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Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519440
First Posted: January 27, 2012
Last Update Posted: October 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
  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:


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

Primary Outcome Measures:
  • unintended extension of uterine incision [ Time Frame: during the operation ]

Secondary Outcome Measures:
  • intraoperative maternal blood loss [ Time Frame: after 48 hours than operation ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 24, 2012
First Posted: January 27, 2012
Last Update Posted: October 23, 2012
Last Verified: October 2012

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