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Description of the Uterine Cavity in Patients With Recurrent Miscarriages

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ClinicalTrials.gov Identifier: NCT02746588
Recruitment Status : Unknown
Verified April 2016 by Kristine Juul Hare, Hvidovre University Hospital.
Recruitment status was:  Recruiting
First Posted : April 21, 2016
Last Update Posted : April 22, 2016
Sponsor:
Collaborator:
University Hospital Copenhagen
Information provided by (Responsible Party):
Kristine Juul Hare, Hvidovre University Hospital

Tracking Information
First Submitted Date April 18, 2016
First Posted Date April 21, 2016
Last Update Posted Date April 22, 2016
Study Start Date February 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2016)
  • Description of the Uterine Cavity in Patients With Recurrent Miscarriages [ Time Frame: 1 year ]
    Observational study describing the uterine cavity in a selected patient group regarding abnormalities
  • Description of the Uterine Cavity in Patients With Recurrent Miscarriages [ Time Frame: 1 year ]
    Observational study describing the uterine cavity in a selected patient group regarding chronic infection
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Description of the Uterine Cavity in Patients With Recurrent Miscarriages
Official Title Not Provided
Brief Summary

To be diagnosed with recurrent miscarriages, a couple might have a child, however experiences three or more miscarriages, primarily this happens during the first trimester.

These miscarriages often needs medical evacuation or a D & C. Surgery or retained tissue increases the risk of complications as infection and/or adhesions, known as asherman syndrome, which may result in subfertility.

Recently chronic infection in the endometrium has been proposed to contribute to the condition, as protocols including treatment with antibiotics have led to birth at term for some of these women.

Using the very minimal invasive office hysteroscopy, the investigators aim to describe the uterine cavity in patients diagnosed with recurrent miscarriages regarding both abnormalities in the endometrium and chromic infection.

Detailed Description The Unit for Recurrent Pregnancy-loss at Rigshospitalet treats about 300 of couples with recurrent miscarriages a year. Together with the current examination program, the investigators plan to describe the uterine cavity according to abnormalities as septa, adhesions and further the condition for the endometrium regarding infection and hormone receptors. This description will include descriptive office hysteroscopy with biopsies for histologic - and immunohistochemically examinations.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Two endometrial biopsies
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with recurrent miscarriages and refurred to the specialist facility af Rigshospitalet
Condition
  • Recurrent Miscarriages
  • Habitual Abortions
Intervention Other: Office hysteroscopy
Diagnostic hysteroscopy with biopsy
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 18, 2016)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Correctly diagnosed with recurrent miscarriages

Exclusion Criteria:

  • Known course of the condition
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02746588
Other Study ID Numbers H-15011157
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kristine Juul Hare, Hvidovre University Hospital
Study Sponsor Hvidovre University Hospital
Collaborators University Hospital Copenhagen
Investigators Not Provided
PRS Account Hvidovre University Hospital
Verification Date April 2016