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Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean

Sponsor
Istanbul Bakirkoy Maternity and Children Diseases Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01519440
Collaborator
(none)
1,076
Enrollment
1
Location
11.1
Duration (Months)
97.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1076 participants
    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
    Study Start Date :
    Mar 1, 2011
    Actual Primary Completion Date :
    Jan 1, 2012
    Actual Study Completion Date :
    Feb 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. unintended extension of uterine incision [during the operation]

    Secondary Outcome Measures

    1. intraoperative maternal blood loss [after 48 hours than operation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 İstanbul Bakırköy Maternal and Childrens Hospital İstanbul Bakırköy Turkey 34274

    Sponsors and Collaborators

    • Istanbul Bakirkoy Maternity and Children Diseases Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osman Aşıcıoğlu, MD, Istanbul Bakirkoy Maternity and Children Diseases Hospital
    ClinicalTrials.gov Identifier:
    NCT01519440
    Other Study ID Numbers:
    • Aşıcıoğlu-01
    First Posted:
    Jan 27, 2012
    Last Update Posted:
    Oct 23, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Osman Aşıcıoğlu, MD, Istanbul Bakirkoy Maternity and Children Diseases Hospital
    unintended extension
    blunt
    sharp
    maternal blood loss
    Additional relevant MeSH terms:
    Surgical Wound

    Study Results

    No Results Posted as of Oct 23, 2012