Diagnosis of uterine anomalies using the new classification of ESHRE/ESGE
| ISRCTN | ISRCTN12592528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12592528 |
| Secondary identifying numbers | AUTH 5867/29.03.2012 |
- Submission date
- 01/04/2018
- Registration date
- 14/06/2018
- Last edited
- 25/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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)
Contact information
Scientific
3rd Department of Obstetrics and Gynecology
Medical School, Aristotle University of Thessaloniki
Thessaloniki General Hospital "Ippokrateio"
49 Konstantinoupoleos Street
Thessaloniki
546 42
Greece
Study information
| Study design | Prospective blind comparative cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Three-dimensional ultrasound in the diagnosis and the classification of congenital uterine anomalies using the ESHRE/ESGE classification: A diagnostic accuracy study |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2012 |
| Completion date | 30/03/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 64 women |
| Key inclusion criteria | 1. Women with suspected uterine malformations 2. A presumptive 2DUS diagnosis of any uterine anomaly 3. Reproductive age |
| Key exclusion criteria | 1. Pre-pubertal adolescents 2. Pregnancy 3. Menopause 4. Any presence of uterine fibroids |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Greece
Study participating centre
Aristotle University of Thessaloniki
Thessaloniki
56403
Greece
Sponsor information
Hospital/treatment centre
Ring Road
Municipality Pavlos Melas
N. Efkarpia
Thessaloniki
56403
Greece
| Phone | +30 231 332 3131 |
|---|---|
| info@papageorgiou-hospital.gr | |
"ROR" |
https://ror.org/01663qy58 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/11/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Anna Kougioumtsidou, akougioum@gmail.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 25/05/2018 | 25/04/2019 | No | No |
Additional files
- ISRCTN12592528_BasicResults_25May18.pdf
- uploaded 25/04/2019
Editorial Notes
25/04/2019: The basic results of this trial have been uploaded as an additional file.
