Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women

Study Overview
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Brief Summary
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Cesarean section is the most common surgical procedure performed on women. Over the years minor variations of each surgical step have been introduced, and cesarean sections are not standardized and many different techniques are employed during surgery. Creation of a bladder flap has been an integral surgical step of the cesarean section for many years. The role of the bladder flap and its usefulness in cesarean section is not known well. Further, in some cases the bladder flap is omitted during cesarean section. The aim of the current study is to compare operating time and postoperative urinary symptoms in cesarean sections using either bladder flap or omission of flap.

Detailed Description
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Cesarean section is the most common surgical procedure performed on women. The main aspects of the surgical approach to low-transverse cesarean delivery have not changed much since1926. Over the years minor variations of each surgical step have been introduced, and cesarean sections are not standardized and many different techniques are employed during surgery. Creation of a bladder flap has been an integral surgical step of the cesarean section for many years. The evidence on the role of the bladder flap and its usefulness in cesarean section is very limited. In emergent cesarean sections where rapid delivery is the main goal, the bladder flap is usually omitted. Literature about the usefulness of a bladder flap is limited and more randomized studies are needed. Most of the study outcomes were focusing operating time however, the investigator in the current study additional focused on postoperative urinary symptoms and dynamics. The aim of the current study is to compare operating time and postoperative urinary symptoms in cesarean sections using either bladder flap or omission of flap.

Official Title
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A Randomized Trial Comparing Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women

Conditions
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Cesarean Section

Intervention / Treatment
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* Procedure: Bladder flap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primiparous women >37 weeks without high-risk pregnancy Exclusion Criteria: presence of microbiologically confirmed urinary tract infection before delivery, twin pregnancies, cervical dilatation at admission ≥4 cm, estimated fetal weight>4000 gr, history of previous abdominal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Bladder Flap group<br>Routine uterine incision performed during cesarean section without incision and dissection of the bladder peritoneum. | |
| Active Comparator: Bladder Flap group<br>Routine uterine incision performed during cesarean section with an incision and a dissection of a bladder flap. | Procedure: Bladder flap<br>* Performing uterine incision and cesarean section with a bladder flap.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total operation time | Total operation time from skin incision to the end of operation | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated blood loss | Estimated blood loss during surgery will be measured in terms of mL | 1 hour | 
| Bladder injury | Bladder injury during cesarean section will be assessed by the number and percentage of patients who had injury | up to 48 hour | 
| Urinary retention | Postoperative urinary retention will be measured by number and percentage of patients who develop this complication | up to 48 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, operating time, bladder, urinary retention