Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier:
NCT01519440
First received: January 24, 2012
Last updated: October 21, 2012
Last verified: October 2012

January 24, 2012
October 21, 2012
March 2011
January 2012   (final data collection date for primary outcome measure)
unintended extension of uterine incision [ Time Frame: during the operation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01519440 on ClinicalTrials.gov Archive Site
intraoperative maternal blood loss [ Time Frame: after 48 hours than operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean
Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques

The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision

Not Provided
Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

elective cesarean delivery cases

Disruption of Uterine Incision After Cesarean Section
Not Provided
  • blunt
    Blunt expansion of the primary incision was derived by placing the index fingers of the operating surgeon into the incision and pulling the fingers apart laterally and cephalad.
  • sharp
    Sharp expansion of the primary incision was developed by cutting laterally and cephalad using bandage scissors
Magann EF, Chauhan SP, Bufkin L, Field K, Roberts WE, Martin JN Jr. Intra-operative haemorrhage by blunt versus sharp expansion of the uterine incision at caesarean delivery: a randomised clinical trial. BJOG. 2002 Apr;109(4):448-52.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1076
February 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Term pregnancy(> 38 weeks of gestation)
  2. Required elective cesarean delivery
  3. maternal age between 18-40 years

Exclusion Criteria:

  1. Required emergency cesarean delivery
  2. Abnormal presentation
  3. Planned cesarean hysterectomy
  4. History of low segment vertical uterine incision
  5. History of classical upper segment uterine incision
  6. multiple pregnancy
  7. cases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies)
  8. Grand multiparity(parity>5)
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT01519440
Aşıcıoğlu-01
Not Provided
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
Istanbul Bakirkoy Maternity and Children Diseases Hospital
Not Provided
Not Provided
Istanbul Bakirkoy Maternity and Children Diseases Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP