The Bladder Flap at Cesarean Section: A Randomized Controlled Trial

Completed · Not applicable

Conditions studied: Cesarean Section

In brief

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.

Key facts

Study ID

NCT00918996

Run by

Washington University School of Medicine

People needed

258

Starts

2010-03-01

Expected to finish

2011-09-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing non-emergent primary and repeat cesarean sections at or greater than 32 weeks gestation at Barnes Jewish Hospital during the study period.

You may not qualify if…

• Emergent cesarean sections, planned vertical uterine incision, previous abdominal surgeries (besides prior cesarean sections), sedation and inability to obtain consent.

Where it is running

• Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.