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Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment

Primary Purpose

Abortion, Spontaneous, Abortion, Induced

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Cytotec
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abortion, Spontaneous focused on measuring Late abortion

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: abortion at gestational age (ultrasound) 14+0 - 20+0 Exclusion Criteria: Allergy to cytotec

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Side-effect
    Complication

    Secondary Outcome Measures

    Quality of life

    Full Information

    First Posted
    November 18, 2005
    Last Updated
    May 31, 2006
    Sponsor
    Rigshospitalet, Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00256009
    Brief Title
    Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment
    Official Title
    Evacuatio Uteri or Conservtive Treatment After Late Abortion. A Randomize Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2005
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2009 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Rigshospitalet, Denmark

    4. Oversight

    5. Study Description

    Brief Summary
    A randomize trial: expectation or evacuatio uteri for the treatment after late abortion
    Detailed Description
    A randomize trial adressing 200 women consecutively recruited from clinical practice at Rigshospitalet.Expectation: administration of 800 microgram Cytotec half an hour after delivery. Surgery: Evacuation of the uterus

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abortion, Spontaneous, Abortion, Induced
    Keywords
    Late abortion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Cytotec
    Primary Outcome Measure Information:
    Title
    Side-effect
    Title
    Complication
    Secondary Outcome Measure Information:
    Title
    Quality of life

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: abortion at gestational age (ultrasound) 14+0 - 20+0 Exclusion Criteria: Allergy to cytotec
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lars Alling Møller, Md phd
    Phone
    0045 35451338
    Email
    Lars.Alling@rh.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lars Alling Møller, MD phd
    Organizational Affiliation
    Rigshospitalet, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Late Abortion: Evacuatio Uteri or Conservative Treatment

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