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

NCT ID: NCT07349108

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group Manual Vacuum Aspiration

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

Group Type: EXPERIMENTAL

Manual Vacuum Aspiration

Intervention Type: 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 Dilatation and Curettage

Performed under paracervical block using 1% xylocaine with adrenaline.

Group Type: ACTIVE_COMPARATOR

Dilatation and Curettage

Intervention Type: 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.

Interventions

Dilatation and Curettage

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

Intervention Type: PROCEDURE

Manual Vacuum Aspiration

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sheikh Zayed Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kainat usman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Afshan Jabeen

Role: PRINCIPAL_INVESTIGATOR

Sheikh Zayed Medical college/Hospital, Rahimyar Khan

Locations

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Sheikh ZMC/H3

Identifier Type: -

Identifier Source: org_study_id