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NCT Number: NCT07349108

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 75000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Adequacy of endometrial tissue sample

    Time frame: During the procedure and at the time of histopathological examination of the collected specimen

    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.

Secondary outcomes

  1. Post-procedure pain score

    Time frame: 24 hours after the endometrial sampling procedure

    Pain intensity was assessed using the Visual Analog Scale, a 10-centimeter scale ranging from 0 representing no pain to 10 representing the worst pain imaginable. Each participant marked the perceived pain level, and the recorded value was used for analysis.

Sponsors and collaborators

Lead sponsor

Sheikh Zayed Medical College

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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