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| Sponsored by: |
Northwestern University |
|---|---|
| Information provided by: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00462306 |
Purpose
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%[1] but the incidence of obstructive sleep apnea in pregnancy is unknown. There is some evidence that pregnancy precipitates or at least exacerbates this condition[2] and that there may be a relationship between intrauterine fetal growth retardation and maternal preeclampsia.[3] 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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Pregnancy |
Procedure: Filling out Berlin questionnaire |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Incidence of Obstructive Sleep Apnea in Pregnancy |
| Estimated Enrollment: | 4500 |
| Study Start Date: | September 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
All patients presenting to the 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 or resident physician or nurse) will use a standard verbal consent script (attached) to obtain verbal consent from the subject for study participation. Study participants will be asked to complete a written validated survey[4] (the Berlin Questionnaire - attached) evaluating self-reported snoring and daytime sleepiness as well as basic demographic data (age, height, current weight and pregnancy weight gain). It is anticipated that the survey will take 1 to 2 min to complete. A study information card will be given to subjects at this time.
The survey will be available in English and Spanish. It will not contain any subject personal health information. The survey sheet will remain in the L&D room with the subject's usual anesthesia medical record paperwork until the patient is discharged from the L&D unit. At the time of discharge, the infant's birthweight and APGAR scores will be recorded on the survey and the survey will be collected.
All female patients, age 18 - 45 years old, presenting to the PWH Operating Room for elective gynecologic surgery, and all female patients, age 18 - 45 y old, presenting the NMH Ambulatory Surgery Center will be 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 or resident physician or certified registered nurse anesthetist) will use a standard verbal consent script (attached) to obtain verbal consent from the subject for study participation. Study participants will be asked to complete a written validated survey[4] (the Berlin Questionnaire - attached) evaluating self-reported snoring and daytime sleepiness as well as basic demographic data (age, height, and weight). The survey will be available in English and Spanish. I t is anticipated that the survey will take 1 to 2 min to complete. This survey will not contain any pt identifying information and will be collected after completion. A study information card will be given to subjects at this time.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pregnant Women
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Cynthia A Wong, M.D. | Northwestern University |
More Information
| Responsible Party: | Northwestern University ( Cynthia A. Wong M.D. ) |
| Study ID Numbers: | 0524-026 |
| Study First Received: | April 17, 2007 |
| Last Updated: | November 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00462306 |
| Health Authority: | United States: Institutional Review Board |
|
Obstructive Sleep Apnea Pregnancy Berlin Questionnaire |
|
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
|
Nervous System Diseases |
