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Completed

NCT Number: NCT02977871

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, 34303, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bladder flap

Procedure

Performing uterine incision and cesarean section with a bladder flap.

Primary outcomes

  1. Total operation time

    Time frame: 1 hour

    Total operation time from skin incision to the end of operation

Secondary outcomes

  1. Estimated blood loss

    Time frame: 1 hour

    Estimated blood loss during surgery will be measured in terms of mL

  2. Bladder injury

    Time frame: up to 48 hour

    Bladder injury during cesarean section will be assessed by the number and percentage of patients who had injury

  3. Urinary retention

    Time frame: up to 48 hour

    Postoperative urinary retention will be measured by number and percentage of patients who develop this complication

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 30, 2016
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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