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

NCT07731581 | Not Yet Recruiting

• 1 other identifier: Exp142
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abnormal Uterine Bleeding (AUB)

Outcome Measures

Primary Outcomes (1)

• 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.

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

Study Arms (2)

Group A: MVA Cannula

ACTIVE COMPARATOR

Participants assigned to Group A will undergo endometrial tissue sampling using a 4 mm Manual Vacuum Aspiration (MVA) cannula attached to an aspiration syringe without local anesthesia or cervical dilation under aseptic conditions.

Other: Manual Vacuum Aspiration (MVA) Cannula

Group B: Pipelle Biopsy

ACTIVE COMPARATOR

Participants assigned to Group B will undergo endometrial sampling using a standard Pipelle device under aseptic conditions without local anesthesia or cervical dilation. The piston will be withdrawn to create vacuum-assisted suction and rotated to acquire tissue.

Other: Pipelle Endometrial Suction Curette

Interventions

Manual Vacuum Aspiration (MVA) Cannula OTHER

Endometrial sampling using a 4 mm flexible polyethylene MVA cannula connected to a manual vacuum aspiration syringe without dilation or anesthesia.

Group A: MVA Cannula

Pipelle Endometrial Suction Curette OTHER

Endometrial biopsy using a flexible Pipelle device operated by pulling the internal piston to create negative pressure without dilation or anesthesia.

Group B: Pipelle Biopsy

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Metrorrhagia

Interventions

Cannula

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All endometrial biopsy specimens will be evaluated independently by a consultant histopathologist who will be blinded to the participants' group allocation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): August 11, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): August 12, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07