Abnormal Uterine Bleeding
Conditions
Keywords
Abnormal uterine bleeding, Endometrial biopsy, Endometrial sampling, Endometrial tissue adequacy, Manual vacuum aspiration, Dilatation and curettage
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.
Interventions
PROCEDUREManual 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.
PROCEDUREDilatation 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.
Sponsors
Sheikh Zayed Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of endometrial tissue sample | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-procedure pain score | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORAfshan Jabeen
Sheikh Zayed Medical college/Hospital, Rahimyar Khan
Outcome results
None listed