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Determination of the Predictors of Nocturnal Desaturation in Postpartum Women

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ClinicalTrials.gov Identifier: NCT02330055
Recruitment Status : Completed
First Posted : January 1, 2015
Results First Posted : April 9, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, MD PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sleep Disordered Breathing
Nocturnal Oxygen Desaturation
Upper Airway Edema
Interventions Procedure: Forty-five degrees elevated upper body position
Procedure: non-elevated upper body position
Device: Noninvasive wrist pulse oximeter (WristOx Model 3150)
Other: Stop-Bang questionnaire
Other: Epworth Sleepiness Scale
Other: P-SAP Score
Other: self-reported pain
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Period Title: Overall Study
Started 50 49
Completed 40 40
Not Completed 10 9
Reason Not Completed
technical issues             2             0
participant forgot to wear device             5             5
data for less than 60 minutes             3             3
participant did not sleep             0             1
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position Total
Hide Arm/Group Description

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
34.5  (5.5) 32.5  (5) 33  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
40
 100.0%
40
 100.0%
80
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Hispanic or Latino
6
  15.0%
4
  10.0%
10
  12.5%
Not Hispanic or Latino
31
  77.5%
32
  80.0%
63
  78.8%
Unknown or Not Reported
3
   7.5%
4
  10.0%
7
   8.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
  10.0%
2
   5.0%
6
   7.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.5%
2
   5.0%
5
   6.3%
White
25
  62.5%
32
  80.0%
57
  71.3%
More than one race
0
   0.0%
1
   2.5%
1
   1.3%
Unknown or Not Reported
8
  20.0%
3
   7.5%
11
  13.8%
Delivery Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Vaginal
20
  50.0%
20
  50.0%
40
  50.0%
Cesarean section
20
  50.0%
20
  50.0%
40
  50.0%
1.Primary Outcome
Title SpO2 < 90%
Hide Description Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
Time Frame 48 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description:

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Overall Number of Participants Analyzed 40 40
Median (Inter-Quartile Range)
Unit of Measure: minutes
All Types of Delivery
0.4
(0.0 to 6.4)
0.0
(0.0 to 0.5)
Vaginal Delivery
0.1
(0.0 to 0.3)
0.0
(0.0 to 0.1)
Cesarean Section
4.1
(0.9 to 19.8)
0.2
(0.0 to 1.8)
2.Secondary Outcome
Title Oxygen Desaturation Index > 3
Hide Description ODI (oxygen desaturation index), assessed by pulse oximetry during the first night after delivery. ODI is defined as number of desaturation events per hour; a desaturation event is defined as drop in SpO2 of 3% or more from baseline SpO2. Baseline SpO2 is defined as the mean SpO2 of the SpO2 values taken over the preceding 120 seconds.
Time Frame 48 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description:

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Overall Number of Participants Analyzed 50 49
Median (Inter-Quartile Range)
Unit of Measure: 1/hr
4.0
(2.6 to 6.5)
3.2
(2.2 to 5.8)
3.Secondary Outcome
Title Minimal & Mean SpO2
Hide Description Basic pulseoximetry in the first night after delivery
Time Frame 48 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description:

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Overall Number of Participants Analyzed 40 40
Median (Inter-Quartile Range)
Unit of Measure: percentage of hemoglobin in the blood
Basal (Mean) SPO2
94.7
(93.4 to 95.4)
95.2
(94.5 to 96.1)
Nadir (Minimum) SPO2
87
(82 to 90)
90
(87 to 92)
4.Secondary Outcome
Title P-SAP Score
Hide Description A Perioperative sleep apnea prediction (P-SAP) Score. This score ranges from 0 to 69, 0 representing low risk of obstructive sleep apnea and 69 representing high risk of obstructive sleep apnea.
Time Frame 48 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed per row differs from the overall number because the analysis was distinguished down by type of delivery and upper body position. Thus, 20 patients belong to each group as seen below.
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description:

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Overall Number of Participants Analyzed 40 40
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Vaginal Delivery Number Analyzed 20 participants 20 participants
1
(1 to 2)
1
(0 to 2)
Cesarean Section Number Analyzed 20 participants 20 participants
2
(2 to 3)
2
(1 to 3)
5.Secondary Outcome
Title STOP-BANG Score
Hide Description The STOP BANG (This abbreviation consists of the first letter of each question in the questionnaire. S-Snore, T-Tired, O-Observed stop in breathing, P-High blood pressure, B-BMI, A - Age, N-Neck circumference, G-Gender. This questionnaire is a proven tool that can be used to screen for obstructive sleep apnea (OSA). This tool will assess if you are low, moderate or high risk group for sleep apnea. Scores range from 0-8. 0 indicates low risk for sleep apnea, 8 indicates high risk for sleep apnea.
Time Frame 48 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description:

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Overall Number of Participants Analyzed 40 40
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Vaginal Delivery
1
(0 to 1)
1
(0 to 1)
Cesarean Section
1
(1 to 2)
2
(1 to 2)
6.Secondary Outcome
Title Pain-score on a Verbal Numerical Rating Scale
Hide Description Assessment of intensity of acute pain. Measured from 0-10, 0 being no pain and 10 being highest level of pain.
Time Frame 48 hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description:

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Overall Number of Participants Analyzed 40 40
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
Vaginal Delivery
3
(1 to 4)
3
(2 to 5)
Cesarean Section
4
(2 to 6)
4
(3 to 6)
7.Secondary Outcome
Title Average Pulse Rate
Hide Description As measured in beats per minute
Time Frame 48 Hours after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description:

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

Overall Number of Participants Analyzed 40 40
Median (Inter-Quartile Range)
Unit of Measure: beats per minute
78.8
(69.9 to 86.1)
75.2
(68.6 to 87.3)
Time Frame Adverse event data were collected 48 hours after delivery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Hide Arm/Group Description

If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire

If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events.

The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Forty-five degrees elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150): The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.

Stop-Bang questionnaire: The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.

All-Cause Mortality
Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/49 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/49 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-elevated Upper Body Position Forty-five Degrees Elevated Upper Body Position
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/49 (0.00%) 
The true prevalence of pregnancy-associated OSA is unknown in our cohort due to lack of diagnosis by polysomnography. We obtained questionnaires validated as OSA screening tools, but their ability to predict OSA in pregnancy remains controversial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Matthias Eikermann
Organization: Beth Israel Deaconess Medical Center
Phone: 6176673364
Responsible Party: Matthias Eikermann, MD PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02330055     History of Changes
Other Study ID Numbers: 2011P001326B
First Submitted: December 23, 2014
First Posted: January 1, 2015
Results First Submitted: January 19, 2018
Results First Posted: April 9, 2018
Last Update Posted: July 6, 2018