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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00550888
Other study ID # IMIP1234
Secondary ID
Status Completed
Phase Phase 3
First received October 29, 2007
Last updated June 8, 2010
Start date August 2005
Est. completion date August 2007

Study information

Verified date August 2007
Source Instituto Materno Infantil Prof. Fernando Figueira
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers
Gender Female
Age group 13 Years to 44 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

Procedure:
suture techniques


Locations

Country Name City State
Brazil IMIP Prof. Fernando Figueira Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary endometritis within the first 30 days after surgery
Secondary 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 from surgery to 30 days after surgery
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