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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014