Recruiting NCT07309692
Different Modalities for the Evaluation of Patients With Peri-menopausal Bleeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: three dimensional ultrasonography, Hysteroscopy.
- Who it may be relevant to
- Registry conditions: Perimenopausal Bleeding. Basic parameters: 40 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Three Dimensional Ultrasonography Versus Hysteroscopy for the Evaluation of Patients With Perimenopausal Bleeding
Overview
The study aims to compare between 3D ultrasonography and hysteroscopy for the evaluation of cases with Peri-menopausal bleeding
Interventions
- Diagnostic test three dimensional ultrasonography
all recruited patients will be subjected to three dimensional ultrasonography to diagnose the cause of perimenopausal bleeding - Diagnostic test Hysteroscopy
diagnostic hysteroscopy will be performed to diagnose the cause of perimenopausal bleeding
Primary outcome measures
- The sensitivity and specificity of the 3D ultrasonography for the diagnosis of the causes of peri-menopausal bleeding as compared to hysteroscopy [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
Any pattern of abnormal uterine bleeding as menorrhagia or metrorrhagia for more than 3 months at age between 40 and 55 years , and no ovarian lesion or local cause of bleeding as vaginal or cervical ulcer
Exclusion criteria
- • Women with postmenopausal bleeding.
- Systemic causes of perimenopausal bleeding DM Hypertension or chronic liver disease.
- Women on hormonal therapy or using any contraception as IUD.
- Women have contraindication for hysteroscopy as cervical stenosis or pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Egypt · 1 center
- Sohag University — Sohag
Publications
- Dokara-Friedrich ML, Loeffler M, Shehaj I, Tahmasbi-Rad M, Gasimli B, Karn T, Sanhaji M, Becker S, Gasimli K. The Clinical Relevance of Fractional Curettage in the Diagnostic Management of Primary Endometrial Cancer. Gynecol Obstet Invest. 2024;89(4):311-322. doi: 10.1159/000538268. Epub 2024 Mar 12. PMID 38471484
- Saponara S, Angioni S, Parry JP, Pacheco LA, Carugno J, Moawad N, Haimovich S, Lasmar RB, Dealberti D, Aksakal E, Urman B, Nappi L, Vitale SG. The Pivotal role of hysteroscopy in diagnosing subtle uterine lesions in infertile patients: Seeing the unseen can make the difference. Eur J Obstet Gynecol Reprod Biol. 2025 Feb;305:132-141. doi: 10.1016/j.ejogrb.2024.12.013. Epub 2024 Dec 9. PMID 39701007
- Xydias EM, Liasidi PN, Papageorgouli D, Tsakos E, Gouliopoulos N, Thanasas I, Daponte A, Ziogas AC. Three-dimensional transvaginal ultrasound versus MRI in the diagnosis and classification of congenital uterine anomalies: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2025 Aug;312:114560. doi: 10.1016/j.ejogrb.2025.114560. Epub 2025 Jul 2. PMID 40628082
- Tetlow RL, Richmond I, Manton DJ, Greenman J, Turnbull LW, Killick SR. Histological analysis of the uterine junctional zone as seen by transvaginal ultrasound. Ultrasound Obstet Gynecol. 1999 Sep;14(3):188-93. doi: 10.1046/j.1469-0705.1999.14030188.x. PMID 10550879
- Okaro E, Condous G, Khalid A, Timmerman D, Ameye L, Huffel SV, Bourne T. The use of ultrasound-based 'soft markers' for the prediction of pelvic pathology in women with chronic pelvic pain--can we reduce the need for laparoscopy? BJOG. 2006 Mar;113(3):251-6. doi: 10.1111/j.1471-0528.2006.00849.x. PMID 16487194
- Mukhopadhayay S, Bhattacharyya SK, Ganguly RP, Patra KK, Bhattacharya N, Barman SC. Comparative evaluation of perimenopausal abnormal uterine bleeding by transvaginal sonography, hysteroscopy and endometrial biopsy. J Indian Med Assoc. 2007 Nov;105(11):624, 626, 628 passim. PMID 18405088
- Babacan A, Gun I, Kizilaslan C, Ozden O, Muhcu M, Mungen E, Atay V. Comparison of transvaginal ultrasonography and hysteroscopy in the diagnosis of uterine pathologies. Int J Clin Exp Med. 2014 Mar 15;7(3):764-9. eCollection 2014. PMID 24753775
- Louis F, Lulla CP. Hysteroscopy is Superior to 3D Ultrasound in Gynecological Diagnosis. J Obstet Gynaecol India. 2020 Dec;70(6):447-461. doi: 10.1007/s13224-020-01384-8. Epub 2020 Dec 4. No abstract available. PMID 33417634
Identifiers
NCT: NCT07309692 · Soh-Med-25-9----11MS