Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-26 @ 5:19 PM
Study NCT ID:
NCT00462306
Status:
COMPLETED
Last Update Posted:
2014-04-14
First Post:
2007-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Incidence of Obstructive Sleep Apnea in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'r-mccarthy@northwestern.edu', 'phone': '312-926-9015', 'title': 'Dr. Robert J. McCarthy', 'organization': 'Northwestern University Feinberg School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The Berlin questionnaire has not been validated as a screening tool in pregnancy.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pregnant Population', 'description': "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.", 'otherNumAtRisk': 4074, 'otherNumAffected': 0, 'seriousNumAtRisk': 4074, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-Pregnant Population', 'description': 'The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery', 'otherNumAtRisk': 503, 'otherNumAffected': 0, 'seriousNumAtRisk': 503, 'seriousNumAffected': 0}], 'frequencyThreshold': '0.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4074', 'groupId': 'OG000'}, {'value': '503', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pregnant Women'}, {'id': 'OG001', 'title': 'Non-Pregnant Women', 'description': 'Non-pregnant women undergoing a surgical procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '1343', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': '4000 parturients and 500 non-pregnant achieves 90% power to detect a difference of 3% positive Berlin Questionnaire rates between pregnant and non-pregnant women using a two sided chi squared test at a significance level of 0.05', 'groupDescription': 'We hypothesized that the rate of positive Berlin questionnaires would be higher in pregnant women compared to age matched controls undergoing surgery.', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1-2 minutes', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "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."}, {'type': 'SECONDARY', 'title': 'Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1343', 'groupId': 'OG000'}, {'value': '2731', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Positive Berlin Questionaires', 'description': 'Pregnant Women with Berlin Questionnaire Responses Indicative of Sleep Disordered Breathing'}, {'id': 'OG001', 'title': 'Negative Berlin Questionnaires', 'description': 'Pregnant Women with Results of Berlin Questionnaire not Indicative of Sleep Disordered Breathing'}], 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared, Corrected', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1-2minutes', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis per protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregnant Population', 'description': "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."}, {'id': 'FG001', 'title': 'Non-Pregnant Population', 'description': 'The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4074'}, {'groupId': 'FG001', 'numSubjects': '503'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4074'}, {'groupId': 'FG001', 'numSubjects': '490'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'insufficient data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'recruitmentDetails': "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.", 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4074', 'groupId': 'BG000'}, {'value': '503', 'groupId': 'BG001'}, {'value': '4577', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pregnant Population', 'description': "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."}, {'id': 'BG001', 'title': 'Non-Pregnant Population', 'description': 'The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4074', 'groupId': 'BG000'}, {'value': '503', 'groupId': 'BG001'}, {'value': '4577', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4074', 'groupId': 'BG000'}, {'value': '503', 'groupId': 'BG001'}, {'value': '4577', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4074', 'groupId': 'BG000'}, {'value': '503', 'groupId': 'BG001'}, {'value': '4577', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4577}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2007-04-17', 'resultsFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2007-04-18', 'lastUpdatePostDateStruct': {'date': '2014-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-25', 'studyFirstPostDateStruct': {'date': '2007-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing', 'timeFrame': '1-2 minutes', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires', 'timeFrame': '1-2minutes', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Pregnancy', 'Berlin Questionnaire'], 'conditions': ['Obstructive Sleep Apnea', 'Pregnancy']}, 'referencesModule': {'references': [{'pmid': '15243018', 'type': 'BACKGROUND', '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.'}, {'pmid': '11991871', 'type': 'BACKGROUND', '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.'}, {'pmid': '14725826', 'type': 'BACKGROUND', '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.'}, {'pmid': '10507956', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nAll 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant Females\n\n 1. 18 years of age and older\n 2. scheduled induction of labor\n 3. spontaneously laboring\n 4. scheduled cesarean delivery\n* Nonpregnant Females\n\n 1. 18 years of age or older\n 2. presenting to the PWH OR for gynecologic surgery\n 3. presenting to the NMH Ambulatory Surgery Center for ambulatory surgery\n\nExclusion Criteria:\n\n* patient refusal\n* patient age \\> 45 years old\n* inability to understand the English language\n* patient presenting for an emergency procedure'}, 'identificationModule': {'nctId': 'NCT00462306', 'acronym': 'OSA', 'briefTitle': 'Incidence of Obstructive Sleep Apnea in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Incidence of Obstructive Sleep Apnea in Pregnancy', 'orgStudyIdInfo': {'id': '0524-026'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant population', 'description': "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.", 'interventionNames': ['Procedure: Survey: Berlin questionnaire']}, {'label': 'Non-Pregnant Population', 'description': 'The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery', 'interventionNames': ['Procedure: Survey: Berlin questionnaire']}], 'interventions': [{'name': 'Survey: Berlin questionnaire', 'type': 'PROCEDURE', 'description': 'Completion of questionnaire', 'armGroupLabels': ['Non-Pregnant Population', 'Pregnant population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Cynthia A Wong, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Cynthia Wong', 'investigatorAffiliation': 'Northwestern University'}}}}