Determination of the Predictors of Nocturnal Desaturation in Postpartum Women

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.

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)

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.

OTHER

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.

OTHER

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.

OTHER

self-reported pain

A verbal numerical rating scale is used to asses the pain during the study-night.

Sponsors & Collaborators

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Matthias Eikermann, MD, PhD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2017-02-28

Completion

2017-12-31

Countries

• United States

Study Locations