Determination of the Predictors of Nocturnal Desaturation in Postpartum Women

Sleep Disordered Breathing Clinical Trial

Official title:

Determination of the Predictors of Nocturnal Desaturation in Postpartum Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330055
• Other study ID #: 2011P001326B
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: June 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of the study is to evaluate the effect of the method of delivery (vaginal delivery vs. cesarean section) on oxygen saturation in the first postpartum night. The investigators hypothesize that nocturnal desaturation occurs more frequently in cesarean section compared with vaginal delivery, expressed as either the duration of SpO2 below 90% or the Oxygen Desaturation Index (ODI). The ODI is defined as number of oxygen desaturations by at least 3 % per hour. Furthermore, the investigators expect a higher pulse rate and a lower mean and minimum SpO2 in the cesarean section group compared with the vaginal delivery group.

The secondary aim of the study is to investigate how the upper body position during sleep (45 degree elevated vs. non-elevated) affects the oxygen saturation during the first postpartum night.

The investigators hypothesize that an upper body elevation to 45 degrees decreases the incidence of desaturation events, expressed as either the duration of SpO2 below 90% or the ODI , compared with a non-elevated body position within each delivery group (vaginal delivery or cesarean section).

The third aim of the study is to identify independent predictors of nocturnal desaturation in postpartum women. To that end, the investigators will administer questionnaires and collect demographic and clinical data according to various obstructive sleep apnea screening scores, including the P-SAP, STOP-Bang, and Epworth Sleepiness Scale. The investigators will also ask the patient to rate the pain during the study night on a verbal numerical rating scale.

Description:

Sleep-disordered breathing is common in pregnancy, persisting into the early postpartum period. Postpartum airway obstruction is a main cause of anesthesia-related maternal death in North America. Upper airway edema following labor and delivery may impair pharyngeal anatomy, which can lead to increased vulnerability of the airway collapse during sleep.

This study evaluates whether the kind of delivery (vaginal birth versus cesarean section) has an effect on nocturnal desaturation in the first night after delivery. Furthermore, the investigators examine if the upper body position during sleep has an effect on the occurrence of oxygen desaturation.

In addition, the investigators evaluate if preexisting conditions, as indicated by a high P-SAP or STOP-Bang-score increase the likelihood of nocturnal desaturation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Postpartum mothers within 24 hours of delivery

• Age over 18 years.

• Admitted to the Massachusetts General Hospital OB service for the delivery.

• Interventions will be randomly assigned to the patients enrolled in this study

Exclusion Criteria:

• 1 Age under 18 years

Related Conditions & MeSH terms

• Nocturnal Oxygen Desaturation
• Sleep Disordered Breathing
• Upper Airway Edema

Intervention

Procedure:
• Forty-five degrees elevated upper body position

• non-elevated upper body position

Device:
• 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.

Other:
• 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 includes snoring, tiredness, observed apneas, blood pressure, Body Mass Index, age, neck circumference and gender. The investigators will ask the patient to answer the questionnaire and measure the neck circumference.
• Epworth Sleepiness Scale
The Epworth Sleepiness Scale is a well-established clinical tool to quantify daytime sleepiness. It is clinically used for the diagnosis of sleep disorders. The investigators will ask the patient to complete the questionnaire and will specify that the questionnaire pertains to the patient's pre-admission condition.
• P-SAP Score
The P-SAP Score is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The investigators will ask the patient to answer the questionnaire and will assess the Mallampati Score. The investigators will also measure the neck circumference and the Thyromental distance.
• self-reported pain
A verbal numerical rating scale is used to asses the pain during the study-night.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 < 90%	Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery	48 hours after delivery
Secondary	Oxygen Desaturation Index > 3	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.	48 hours after delivery
Secondary	Minimal & Mean SpO2	Basic pulseoximetry in the first night after delivery	48 hours after delivery
Secondary	P-SAP Score	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.	48 hours after delivery
Secondary	STOP-BANG Score	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.	48 hours after delivery
Secondary	Pain-score on a Verbal Numerical Rating Scale	Assessment of intensity of acute pain. Measured from 0-10, 0 being no pain and 10 being highest level of pain.	48 hours after delivery
Secondary	Average Pulse Rate	As measured in beats per minute	48 Hours after delivery