Trial Outcomes & Findings for Incidence of Obstructive Sleep Apnea in Pregnancy (NCT NCT00462306)
NCT ID: NCT00462306
Last Updated: 2014-04-14
Results Overview
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.
COMPLETED
4577 participants
1-2 minutes
2014-04-14
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Non-Pregnant Population
The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
|
|---|---|---|
|
Overall Study
STARTED
|
4074
|
503
|
|
Overall Study
COMPLETED
|
4074
|
490
|
|
Overall Study
NOT COMPLETED
|
0
|
13
|
Reasons for withdrawal
| Measure |
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.
|
Non-Pregnant Population
The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
|
|---|---|---|
|
Overall Study
insufficient data
|
0
|
13
|
Baseline Characteristics
Incidence of Obstructive Sleep Apnea in Pregnancy
Baseline characteristics by cohort
| Measure |
Pregnant Population
n=4074 Participants
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.
|
Non-Pregnant Population
n=503 Participants
The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
|
Total
n=4577 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4074 Participants
n=5 Participants
|
503 Participants
n=7 Participants
|
4577 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4074 Participants
n=5 Participants
|
503 Participants
n=7 Participants
|
4577 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4074 participants
n=5 Participants
|
503 participants
n=7 Participants
|
4577 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-2 minutesPopulation: 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.
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.
Outcome measures
| Measure |
Pregnant Women
n=4074 Participants
|
Non-Pregnant Women
n=503 Participants
Non-pregnant women undergoing a surgical procedure
|
|---|---|---|
|
Positive Berlin Questionnaire Indicative of Sleep Disordered Breathing
|
1343 participants
|
96 participants
|
SECONDARY outcome
Timeframe: 1-2minutesPopulation: Analysis per protocol
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.
Outcome measures
| Measure |
Pregnant Women
n=1343 Participants
|
Non-Pregnant Women
n=2731 Participants
Non-pregnant women undergoing a surgical procedure
|
|---|---|---|
|
Diagnosis of Pre-eclampsia Among Subjects With Positive Berlin Questionnaires
|
135 participants
|
49 participants
|
Adverse Events
Pregnant Population
Non-Pregnant Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Robert J. McCarthy
Northwestern University Feinberg School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place