Clinical trial NCT02330055: Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
Official title: Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Nocturnal Oxygen Desaturation
Upper Airway Edema
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: SpO2 < 90%
timeFrame: 48 hours after delivery
Secondary outcomes:
measure: Oxygen Desaturation Index > 3
timeFrame: 48 hours after delivery
measure: Minimal & Mean SpO2
timeFrame: 48 hours after delivery
measure: P-SAP Score
timeFrame: 48 hours after delivery
measure: STOP-BANG Score
timeFrame: 48 hours after delivery
measure: Pain-score on a Verbal Numerical Rating Scale
timeFrame: 48 hours after delivery
measure: Average Pulse Rate
timeFrame: 48 Hours after delivery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Matthias Eikermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: