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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: Completed NA study of Pregnancy and Obese, sponsored by St. Louis University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
We will compare the number of patients with wound infections or disruptions when the Alexis O C-Section retractor is used vs when it is not used.
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 |
What the finished NCT01826604 record still lists
NCT01826604 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (65% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01826604's enrollment target sits among peer trials
301 67th of 191 higher than 125 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy 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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