Description of the Uterine Cavity in Patients With Recurrent Miscarriages

Completed

• Conditions: Habitual Abortions; Recurrent Miscarriages

• Registration Number: NCT02746588
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-02-01
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Correctly diagnosed with recurrent miscarriages

Exclusion Criteria

• Known course of the condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of the Uterine Cavity in Patients With Recurrent Miscarriages	1 year	Observational study describing the uterine cavity in a selected patient group regarding chronic infection

Trial Locations

Locations (1)

Hvidovre Hospital, Department of Gynecology and Obstetrics; 🇩🇰 Copenhagen, Hvidovre, Denmark