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

This study has been completed.
Sponsor:
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00550888
First received: October 29, 2007
Last updated: June 8, 2010
Last verified: August 2007
  Purpose

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


Condition Intervention Phase
Cesarean Section
Procedure: suture techniques
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Resource links provided by NLM:


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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00550888     History of Changes
Other Study ID Numbers: IMIP1234
Study First Received: October 29, 2007
Last Updated: June 8, 2010
Health Authority: Brazil: Ministry of Health

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
uterus
abdominal delivery
suture techniques

ClinicalTrials.gov processed this record on April 17, 2014