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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA PROFORMA FOR REGISTRATION OF DISSERTATION TOPIC TRANSVAGINAL SONOGRAPHY IN FIRST TRIMESTER OF PREGNANCY DR. ADITHI S HEGDE POSTGRADUATE DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY K.S.HEGDE MEDICAL ACADEMY DERALAKATTE, MANGALORE - 575018. RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE. PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION 1. Name of the candidate And Address Dr. ADITHI.SATHYANANDA HEGDE POSTGRADUATE DEPARTMENT OF OBG K.S.HEGDE MEDICAL ACADEMY DERALAKATTE,MANGALORE KARNATAKA- 575018 2. Name of institution K.S.HEGDE MEDICAL ACADEMY DERALAKATTE,MANGALORE KARNATAKA-575018 3. Course of study and subject MASTER OF SURGERY in OBSTETRICS AND GYNAECOLOGY 4. Date of admission to course 31ST MAY 2007 5. Title of topic “TRANSVAGINAL SONOGRAPHY IN THE FIRST TRIMESTER OF PREGNANCY” 6 BRIEF REUME OF THE INTENDED WORK 6.1 NEED FOR THE STUDY First trimester pregnancy is a dynamic period , during which changes occur in human development at a more rapid rate than any other time during human life1. First trimester scanning is useful to identify normal pregnancies and abnormalities in early development of a pregnancy including miscarriage and ectopic pregnancies and provides the most accurate dating of a pregnancy2 . Transvaginal ultrasound has revolutionised the diagnosis of early pregnancy as it can detect a pregnancy at an earlier stage, whether it is normal and therefore reassuring or abnormal and requires intervention3. Transvaginal ultrasound has proven to be more accurate than transabdominal scan in the diagnosis of early pregnancy and its complications.It allows earlier and detailed visualisation of the gestational sac followed by the yolk sac and embryonic fetal pole and any abnormalities one week earlier4,5 . Yolk sac measurement in early gestation is a useful marker for pregnancy outcome2. 6.2 REVIEW OF LITERATURE According to the study done by Jain KA , Hamper UM , Sanders RC5, 90 women with symptoms(about 4-5 weeks) were studied. Transvaginal detected 100% of pregnancies while transabdominal identified only 20%. Yolk sac was identified from 34 days of gestation by transvaginal sonography and was identified from 42 days of gestation by transabdominal sonography. 117 first trimester singleton pregnancies were studied by Stampone C, Nicotra M, Muttinelli C, Cosmi EV 2 to evaluate yolk sac size and abnormalities using transvaginal ultrasound. A yolk sac of abnormal size was statistically significant ( p < 0.001 ) in spontaneous abortion when compared with normal pregnancy outcomes with a sensitivity of 68.7% , a specificity of 99% , positive predictive value of 91.6% and negative predictive value of 95.2%. According to the study done by Hernadi L, Farkas M6 on 180 patients in first trimester in both normal and pathological pregnancies, the sensitivity of transvaginal sonography in ectopic pregnancies , especially unruptured ectopic pregnancy is very high. Among 425 women in first trimester pregnancies studied by Basamar FM, Crosfill F, Price A,7 transvaginal ultrasound was considered not embarrassing(88.9%), acceptable(98%), not painful(98.6%) and not stressful(90.6%). According to the study done by Sydow P, Lisse K, Wilken T ,Pfuller B8 on 401 transvaginal sonographic examinations in first trimester , it is possible to study details of embryonic development in first trimester 1-2 weeks earlier than with abdominal ultrasound. Mariette H Schouwink et al4 studied 372 first trimester pregnancies who underwent transvaginal ultrasound. Among them 92( 25%) were non-viable. The combination of absence of both yolk sac and cardiac activity gave a specificity of 99% and sensitivity of 40%. 6.3. AIMS AND OBJECTIVES: 1. Comparison of Transabdominal and Transvaginal sonography in the first trimester of pregnancy- normal and pathological 2. To study the significance of the yolk sac- presence, size and shape as a predictor of pregnancy outcome for the first trimester. 3. To study the women’s perception of transvaginal sonography in first trimester of pregnancy. A study was done by Mitra AG et al9 in 141 patients between 6weeks and 11weeks of gestation who underwent both transvaginal and transabdominal Doppler evaluation for detection of fetal heart rate. Transvaginally it was detected in 60.5% and in 87.5% and Transabdominally it was 22.9% and 56% at 8 and 9 weeks respectively. Mayank Goyal et al10 compared the Transabdominal and Transvaginal ultrasounds of 60 patients. According to their study Transvaginal ultrasound has a temporal advantage of one week over Transabdominal scan in both normal and abnormal pregnancies. 6.3 AIMS AND OBJECTIVES 1.Comparison of Transabdominal and Transvaginal sonography in the first trimester of pregnancy- normal and pathological 2.To study the significance of the yolk sac as a predictor of pregnancy outcome in the first trimester . 3.To study the women’s perception of transvaginal sonography in first trimester of pregnancy. 7. MATERIALS AND METHODS 7.1 SOURCE OF DATA 100 patients attending the OBG out patient department, inpatient wards of K.S.Hegde Charitable Hospital between November 2007 to June 2009 diagnosed to be in the first trimester of pregnancy, with their consent will be included. Inclusion criteria: All patients in the gestational age of 5- 12 weeks come either for confirmation of pregnancy , confirmation of gestational age or any other pregnancy related complaints who have given their consent will be included. Exclusion criteria 1.All patients in the gestational age of 5- 12 weeks who have not given their consent will be excluded. 2. If the patient has an active pelvic infection. 7.2 METHOD OF COLLECTION OF DATA Its a prospective study of a total of 100 patients with first trimester pregnancies. First a detailed History with thorough physical examination is done. Urine pregnancy test is done if not done before following which routine blood investigations and urine tests are done. Then ultrasound study is done on the patient. The Machine used for the study is-LOGIC 400 PROGE series The transducers used were1.For transabdominal scan: 3.5 MHz transducer 2.For transvaginal scan : 7 MHz transducer For each patient, first a trans abdominal scan is done on full bladder after which the patient empties her bladder and a transvaginal ultrasound was done. At each sonographic evaluation the following parameters are noted1. Gestational sac- location and measurement 2. Yolk sac3. Fetal pole 4. Crown rump length 5. Cardiac activity 6. Limb buds 7. Embryo body movements A scan is considered normal if it showed all the normal sonological features that particular gestational age and was considered abnormal if it showed any deviation from the findings considered normal for that particular gestation . The yolk sac was studied in detail. Then the patient’s perception of transvaginal ultrasound was also assessed by asking her certain questions. The patient will be followed up till end of first trimester and the pregnancy outcome will be noted. 7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly Yes , Investigations – Urine pregnancy test if not done before, routine blood investigations, urine test and Ultrasound- Transabdominal and Transvaginal. 7.4 Has ethical clearance been obtained from your institution in case of 7.3? Yes 8. LIST OF REFERENCES 1.Levi CS, Lyons EA, Lindsay DJ, Ultrasound in first trimester of pregnancy, fetal ultrasound . Radiologic Clinics of North America 1990; 28(1) 2.Stampone C, Nicotra M, Multinelli C, Cosmi EV, Transvaginal sonography of the yolk sac in normal and abnormal pregnancy. J Clinical Ultrasound 1996 Jan ; 24(1) : 3-9 3.Sawyer E, Jurkovic D, Ultrasonography in diagnosis and management of abnormal early pregnancy. Clinical Obstetrics Gynaecology 2007 March; 50(1) :31-54 4.Mariette H Schouwink, Bianca F Fong, Ben WJ Mol and Fulco van der Veen, Ultrasonographic criteria for non-viability of first trimester intrauterine pregnancy. Fertil Steril 2000 July ; IV(3) : 203-213 5..Jain KA, Hampu UM, Sanders RC, Comparison of transvaginal sonography and transabdominal sonography in detection of early pregnancy and its complications. AJR 1988; 151: 1139 6.Hernadi L, Torocsik M, Farkas M, Significance of transvaginal ultrasonic examination in the first pregnancy trimester. Orv Hetil 1990 Dec ;131(49) : 2687-91 7.Basama FM, Crosfill F, Price A, Women’s perception of transvaginal ultrasound in the first trimester; in an early pregnancy assessment unit.Arch Gynecol Obstet 2004 Jan; 269(2): 117-20. 8.Sydow P, Lisse K, Wilken T, Pfuller B, Vaginal sonography in diagnosis of early pregnancy. Zentralbe Gynekol 1989 ; 111(7) : 453-60 9.Mitra AG, Laurent SL, Moore JE, Blanchard GF Jr, Chescheir NC, Transvaginal versus transabdominal Doppler auscultation of fetal heart activity: A comparative study. July; 175(1) : 41-4 10.Mayank Goyal, Sushma Vashisht, Manorama Berry, Supriya Mayank, Vijay Lakshmi Bhargava, Comparitive evaluation of transabdominal and transvaginal sonography in first trimester of pregnancy: Ind J Radiol Imag 1994;4 :157-162. 9. Signature of candidate 10. Remarks of the guide 11. Name and designation of (in block letters) 11.1 Guide Dr.HARISH SHETTY MBBS MD DGO ASSOCIATE PROFESSOR DEPARTMENT OF OBG KSHEMA, MANGALORE 11.2 Signature 11.3 Co-guide(if any) Dr. RABINDRA PRABHU MDRD PROFESSOR AND HOD DEPARTMENT OF RADIOLOGY KSHEMA, MANGALORE 11.4 Signature 11.5 Head of the department Dr. D.K.SHETTY DGO, MRCOG ,FRCOG PROFESSOR AND HOD DEPARTMENT OF OBG KSHEMA, MANGALORE 11.6 Signature 12. 12.1 Remarks of the chairman and Principal 12.2 Signature PATIENT INFORMED CONSENT FORM Study title : “ TRANSVAGINAL SONOGRAPHY IN THE TRIMESTER OF PREGNANCY” FIRST INFORMATION First trimester scanning is a safe investigation which provides reassuarance , charts the normal development and identifies women with abnormal high risk pregnancy. My aim is to compare the transabdominal and transvaginal sonography in the first trimester of pregnancy – normal and pathological and to study the prognostic value of the ultrasound of yolk sac in first trimester of pregnancy and to study the women’s perception of transvaginal ultrasound. In the study all women with first trimester pregnancy will be asked a detailed history , followed by a physical examination and will be subjected to investigations- routine blood investigations and urine test and ultrasound- transabdominal and transvaginal and will be asked certain questions with regards to the perception of women on transvaginal ultrasound. CONSENT I ------------------------------- declare that I have been briefed and hereby consent to be included as a subject in the following dissertation “ Transvaginal Sonography In First Trimester Of Pregnancy” . I have been informed to my satisfaction by the attending Dr. Adithi . Sathyananda . Hegde, the purpose of work done and the required investigations . This has been explained to me in the language I understand and I fully consent for the same. Signature of the doctor Name of the doctor: Date: Signature of the patient PROFORMA NAME: OP/IP NO.: AGE: ADDRESS: SEX: DATE: PRESENTING COMPLAINTS: LMP: EDD: OBSTETRIC – HISTORY: MARRIED LIFE: MENSTRUAL- HISTORY: CYCLES: PAST- HISTORY: FAMILY- HISTORY: PERSONAL- HISTORY OBSTETRIC – FORMULA: ON EXAMINATION: EDEMA: ICTERUS: VITAL SIGNS: Temp: PR: HT: RR: BP: THYROID: BREAST: CVS: RS: OBSTETRIC EXAMINATION: P/A: P/S: INVESTIGATIONS: Hb: BL. GROUP: PCV: RBS: OTHERS: 1.GESTATIONAL- SAC -SITE : -SIZE : -SHAPE : 2.YOLK SAC -PRESENT/ABSENT: -SHAPE : -SIZE : - If abnormal – details: : 4.CROWN RUMP LENGTH: 5.CARDIAC PULSATION: 6.FETAL MOVEMENTS : 7.LIMB BUDS IMPRESSION: : P/V: URINE-ROUTINE: URINE PREGNANCY TEST: ULTRASOUND EXAMINATION: PARAMETERS TRANSABDOMINAL 3.FETAL POLE WT: : TRANSVAGINAL PALLOR: PATIENT’S PERCEPTION OF TRANSVAGINAL SONOGRAPHY: Do you have a prior knowledge of trasvaginal ultrasound? Did you find it embarrassing? Did you find it painful? If it has to be repeated will you consent for it again? ADVISE: FOLLOW UP: