N/A
N=99
Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
Sleep Disordered Breathing · Nocturnal Oxygen Desaturation · Upper Airway Edema
Bottom Line
View on ClinicalTrials.gov: NCT02330055 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: SpO2 < 90% — 0.4; 0.0; 0.1; 0.0 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Forty-five degrees elevated upper body position (Procedure); non-elevated upper body position (Procedure); Noninvasive wrist pulse oximeter (WristOx Model 3150) (Device); Stop-Bang questionnaire (Other); Epworth Sleepiness Scale (Other); P-SAP Score (Other); self-reported pain (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SpO2 < 90% |
0.4; 0.0; 0.1; 0.0; 4.1; 0.2 | — |
| SECONDARY Oxygen Desaturation Index > 3 |
4.0; 3.2 | — |
| SECONDARY Minimal & Mean SpO2 |
94.7; 95.2; 87; 90 | — |
| SECONDARY P-SAP Score |
1; 1; 2; 2 | — |
| SECONDARY STOP-BANG Score |
1; 1; 1; 2 | — |
| SECONDARY Pain-score on a Verbal Numerical Rating Scale |
3; 3; 4; 4 | — |
| SECONDARY Average Pulse Rate |
78.8; 75.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02330055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.