Determination of the Predictors of Nocturnal Desaturation in Postpartum Women



Status:Completed
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 55
Updated:7/8/2018
Start Date:May 2014
End Date:December 2017

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials