Abnormal Uterine Bleeding (AUB)
Conditions
Brief summary
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.
Interventions
OTHERManual Vacuum Aspiration (MVA) Cannula
Endometrial sampling using a 4 mm flexible polyethylene MVA cannula connected to a manual vacuum aspiration syringe without dilation or anesthesia.
OTHERPipelle Endometrial Suction Curette
Endometrial biopsy using a flexible Pipelle device operated by pulling the internal piston to create negative pressure without dilation or anesthesia.
Sponsors
University of Health Sciences Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
All endometrial biopsy specimens will be evaluated independently by a consultant histopathologist who will be blinded to the participants' group allocation.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield for Endometrial Pathology | At the time of histopathological assessment (within 7 days post-procedure) | Proportion of patients receiving a definitive histopathological diagnosis (differentiating benign vs. malignant/premalignant conditions) based on microscopic evaluation by a blinded consultant histopathologist. |
Outcome results
None listed