RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE AND DR. B. SWETHA ADDRESS D/O LATE DR. B. MUNI SWAMY (in block letters) FLAT 3D, IQBAL APARTMENTS, 3-4-540, NARAYANGUDA. HYDERABAD. ANDHRA PRADESH.

2. NAME OF THE INSTITUTION NAVODAYA MEDICAL COLLEGE HOSPITAL & RESEARCH CENTER, RAICHUR. KARNATAKA. 584103.

COURSE OF THE STUDY AND 3. SUBJECT M D IN RADIODIAGNOSIS

4. DATE OF ADMISSION TO COURSE 30-05-2013

5. TITLE OF THE TOPIC: “ROLE OF ULTRASOUND IN DETECTING THE CONGENITAL ANOMALIES IN THE FETUS IN THE SECOND TRIMESTER OF PREGNANCY”

BRIEF RESUME OF THE INTENDED APPENDIX-I 6. WORK

APPENDIX - IA

1 6.1 : NEED FOR THE STUDY: Congenital fetal anomalies are one of the most threatening complications which are prevalent in the society associated with severe morbidity and mortality in the new born fetus or neonates. Ultrasound is the best possible non-invasive technique available to detect any congenital anomalies in pregnant women which will help to identify the severity of the disease, its outcome leading to pregnancy termination or gives an opportunity for fetal therapy or better neonatal care.

The study would determine the sensitivity and specificity of ultrasound modality in evaluating congenital fetal anomalies. Many modalities are available to detect congenital anomalies at an early stage like laboratory & imaging studies, out of which sonography has emerged as the investigation of choice. Ultrasound is non-invasive and safe and hence can be used repeatedly. It is quick, inexpensive, and sensitive causing no discomfort to the patient at any time of gestation. Fetal anomaly scan is usually carried out at second trimester of pregnancy.

APPENDIX – IB

2 6.2 REVIEW OF LITERATURE: A study conducted by Trish Chudleigh1 from Rosie Ultrasound Department, Cambridge University Hospitals NHS Foundation Trust stated that Ultrasound screening for fetal abnormalities has been available to pregnant women in England for over two decades. The Department of Health commissioned the Fetal Anomaly Screening Programme to develop and extend the second trimester anomaly scan to ensure an effective and accessible service for all pregnant women in England.

Muhammad Nafees, Muhammad Hamid Akram, Makki Muhammad Afridi and Aqsa Javed have conducted an ultrasonographic study on 200 patients out of which 134 had different congenital anomalies.2 The most common congenital anomalies detected were from central nervous system with relatively more prevalent in cousin marriages.

According to Sarah A. Waller, Theodore J. Dubinsky and Manjiri Dighe3 Ultrasonography provides patients with an excellent means of screening for anomalies, and the use of soft markers has individualized each patient’s decision to pursue diagnostic testing.

A study conducted by Grandjean H et al, on the purpose of the Eurofetus study was to evaluate the accuracy of the antenatal detection of malformations by routine ultrasonography in unselected populations concluded that systemic ultrasonographic screening during pregnancy can now detect a large population of fetal malformations.4

A report published in ‘The society of Obstetricians and Gynaecologists of Canada’ by Yvonne Cargill and Lucie Morin was done to review the benefits and requirements for a complete second trimester ultrasound and the documentation needed. The outcome of the report was that a complete second trimester ultrasound provides information about the number of fetuses, the gestational age, the location of the placenta, and fetal and maternal anatomy.5

APPENDIX - IC

6.3 AIMS AND OBJECTIVES OF THE STUDY:

3 1. To evaluate the efficacy of antenatal sonography in the detection of various congenital anomalies of fetus in second trimester pregnancy.

2. To detect the incidence of various congenital malformations in antenatal cases in patients presenting with risk factors.

3. The risk factors are as follows:  Maternal age - elderly primi age more than 30.  Consanguineous marriages.  History of congenital anomaly in family or previous gestation of congenital anomaly.

7. MATERIALS AND METHODS APPENDIX-II

4 A prospective study will be done. After clinical evaluation & patient selection, Sonography for fetal congenital anomalies will be performed in second trimester pregnancy. The antenatal sonographic findings will be correlated with the pregnancy outcome in terms of normal fetus or fetus with malformations

APPENDIX – IIA

7.1 Source of data: The main source of data for this study will be patients referred from Department of Obstetrics & Gynaecology, NAVODAYA MEDICAL COLLEGE, RAICHUR.

APPENDIX - IIB 7.2 Method of collection of data : All pregnant females of second trimester who are referred from obstetrics and gynaecology department and thus sent to department of Radio diagnosis for antenatal sonographic examination. A complete antenatal ultrasound examination of pregnant women included in the study will be done using gray scale & colour duplex examination. Study Design : Prospective Study Study Period : 18 Months

Inclusion Criteria: All pregnant women coming for antenatal sonographic examination during the second trimester at Department of Radio diagnosis, NET, Raichur.

Exclusion Criteria : 1. Multiple gestations.

APPENDIX - IIC 7.3 Does the study require any investigation or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.

5 Ultrasonographic examination on the antenatal patients who are referred to the Department of RADIODIAGNOSIS, Navodaya Medical College, Raichur.

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

8. APPENDIX – III List of references: 1. Yvonne Cargill and Lucie Morin Content of a Complete Routine Second Trimester Obstetrical Ultrasound Examination and Report – 223 published March 2009.

2. Muhammed Nafees, Muhammad Hamid, Akram, Makki Muhammed Afridi and Aqsa Javed Congenital Fetal Anomalies Antenatal Ultrasound Detection Issue year : 2006, Issue No: 3, Issue month September.

3. Trish Chudleigh The British Medical Ultrasound Society doi : 10.1258/ult.2010.010014 Ultrasound May 2010 Vol no18, 292–98.

4. Sarah A.Waller, Theodore J. Dubinsky and Manjiri Dighe Ultrasound Clinics Jan 2011 Vol 6, Issue 1, Pages 11-24.

5. Grandjean H, Larroque D, Devis The performance of routine Ultrasonographic Screening of Pregnancies in the Eurofetus study Am J Obstel Gynecol.1999 Aug; 181(2):446-54

9. Signature of the candidate

10. Remark of the guide The study helps to know the common causes of congenital anomalies.

6 11. 11.1 Name and Dr. M.BHARATHI designation of Guide PROFESSOR DEPARTMENT OF RADIO-DIAGNOSIS NAVODAYA MEDICAL COLLEGE, RAICHUR.

11.2 Signature

11.3 Head of the Dr. JAYSHREE.R.G. Department PROFESSOR AND HEAD OF DEPARTMENT OF RADIO-DIAGNOSIS NAVODAYA MEDICAL COLLEGE, RAICHUR.

11.4 Signature

12 12.1 Remarks of the Principal

12.2 Signature

7