ISRCTN - ISRCTN12592528: Diagnosis of uterine anomalies using the new classification of ESHRE/ESGE

Plain English Summary

Background and study aims
Congenital anomalies of the uterus (womb) are defects of uterus development and shape that occur during fetal life. Their prevalence is estimated to be 5%, but up to a quarter of women who have had miscarriages or preterm deliveries have such defects.
Uterine abnormalities are natural in some women, who do not know about it until they start trying for a pregnancy. Until then, they usually cause no problem at all.
Septate uterus is when the uterus is separated on the inside into two different halves by a septum (partition) of varying size and thickness, and is the most common of diagnosed anomalies. Thus there are two uterus cavities. It is thought that even a small septum may affect embryo implantation and early pregnancy as the divided structure is different compared to the normal uterus lining and cannot sustain implantation. The diagnosis is confirmed by imaging studies, such as hysterosalpingography (a type of xray) 2D or 3D ultrasonography (ultrasound scan) and Magnetic Resonance Imaging (MRI).
Most uterine abnormalities can be diagnosed by means of hysteroscopy/laparoscopy which are procedures using a narrow telescope with a light and camera at the end (called a hysteroscope) to examine the inside of the uterus. These help the doctor examine the uterine cavity and the outer shape of the uterus.
Hysteroscopy offers the advantage that the patient can be diagnosed and treated (removal of the septate) at the same time, but its disadvantage is that it is a surgical procedure.
This study aims to estimate the diagnostic accuracy of three-dimensional ultrasonography (3D US) compared to hysteroscopy/laparoscopy.

Who can participate?
Adult women of reproductive age with suspected uterine malformations

What does the study involve?
All participants have a medical interview and clinical examination, 2D and 3D ultrasound and surgical procedures (hysteroscopy and laparoscopy) to diagnose and classify any uterine abnormalities.

What are the possible benefits and risks of participating?
Τhe direct benefit of participating in the study is that women and particularly symptomatic women (with infertility, recurrent miscarriage) know exactly what their problem is and at the same time they can undergo the correction of the problem. Their participation in the study may result in information that will help others in the future.
There are no risks and side effects of the 3D ultrasound.

Where is the study run from?
Papageorgiou General Hospital (Greece)

When is the study starting and how long is it expected to run for?
January 2012 to March 2016

Who is funding the study?
Papageorgiou General Hospital (Greece)

Who is the main contact?
Dr Anna Kougioumtsidou (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Anna Kougioumtsidou

ORCID ID

Contact details

3rd Department of Obstetrics and Gynecology
Medical School
Aristotle University of Thessaloniki
Thessaloniki General Hospital "Ippokrateio"
49 Konstantinoupoleos Street
Thessaloniki
546 42
Greece

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AUTH 5867/29.03.2012

Study information

Scientific title

Three-dimensional ultrasound in the diagnosis and the classification of congenital uterine anomalies using the ESHRE/ESGE classification: A diagnostic accuracy study

Acronym

Study hypothesis

To estimate the diagnostic accuracy of three-dimensional ultrasonography (3D US) compared with the gold standard of hysteroscopy / laparoscopy, in the investigation of uterine congenital anomalies using the ESHRE/ESGE classification of female genital tract congenital anomalies.

Ethics approval

Committee of Bioethics and Deontology School of Medicine of the Faculty of Health Sciences of Aristotle University of Thessaloniki, 28/06/2013, ref: AUTH Protocol No 49

Study design

Prospective blind comparative cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Congenital uterine anomalies

Intervention

All participants have a medical interview and clinical examination, 2D US and 3D US to diagnose and classify any uterine malformations according to ESHRE/ESGE classification of congenital anomalies of female genital tract.
They also have hysteroscopy and laparoscopy to diagnose and classify any uterine malformations according to ESGE/ESHRE classification.
Results of both diagnoses are compared for accuracy.
The participants are not followed up after the end of these assessments.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

The accuracy of 3D US for the diagnosis of congenital uterine anomalies is assessed by comparing these results to hysteroscopy and laparoscopy results

Secondary outcome measures

The accuracy of 3D US for diagnosis according to the type of uterine congenital malformation is assessed by comparing results to hysteroscopy and laparoscopy results

Overall trial start date

01/01/2012

Overall trial end date

30/03/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women with suspected uterine malformations
2. A presumptive 2DUS diagnosis of any uterine anomaly
3. Reproductive age

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

64 women

Participant exclusion criteria

1. Pre-pubertal adolescents
2. Pregnancy
3. Menopause
4. Any presence of uterine fibroids

Recruitment start date

01/07/2013

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Greece

Trial participating centre

Papageorgiou General Hospital
1st Department of Obstetrics and Gynecology Aristotle University of Thessaloniki
Thessaloniki
56403
Greece

Sponsor information

Organisation

Papageorgiou General Hospital

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type