Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy in Women With Abnormal Uterine Bleeding

N/ANot Yet RecruitingNCT07731581

University of Health Sciences Lahore80 enrolled

Overview

women globally, often requiring endometrial tissue sampling for accurate evaluation and diagnosis. Traditional office-based sampling techniques like Pipelle are widely used, but the disposable instruments can be relatively expensive in resource-limited settings. Manual Vacuum Aspiration (MVA) using a flexible cannula is an inexpensive, reusable alternative, but clinical data comparing its performance directly to Pipelle remains limited. The objective of this randomized clinical trial is to compare Pipelle endometrial biopsy and Manual Vacuum Aspiration (MVA) cannula in terms of sample adequacy, patient satisfaction, and post-procedure complications in women presenting with abnormal uterine bleeding. Participants will be randomly assigned to undergo endometrial sampling using either a 4 mm MVA cannula or a Pipelle device without anesthesia or cervical dilation. Samples will be analyzed for histopathological diagnosis, and outcomes such as procedure pain, adequacy of tissue, and complications will be recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Abnormal Uterine Bleeding (AUB)

Interventions

Eligibility

Sex: FEMALEMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Married women aged 35 years and above. 2. Presentation with abnormal uterine bleeding (AUB), including but not limited to metrorrhagia, menorrhagia, or postmenopausal bleeding. 3. Clinical indication for endometrial sampling for diagnostic evaluation of abnormal uterine bleeding. 4. Patient fit for both MVA and Pipelle procedures, with no contraindications to either method. Exclusion Criteria: 1. Pregnancy or suspicion of pregnancy. 2. Acute pelvic inflammatory disease or active genital tract infection. 3. Current use of anticoagulant therapy or presence of bleeding disorders that pose a risk for excessive bleeding during endometrial sampling.

Outcomes

Primary Outcomes

Diagnostic Yield for Endometrial Pathology

Proportion of patients receiving a definitive histopathological diagnosis (differentiating benign vs. malignant/premalignant conditions) based on microscopic evaluation by a blinded consultant histopathologist.

Time frame: At the time of histopathological assessment (within 7 days post-procedure)