Obstructive Sleep ApneaOSANCT00462306
Incidence of Obstructive Sleep Apnea in Pregnancy
An observational study of Obstructive Sleep Apnea and Pregnancy, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Pregnancy
- What is being tested?
- Survey: Berlin questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 4,577 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- Pregnant Females
- 18 years of age and older
- scheduled induction of labor
- spontaneously laboring
- scheduled cesarean delivery
- Nonpregnant Females
Show all 9Show fewer
- 18 years of age or older
- presenting to the PWH OR for gynecologic surgery
- presenting to the NMH Ambulatory Surgery Center for ambulatory surgery
Who cannot join
- patient refusal
- patient age > 45 years old
- inability to understand the English language
- patient presenting for an emergency procedure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Pregnancy
- Being tested
- Survey: Berlin questionnaire
- Keywords
- Obstructive Sleep Apnea, Pregnancy, Berlin Questionnaire
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey: Berlin questionnaireProcedure or surgery
Completion of questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Survey: Berlin questionnaire | |
| Non-Pregnant Population | The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery Receives: Procedure: Survey: Berlin questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 minutes
Secondary outcomes (1)
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.
Measured: 1-2minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startSep 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,577 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Wong, Northwestern University
- Investigators
- Cynthia A Wong, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462306
- Sponsor's protocol ID
- 0524-026
- Acronym
- OSA
- Status last verified
- Mar 2014
- First submitted
- 17 Apr 2007
- Last updated
- 14 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 15243018Young 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.
PubMed 11991871Guilleminault 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.
PubMed 14725826Netzer 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.
PubMed 10507956
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Obstructive Sleep Apnea in Pregnancy
- ClinicalTrials.gov ID
- NCT00462306
- Acronym / sponsor ID
- OSA / 0524-026
- Conditions
- Obstructive Sleep Apnea, Pregnancy
- Keywords
- Obstructive Sleep Apnea, Pregnancy, Berlin Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,577 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 25 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant population | – | Procedure: Survey: Berlin questionnaireThe 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. |
| Non-Pregnant Population | – | Procedure: Survey: Berlin questionnaireThe study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- Pregnant Females
- Nonpregnant Females
Key exclusion criteria (4 listed)
- patient refusal
- patient age > 45 years old
- inability to understand the English language
- patient presenting for an emergency procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey: Berlin questionnaireCompletion of questionnaire | Procedure or surgery | Non-Pregnant Population, Pregnant population |
Primary outcome
Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing
Time frame: 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.
1 secondary outcome
Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires
Time frame: 1-2minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15243018Roush 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.
- Background: PubMed 11991871Young 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.
- Background: PubMed 14725826Guilleminault 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.
- Background: PubMed 10507956Netzer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia A Wong, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Pregnancy, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing (time frame: 1-2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00462306, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.