Comparison of Uterine Exteriorization Versus in Situ Repair at Cesarean Section: a Randomized Clinical Trial (EXT)

June 8, 2010 updated by: Instituto Materno Infantil Prof. Fernando Figueira
There is no difference between extra-abdominal or in situ suture of the uterus in cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • IMIP Prof. Fernando Figueira

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

13 years to 44 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • indication of cesarean section
  • gestational age > 24 weeks

Exclusion Criteria:

  • two or more cesarean sections
  • chorioamnionitis
  • hemorrhagic complications
  • unable to consent
  • previous abdominal surgery

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

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endometritis
Time Frame: within the first 30 days after surgery
within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
nausea and vomiting during surgery, mean operative time, estimated intraoperative blood loss, number of surgical sutures for uterine repair, pain postoperative, number of postoperative analgesic doses, surgical site infection
Time Frame: from surgery to 30 days after surgery
from surgery to 30 days after surgery

Collaborators and Investigators

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

Sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Investigators

  • Study Director: Eronildo F Silva, IMIP

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

August 1, 2005

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

October 29, 2007

First Submitted That Met QC Criteria

October 29, 2007

First Posted (ESTIMATE)

October 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2010

Last Update Submitted That Met QC Criteria

June 8, 2010

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IMIP1234

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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