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

NCT ID: NCT02977871

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-11-30

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.

Conditions

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Cesarean Section

Keywords

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Cesarean section operating time bladder urinary retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Bladder Flap group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Bladder Flap group

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

Group Type ACTIVE_COMPARATOR

Bladder flap

Intervention Type PROCEDURE

Performing uterine incision and cesarean section with a bladder flap.

Interventions

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Bladder flap

Performing uterine incision and cesarean section with a bladder flap.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Berna Aslan Cetin

Attending Physician, ObGyn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berna Aslan Cetin, MD,ObGyn

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Training and Research Hospital

Locations

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Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 15802429 (View on PubMed)

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

Reference Type RESULT
PMID: 10509303 (View on PubMed)

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.

Reference Type RESULT
PMID: 16260200 (View on PubMed)

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.

Reference Type RESULT
PMID: 19018545 (View on PubMed)

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.

Reference Type RESULT
PMID: 24411951 (View on PubMed)

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.

Reference Type RESULT
PMID: 22395144 (View on PubMed)

Other Identifiers

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1828

Identifier Type: -

Identifier Source: org_study_id