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CompletedNCT02977871Updated Dec 1, 2016

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

An interventional study of Bladder flap in Cesarean Section, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-01.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

Read the detailed 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.

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Conditions studied

  • Cesarean Section

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Keywords

  • Cesarean section
  • operating time
  • bladder
  • urinary retention
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In context

Urinary Retention

240 studies on the registry are indexed under Urinary Retention; 39 are open to participants now.

This study's enrollment of 201 is above the median of 96 across 188 interventional studies indexed under Urinary Retention.

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Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 224 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • primiparous women >37 weeks without high-risk pregnancy

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
201 participants (actual)

Study arms

  • No intervention
    No Bladder Flap group

    Routine uterine incision performed during cesarean section without incision and dissection of the bladder peritoneum.

  • Active comparator
    Bladder Flap group

    Routine uterine incision performed during cesarean section with an incision and a dissection of a bladder flap.

    Procedure: Bladder flap

Interventions

  • ProcedureBladder flap

    Performing uterine incision and cesarean section with a bladder flap.

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What researchers measure

Primary outcomes

  1. Total operation time

    Total operation time from skin incision to the end of operation

    Time frame: 1 hour

Secondary outcomes

  1. Estimated blood loss

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

    Time frame: 1 hour

  2. Bladder injury

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

    Time frame: up to 48 hour

  3. Urinary retention

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

    Time frame: up to 48 hour

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Study locations

1 site
  • Kanuni Sultan Suleyman Training and Research Hospital
    Istanbul, 34303, Turkey (Türkiye)
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References and documents

Publications

  • Pelosi MA 2nd, Pelosi MA 3rd. Risk factors for bladder injury during cesarean delivery. Obstet Gynecol. 2005 Apr;105(4):900; author reply 901. doi: 10.1097/01.AOG.0000158756.29999.0a. No abstract available. PubMed 15802429 ↗
  • Wood RM, Simon H, Oz AU. Pelosi-type vs. traditional cesarean delivery. A prospective comparison. J Reprod Med. 1999 Sep;44(9):788-95. PubMed 10509303 ↗
  • Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063. PubMed 16260200 ↗
  • 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. Epub 2008 Nov 19. PubMed 19018545 ↗
  • 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. doi: 10.1016/j.ejogrb.2013.12.020. Epub 2013 Dec 22. PubMed 24411951 ↗
  • 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. PubMed 22395144 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02977871
Responsible party
Berna Aslan Cetin (Attending Physician, ObGyn, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Nov 30, 2016
Start date
Jul 2016
Primary completion
Oct 2016
Completion
Nov 2016
Last update
Dec 1, 2016

Study contacts

Berna Aslan Cetin, MD,ObGyn
principal investigator · Kanuni Sultan Suleyman Training and Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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