Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02330055 · ClinicalTrials.gov registry record · NA
Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 99
- Enrollment target
NCT02330055: Completed NA study, sponsored by Massachusetts General Hospital.
NCT02330055 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 99 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02330055, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 99 participants
- Enrollment target
Study 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.
Interventions
- OTHER Epworth Sleepiness Scale
- PROCEDURE Forty-five degrees elevated upper body position
- PROCEDURE non-elevated upper body position
- DEVICE Noninvasive wrist pulse oximeter (WristOx Model 3150)
- OTHER Stop-Bang questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02330055
The ClinicalTrials.gov registry entry for NCT02330055 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Epworth Sleepiness Scale is the first listed.
NCT02330055 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02330055 about?
NCT02330055 is a clinical study titled "Determination of the Predictors of Nocturnal Desaturation in Postpartum Women". 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 deli...
What is the current status of trial NCT02330055?
This trial is currently completed. It is a NA study. The enrollment target is 99 participants. The study started on 2014-05. Estimated completion is 2017-12.
What interventions are being tested in trial NCT02330055?
The interventions under investigation include: Epworth Sleepiness Scale (OTHER), 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).
Who is sponsoring clinical trial NCT02330055?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.