1



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1 |Name of the candidate and address ( in block |: |Dr. PAULAMI DEY |

| |letters) | |DEPARTMENT OF Obstetrics and Gynaecology |

| | | |MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA – 585105 |

| |Permanent address |: |DR.PAULAMI DEY |

| | | |C/O SHRI SWAPAN KUMAR DEY |

| | | |FLAT NO C-201 JAILAXMI COMPLEX , FAFADIH, RAIPUR ,CHHATTISGARH 492009 |

|2 |Name of the institution |: |H.K.E. SOCIETY’S MAHADEVAPPA |

| | | |RAMPURE MEDICAL COLLEGE, |

| | | |GULBARGA – 585105 |

|3 |Course of study and subjects |: |m.S (Obstetrics and Gynaecology ) |

|4 |Date of admission to the course |: |21 MAY 2012 |

|5 |Title of Topic |: |single ultrasonic biparietal diameter, femur length, abdominal circumference |

| | | |and head circumference in full term pregnancy and their use in predicting |

| | | |gestational age and fetal birth weight. |

|6 |Brief Resume of the intended work |

| |6.1 |Need for the study |

| | | Predicting gestational age and birth weight is the most important part of obstetrics management. Many obstetrical decisions |

| | |are influenced by the weight of fetus and gestational age. Ultrasonography has revolutionized this field by being non |

| | |invasive, simple OPD procedure causing no discomfort, so better accepted by patients. All the above advantages makes |

| | |ultrasound at present the best available tool for obtaining certain fetal parameters that correlate with fetal weight and |

| | |gestational age. |

| | | |

| | |In 1974, Dr. Ian Donald , a pioneer in obstetric ultrasound observed “A day may come shortly when a routine ultrasonographic |

| | |examination will be offered to every pregnant patient.”Today three USG studies are routine in India. |

| | | |

| | |It is generally accepted that a simple, accurate and universally applicable method to access in utero fetal weight and |

| | |accurate gestational age leads to an improved prospective management of high risk pregnancies and a possible reduction in |

| | |perinatal morbidity and mortality . |

| | |Conventional methods of estimation of birth weight using clinical parameters are neither accurate nor reproducible. Johnson’s|

| | |formula (1957) and down’s formula (1981), though very easy are less accurate. The fetal parameters used for estimating fetal |

| | |weight are BPD , AC, HC and FL. |

| | | |

| | |Wartsoff et al 1977 found combination of BPD and AC to be more accurate. They are 78% accurate within 10% of actual birth |

| | |weight. Similarly , shepherd et al in 1982(error of 40.85gms/kg)and key et al in 1983(falling in 10% of error) found |

| | |different accuracy. Thus , different accuracy by different authors prompted us to carry out present study. |

| | | |

| | |Similarly, it is rather difficult to assess accurate gestational age especially in our country. In a developing country like |

| | |India women do not remember exactly the normal menstrual date. Majority of them attend antenatal clinics late in pregnancy or|

| | |present themselves when complications have set in. It becomes important to estimate the gestational age for proper |

| | |management. So the importance of knowing the predictive value of different parameters in estimating gestational age in late |

| | |pregnancy. |

| | | |

| | |It is well known fact that prematurity and low birth weight are leading factors associated with neonatal mortality and |

| | |morbidity and survivors with long term sequelae of learning disabilities, mental retardation of varying degrees etc. At the |

| | |same time prolonging the pregnancy after attaining maturity with wrong assessment of gestational age is dangerous to fetus |

| | |because of placental insufficiency. Similarly , identification of large for gestational age babies helps to detect maternal |

| | |diabetes mellitus which helps us to be more cautious during delivery (as it leads to CPD, shoulder dystocia, difficult |

| | |labour) and also in future pregnancies. Perinatal morbidity and mortality increases dramatically if these parameters are not |

| | |taken care for. |

| | | |

| | |Presently , it appears that the most effective way to date pregnancy is by use of ultrasound examination of various |

| | |parameters of fetus like BPD , FL, HC and AC etc. the ideal time for routine ultrasound study is 16-18 weeks. At this |

| | |gestational age , pregnancy can be accurately dated and majority of fetal anomalies can be picked up. |

| | |But India being economically backward country , cost effectiveness of doing serial scanning which can determine gestational |

| | |age more accurately is questioned. |

| | | |

| | |Keeping in view all the above factors the present study involves predictive value of estimating gestational age and fetal |

| | |weight by single ultrasound reading in term pregnancy. |

| | | |

| | | |

| |6.2 |Review of Literature |

| | |1.Akinola, R.A.1*, Akinola, O.I.2 and Oyekan, O.O.3 Educational Research and Review Vol. 4 (1), pp. 016-020, January, 2009 |

| | |Sonography in fetal birth weight estimation. The information and knowledge gained through this study, comparing a combination|

| | |of various fetal parameters using computer assisted analysis, will help the obstetrician to screen the high risk pregnancies,|

| | |monitor the growth and development, and determine the gestational age and weight of fetuses more accurately. A prospective |

| | |ultrasonic study of 120 booked pregnant patients, with singleton pregnancies, at term, without any chronic illness was done 1|

| | |- 20 days prior to delivery. Measurements of their head and abdominal circumference (HC and AC), biparietal diameter (BPD) |

| | |and femur length (FL) were obtained to calculate the fetal birth weight. Computerized statistical evaluation was done using |

| | |various internationally recognized models and results were compared with actual birth weight at delivery. The gestational age|

| | |at delivery was between 37 - 42 weeks. The age range of patients was between 16 - 41 years, with a mean of 30.7 years. The |

| | |actual range of birth weights was 2500 – 4700 g, with a mean of 3390 g (SD 381). This study showed that regression models |

| | |incorporating HC and AC were not as good as those using AC and BPD. The use of femur length and abdominal circumference, |

| | |AC/FL, did not improve accuracy. The use of multiple parameters, gives the most accurate prediction of fetal weight. |

| | | |

| | |2.Ben-Haroush A, Yogev Y, Bar J, Mashiach R, Kaplan B, Hod M, |

| | |Meizner I (2004). Ultrasound Obstet. Gynecol. 23(2):172-176 they evaluated the accuracy of sonographically estimated fetal |

| | |weight in 840 women with different pregnancy complications prior to induction of labor.:To evaluate the accuracy of |

| | |sonographically estimated fetal weight (EFW) shortly before induction of labor in the presence of different pregnancy |

| | |complications, and to define possible variables affecting it.The study sample consisted of 840 women with singleton |

| | |pregnancies and cephalic presentation who were admitted to our unit for induction of labor between January 1999 and December |

| | |2000. All underwent detailed ultrasound assessment for EFW, amniotic fluid index, biophysical profile and placental location.|

| | |Indications included previous Cesarean section, postdate pregnancy, pregnancy-induced hypertension, diabetic pregnancy, |

| | |suspected large-for-gestational age (LGA) infants, suspected fetal growth restriction (FGR), oligohydramnios, decreased fetal|

| | |movements, premature rupture of membranes at or before term. EFW was calculated after measuring fetal abdominal circumference|

| | |and femur length. The EFW was compared with the weight at delivery, 1-3 days later. They c sonographic EFW is highly |

| | |correlated with birth weight. However, clinicians should be aware of the risk of overestimation in pregnancies with suspected|

| | |LGA and underestimation in pregnancies with PPROM and suspected FGR. |

| | | |

| | |3.D. A. Nzeh, MBBS, FMCR, S. Rimmer, FRCR, *W. M. 0. Moore, FRCOG and tl_. Hunt, PhD 1992, The British Journal of Radiology,|

| | |66, 987-989 Prediction of birthweight by fetal ultrasound biometry was done. A total of 104 |

| | |women with singleton pregnancies who were delivered between 37 and 42 weeks gestation had ultrasound scans during the |

| | |fortnight before delivery. The biparietal diameter (BPD), abdominal circumference (AC) and femur length (FL) were measured in|

| | |all cases. Estimation of fetal weight (EFW) was done by four different methods: using AC alone, AC/BPD, AC/FL and AC/BPD/FL. |

| | |Results were compared with values of actual birthweights at delivery. There was no significant difference between the mean |

| | |birthweights of the 47 boy and 57 girl fetuses studied. The EFW(Shepard) method showed the least bias overall: mean |

| | |percentage error 1.7%, standard deviation (SD) 10.6%. The other three methods significantly underestimated birthweights on |

| | |average: EFW(Deter), mean error 2.2%, SD 9.3%, p < 0.02; EFW^^p,^, mean error 5.4%, SD 9.5%, p < 0.001; EFW(Hadlock), mean |

| | |error 5.6%, SD 9.3%, p < 0.001. The percentage error in each group was significantly negatively correlated (p < 0.001) with |

| | |the scan-delivery interval. Two new equations were generated which gave more accurate |

| | |predictions for the cases under study using AC, BPD and FL as a combination and also in addition to scan-delivery interval |

| | |(SDI) in days. Comparison of fetal weight models from different studies has shown that the use of multiple parameters, and in|

| | |particular the combination of head, abdomen and femur length measurements, provide the most adequate estimations of fetal |

| | |weight with 95% confidence interval in the range of 15-16% (Hadlock, 1990).Studying the weight estimation for fetuses small |

| | |and large for their gestational age, it was observed that only formulae dependent on femur length (FL) fitted both groups |

| | |well (Miller et al, 1988). Abdominal diameter measurement has been found to be less accurate in cases of oligohydramnios |

| | |because the fetal skin edge may be |

| | |difficult to identify when liquor volume is diminished. |

| | | |

| | |4.Carol B. Benson1 Peter M. Doubilet: AJR 157:1275-1277, December 1991 |

| | |Sonographic Prediction of Gestational Age: Accuracy of Second-and Third-Trimester Fetal Measurements .They measured the |

| | |accuracy of second- and third-trimester sonographic predictors of gestational age against highly reliable gold standard |

| | |(crown-rump length) in a group of fetuses. Using a prospectively collected computerized data base, we selected 460 fetal |

| | |sonograms obtained at 14-42 weeks of gestation in which age could be reliably established on the basis of crown-rump length |

| | |in the first trimester. We used data obtained from these sonograms to compare several predictors of fetal age. The accuracy |

| | |of all predictors worsened progressively as pregnancy proceeded. In the second trimester, corrected biparietal diameter and |

| | |head circumference were more accurate predictors of gestational age than were biparietal diameter, femoral length, and |

| | |abdominal circumference (p < .05, F test). In the third trimester, the corrected biparietal diameter, head circumference, and|

| | |femoral length were the best predictors, significantly better than biparietal diameter and abdominal circumference (p < .05, |

| | |F test). Prediction of gestational age that relies on a single sonographic measurement should be based on the head |

| | |circumference or corrected biparietal diameter in the second trimester and on one of these two predictors or the femoral |

| | |length in the third trimester |

| | | |

| | |5.Egley CC, Seeds JW, Cefalo RC. AM J Perinatol..1986 Apr;3(2):77-9. |

| | |They studied Femur length versus biparietal diameter for estimating gestational age in the third trimester. It is well |

| | |established that ultrasound measurement. The present study compares the relative accuracy of biparietal diameter and femur |

| | |length when obtained in the third trimester. It is concluded from linear regression analysis that the correlation between |

| | |gestational age estimated from femur length and the actual gestational age is stronger than that between gestational age |

| | |estimated from biparietal diameter and actual gestational age. Furthermore, gestational age calculated from femur length is |

| | |significantly more likely to be within 2 weeks (P less than or equal to .01) and 3 weeks (P less than or equal to .05) of |

| | |actual gestational age than is gestational age calculated from biparietal diameter. Estimating gestational age from the mean |

| | |of the gestational age based on biparietal diameter and that based on femur length is less accurate than estimating |

| | |gestational age from femur length alone. |

| | | |

| | |6.Wolfson RN, Peisner DB, Chik LL, Sokol RJ. J Ultrasound Med 1986 Mar;5(3):145-9. There was Comparison of biparietal |

| | |diameter and femur length in the third trimester: effects of gestational age and variation in fetal growth. A multiple |

| | |regression-based statistical model capable of quantitatively comparing two or more sonographic parameters for the effects of |

| | |gestational age, variation in fetal growth and error in sonographic measurement is presented and then used to compare the |

| | |biparietal diameter and femur length as estimators of gestational age in late pregnancy. A total of 311 patients were studied|

| | |between 24 and 42 weeks' gestation. Variation in fetal growth was expressed as the birth weight percentile for gestational |

| | |age. Biparietal diameter and femur length correlated equally well with gestational age. However, the biparietal diameter was |

| | |more than twice as sensitive as the femur length to variation in fetal growth. Femur length had a larger error associated |

| | |with its measurement. These results suggest that the biparietal diameter and femur length in late pregnancy are equal |

| | |estimators of gestational age; that the femur length is a more stable estimator of gestational age when fetal growth deviates|

| | |from normal; and that the femur length is technically more difficult to obtain. |

| | | |

| | |7.Hadlock FP, Deter RL, Harrist RB, Park SK . JCU1983 Aug;11(6):313-6. |

| | |Computer assisted analysis of fetal age in the third trimester using multiple fetal growth parameters. A new technique is |

| | |described for predicting menstrual age in the third trimester of pregnancy (28-42 weeks) using multiple fetal growth |

| | |parameters (biparietal diameter, head circumference, abdominal circumference, femur length). Evaluation of this technique in |

| | |177 normal third trimester pregnancies demonstrated that significant improvement in the variability in predicting menstrual |

| | |age can be achieved when two or more parameters are used collectively instead of a single parameter used individually. The |

| | |optimal combination prior to 36 weeks was biparietal diameter, abdominal circumference, and femur length, while after 36 |

| | |weeks the optimal combination was head circumference, abdominal circumference, and femur length. The use of these |

| | |combinations resulted in smaller mean errors, standard deviations, and maximum errors. |

| | | |

| | |8.Yeh MN, Bracero L, Reilly KB, Murtha L, Aboulafia M, Barron BA. Am J Obstet Gynecol. 1982 Nov 1;144(5):519-22.Ultrasonic |

| | |measurement of the femur length as an index of fetal gestational age.Fetal femur length was measured with a linear-array, |

| | |real-time ultrasound scanner in 145 uncomplicated gravid patients from 16 to 42 weeks' gestation. The data were analyzed by |

| | |means of the method of least-squares linear regression. The results of this analysis generated the following equation: Y = |

| | |-0.6809 + 0.2127 X (Y = femur length; X = gestational age.) With the use of these data, the error in estimation of |

| | |gestational age given femur length in the interval 25 to 35 weeks' gestation is less than 5 days. Outside these intervals, |

| | |there is less precision in this measurement, with a range from 8 days at 15 weeks to 6 days at 40 weeks. Furthermore, the |

| | |correlation coefficient of gestational age versus fetal femur length is statistically greater than that of the gestational |

| | |age versus fetal biparietal diameter. These results suggest that the measurement of the fetal femur length is a more precise |

| | |index of gestational age than is the biparietal diameter. We propose that the ultrasonic measurement of the fetal femur |

| | |length is a sensitive and precise variable for estimation of fetal growth and development. |

| | | |

| |6.3 |Objectives of the study |

| | | |

| | |1. To evaluate the usefulness and accuracy of foetal growth monitoring by comparing a single reading of foetal femur length ,|

| | |biparietal diameter, head circumference and abdominal circumference in predicting gestational age and birth weight. |

| | |2. Comparison of biparietal diameter ,femur length, head circumference and abdominal circumference at term (38-42weeks) as a |

| | |predictor of gestational age and birth weight. |

| | |3. Comparison of gestational age as obtained by BPD and FL with the known gestational age as got from LNMP. |

| | |4. Comparison of birth weight as obtained by BPD and AC with the actual birth weight. |

| | |5. Comparison of the gestational age as obtained by BPD and FL with estimated age of baby postnatally using Dubowitz scoring|

| | |method. |

| | |

| | |

|7 |Materials and methods |

| |7.1 |Source of data |

| | |Patients at term admitted to either Basaveshwar Teaching and General Hospital and Sangameshwar Hospital, attached to MRMC, |

| | |Gulbarga. |

| | | |

| | |Study period : Dec 2012 to August 2014 |

| | | |

| |7.2 |Methods of collection of data (including sampling procedure, if any) |

| | |Inclusion criteria |

| | |1.Full term pregnancies(38weeks-42weeks) |

| | |2. Single live fetus with vertex presentation with absence of any maternal diseases. |

| | | |

| | |Exclusion criteria |

| | |1.congenital malformation |

| | |2.multiple pregnancy |

| | |3.malpresentation. |

| | |4.Engaged head |

| | |5.Obstructed labour |

| | | |

| | |Sampling procedure: All 100 samples were selected by simple random sampling technique after considering all inclusion |

| | |criteria in the study. |

| | | |

| | |Collection of data: After applying jelly to the patients abdomen ultrasound examination was done using the abdominal |

| | |transducer and fetal parameters of BPD ,AC, HC and FL noted. After birth external cephalometry was performed using a pair of|

| | |steel calipers to measure biparietal diameter within 24hours of birth . |

| | | |

| | |Data Analysis: It will carried out by mean ,standard deviations , correlation and proportions and tested with test of |

| | |significance of chi-square test, paired and unpaired t-test, ANOVA, and other test which are necessary and revealed by spss |

| | |17.5 version. |

| | | |

| |7.3 |Does the study require any investigation or intervention to be conducted on patients or other humans or animals? if so please|

| | |describe briefly |

| | |100 women at term admitted to either Basaveshwar Teaching and General Hospital and Sangameshwar Hospital .Cases were |

| | |selected after thorough history taking and clinical examination. |

| | | |

| | |A detailed history of present pregnancy in terms of parity, period of amenorrhoea , regularity of cycles has to be asked for |

| | |and a general and systemic examination and obstetrical examination is to be conducted. Ultrasound examination of all the |

| | |cases has to be done prior to delivery . BPD, AC and HC, FL measured and co-related with fetal birth weight and |

| | |gestational age . |

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

| | |Yes. Ethical clearance has been obtained from “Ethical clearance committee” of the institution. |

| | | |

| | |The consent from the patients taken. |

| 8 |List of Reference |

| |Akinola, R.A, Akinola OI and Oyekan OO. Sonography in fetal birth weight estimation. Educational Research and Review Vol. 4 (1), pp. |

| |016-020, January, 2009. |

| |Ben-Haroush A, Yogev Y, Bar J, et al. to evaluate the accuracy of sonographically estimated fetal weight (EFW) shortly before induction |

| |of labor in the presence of different pregnancy complications, and to define possible variables affecting. Ultrasound Obstet. Gynecol. |

| |2004; 23 (2): 172-176. |

| |D. A. Nzeh, MBBS, FMCR, S. Rimmer, FRCR, *W. M. 0. Moore, FRCOG and tl_. Hunt, PhD 1992, The British Journal of Radiology, 66, 987-989 |

| | |

| |Carol B. Benson1 Peter M, Doubilet . Sonographic prediction of Gestational age. AJR. 1991 Dec; 157:1275-1277. AJR 157:1275-1AJR |

| |157:1275-1277, December 1991277, December 1991 |

| |Egley CC, Seeds JW, Cefalo RC. AMJ Perinatol..1986 Apr;3(2):77-9. Femur length versus biparietal |

| |diameter for estimating gestational age in the third trimester. |

| |Wolfson RN, Peisner DB, Chik LL, Sokol RJ. Comparison of biparietal diameter and femur length in the third trimester. J Ultrasound Med.|

| |1986 Mar;5(3):145-9. |

| |Hadlock FP, Deter RL, Harrist RB, Park SK. Computer assisted analysis of fetal age in the third trimester using multiple fetal growth |

| |parameters. JCU1983 Aug;11(6):313-6. |

| | |

| |Yeh MN, Bracero L, Reilly KB, Murtha L, Aboulafia M, Barron BA. ultrasonic measurement of femur length as an index of fetal gestational |

| |age, Am J Obstet Gynecol. 1982 Nov 1;144(5):519-22. |

| |Salomon LJ , Bernard JP, Ville Y (2007). Estimation of fetal weight :reference range at 20-36 weeks’ gestation and comparison with |

| |actual birth-weight reference range. Ultrasound Obstet Gynecol. 29(5):550-555. |

| |Selbing A. Conceptual dating using ultrasonically measured fetal femur length and abdominal diameters in early pregnancy. Br J Obstet |

| |Gynaecol. 1986 Feb;93(2):116-21. |

| | |

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| | | |

|9 |Signature of Candidate | |

| | |The study has immense value in the prediction of gestational age and birth weight |

|10 |Remarks of guide |using USG parameters and henceforth helps in taking many obstetrical decisions for|

| | |high risk pregnancies and has been suggested by me as the topic for dissertation.|

| | | | |

|11 |11.1 |Name and designation of the | |

| | | | |

| | |Guide |Dr. mangala . b. rudrawadi |

| | | |MS (OBG) |

| | | |ASSOCIATE PROFESSOR, |

| | | |DEPARTMENT OF OBG, |

| | | |M.R. MEDICAL COLLEGE, GULBARGA |

| | | | |

| |11.2 |Signature | |

| | | |Dr. CHETAN DURGI |

| |11.3 |Co- guide (if any) |MD( RADIODIAGNOSIS) |

| | | |PROFESSOR, |

| | | |DEPARTMENT OF RADIOLOGY, |

| | | |M.R.MEDICAL COLLEGE,GULBARGA |

| | | | |

| |11.4 |Signature | |

| | | | |

| |11.5 |Head of the Department |Dr. Gangambika M Nisty |

| | | |MD. (OBG) |

| | | |PROFESSOR AND HOD |

| | | |DEPARTMENT OF OBG |

| | | |M.R.MEDICAL COLLEGE, GULBARGA |

| | | | |

| |11.6 |Signature | |

| | | | |

|12 |12.1 |Remarks of the Chairman and Principal | |

| | | | |

| |12.2 |Signature | |

| | | | |

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