Comparison of Manual Vacuum Aspiration and Dilatation and Curettage for Endometrial Sampling Adequacy in Women With Abnormal Uterine Bleeding

NCT07349108 | Active Not Recruiting

• 1 other identifier: Sheikh ZMC/H3
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial was conducted in the Department of Obstetrics and Gynecology, Sheikh Zayed Hospital, Rahim Yar Khan, to compare two commonly used methods for obtaining endometrial tissue in women aged 30 to 60 years presenting with abnormal uterine bleeding. Endometrial sampling is required to identify the underlying cause of abnormal bleeding, including precancerous changes and endometrial cancer. Participants who met eligibility criteria and provided informed consent were allocated to undergo either manual vacuum aspiration or dilatation and curettage. The primary purpose was to determine whether there was a significant difference between the two procedures in obtaining an adequate endometrial sample for histopathological reporting, where adequacy was defined as tissue containing both endometrial glands and stroma in sufficient quantity for interpretation. Pain severity was additionally assessed 24 hours after the procedure using a visual analog scale. The study hypothesis was that a significant difference existed in endometrial sampling adequacy between manual vacuum aspiration and dilatation and curettage among women with abnormal uterine bleeding.

Conditions

Abnormal Uterine Bleeding

Keywords

Abnormal uterine bleeding; Endometrial biopsy; Endometrial sampling; Endometrial tissue adequacy; Manual vacuum aspiration; Dilatation and curettage

Outcome Measures

Primary Outcomes (1)

• Adequacy of endometrial tissue sample

  Adequacy of the endometrial specimen was determined by a consultant histopathologist and defined as the presence of both endometrial glands and stroma in at least 50% of the specimen, with minimal contamination by blood, mucus, or necrotic tissue, and preservation of tissue integrity sufficient for accurate histopathological interpretation.

  During the procedure and at the time of histopathological examination of the collected specimen

Secondary Outcomes (1)

• Post-procedure pain score

  24 hours after the endometrial sampling procedure

Study Arms (2)

Group Manual Vacuum Aspiration

EXPERIMENTAL

Performed under paracervical block using 1% xylocaine with adrenaline in an outpatient setting.

Procedure: Manual Vacuum Aspiration

Group Dilatation and Curettage

ACTIVE COMPARATOR

Performed under paracervical block using 1% xylocaine with adrenaline.

Procedure: Dilatation and Curettage

Interventions

Manual Vacuum Aspiration PROCEDURE

Endometrial tissue was obtained using a handheld manual vacuum aspirator with appropriately sized cannula (No. 3 to No. 12), generating negative pressure to aspirate tissue from the endometrial cavity for histopathological examination.

Group Manual Vacuum Aspiration

Dilatation and Curettage PROCEDURE

The cervix was gradually dilated using cervical dilators, followed by curettage of the endometrial lining with a curette to obtain tissue for histopathological examination.

Group Dilatation and Curettage

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Females aged 30-60 years.
• Patients presenting with abnormal uterine bleeding (AUB) as per operational definition.
• Patients who provide informed consent to participate in the study.

You may not qualify if:

• Patients with known pregnancy, active pelvic infection, or untreated sexually transmitted infections as per medical records.
• Patients with known coagulopathy, bleeding disorders, or currently on anticoagulant therapy.
• Patients with a history of endometrial or cervical cancer, abnormal Pap smear, pelvic pathology, or current hormonal use for endometrial pathology.
• Patients who have undergone surgical intervention involving the uterus in the past three months.
• Patients with severe medical conditions that could interfere with the study outcomes or pose a risk during the procedure (e.g., severe cardiovascular disease, uncontrolled diabetes).
• Patients with a history of severe allergic reactions to local anesthesia or NSAIDs were used in the study.
• Patients with stenotic cervical ostium.
• Females with malignancy undergoing chemotherapy or radiotherapy (as per medical records).

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 75000, Pakistan

Location

MeSH Terms

Conditions

Metrorrhagia; Dilatation, Pathologic

Interventions

Dilatation and Curettage

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; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Curettage; Surgical Procedures, Operative; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Afshan Jabeen

  Sheikh Zayed Medical college/Hospital, Rahimyar Khan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: September 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

PA (1)