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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). 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.
Primary Outcome
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
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 |
What the finished NCT02330055 record still lists
NCT02330055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 5 interventions - of which Epworth Sleepiness Scale is the first listed.
NCT02330055 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02330055's enrollment target sits among peer trials
99 920th of 2000 higher than 1,079 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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