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

S

Sheikh Zayed Medical College

Status

Active, not recruiting

Conditions

Abnormal Uterine Bleeding

Treatments

Procedure: Manual Vacuum Aspiration
Procedure: Dilatation and Curettage

Study type

Interventional

Funder types

Other

Identifiers

NCT07349108
Sheikh ZMC/H3

Details and patient eligibility

About

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.

Enrollment

126 patients

Sex

Female

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

126 participants in 2 patient groups

Group Manual Vacuum Aspiration
Experimental group
Description:
Performed under paracervical block using 1% xylocaine with adrenaline in an outpatient setting.
Treatment:
Procedure: Manual Vacuum Aspiration
Group Dilatation and Curettage
Active Comparator group
Description:
Performed under paracervical block using 1% xylocaine with adrenaline.
Treatment:
Procedure: Dilatation and Curettage

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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