Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy in Women With Abnormal Uterine 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: Manual Vacuum Aspiration (MVA) Cannula, Pipelle Endometrial Suction Curette.
- Who it may be relevant to
- Registry conditions: Abnormal Uterine Bleeding (AUB). Basic parameters: from 35 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study of Pipelle Versus Manual Vacuum Aspiration Cannula for Endometrial Biopsy
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.
Interventions
- Other Manual 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. - Other Pipelle Endometrial Suction Curette
Endometrial biopsy using a flexible Pipelle device operated by pulling the internal piston to create negative pressure without dilation or anesthesia.
Primary outcome measures
- Diagnostic Yield for Endometrial Pathology [Time frame: At the time of histopathological assessment (within 7 days post-procedure)]
Eligibility criteria
Inclusion criteria
- Married women aged 35 years and above.
- Presentation with abnormal uterine bleeding (AUB), including but not limited to metrorrhagia, menorrhagia, or postmenopausal bleeding.
- Clinical indication for endometrial sampling for diagnostic evaluation of abnormal uterine bleeding.
- Patient fit for both MVA and Pipelle procedures, with no contraindications to either method.
Exclusion criteria
- Pregnancy or suspicion of pregnancy.
- Acute pelvic inflammatory disease or active genital tract infection.
- Current use of anticoagulant therapy or presence of bleeding disorders that pose a risk for excessive bleeding during endometrial sampling.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07731581 · Exp142