Determination of the Predictors of Nocturnal Desaturation in Postpartum Women

Mass General Brigham

Status: Completed

Conditions: Sleep Disordered Breathing; Upper Airway Edema; Nocturnal Oxygen Desaturation

Treatments: Device: Noninvasive wrist pulse oximeter (WristOx Model 3150); Other: self-reported pain; Procedure: non-elevated upper body position; Other: P-SAP Score; Other: Stop-Bang questionnaire; Other: Epworth Sleepiness Scale; Procedure: Forty-five degrees elevated upper body position

Study type: Interventional

Funder types: Other

Identifiers

NCT02330055

2011P001326B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups, including a placebo group

Forty-five degrees elevated upper body position

Active Comparator group

Description:

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.

Treatment:

Procedure: Forty-five degrees elevated upper body position

Other: Stop-Bang questionnaire

Other: self-reported pain

Other: P-SAP Score

Other: Epworth Sleepiness Scale

Device: Noninvasive wrist pulse oximeter (WristOx Model 3150)

Non-elevated upper body position

Placebo Comparator 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.

Treatment:

Other: Stop-Bang questionnaire

Other: self-reported pain

Procedure: non-elevated upper body position

Other: P-SAP Score

Other: Epworth Sleepiness Scale

Device: Noninvasive wrist pulse oximeter (WristOx Model 3150)