Description of the Uterine Cavity in Patients With Recurrent Miscarriages

NCT ID: NCT02746588

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2019-01-01

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.

Conditions

Recurrent Miscarriages; Habitual Abortions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Office hysteroscopy

Diagnostic hysteroscopy with biopsy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Correctly diagnosed with recurrent miscarriages

Exclusion Criteria

• Known course of the condition

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kristine Juul Hare

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hvidovre Hospital, Department of Gynecology and Obstetrics

Copenhagen, Hvidovre, Denmark

Countries

Denmark

Other Identifiers

H-15011157

Identifier Type: -

Identifier Source: org_study_id