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An interventional clinical trial to compare pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy in patient with abnormal uterine bleeding .

Comparison of Pipelle endometrial sampling versus Hysteroscopic guided endometrial biopsy in patients with abnormal uterine bleeding -Interventional prospective clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070832
Enrollment
80
Registered
2024-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified Health Condition 2: N924- Excessive bleeding in the premenopausal period Health Condition 3: N926- Irregular menstruation, unspecified Health Condition 4: N950- Postmenopausal bleeding

Interventions

Intervention1: Pipelle endometrial sampling: Patient with abnormal uterine bleeding will be admitted and before getting induced under general anesthesia for hysteroscopic guided biopsy , pipelle endom

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Women with more than 40 years of age with symptoms suggestive of abnormal uterine bleeding . 2.In pre-menopausal women with endometrial thickness with 7 to 12 millimeters. 3.In post-menopausal women with endometrial thickness with more than 4 millimeters. 4. In post-menopausal women with endometrial thickness less than 4 millimeters endometrial sampling will be done if - a. If repeated bleeding after primary treatment. b. If endometrium shows diffuse /focal increase in echogenicity. c. If endometrium is not adequately visualized on sonography.

Exclusion criteria

Exclusion criteria: 1. Patient on contraceptives, anticoagulants , thrombolytics or any evidence of blood dyscrasia or coagulation defects, autoimmune illness or chronic illness. 2. Patient with thrombocytopenia ( less than 100000 platelet/mm3 ). 3.Patient with active genital infection . 4.Patient with focal lesions of cervix or endometrium .

Design outcomes

Primary

MeasureTime frame
To compare the diagnostic accuracy of pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy in patient with abnormal uterine bleeding with endometrial pathology which is based on - 1. Histopathological report obtained by the two sampling techniquesTimepoint: It will be analysed based on the histopathological report obtained by the two screening techniques which will be available in 1 week

Secondary

MeasureTime frame
To compare the pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy as two screening modalities in terms of 1.Comparing the associated complications in both the techniques . 2. Comparing the patient compliance in both the procedure. 3. comparing the time duration & post procedure complications.Timepoint: It will be analysed by the subjective experience of the patient regarding the compliance & post procedure complications including anesthesia related & procedural during the immediate post operative period & subsequent follow up at 1 week with histopathological report

Countries

India

Contacts

Public ContactDr. Lajja Devi Goyal

AIIMS BATHINDA

lajja.goyal@rediffmail.com9417658846

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026