Abnormal Uterine BleedingNCT07349108
Comparison of Manual Vacuum Aspiration and Dilatation and Curettage for Endometrial Sampling Adequacy in Women With Abnormal Uterine Bleeding
A study testing Manual Vacuum Aspiration and Dilatation and Curettage in people with Abnormal Uterine Bleeding, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding
- What is being tested?
- Manual Vacuum Aspiration and Dilatation and Curettage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Medical college/hospital
Rahim Yar Khan, Punjab Province, 75000
About this study
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
- Being tested
- Manual Vacuum Aspiration, Dilatation and Curettage
- Keywords
- Abnormal uterine bleeding, Endometrial biopsy, Endometrial sampling, Endometrial tissue adequacy, Manual vacuum aspiration, Dilatation and curettage
- Medical subject headings
- Metrorrhagia, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Vacuum AspirationProcedure or surgery
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 CurettageProcedure or surgery
The cervix was gradually dilated using cervical dilators, followed by curettage of the endometrial lining with a curette to obtain tissue for histopathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Group Manual Vacuum Aspiration | Experimental | Performed under paracervical block using 1% xylocaine with adrenaline in an outpatient setting. Receives: Procedure: Manual Vacuum Aspiration |
| Group Dilatation and Curettage | Active comparator | Performed under paracervical block using 1% xylocaine with adrenaline. Receives: Procedure: Dilatation and Curettage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of endometrial tissue sample
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.
Measured: During the procedure and at the time of histopathological examination of the collected specimen
Secondary outcomes (1)
Post-procedure pain score
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.
Measured: 24 hours after the endometrial sampling procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Sep 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kainat usman, Sheikh Zayed Medical College
- Investigators
- Afshan Jabeen, Principal investigator, Sheikh Zayed Medical college/Hospital, Rahimyar Khan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349108
- Sponsor's protocol ID
- Sheikh ZMC/H3
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Manual Vacuum Aspiration and Dilatation and Curettage for Endometrial Sampling Adequacy in Women With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT07349108
- Acronym / sponsor ID
- Sheikh ZMC/H3
- Conditions
- Abnormal Uterine Bleeding
- Keywords
- Abnormal uterine bleeding, Endometrial biopsy, Endometrial sampling, Endometrial tissue adequacy, Manual vacuum aspiration, Dilatation and curettage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Manual Vacuum Aspiration | Experimental | Procedure: Manual Vacuum AspirationPerformed under paracervical block using 1% xylocaine with adrenaline in an outpatient setting. |
| Group Dilatation and Curettage | Active comparator | Procedure: Dilatation and CurettagePerformed under paracervical block using 1% xylocaine with adrenaline. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Vacuum AspirationEndometrial 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. | Procedure or surgery | Group Manual Vacuum Aspiration |
| Dilatation and CurettageThe cervix was gradually dilated using cervical dilators, followed by curettage of the endometrial lining with a curette to obtain tissue for histopathological examination. | Procedure or surgery | Group Dilatation and Curettage |
Primary outcome
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.
1 secondary outcome
Post-procedure pain score
Time frame: 24 hours after the endometrial sampling procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afshan Jabeen principal investigator
Sheikh Zayed Medical college/Hospital, Rahimyar Khan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Vacuum Aspiration and Dilatation and Curettage in people with Abnormal Uterine Bleeding, run by Sheikh Zayed Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of endometrial tissue sample (time frame: During the procedure and at the time of histopathological examination of the collected specimen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.