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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
History of Changes
  Purpose

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


Condition
Disruption of Uterine Incision After Cesarean Section

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Istanbul Bakirkoy Maternity and Children Diseases Hospital:

Primary Outcome Measures:
  • unintended extension of uterine incision [ Time Frame: during the operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • intraoperative maternal blood loss [ Time Frame: after 48 hours than operation ] [ Designated as safety issue: No ]

Enrollment: 1076
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

elective cesarean delivery cases

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519440

Locations
Turkey
İstanbul Bakırköy Maternal and Childrens Hospital
İstanbul, Bakırköy, Turkey, 34274
Sponsors and Collaborators
Istanbul Bakirkoy Maternity and Children Diseases Hospital
  More Information

Publications:

Responsible Party: Osman Aşıcıoğlu, MD, Istanbul Bakirkoy Maternity and Children Diseases Hospital
ClinicalTrials.gov Identifier: NCT01519440     History of Changes
Other Study ID Numbers: Aşıcıoğlu-01
Study First Received: January 24, 2012
Last Updated: October 21, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul Bakirkoy Maternity and Children Diseases Hospital:
unintended extension
blunt
sharp
maternal blood loss

ClinicalTrials.gov processed this record on June 18, 2013