N/A
Completed N=4,577
Incidence of Obstructive Sleep Apnea in Pregnancy
Source: ClinicalTrials.gov NCT00462306 ↗Enrolled (actual)
4,577
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing — 1343; 96 participants — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing |
1343; 96 | 0.001 sig |
| SECONDARY Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires |
135; 49 | 0.01 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00462306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.