Comparison of Manual Vacuum Aspiration and Dilatation and Curettage for Endometrial Sampling Adequacy in Women With Abnormal Uterine Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Adequacy of endometrial tissue sample
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Group Manual Vacuum Aspiration
Performed under paracervical block using 1% xylocaine with adrenaline in an outpatient setting.
干预措施: Manual Vacuum Aspiration (Procedure)
Group Dilatation and Curettage
Performed under paracervical block using 1% xylocaine with adrenaline.
干预措施: Dilatation and Curettage (Procedure)
结局指标
主要结局
Adequacy of endometrial tissue sample
时间窗: 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.
次要结局
- Post-procedure pain score(24 hours after the endometrial sampling procedure)
研究者
Kainat usman
Principal Investigator
Sheikh Zayed Medical College