pre-assignment details
An anesthesia team member used a standard verbal consent script to obtain verbal consent for study participation. 4074 parturients and 503 non-pregnant women completed the Berlin Questionnaire. 13 of the non-pregnant patient questionnaires were excluded due to insufficient data.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4,074 |
| Non-Pregnant Population The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery | 503 |
| Total | 4,577 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | insufficient data | 0 | 13 |
Baseline characteristics
| Characteristic | Pregnant Population | Non-Pregnant Population | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4074 Participants | 503 Participants | 4577 Participants |
| Region of Enrollment United States | 4074 participants | 503 participants | 4577 participants |
| Sex: Female, Male Female | 4074 Participants | 503 Participants | 4577 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4,074 | 0 / 503 |
| serious Total, serious adverse events | 0 / 4,074 | 0 / 503 |
Outcome results
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.
Time frame: 1-2 minutes
Population: Pregnant Women presenting to Prentice Women's Hospital or non-pregnant women or childbearing age presenting for ambulatory surgery from 10/2005 to 9/2007 were selected randomly and asked to complete the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women | Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing | 1343 participants |
| Non-Pregnant Women | Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing | 96 participants |
Comparison: We hypothesized that the rate of positive Berlin questionnaires would be higher in pregnant women compared to age matched controls undergoing surgery.p-value: 0.001Chi-squared, Corrected
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.
Time frame: 1-2minutes
Population: Analysis per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women | Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires | 135 participants |
| Non-Pregnant Women | Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires | 49 participants |
p-value: 0.01Chi-squared, Corrected