A Comparison of Extraperitoneal Versus Transperitoneal Cesarean Section

NCT ID: NCT02479932

Last Updated: 2016-03-15

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

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

Brief Summary

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The aim of study is to compare skin-to-delivery time and postoperative morbidity between extraperitoneal cesarean and transpirational cesarean.

Detailed Description

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Conditions

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Labor Pain

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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Extraperitoneal cesarean

Group Type ACTIVE_COMPARATOR

Extraperitoneal cesarean technique

Intervention Type OTHER

Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry

Transperitoneal cesarean

Group Type ACTIVE_COMPARATOR

Transperitoneal cesarean technique

Intervention Type OTHER

Pfannenstiel-Kerr technique for laparatomy and uterine entry

Interventions

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Transperitoneal cesarean technique

Pfannenstiel-Kerr technique for laparatomy and uterine entry

Intervention Type OTHER

Extraperitoneal cesarean technique

Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* elective cesarean
* previous cesarean (\<4)
* cesarean for distocia

Exclusion Criteria

* emergency cesarean ( fetal distress)
* risk of obstetrical bleeding
* maternal coagulation defects
* adnexial mass
* uterin myoma at incision site
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ragıp Atakan Al

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunus E TOPDAGI, MD

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Omer E Yapca, MD

Role: STUDY_DIRECTOR

Ataturk University

Locations

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Atatürk Üniversitesi Araştırma Hastanesi

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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77-2015

Identifier Type: -

Identifier Source: org_study_id

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