An interventional clinical trial to compare pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy in patient with abnormal uterine bleeding .
- Conditions
- Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecifiedHealth Condition 2: N924- Excessive bleeding in the premenopausal periodHealth Condition 3: N926- Irregular menstruation, unspecifiedHealth Condition 4: N950- Postmenopausal bleeding
- Registration Number
- CTRI/2024/07/070832
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 .
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 - <br/ ><br> <br/ ><br>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 Outcome Measures
Name Time Method To compare the pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy as two screening modalities in terms of <br/ ><br> <br/ ><br>1.Comparing the associated complications in both the techniques . <br/ ><br>2. Comparing the patient compliance in both the procedure. <br/ ><br>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