Description of the Uterine Cavity in Patients With Recurrent Miscarriages

NCT02746588 | Completed

• 1 other identifier: H-15011157
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Miscarriages; Habitual Abortions

Keywords

miscarriage; uterine abnormalities; Chronic infection

Outcome Measures

Primary Outcomes (2)

• Description of the Uterine Cavity in Patients With Recurrent Miscarriages

  Observational study describing the uterine cavity in a selected patient group regarding abnormalities

  1 year

• Description of the Uterine Cavity in Patients With Recurrent Miscarriages

  Observational study describing the uterine cavity in a selected patient group regarding chronic infection

  1 year

Interventions

Office hysteroscopy OTHER

Diagnostic hysteroscopy with biopsy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with recurrent miscarriages and refurred to the specialist facility af Rigshospitalet

You may qualify if:

• Correctly diagnosed with recurrent miscarriages

You may not qualify if:

• Known course of the condition

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital, Department of Gynecology and Obstetrics

Copenhagen, Hvidovre, 2650, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Two endometrial biopsies

MeSH Terms

Conditions

Abortion, Habitual; Abortion, Spontaneous; Uterine Anomalies; Persistent Infection

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 18, 2016
• First Posted: April 21, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)