Rajiv Gandhi University of Health Science, Bangalore, Karnataka

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE, BANGALORE, KARNATAKA.

PROFORMA FOR REGISTRATION OF DISSERTATION

ROLE OF ULTRASONOGRAPHY IN THE EVALUATION OF CAUSES OF BLEEDING PER VAGINUM IN THE FIRST TRIMESTER OF PREGNANCY

DR. VISHWANATH YADAV POSTGRADUATE DEPARTMENT OF RADIO- DIAGNOSIS NAVODAYA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, RAICHUR- 584101. ANNEXURE-I

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE

PROFORMA FOR REGISTRATATION OF SUBJECTS FOR DISSERTATION 1. Name of the Candidate DR. VISHWANATH YADAV And POSTGRADUATE Address: DEPARTMENT OF RADIO – DIAGNOSIS NAVODAYA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, RAICHUR- 584101 2. Name of the Institution: NAVODAYA MEDICAL COLLEGE HOSPITAL AND RESERCH CENTRE, MANTRALAYA ROAD, RAICHUR – 584101

3. Course of study and subject: M.D. RADIODIAGNOSIS 4. Date of admission to course: 30/05/2013(Three Years) 5. Title of the topic: ROLE OF ULTRASONOGRAPHY IN THE EVALUATION OF CAUSES OF BLEEDING PER VAGINUM IN THE FIRST TRIMESTER OF PREGNANCY 6 Brief resume of the intended work:

6.1 Need for the study: Bleeding per vaginum in the first trimester is one of the most common obstetric problems. Nearly 27 to 30% of all pregnant women complain of bleeding in first trimester of pregnancy. By history and clinical examination a definitive diagnosis is usually difficult. Ultrasonography is a useful modality to arrive at an accurate diagnosis. It is a non- invasive, less time consuming, easy to perform, repeatable modality that causes minimal discomfort to the patient. Most importantly, it does not employ any ionizing radiation which is harmful to the patient and the fetus. Performing ultrasound in patients who present with bleeding in the first trimester of pregnancy is useful:  To confirm pregnancy and qualify whether it is intra or extra uterine.  To confirm multiple pregnancies.  To assess the period of gestation,  To confirm the viability of the foestus.  To confirm or to rule out suspected hydatidiform mole.  To assess cause of first trimester pregnancy failure such as blighted ovum, incomplete, complete or missed abortion.  To ascertain other pelvic causes for bleeding.

This study aims to evaluate the role of ultrasound in the accurate diagnosis of causes of bleeding in the first trimester of pregnancy.

6.2 Review of literature: Mark Deutchman, Amy Tanner Tubay et al1 2009 observed that vaginal bleeding in the first trimester occurs in about one fourth of pregnancies and one half of those who bleed will miscarry. Transvaginal ultrasonography and beta subunit of human chorionic gonadotropin testing aid in distinguishing many conditions of first trimester bleeding. Familiarity with the normal progression of early pregnancy anatomy, sonographic findings, and beta subunit of human chorionic gonadotropin values can make a definitive diagnosis and proceed with appropriate treatment. Dighe M, cuevas C, Moshiri M, et al2 2008 stated that, vaginal bleeding is the most common cause of presentation to the emergency department in the first trimester and approximately half the patients lose the pregnancy. Clinical assessment is often difficult, and sonography is necessary to determine if a normal fetus is present and alive to exclude other causes of bleeding such as ectopic or molar pregnancy. Improved ultrasound technology and high frequency endovaginal transducers have enabled early diagnosis of abnormal and ectopic pregnancies, decreasing maternal morbidity and mortality.

Timothy B. Jang et al3 2006 did a prospective study on 670 patients with first- trimester vaginal bleeding or pain who underwent emergency bedside sonography followed by pelvic sonography. Results of emergency bedside sonography were compared with those of pelvic sonography, which showed increase in sensitivity and specificity for an intraerine pregnancy from 80% and 86% respectively to 100 % and 100%, for an adnexal mass or ectopic pregnancy changed from 43% and 94% to 75% and 89% and for a molar pregnancy changed from 71% and 98% to 100%.

Bjarne Chr. Eriksen MD et al4 2005 did a prospective study on 169 patients with threatened abortion with bleeding per vagina. The diagnostic and prognostic value of ultrasound, B- human chorionic gonadotropin (b-hCG) subnit, and progesterone were evaluated. With ultrasound, correct diagnosis of in- utero situation (true positive and true negative) was made at admission it 93% and after I week in 99% of the cases, in 1% of the cases mistaken for abortions (false positive) and concluded ultrasound had the highest sensitivity in detecting a pathologic pregnancy and also the best predicative value when a pathologic condition was discovered.

Dogra V et al5. 2005 in their study stated that, ultrasound evaluation of patients with trimester bleeding is the mainstay of the examination. The intrauterine gestational gestational sac should be visualized by trans vaginal ultrasonography with beta hCG levels between 1000 to 2000 mlU/mlL. A Gestational sac with a mean sac diameter of 8 mm or more without a yolk sac and or mean sac diameter of 16 mm or more without an embryo, are important predictors of a nonviable gestation A difference of less than 5 mm between the mean sac diameter and the crown Rump length carries an 80% risk of spontaneous abortion.

Paspulati RM, Bhatt S et al6 2004 observed that vaginal bleeding is a leading cause of presentation for emergency care during the first trimester of the pregnancy and stated that ultrasonography examination is crucial in establishing intrauterine pregnancy and early pregnancy failure and to exclude other causes of bleeding, such as ectopic pregnancy and molar pregnancy. With recent advances in ultrasonography technology and the availability of high frequency transvaginal transducers, reliable diagnosis of early pregnancy failure can be made even before the embryo is visible.

Falco P, Zagonari S, Gabrielli S et.al7.2003 did a prospective observational cohort study on 50 patient to evaluate the outcome of pregnancies with first- trimester bleeding and a gestational sac less than or equal to 16 mm without a demonstrable embryo. Results suggested that in general a gestational sac less than or equal to 16mm without a demonstrable embryo is associated with a poor outcome, with miscarriage in two- thirds of patients.

6.3 Aims & Objectives of the study: 1. To evaluate the role of ultrasonography in patient with bleeding per vaginum in the first trimester of pregnancy. 2. To correlate ultrasound findings with clinical diagnosis thus helping the treating obstetrician in deciding the management protocol.

7 Materials and Methods: 7.1 Source of data: A minimum of fifty female patients in first trimester of pregnancy with bleeding per vaginum, referred to the department of Radiodiagnosis from department of Obstetrics and Gynecology of Navodaya medical college hospital and research centre for the period of 24 months. 7.2 Method of collection of data (including sampling procedure if any): Definition of a study subject: Female patients in first trimester of pregnancy with bleeding per vaginum referred to the department of Radio- diagnosis, Navodaya medical college hospital and research centre, Raichur

The method of a study consists of: A structured pre-prepared proforma containing the patient details clinical history, physical examination and investigations who meet the inclusion criteria will be prepared and patient will be subjected to trans- abdominal ultrasonographic examination which will be done using curvilinear array transducer of TOSHIBA NEMIO-XG ultrasound machine. Transvaginal ultrasonography will be performed using transvaginal probe whenever trans-abdominal study shows inconclusive or equivocal study.

Inclusion Criteria: All female patients with history of bleeding per vaginum in first trimester of pregnancy.

Exclusion Criteria: 1. Patients with bleeding per vagina due to uterine anomaly and pathology will be excluded from the study. 2. All female patients with bleeding disorders such as hemophilia will be excluded from the study.

Statistical Methods: Descriptive statistic (Tabulations, graphs & charts, proportions, percentage, etc) are used.

7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals? No, the study does not require any interventional procedure.

7.4 Has ethical clearance been obtained from your institutions in case of 7.3 ? Yes 8 List of references: 1. Mark deutchmanj MD, Colorado, Amy tanner tubay MD, David. K. Turo MD. First trimester bleeding. American family physician. Journ. 2009 June 1; 79(11) : 985-992.

2.Dighe M, Cuevas C, Moshiri M, Dubinsky T, Dogra VS. sonography in first trimester bledding. J clin ultrasound. 2008 Jul-Aug: 36(6) : 352-66.

3. Timothy B. Jang, MD, Wendy Ruggeri, MD, Pamela Dyne, MD and Amy H. Kaji, MD, phD. Learning curve of emergency physicians using emergency beside sonography for symptomatic first – trimester pregnancy. Journal of ultrasound in medicine. October 1,2010; vol,29 no, 10 1423-1428. 4. Bjarne chr. Eriksen MD, Sturla H. Eik-Nes MD, phD. Prognostic value of ultrasound, HCG and progesterone in threatened abortion. Journal of clinical ultrasound 14:3-9.2 dec 2005 doi; 10. 1002 / jcu. 1870140103. 5. Dogra V, paspulati RM, Bhatt S. first trimester bleeding evaluation. Ultrasound Q.2005 Jun 21; (2) :69-85; quiz 149-50,153-4. 6. Paspulati RM, Bhatt S, Nour SG. Sonographic evaluation of first –trimester bleeding. [published correction appers in Radiol clin north Am. 2008;46(2) ;437] Radiol clin north Am. 2004; 42(2) :297-314. 7. Falco P, Zagonari S, Gabrielli S, Bevini M, pilu G, Bovicelli L. sonography of pregnancies with first – trimester bleeding and a small intrauterine gestational sac without a demonstrable embryo. Ultrasound obstete Gynecol. 2003 Jan 21; (1) :62.

9 Signature of Candidate: 10 Remarks of the Guide: The study helps to know the causes of first trimester bleeding per vagina thus helps to know the accuracy of ultrasonographic diagnosis. Ultrasonography is cost effective and easily available.

11 Name & Designation of (in block letters) 11.1 Guide DR.JAYSHREE R G PROFESSOR, Department of RADIO-DIAGNOSIS, NAVODAYA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 11.2 Signature

11.3 Co- Guide (if any) NO.

11.4 Head of Department DR.JAYSHREE R G PROFESSOR,& HEAD- DIAGNOSIS, Department of RADIO-DIAGNOSIS, NAVODAYA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 11.5 Signature

12 12.1 Remarks of the chairman & principal

12.2 Signature