Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609862619495 Date of Registration: 07/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of manual vacuum aspiration versus pipelle biopsy for endometrial sampling in women with abnormal uterine bleeding at federal medical centre,Abeokuta
Official scientific title Effectiveness of manual vacuum aspiration versus pipelle biopsy for endometrial sampling in women with abnormal uterine bleeding at federal medical centre, Abeokuta.
Brief summary describing the background and objectives of the trial Abnormal uterine bleeding (AUB) is a frequent reason for gynaecological consultation and a major cause of morbidity among women of reproductive age. Accurate histological evaluation of the endometrium is essential for diagnosis, often using outpatient techniques like Manual Vacuum Aspiration (MVA) and Pipelle biopsy. Comparative evidence on the effectiveness of both methods is limited, especially in low-resource settings like Nigeria. The objective of this trial ; To compare the effectiveness of Manual Vacuum Aspiration (MVA) versus Pipelle biopsy for endometrial sampling in women with AUB at the Federal Medical Centre, Abeokuta.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied ENDOMETRIAL BIOPSY
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 29/04/2026
Actual trial start date 01/06/2026
Anticipated date of last follow up 17/08/2026
Actual Last follow-up date 30/10/2026
Anticipated target sample size (number of participants) 58
Actual target sample size (number of participants) 58
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group MANUAL VACUUM ASPIRATION NIL NIL collection of endometrial sample using manual vacuum aspiration 29 Uncontrolled
Experimental Group PIPELLE NIL NIL collection of endometrial sample with pipelle 29
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All consenting women with abnormal uterine bleeding who are referred to our reproductive health care centre (our reproductive health care centre provides the following services such as family planning clinic, endometrial sampling, colposcopy and pap smear) from the outpatient gynaecology clinic/gynaecological emergency or the peripheral hospitals for instant service for endometrial sampling after review of their preliminary results by the managing team will be enrolled for the study. These preliminary results would include pelvic ultrasound scan to rule out any exclusion criteria (submucous fibroid). Patients who decline consent to participate in the study. • Pregnant women. • Women with ultrasound diagnosis of submucous fibroid. • Women with an abnormal pap smear. • Patients currently on hormonal drugs. 37 • Patients with stenotic cervical os or a history of surgery on the cervix • Patient with pelvic inflammatory disease. • Cervical cancer patient. • Menopausal women with endometrial thickness <4 mm on transvaginal sonography (TVS). • Patients on anticoagulant therapy. • Patient who reacts to misoprostol and non-steroidal anti-inflammatory drugs. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/10/2025 FEDERAL MEDICAL CENTRE ABEOKUTA HEALTH RESEARCH ETHICS COMMITTE
Ethics Committee Address
Street address City Postal code Country
OLABISI ONABANJO WAY, IDI-ABA ABEOKUTA 110101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the primary outcome is assessed by the yield of the sample collected samples are processed as soon as they are gotten by the pathologist which is usually same day as soon as it gets to the pathologist
Secondary Outcome The duration of the procedure , the degree of pain during the procedure, the complications that arise during the procedure during the procedure, 30mins after the procedure and within 2 weeks after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
FEDERAL MEDICAL CENTRE ABEOKUTA OLABISI ONABANJO WAY, IDI-ABA ABEOKUTA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
DR ERINOSO ADEBAYO ADENIYI DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, FEDERAL MEDICAL CENTRE ABEOKUTA Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR ERINOS ADEBAYO. A DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, FEDERAL MEDICAL CENTRE,IDI-ABA ABEOKUTA Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries ADEBAYO ADENIYI ERINOSO adebayoerin2@gmail.com +2348034993996 DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, FEDERAL MEDICAL CENTRE, IDI-ABA
City Postal code Country Position/Affiliation
ABEOKUTA Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries ADEBAYO ADENIYI ERINOSO adebayoerin2@gmail.com +2348034993996 DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, FEDERAL MEDICAL CENTRE,IDI-ABA
City Postal code Country Position/Affiliation
ABEOKUTA Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Scientific Enquiries ADEBAYO ADENIYI ERINOSO adebayoerin2@gmail.com +2348034993996 DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY, FEDERAL MEDICAL CENTRE, IDI-ABA
City Postal code Country Position/Affiliation
ABEOKUTA Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Principal Investigator ADEBAYO ADENIYI ERINOSO adebayoerin2@gmail.com +2348034993996 PLOT XVI, ADEGBOYEGA STREET, ASERO ESTATE
City Postal code Country Position/Affiliation
ABEOKUTA Nigeria SENIOR REGISTRAR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes it is intended that the deidentified individual participant data will be shared after the completion and analysis of the result Informed Consent Form ONE YEAR OPEN
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 28/08/2026 as requested by the assesor EFFECTIVENESS OF MANUAL VACUUM ASPIRATION VERSUS PIPELLE BIOPSY FOR ENDOMETRIAL SAMPLING IN WOMEN WITH ABNORMAL UTERINE BLEEDING AT FEDERAL MEDICAL CENTRE, ABEOKUTA. Effectiveness of manual vacuum aspiration versus pipelle biopsy for endometrial sampling in women with abnormal uterine bleeding at federal medical centre,Abeokuta
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 28/08/2026 as requested by the assesor EFFECTIVENESS OF MANUAL VACUUM ASPIRATION VERSUS PIPELLE BIOPSY FOR ENDOMETRIAL SAMPLING IN WOMEN WITH ABNORMAL UTERINE BLEEDING AT FEDERAL MEDICAL CENTRE, ABEOKUTA. Effectiveness of manual vacuum aspiration versus pipelle biopsy for endometrial sampling in women with abnormal uterine bleeding at federal medical centre, Abeokuta.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/08/2026 as requested by the assesor Control Group, MANUAL VACUUM ASPIRATION, NIL, NIL, collection of endometrial sample using manual vacuum aspiration, 29, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 28/08/2026 as requested by the assesor Experimental Group, PIPELLE, NIL, NIL, ENDOMETRIAL BIOPSY ADEQUACY YIELD, 58, Experimental Group, PIPELLE, NIL, NIL, collection of endometrial sample with pipelle, 29,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 28/08/2026 as requested by the assesor Primary Outcome, YIELD , THE YIELD IS MEASURED BY THE HISTOPATHOLOGIST Primary Outcome, the primary outcome is assessed by the yield of the sample collected, samples are processed as soon as they are gotten by the pathologist which is usually same day as soon as it gets to the pathologist
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 28/08/2026 as requested by the assesor Secondary Outcome, ASSESSMENT OF PAIN FOLLOWING THE PROCEDURE, 2 WEEKS Secondary Outcome, The duration of the procedure , the degree of pain during the procedure, the complications that arise during the procedure, during the procedure, 30mins after the procedure and within 2 weeks after the procedure
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 28/08/2026 as requested by the assesor All consenting women with abnormal uterine bleeding who are referred to our reproductive health care centre from the outpatient gynaecology clinic/gynaecological emergency or the peripheral hospitals for instant service for endometrial sampling after review of their preliminary results by the managing team will be enrolled for the study. These preliminary results would include pelvic ultrasound scan to rule out any exclusion criteria (submucous fibroid). it is intended that the deidentified individual participant data will be shared after the completion and analysis of the result