NCT00550888

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2007

Completed
Last Updated

June 9, 2010

Status Verified

August 1, 2007

First QC Date

October 29, 2007

Last Update Submit

June 8, 2010

Conditions

Cesarean Section

Keywords

uterusabdominal deliverysuture techniques

Outcome Measures

Primary Outcomes (1)

  • endometritis

    within the first 30 days after surgery

Secondary Outcomes (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

    from surgery to 30 days after surgery

Interventions

suture techniquesPROCEDURE

Eligibility Criteria

Age13 Years - 44 Years
Sexfemale
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • indication of cesarean section
  • gestational age \> 24 weeks

You may not qualify if:

  • two or more cesarean sections
  • chorioamnionitis
  • hemorrhagic complications
  • unable to consent
  • previous abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMIP Prof. Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Location

Related Publications (1)

  • Coutinho IC, Ramos de Amorim MM, Katz L, Bandeira de Ferraz AA. Uterine exteriorization compared with in situ repair at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2008 Mar;111(3):639-47. doi: 10.1097/AOG.0b013e31816521e2.

    PMID: 18310366DERIVED

MeSH Terms

Interventions

Suture Techniques

Intervention Hierarchy (Ancestors)

Wound Closure TechniquesSurgical Procedures, Operative

Study Officials

  • Eronildo F Silva

    IMIP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 30, 2007

Study Start

August 1, 2005

Study Completion

August 1, 2007

Last Updated

June 9, 2010

Record last verified: 2007-08

Locations

BR(1)