Different Modalities for the Evaluation of Patients With Peri-menopausal Bleeding

NCT07309692 | Recruiting

• 1 other identifier: Soh-Med-25-9----11MS
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare between 3D ultrasonography and hysteroscopy for the evaluation of cases with Peri-menopausal bleeding

Conditions

Perimenopausal Bleeding

Keywords

ultrasonography; hysteroscopy

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of the 3D ultrasonography for the diagnosis of the causes of peri-menopausal bleeding as compared to hysteroscopy

  9 months

Study Arms (1)

Patients with perimenopausal bleeding

EXPERIMENTAL

Diagnostic Test: three dimensional ultrasonography; Diagnostic Test: Hysteroscopy

Interventions

three dimensional ultrasonography DIAGNOSTIC_TEST

all recruited patients will be subjected to three dimensional ultrasonography to diagnose the cause of perimenopausal bleeding

Patients with perimenopausal bleeding

Hysteroscopy DIAGNOSTIC_TEST

diagnostic hysteroscopy will be performed to diagnose the cause of perimenopausal bleeding

Patients with perimenopausal bleeding

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Egypt

RECRUITING

Related Publications (15)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Kolhe S. Management of abnormal uterine bleeding - focus on ambulatory hysteroscopy. Int J Womens Health. 2018 Mar 22;10:127-136. doi: 10.2147/IJWH.S98579. eCollection 2018.

  PMID: 29606892 RESULT

• Yasa C, Gungor Ugurlucan F. Approach to Abnormal Uterine Bleeding in Adolescents. J Clin Res Pediatr Endocrinol. 2020 Feb 6;12(Suppl 1):1-6. doi: 10.4274/jcrpe.galenos.2019.2019.S0200.

  PMID: 32041387 RESULT

• Pandey D, Kunamneni S, Inukollu PR, Su H. Establishing patterns on hysteroscopy in abnormal uterine bleeding (AUB). Gynecol Minim Invasive Ther. 2017 Oct-Dec;6(4):178-182. doi: 10.1016/j.gmit.2017.08.001. Epub 2017 Aug 26.

  PMID: 30254909 RESULT

• Ong CL. The current status of three-dimensional ultrasonography in gynaecology. Ultrasonography. 2016 Jan;35(1):13-24. doi: 10.14366/usg.15043. Epub 2015 Sep 25.

  PMID: 26537304 RESULT

• Turkgeldi E, Urman B, Ata B. Role of Three-Dimensional Ultrasound in Gynecology. J Obstet Gynaecol India. 2015 May;65(3):146-54. doi: 10.1007/s13224-014-0635-z. Epub 2014 Nov 8.

  PMID: 26085733 RESULT

• Wang L, Quan S, Bai E, Yang X. Analysis of clinical data of different endometrial pathological types in perimenopausal women with abnormal uterine bleeding. Front Oncol. 2024 Feb 29;14:1370681. doi: 10.3389/fonc.2024.1370681. eCollection 2024.

  PMID: 38487719 RESULT

• Dreisler E, Frandsen CS, Ulrich L. Perimenopausal abnormal uterine bleeding. Maturitas. 2024 Jun;184:107944. doi: 10.1016/j.maturitas.2024.107944. Epub 2024 Feb 22.

  PMID: 38412750 RESULT

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

ahmed abdelrahem fattouh, resident of Obstetrics and Gyn

CONTACT

00201146329946; ahmedalatoon04@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at obstetric and gynecology department of sohag university

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 30, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

EG (1)