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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977871
• Other study ID #: 1828
• Status: Completed
• Phase: N/A
• First received: November 21, 2016
• Last updated: November 30, 2016
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Procedure:
• Bladder flap
Performing uterine incision and cesarean section with a bladder flap.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. Review. — View Citation

Mahajan NN. Justifying formation of bladder flap at cesarean section? Arch Gynecol Obstet. 2009 Jun;279(6):853-5. doi: 10.1007/s00404-008-0838-6. Review. — View Citation

O'Neill HA, Egan G, Walsh CA, Cotter AM, Walsh SR. Omission of the bladder flap at caesarean section reduces delivery time without increased morbidity: a meta-analysis of randomised controlled trials. Eur J Obstet Gynecol Reprod Biol. 2014 Mar;174:20-6. d — View Citation

Pelosi MA 2nd, Pelosi MA 3rd. Risk factors for bladder injury during cesarean delivery. Obstet Gynecol. 2005 Apr;105(4):900; author reply 901. — View Citation

Tuuli MG, Odibo AO, Fogertey P, Roehl K, Stamilio D, Macones GA. Utility of the bladder flap at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2012 Apr;119(4):815-21. doi: 10.1097/AOG.0b013e31824c0e12. — View Citation

Wood RM, Simon H, Oz AU. Pelosi-type vs. traditional cesarean delivery. A prospective comparison. J Reprod Med. 1999 Sep;44(9):788-95. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total operation time	Total operation time from skin incision to the end of operation	1 hour	No
Secondary	Estimated blood loss	Estimated blood loss during surgery will be measured in terms of mL	1 hour	Yes
Secondary	Bladder injury	Bladder injury during cesarean section will be assessed by the number and percentage of patients who had injury	up to 48 hour	Yes
Secondary	Urinary retention	Postoperative urinary retention will be measured by number and percentage of patients who develop this complication	up to 48 hour	Yes