Pulse - Rajiv Gandhi University of Health Sciences



6. BRIEF RESUME OF THE INTENDED WORK

6.1 NEED FOR STUDY

Menopause is the permanent cessation of menstruation which occurs following loss of ovarian activity. It is derived from Greek word 'mens'- month, 'pausis'- cessation.1 Perimenopause is a period 3-4 years before menopause and followed by 1 year of amenorrhea. It encompasses the change from normal ovulatory cycles to cessation of menses, marked by irregularity of menstrual cycles.2

The Perimenopausal Transition: Age of onset for 95% of women is 39-51 years. Average age of onset is 46 years. Duration for 95% of women is 2-8years. Average duration is 5 years.1

While significant awareness has been raised about menopause, less attention has been focused on the perimenopausal or "menopausal transition" period. Many women and their physicians remain unaware of the impact of this transitional phase into menopause.1 Specifically, heavy and unpredictable perimenopausal bleeding is extremely common. 3

The purpose of this review is to focus on the hormonal and physiologic changes that are associated with perimenopausal heavy vaginal bleeding, to present the essential evaluation of causes for this heavy flow, and to outline the evidence for effective medical and surgical treatments. Advances in the understanding of the normal physiology of perimenopause have led to medical therapies that may lead to fewer surgical procedures and hysterectomies and should be of interest to health care practitioners focusing on women's health. 3

Abnormal uterine bleeding (AUB) refers to a symptom of excessive, prolonged, unexpected or acyclic bleeding regardless of diagnosis or cause. AUB not only affects quality of life such as intimate relationships, day to day living but can have serious adverse consequences as anaemia or malignancy. 4

The diagnostic goal with perimenopausal bleeding is to exclude carcinoma and to identify the underlying pathology to allow optimal treatment. 5

Ultrasonography may reveal an obvious cavitary lesion or an abnormally thin or thick endometrium. In perimenopausal and postmenopausal women with abnormal bleeding, endometrial biopsy is generally considered unnecessary when the endometrial thickness is less than 4 or 5 mm because the risk of endometrial hyperplasia or cancer is remote. Biopsy is indicated when clinical history suggests long term unopposed estrogen exposure. An endometrial stripe of 5 mm thickness has been shown to be associated with an extremely low risk of endometrial hyperplasia or carcinoma.(2) Women with endometrial thickness >5 mm warrant additional evaluation with saline infusion sonography or endometrial biopsy. 3

An accurate method of determining whether AUB is functional or structural, one needs a minimally invasive accurate method. D&C under general anaesthesia was once considered as gold standard investigation in the evaluation of AUB. It can however miss 2-6% of cases of cancer or hyperplasia.5 Uterine cancer, the most serious cause of uterine bleeding is diagnosed in fewer than 10% of endometrial biopsies in women presenting with AUB, indicating that more than 90% of endometrial biopsies revealed benign findings. 6

The older terms perimenopause or climacteric generally refer to the time period in the late reproductive years usually late 40s to early 50s. The more correct terminology for this term is menopausal transition.7

The present study is designed to evaluate the causes of abnormal uterine bleeding in Menopausal Transition & to correlate the clinical evaluation with ultrasonographic & histopathological examination.

6.2 REVIEW OF LITERATURE:

1. Avantika Gupta et. al.8 (2013) evaluated the causes of abnormal uterine bleeding in perimenopausal woman & correlated the clinical evaluation with ultra sound and histopathological examination. Retrospective study of 100 perimenopausal women with complaint of abnormal uterine bleeding in the age group ranging from 40 years till one year with in the menopause. These women were evaluated, clinical, ultrasound and histopathological findings were correlated. The major symptom with which the women presented was menorrhagia and fibroid uterus was responsible for abnormal uterine bleeding in 53% women. All these women underwent endometrial biopsy followed by medical management or hysterectomy depending upon the diagnosis. Clinical, radiological and histopathological evaluation correlated well to diagnose fibroids however clinically as well as ultra sound proved to be of little help in diagnosis of adenomyosis.

2. Dasgupta shubhankar et. al.9,(2010) done the comparative study of diagnostic accuracy of TVS, saline infusion sonography & dilatation and curettage were compared with hysteroscopy guided biopsy to determine the etiology in abnormal uterine bleeding with perimenopausal women. In this study 252 patients had to undergo TVS & Saline infusion sonography in the same setting followed by hysteroscopy guided biopsy & dilatation and curettage. All the materials sent for histopathological examination. It determines the uterine pathology positive likelihood ratio (PLR) of TVS, saline infusion sonography and dilatation and curettage are 2.81, 2.5 and 3.81 respectively considering hysteroscopy as standard. From the present study it is clear that accuracy of saline infusion sonography a test for detecting pathology in abnormal uterine bleeding in perimonopausal patients is moderately good & suitable for developing countries. However hysteroscopy and guided biopsy if feasible can be performed as office procedure, still is a tool of choice both for screening as well as diagnostic purposes.

3. Archana B et.al.10 (2007) evaluated clinically the gynaecological causes of abnormal uterine bleeding in perimenopausal women and correlated clinical evaluation with ultrasonographic and histopathological examination. Retrospective study of 112 perimenopausal women with abnormal uterine bleeding for a period of 6 months was done. These women were evaluated and clinical, ultrasonographic and histopathological findings were correlated. The major symptom with which the women presented was menorrhagia in 53.3%. All these women underwent dilatation and curettage followed by medical management or hysterectomy depending upon the diagnosis. The histopathological examination (HPE) of endometrium was analysed. The HPE of uterus confirmed fibroid uterus and dysfunctional uterine bleeding correlated well with ultrasonographic and histopathological examination.

4. Bedner R et. al.,11 (2002) did a study to estimate the diagnostic value of ultrasonic endometrium thickness measurement and estimation of ultrasonic endometrium qualitative features in detecting pathological changes in women in perimenopausal period. The group of the patients consisted of 242 patients in age group of 45-86 years, with abnormal uterine bleeding. In all cases TVS and hysteroscopy were performed. The average thickness of endometrium in carcinoma, hyperplasia and polyps group (properly 8.96 and 6.09 and 5.02 mm) showed essential differences in comparison with a group without changes in endometrium(3.38 mm). In group carcinoma and hyperplasia the greatest cumulation of abnormal features of ultrasonic image was ascertained. Ultrasonic measurement of endometrial thickness is a sensitive index in detecting cancer and pathological endometrial hyperplasia. The combination measurement of endometrial thickness and estimation of qualitative features of endometrial and uterine cavity TVS image improved the results of detecting all types of intrauterine pathology.

5. Goldchmitt R et. al.,12 (1993) did a study to evaluate the accuracy of Pipelle endometrial sampling with and without sonographic measurement of endometrial thickness. They studied prospectively 176 consecutive patients (23% after and 77% before menopause) scheduled for D&C. Sonographic measurement of the endometrium and endometrial biopsy with the Pipelle were performed before the curettage. In 159 cases (90%), the endometrial histologic results of curettage agreed with those of the Pipelle biopsy. All three cases of endometrial cancer were identified by Pipelle aspiration. In seven cases (4%), the Pipelle aspiration failed to detect hyperplasia. Sonographic endometrial thickness of more than 5 mm slightly increased the sensitivity and slightly decreased the specificity of Pipelle aspiration from 82 to 92% and from 99 to 96%, respectively. In postmenopausal patients admitted for bleeding, the sensitivity and specificity reached 100%.They concluded that normal Pipelle aspirates in premenopausal patients with abnormal uterine bleeding are highly accurate. In postmenopausal patients with sonographic endometrial thickness of 5 mm or less, the accuracy reached 100%.

6. Fl Cornitescu et al.,13 (2011) did a clinical, histopathological & therapeutic considerations in non neoplastic abnormal uterine bleeding in menopause transition. This retrospective study included a total of 256 patients with abnormal uterine bleeding in menopause transition. In this study group menstrual irregularity was seen mainly in the 46-52 year old group ( 64.5%) & 35% of high multiparous patients.

The dominant symptom was meno metrorrhagia (34%). From the histopathological point of view in our study leiomyoma were the most common cause of abnormal uterine bleeding (49.6%). The abnormal uterine bleeding is the result of hyperestrogenic conditions in which the endometrium is in the proliferative phase (3.12%) & if untreated may lead to endometrial adenocarcinoma. The choice for progesterone substitution therapy in menopause remains an individual decision that requires careful consideration of symptoms, risk factors & the risk / benefit ratio.

6. 3 OBJECTIVES OF THE STUDY

1. To evaluate clinically the gynaecological causes of abnormal uterine bleeding in Menopausal Transition

2. To correlate the clinical evaluation with ultrasonographic and histopathological examination

7. MATERIALS AND METHODS

7.1 Source of data

Menopausal transition women presented with abnormal uterine bleeding who are seen at Cheluvamba Hospital

7.2 Methods of data collections

7.21 Study design

Present study is a cross sectional study to evaluate the gynaecological causes and histopathological correlation of abnormal uterine bleeding in menopausal transition

7.22 Study duration

Patients with history of abnormal uterine bleeding in menopausal transition age group at Cheluvamba Hospital between November 2013 to October 2014 are enrolled

7.23 Eligibility criteria

a) Inclusion criteria

❖ Patients complaining of abnormal uterine bleeding

❖ Age; 39 to 51 years

❖ Married and unmarried

❖ Nulliparous and multiparous

b) Exclusion criteria

❖ Post menopausal women

7.2.4 Study procedure

Data will be collected using a pretested proforma meeting the objective of the study by convenience sampling method, detailed history, physical examination and necessary investigation will be undertaken

7.2.5 Statistical Analysis:

The variables will be analyzed using descriptive statistics, Chi square test Contingency co-efficient analysis, sensitivity, specificity, PPV and NPV using SPSS for windows (v16).

7.3 Does the study require any investigations?

Yes.

1. Ultrasound.

2. Dilatation and Curettage.

3. Histopathological examination.

7.4 Ethical committee clearance has been obtained?

Yes (Copy Enclosed)

8. LIST OF REFERENCES

1. Fritz MA, Speroff L. Menopause and the Perimenopausal Transition. Clinical Gynecologic Endocrinology and Infertility. 8th ed. Lippincott Williams and Wilkins; 2011,681-84.

2. Kumar P, Malhotra N. Abnormal and Excessive Uterine Bleeding. Jeffcoate's Principles of Gynaecology. 7th ed. Arnold; 2008,613-16.

3. Choudhary S, Berkley C, Warren M. Perimenopausal vaginal bleeding: Diagnostic evaluation and therapeutic options. Journal of women's health 2011; 21(3): 30210.

4. McCluggage WG. My approach to the interpretation of endometrial biopsies and curettings, J Clin Pathol 2006; 59:801-12.

5. Conoscenti G, Meir YJ, Fischer-Tamaro L, Maieron A, Natale R, D'Ottavio G, et al. Endometrial assessment by transvaginal sonography and histological findings after D&C in women with postmenopausal bleeding. Ultrasound Obstet Gynecol 1995; 61:8-115.

6. Bakour S, Khan S, Gupta JK. The risk of premalignant and malignant pathology in endometrial polyps. Aca Obstet Gynecol Scand 2000; 79: 317-20.

7. Hoffman, Schorge, Schaffer, Halvorson, Bradshaw, Cunningham, Williams Gynecology, Second Edition, Chapter 21, Menopausal Transition, 555-579.

8. Avantika Gupta, Asmita Muthal Rathore, Usha Manaktala and Poonam Rudingwa, Evaluation and Histopathological correlation of abnormal uterine bleeding in perimenopausal women, Intenational Journal of Biomedical and Advance Research, 2013.

9. Dasgupta Subhankar, Chakraborty Barunoday, Karim Rejaul, Aich Ranen Kanti, Mitra Pradip Kumar, Ghosh Tarun Kumar, Abnormal Uterine Bleeding in Peri-Menopausal Age: Diagnostic Options and Accuracy, The Journal of Obstetrics and Gynecoiogy of India March/April 2011 pg 189- 194.

10. Archana B, Michelle F. Evaluation and histopathological correlation of abnormal uterine bleeding in Perimenopausal women. Bombay Hospital Journal 2010.

11. Bedner R, Arska RG. Transvaginal ultrasonography in the diagnosis of endometrial and uterine cavity changes in perimenopausal women. GinekoPol 2002 Nov; 73(11): 985-90.

12. Goldchmit R, Katz Z, Blickstein I, Caspi B,Dgani R. The accuracy of endometrial Pipelle sampling with and without sonographic measurement of endometrial thickness. Obstet Gynecol. 1993 Nov;82(5): 727-30.

13. Fl. Cornitescu, Florentina Taimase, Cristiana Simionescu, D. Iliescu, Clinical, histopathological and therapeutic considerations in non-neoplastic abnormal uterine bleeding in menopause transition, Rom J Morphol Embryol 2011, 52(3): 759-765

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