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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

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.


Condition or disease Intervention/treatment
Recurrent Miscarriages Habitual Abortions Other: Office hysteroscopy

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : February 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage


Intervention Details:
  • Other: Office hysteroscopy
    Diagnostic hysteroscopy with biopsy


Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
Two endometrial biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with recurrent miscarriages and refurred to the specialist facility af Rigshospitalet
Criteria

Inclusion Criteria:

  • Correctly diagnosed with recurrent miscarriages

Exclusion Criteria:

  • Known course of the condition

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): NCT02746588


Contacts
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Contact: Kristine J Hare, MD, PhD +45 3880 1880 kjhare@dadlnet.dk

Locations
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Denmark
Hvidovre Hospital, Department of Gynecology and Obstetrics Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Kristine Juul Hare, MD, PhD       kjhare@dadlnet.dk   
Sponsors and Collaborators
Hvidovre University Hospital
University Hospital Copenhagen
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Responsible Party: Kristine Juul Hare, MD, PhD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02746588    
Other Study ID Numbers: H-15011157
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kristine Juul Hare, Hvidovre University Hospital:
miscarriage
uterine abnormalities
Chronic infection
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications