The Bladder Flap at Cesarean Section: A Randomized Controlled Trial
Public ClinicalTrials.gov record NCT00918996. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
The Bladder Flap at Cesarean Delivery: Establishing Evidence for Practice
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 hypothesize that omission of the bladder flap in both primary and repeat cesarean sections will be associated with shorter operating time without a significant increase in intraoperative and postoperative complications.
Study identification
- NCT ID
- NCT00918996
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 258 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 42 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2010
- Primary completion
- Apr 30, 2011
- Completion
- Aug 31, 2011
- Last update posted
- Oct 8, 2015
2010 – 2011
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00918996, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2015 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00918996 live on ClinicalTrials.gov.