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

NCT ID: NCT07309692

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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Conditions

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Perimenopausal Bleeding

Keywords

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ultrasonography hysteroscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with perimenopausal bleeding

Group Type EXPERIMENTAL

three dimensional ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Hysteroscopy

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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three dimensional ultrasonography

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

Intervention Type DIAGNOSTIC_TEST

Hysteroscopy

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abd Al Rahim Fattouh

Resident doctor at obstetric and gynecology department of sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed abdelrahem fattouh, resident of Obstetrics and Gyn

Role: CONTACT

Phone: 00201146329946

Email: [email protected]

Facility Contacts

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hatem aboelftooh awaga, assistant professor

Role: primary

References

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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.

Reference Type RESULT
PMID: 38487719 (View on PubMed)

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.

Reference Type RESULT
PMID: 38412750 (View on PubMed)

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.

Reference Type RESULT
PMID: 26085733 (View on PubMed)

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.

Reference Type RESULT
PMID: 38471484 (View on PubMed)

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.

Reference Type RESULT
PMID: 39701007 (View on PubMed)

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.

Reference Type RESULT
PMID: 40628082 (View on PubMed)

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.

Reference Type RESULT
PMID: 10550879 (View on PubMed)

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.

Reference Type RESULT
PMID: 16487194 (View on PubMed)

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.

Reference Type RESULT
PMID: 18405088 (View on PubMed)

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.

Reference Type RESULT
PMID: 24753775 (View on PubMed)

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.

Reference Type RESULT
PMID: 33417634 (View on PubMed)

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.

Reference Type RESULT
PMID: 29606892 (View on PubMed)

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.

Reference Type RESULT
PMID: 32041387 (View on PubMed)

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.

Reference Type RESULT
PMID: 30254909 (View on PubMed)

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.

Reference Type RESULT
PMID: 26537304 (View on PubMed)

Other Identifiers

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Soh-Med-25-9----11MS

Identifier Type: -

Identifier Source: org_study_id