search
Back to results

Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding (Niche)

Primary Purpose

Cesarean Section; Dehiscence, Abnormal Uterine Bleeding

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Office Hysteroscope
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cesarean Section; Dehiscence focused on measuring Hytsteroscopy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients with a history of cesarean section who are complaining of abnormal uterine bleeding with the following criteria :

  • Normal complete blood count apart from paramaters of anemia
  • Not using drugs affecting coagulation profile
  • Bleeding is not related to pregnancy
  • Not using intrauterine contraceptive devices or hormonal contraceptives
  • By ultrasonography : no abnormalities in the pelvis e.g benign or malignant tumors , ovarian cysts or tumors
  • No evidence of cervical abnormalities as cause of bleeding with cervical examination or cervical smears

Exclusion Criteria:

  • Any patient not fulfilling the inclusion criteria
  • If the patient refused the technique ( office hysteroscopy )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Office hysteroscopy

    Arm Description

    Examinatin with Office hysteroscope for women with abnormal uterine bleeding who had a history of previous cesarean section

    Outcomes

    Primary Outcome Measures

    Prevalence of cisarean section niche
    Prevalence of cisarean section niche in women complainig of unexplained abnormal uterine bleeding

    Secondary Outcome Measures

    Full Information

    First Posted
    April 22, 2017
    Last Updated
    April 25, 2017
    Sponsor
    Ain Shams University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03130387
    Brief Title
    Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding
    Acronym
    Niche
    Official Title
    Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    April 20, 2017 (Actual)
    Study Completion Date
    April 20, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Prevalence of Cesarean Section Niche in women With Unexplained Abnormal Uterine Bleeding
    Detailed Description
    Prevalence of Cesarean Section Niche as diagnosed by office hysteroscopy and transvaginal sonography in women With Unexplained Abnormal Uterine Bleeding

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cesarean Section; Dehiscence, Abnormal Uterine Bleeding
    Keywords
    Hytsteroscopy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Hysteroscopic examination for patients with AUB
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    95 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Office hysteroscopy
    Arm Type
    Other
    Arm Description
    Examinatin with Office hysteroscope for women with abnormal uterine bleeding who had a history of previous cesarean section
    Intervention Type
    Device
    Intervention Name(s)
    Office Hysteroscope
    Intervention Description
    Diagnosis of C.S niche in patients wit AUB by office hysteroscope
    Primary Outcome Measure Information:
    Title
    Prevalence of cisarean section niche
    Description
    Prevalence of cisarean section niche in women complainig of unexplained abnormal uterine bleeding
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Females only
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a history of cesarean section who are complaining of abnormal uterine bleeding with the following criteria : Normal complete blood count apart from paramaters of anemia Not using drugs affecting coagulation profile Bleeding is not related to pregnancy Not using intrauterine contraceptive devices or hormonal contraceptives By ultrasonography : no abnormalities in the pelvis e.g benign or malignant tumors , ovarian cysts or tumors No evidence of cervical abnormalities as cause of bleeding with cervical examination or cervical smears Exclusion Criteria: Any patient not fulfilling the inclusion criteria If the patient refused the technique ( office hysteroscopy )

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Prevalence of Cesarean Section Niche in Women With Unexplained Abnormal Uterine Bleeding

    We'll reach out to this number within 24 hrs