Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean

October 21, 2012 updated by: Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital

Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques

The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1076

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bakırköy
      • İstanbul, Bakırköy, Turkey, 34274
        • İstanbul Bakırköy Maternal and Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

elective cesarean delivery cases

Description

Inclusion Criteria:

  1. Term pregnancy(> 38 weeks of gestation)
  2. Required elective cesarean delivery
  3. maternal age between 18-40 years

Exclusion Criteria:

  1. Required emergency cesarean delivery
  2. Abnormal presentation
  3. Planned cesarean hysterectomy
  4. History of low segment vertical uterine incision
  5. History of classical upper segment uterine incision
  6. multiple pregnancy
  7. cases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies)
  8. Grand multiparity(parity>5)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
blunt
Blunt expansion of the primary incision was derived by placing the index fingers of the operating surgeon into the incision and pulling the fingers apart laterally and cephalad.
sharp
Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
unintended extension of uterine incision
Time Frame: during the operation
during the operation

Secondary Outcome Measures

Outcome Measure
Time Frame
intraoperative maternal blood loss
Time Frame: after 48 hours than operation
after 48 hours than operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (ESTIMATE)

January 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2012

Last Update Submitted That Met QC Criteria

October 21, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aşıcıoğlu-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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