Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

May 1, 2014

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed

9 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed

10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

4 months until next milestone

Results Posted

Study results publicly available

April 9, 2018

Completed

Last Updated

July 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

December 23, 2014

Results QC Date

January 19, 2018

Last Update Submit

June 8, 2018

Conditions

Sleep Disordered Breathing Nocturnal Oxygen Desaturation Upper Airway Edema

Outcome Measures

Primary Outcomes (1)

SpO2 < 90%
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
48 hours after delivery

Secondary Outcomes (6)

Oxygen Desaturation Index > 3
48 hours after delivery
Minimal & Mean SpO2
48 hours after delivery
P-SAP Score
48 hours after delivery
STOP-BANG Score
48 hours after delivery
Pain-score on a Verbal Numerical Rating Scale
48 hours after delivery
+1 more secondary outcomes

Study Arms (2)

Forty-five degrees elevated upper body position

ACTIVE COMPARATOR

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.

Procedure: Forty-five degrees elevated upper body positionDevice: Noninvasive wrist pulse oximeter (WristOx Model 3150)Other: Stop-Bang questionnaireOther: Epworth Sleepiness ScaleOther: P-SAP ScoreOther: self-reported pain

Non-elevated upper body position

PLACEBO COMPARATOR

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.

Procedure: non-elevated upper body positionDevice: Noninvasive wrist pulse oximeter (WristOx Model 3150)Other: Stop-Bang questionnaireOther: Epworth Sleepiness ScaleOther: P-SAP ScoreOther: self-reported pain

Interventions

Forty-five degrees elevated upper body positionPROCEDURE

Forty-five degrees elevated upper body position

non-elevated upper body positionPROCEDURE

Non-elevated upper body position

Noninvasive wrist pulse oximeter (WristOx Model 3150)DEVICE

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.