RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

PROFORMA FOR REGISTRATION OF DISSERTATION

TOPIC

ULTRASONOGRAPHIC EVALUATION OF PATIENTS WITH BLEEDING PER VAGINUM IN THE FIRST TRIMESTER OF PREGNANCY

DR. RAVI KUMAR. M

POSTGRADUATE

DEPARTMENT OF RADIO-DIAGNOSIS

MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL,

HOSAKOTE, BANGALORE - 562114.

ANNEXURE- I

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

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|1. |Name of the Candidate |Dr. RAVI KUMAR.M |

| |And |ROOM NO S3, MEN’S HOSTEL, |

| |Address : |MVJMEDICALCOLLEGE AND RESEARCH HOSPITAL, |

| | |DANDUPALYA, KOLATHUR POST |

| | |HOSAKOTE, BANGALORE-562114. |

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|2. |Name of the Institution: |MVJ MEDICAL COLLEGE AND RESEARCH HOSPITAL, |

| | |DANDUPALYA, KOLATHUR POST |

| | |HOSAKOTE, BANGALORE-562114. |

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|3. |Course of study and subject: |M.D. RADIODIAGNOSIS |

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|4. |Date of admission to course: |31/05/2011 (Three Years) |

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|5. |Title of the Topic: |ULTRASONOGRAPHIC EVALUATION OF PATIENTS WITH BLEEDING PER VAGINUM INTHE FIRST |

| | |TRIMESTER OF PREGNANCY |

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|6. |Brief resume of the intended work: |

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| |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 ionising radiation which is harmful to the patient. |

| |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 extrauterine. |

| |To confirm multiple pregnancies. |

| |To assess the period of gestation, |

| |To confirm the viability of the foetus. |

| |To confirm or to rule out suspected hydatidiform mole. |

| |To assess causes of first trimester pregnancy failure such as blighted ovum, incomplete, complete or missed abortion. |

| |To ascertain other pelvic causes for bleeding. |

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

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| |6.2 Review of literature: |

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| |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. |

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| |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 and 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. |

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| |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 intrauterine 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% and 100%. |

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| |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, β-human chorionic gonadotropin(β-hCG) subunit, and progesterone were evaluated. With ultrasound, a correct |

| |diagnosis of in-utero situation (true positive and true negative) was made at admission in 93% and after 1 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 predictive value when a pathologic condition was discovered. |

| |Dogra V et al5.2005 in their study stated that, ultrasound evaluation of patients with first trimester bleeding is the mainstay of the |

| |examination. The intrauterine gestational sac should be visualized by Trans Vaginal Ultrasonography with beta hCG levels between 1000 to 2000 |

| |mIU/mL . 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. |

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| |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. |

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| |Falco P, Zagonari S, Gabrielli S et.al7.2003 did a prospective observational cohort study on 50 patients 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 16 mm without a demonstrable embryo is associated with a poor outcome, with miscarriage in two-thirds of |

| |patients. |

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| |6.3 Aims &Objectives of the study: |

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| |1. To evaluate the role of ultrasonography in patients with bleeding per vaginum in the first trimester of pregnancy. |

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| |2. To correlate ultrasound findings with clinical diagnosis thus helping the treating obstetrician in deciding the management protocol. |

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|7. |Materials and Methods: |

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| |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 Gynaecology of M.V.J. Medical College & Research Hospital, Hosakote during the period from |

| |November 2011 to August 2013. |

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| |7.2 Method of collection of data(including sampling procedure if any): |

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| |Definition of a study subject: |

| |Female patients in first trimester of pregnancy with bleeding per vaginum referred to the Department of Radio-Diagnosis, MVJ. Medical College |

| |&Research Hospital, Hosakote. |

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| |The method of 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 patients will be subjected to Trans-abdominal ultrasonographic examination which will be done using |

| |Curvilinear array transducer of GE VOLUSION 730 PRO Ultrasound machine. Transvaginal ultrasonography will be performed using Transvaginal probe |

| |whenever Trans-abdominal study shows inconclusive or equivocal study. |

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| |Inclusion Criteria: |

| |All female patients with bleeding per vaginum in first trimester of pregnancy. |

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| |Exclusion criteria: |

| |1) Patient 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. |

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| |Statistical methods : |

| |Descriptive statistics (Tabulations, graphs & charts, proportions, percentage, etc) are used. |

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| |7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals? |

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| |Yes, the present study requires : Haemoglobin percentage. |

| |Blood grouping and typing. |

| |Total count , Differential count. |

| |Erythrocyte sedimentation rate (ESR) |

| |Fasting blood sugar. |

| |  Urine pregnancy test. |

| |Thyroid profile. |

| |Urine routine. |

| |Bleeding time,clotting time, platelet count. |

| |Serological tests. |

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| |7.4 Has ethical clearance been obtained from your institution in case of 7.3? |

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|8. |List of references: |

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| |1) Mark deutchman MD, Colorado,Amy tanner tubay MD, and 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 bleeding. J Clin Ultrasound.2008 Jul-Aug; 36(6):352-66. |

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| |3) Timothy B. Jang, MD, Wendy Ruggeri, MD, Pamela Dyne, MD and Amy H. Kaji, MD, PhD. Learning Curve of Emergency Physicians Using Emergency |

| |Bedside Sonography for Symptomatic First-Trimester Pregnancy. Journal of Ultrasound in Medicine. October 1,2010; vol,29 no,10 1423-1428. |

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| |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. |

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| |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 appears 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 Obstet Gynecol. 2003 Jan 21; (1):62. |

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|9. |Signature of Candidate : |

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|10. |Remarks of the Guide : |

| |Bleeding per vagina in first trimester of pregnancy is a very common presentation and diagnosis of the cause is done mostly on the history and |

| |clinical examination. Many times clinical examination is difficult and may not be accurate. Management depends on an accurate diagnosis which can|

| |be obtained only by ultrasound examination. On ultrasound findings, even with bleeding, it depends whether to allow the pregnancy to continue or |

| |not, which cannot be done otherwise. Hence this study is taken up aptly for an accurate, quick diagnosis. |

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| |Name & Designation of |

|11. |(in block letters) |

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| |11.1 Guide |DR. GEETA.S.SHANKAR |

| | |PROFESSOR, |

| | |Department of RADIO-DIAGNOSIS, |

| | |M.V.J Medical College And Research Hospital |

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| |11.2 Signature | |

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| |11.3 Co-Guide (if any) |DR.SUJATA N.DATTI. |

| | |PROFESSOR, |

| | |Department of OBSTETRICS AND GYNAECOLOGY, |

| | |M.V.J Medical College And Research Hospital. |

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| |11.4 Signature | |

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| |11.5 Head of Department |DR. T.RAMACHANDRA PRASAD, |

| | |PROFESSOR & HEAD OF DEPARTMENT, |

| | |Department of RADIO-DIAGNOSIS, |

| | |M.V.J Medical College And Research Hospital. |

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| |11.6 Signature | |

|12 | | |

| |12.1 Remarks of the chairman & principal | |

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| |12.2 Signature | |

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