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Comparison of Uterine Exteriorization Versus in Situ Repair at Cesarean Section: a Randomized Clinical Trial (EXT)
This study has been completed.
Sponsored by: Instituto Materno Infantil Prof. Fernando Figueira
Information provided by: Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT00550888
  Purpose

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


Condition Intervention Phase
Uterus
Cesarean Section
Abdominal Delivery
Suture Techniques
Procedure: suture techniques
Phase III

MedlinePlus related topics: Cesarean Section Nausea and Vomiting
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind (Subject), Parallel Assignment

Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

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

Secondary Outcome Measures:
  • 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 ]

Study Start Date: August 2005
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   13 Years to 44 Years
Genders Eligible for Study:   Female
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00550888

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

Study ID Numbers: IMIP1234
Study First Received: October 29, 2007
Last Updated: October 29, 2007
ClinicalTrials.gov Identifier: NCT00550888  
Health Authority: Brazil: Ministry of Health

ClinicalTrials.gov processed this record on January 15, 2009