Trial · NCT00462306
Incidence of Obstructive Sleep Apnea in Pregnancy
NCT00462306, Completed, Northwestern University; results first posted 2011-05-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Incidence of Obstructive Sleep Apnea in Pregnancy. Trials, record NCT00462306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00462306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Incidence of Obstructive Sleep Apnea in Pregnancy
- NCT number
- NCT00462306
- Status
- Completed
- Enrollment
- 4,577 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Obstructive Sleep Apnea, Pregnancy
- Interventions
- Survey: Berlin questionnaire
- First posted
- 2007-04-19
- Last updated
- 2014-04-14
- Results first posted
- 2011-05-25
- Limitations and caveats
- The Berlin questionnaire has not been validated as a screening tool in pregnancy.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing | 1-2 minutes | 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. | participants | NUMBER |
| SECONDARY | Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires | 1-2minutes | Analysis per protocol | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing | Pregnant Women | 1343 | participants | ||
| Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing | Non-Pregnant Women | 96 | participants | ||
| Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires | Positive Berlin Questionaires | 135 | participants | ||
| Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires | Negative Berlin Questionnaires | 49 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregnant Population | 4,074 | |
| Overall Study | STARTED | Non-Pregnant Population | 503 | |
| Overall Study | COMPLETED | Pregnant Population | 4,074 | |
| Overall Study | COMPLETED | Non-Pregnant Population | 490 | |
| Overall Study | NOT COMPLETED | Pregnant Population | 0 | |
| Overall Study | NOT COMPLETED | Non-Pregnant Population | 13 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregnant Population | ||
| Total, all-cause mortality | Non-Pregnant Population | ||
| Total, other adverse events | Pregnant Population | 0 | 4,074 |
| Total, other adverse events | Non-Pregnant Population | 0 | 503 |
| Total, serious adverse events | Pregnant Population | 0 | 4,074 |
| Total, serious adverse events | Non-Pregnant Population | 0 | 503 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pregnant Women vs Non-Pregnant Women: Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing | Trial comparisons |
| Positive Berlin Questionaires vs Negative Berlin Questionnaires: Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires | Trial comparisons |
| Pregnant Population vs Non-Pregnant Population: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00462306
GET https://conductscience.org/api/trials/v1/NCT00462306/registered