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NCT01826604 · ClinicalTrials.gov registry record · NA
Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section
A NA study of Pregnancy and Obese, sponsored by St. Louis University.
- Completed
- Registry status
- NA
- Development phase
- 301
- Enrollment target
- 1
- Study location
NCT01826604 is a NA study of Pregnancy and Obese that has completed, run by St. Louis University. The registered enrollment target is 301 participants, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01826604, a NA study of Pregnancy and Obese, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- NA
- Development phase
- 301 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to investigate the effects of the Alexis O C-section retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized to the use of the Alexis retractor during Cesarean section (treatment group) or the use of traditional hand-held retractors (control group). We will determine if there is any difference in surgical site infection or wound disruption rates. We will also determine if there is a difference in the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rate between the two groups.
Interventions
- DEVICE Alexis O C-Section Retractor
- OTHER Control- Conventional retractors
Study Locations (1)
Missouri
- St. Mary's Health Center - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01826604
The ClinicalTrials.gov registry entry for NCT01826604 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (65% lower). The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 2 interventions - of which Alexis O C-Section Retractor is the first listed.
NCT01826604 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT01826604 about?
NCT01826604 is a clinical study titled "Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section". The purpose of this study is to investigate the effects of the Alexis O C-section retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized to the use of the Alexis retractor during Cesarean section (treatment group) or the use of traditional hand-held re...
What is the current status of trial NCT01826604?
This trial is currently completed. It is a NA study. The enrollment target is 301 participants. The study started on 2013-01. Estimated completion is 2014-09.
What conditions does trial NCT01826604 study?
This clinical trial studies the following conditions: Pregnancy, Obese.
What interventions are being tested in trial NCT01826604?
The interventions under investigation include: Alexis O C-Section Retractor (DEVICE), Control- Conventional retractors (OTHER).
Who is sponsoring clinical trial NCT01826604?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01826604 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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