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NCT00918996 · ClinicalTrials.gov registry record · NA
The Bladder Flap at Cesarean Section: A Randomized Controlled Trial
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 258
- Enrollment target
NCT00918996 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 258 participants.
The verdict
NCT00918996, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 258 participants
- Enrollment target
Study Summary
Cesarean section is now the most common major surgical procedure performed on women world wide. In the United States, approximately 1 in 4 deliveries is by this method. With the increasing numbers of cesarean sections, there is the need to utilized evidence based techniques to optimize outcomes and minimize complications.Creation of the bladder flap is an integral step of the standard cesarean section. The bladder flap is made by superficially incising and dissecting the peritoneal lining to separate the urinary bladder from the lower uterine segment. Started in the pre-antibiotic era, the rationale for the bladder flap was to enable the surgeon gain access to the lower uterine segment while minimizing injury to the bladder. Its subsequent closure was supposed to protect the peritoneal cavity from intrauterine infection. Since then, closure of the bladder flap has been demonstrated to be unnecessary and has been abandoned. The bladder flap however, continues to be performed without evidence of benefit. Evidence on the role of the bladder flap in cesarean section is very limited. In emergent cesarean sections where rapid delivery is the goal, the bladder flap is commonly omitted. A simplified method of cesarean section (Pelosi-type) including omission of the bladder among other modifications has been shown to be safe and cost saving. The single randomized trial on omission of the bladder flap as the only modification suggests short term benefits including shorter operating times, reduced blood loss and decreased postoperative analgesic requirements. This study has been criticized for evaluating only short term outcomes and including only primary cesarean sections. The paucity of evidence for or against this commonly utilized technique in cesarean section is the rationale for this study. The goal of this study is to employ a well designed randomized controlled clinical trial to evaluate the effects of omitting the bladder flap creation at cesarean section. We hypoth
Interventions
- PROCEDURE Omission of Bladder Flap Creation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00918996
The ClinicalTrials.gov registry entry for NCT00918996 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omission of Bladder Flap Creation is the first listed.
NCT00918996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00918996 about?
NCT00918996 is a clinical study titled "The Bladder Flap at Cesarean Section: A Randomized Controlled Trial". Cesarean section is now the most common major surgical procedure performed on women world wide. In the United States, approximately 1 in 4 deliveries is by this method. With the increasing numbers of cesarean sections, there is the need to utilized evidence based techniques to optimize outcomes and ...
What is the current status of trial NCT00918996?
This trial is currently completed. It is a NA study. The enrollment target is 258 participants. The study started on 2010-03. Estimated completion is 2011-09.
What interventions are being tested in trial NCT00918996?
The interventions under investigation include: Omission of Bladder Flap Creation (PROCEDURE).
Who is sponsoring clinical trial NCT00918996?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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