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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00550888
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : June 9, 2010
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira

Brief Summary:
There is no difference between extra-abdominal or in situ suture of the uterus in cesarean section.

Condition or disease Intervention/treatment Phase
Cesarean Section Procedure: suture techniques Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Study Start Date : August 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Primary Outcome Measures :
  1. endometritis [ Time Frame: within the first 30 days after surgery ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00550888

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IMIP Prof. Fernando Figueira
Recife, Pernambuco, Brazil, 50070-550
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
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Study Director: Eronildo F Silva IMIP

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00550888     History of Changes
Other Study ID Numbers: IMIP1234
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: June 9, 2010
Last Verified: August 2007
Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
abdominal delivery
suture techniques