RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE
KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1 / Name of the candidate and address / Dr. Ananya R.Pragathi Farms, 19th Km, Tumkur Road, Madavara Post, Madanayakanahalli, Bangalore 562 123.
2 / Name of the Institution / Kempegowda Institute of Medical Sciences & Research Center,
Bangalore 560 002.
3 / Course of the study and subject / M.S. in Obstetrics & Gynecology
4 / Date of admission to the course / 28 May 2010
5 / Title of the topic / Foetal Kidney Length as a Parameter for Determination of Gestational Age in Pregnancy
6 / Brief resume of the intended work
6.1 Introduction
The accurate knowledge of gestational age is a keystone in an obstetrician's ability to successfully manage the ante partum care of a patient and is of critical importance in ante-natal test and successful planning of appropriate therapy or intervention.
Failure can result in iatrogenic prematurity or post-maturity which is associated with increased perinatal morbidity and mortality.
Foetal kidney length fulfils the need of the hour; it is an investigational tool that will accurately predict the estimated date of confinement without being affected by the discrepancy of late trimester or by growth retardation of the foetus. [3]
In India, where routine early antenatal registration is not a very common phenomenon, particularly in the rural area and where illiteracy makes it difficult to elicit proper menstrual history, it is very imperative that accurate dating is available.
The foetal kidney length can hence be used as a valuable and easy diagnostic tool.
6.2 Review of literature
J.C.Konje et al [4] conducted a study on 73 uncomplicated singleton pregnancies to determine kidney length every two weeks between 24 and 38 weeks gestation. Linear regression models were derived using the data and the study concluded that kidney length could predict the gestational age with a standard error of ±8.57 days.
Nahid Yusuf et. al. [5] conducted a prospective study in 102 pregnant women after 30 weeks of pregnancy whose gestational ages were confirmed by early USG. (<24 weeks). The aim of this study was to establish a correlation between the fetal kidney length & gestational age in 3rd trimester. The mean fetal kidney length in mm approximates the gestational age in weeks in 3rd trimester as predicated by BPD, FL, AC & HC (P<0.001). Maternal height, weight & socioeconomic status did not show any effect on growth of fetal kidneys. The result obtained confirmed that measurement of fetal kidney length in mm can be used as an additional parameter for documentation of gestational age in 3rd trimester & also an early means of detection of abnormal renal development.
Kyosun Kim et. al.[6] determined the sonographic standards of normal fetal kidney in 229 foetus after 20 weeks gestation and reported a mean kidney length for each gestational age was derived using Regression equations. In conclusion kidney size showed linear correlation to gestational age and growth rate of fetal kidney length was 0.87mm and width was 0.47mm per week after 20th week.
JJ Kansaria et. al. [3] conducted a study on 70 women who were sure of their LMP and had regular cycles to determine foetal biometry at two weekly intervals between 22 and 38 weeks gestation. They concluded that kidney length grows at rate of 1.7 mm fortnightly and that pregnancy could be dated within 9.17 days in women booking late or in those who did not know their LMP.
Harris L et. al. [7] determined the kidney length in 498 foetus between 18 and 41 weeks gestation and showed that strong correlation existed between gestational age and kidney length and that no significant difference was found between right and left kidneys.
6.3 Objective of the study
· To assess the application and accuracy of foetal kidney length measurement in determining the gestational age of the foetus and to compare its accuracy with that of other foetal biometric indices.
· To study the effect of IUGR on kidney length.
7 / Materials and methods
7.1 Source of data
Pregnant women booked at KIMS shall be made to undergo a serial ultrasound scanning after 24 weeks of gestation. Foetal kidney length will be estimated in the scans.
7.2 Method of collection of data
Ø STUDY PLACE:
o KIMS hospital Bangalore.
Ø STUDY PERIOD:
o One and half years.
Ø SAMPLE SIZE:
o 60
Ø SAMPLE DESIGN:
o Purposive sampling.
Ø PROCEDURE:
o Sixty women with singleton uncomplicated Pregnancies will undergo standard ultrasound fetal biometry and kidney length measurement periodically in pregnancy.
o These measurements will be used to date the pregnancies.
o Standard fetal biometry including BPD, FL, HC, & AC will also be recorded.
o The length of fetal kidney will be a bipolar measurement using gray scale real time ultrasonographic scanner with 3.5 mHz transducer.
o Comparisons will then be made between the accuracy of these models in the determination of gestational age.
Ø INCLUSION CRITERIA:
o Only singleton foetus with complete visualization of at least one kidney
o Booked antenatal cases at KIMS after 24 weeks of gestation calculated from LMP
o women who were certain of their last menstrual periods (LMP) and who had regular menstrual cycle
o Women who have had a dating scan done.
Ø EXCLUSION CRITERIA:
o Patients with known multiple pregnancies, suspected fetal anomalies & gross maternal obesity shall be excluded
o Unclear adrenal or renal borders, abnormal renal morphology & renal pelvic dilatation more than 4 mm
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals?
Yes.
INVESTIGATIONS:
Obstetric ultrasound to determine foetal kidney length.
Routine antenatal investigations as per hospital protocol.
On Animals : Nil
INTERVENTIONS:
Nil.
7.4 Ethical Clearance
Has this study been approved by the Ethical Committee?
Yes
The study will not include any invasive procedure on patients or other humans or animals.
Use of Ultrasound does not pose any harm or risk of radiation on the mother or the growing foetus.
Regular antenatal check up and routine investigation will be carried out as per hospital protocol.
The cost of the ultrasound scan will be borne by me.
Informed written consent will be taken from all involved patients.
7.5 Statistical Analysis
o Linear regression models for estimation of gestational age will be derived from the biometric indices and kidney length.
o In addition, stepwise regression models will be constructed to determine the best model for determining gestational age in pregnancy.
o Comparisons would then be made between the accuracy of these models in the determination of gestational age.
8 / References
[1] D.C. Dutta, “Text book of Obstetrics”, Sixth Edition, 2004, ISBN: 81-7381-142-3
[2] Anderson HF, Johnson TRB, Flora JD, Barclay MLII., “Prediction of gestational age from combined clinical observations”, Am J Obstet Gynecol 1981: 140, 770–774
[3] JJ Kansaria, SV Parulekar, “Nomogram for Foetal Kidney Length”, Bombay Hospital Journal, 2009: 51(2), 155-162.
[4] Konje JC, Abrams KR., “Determination of gestational age after 24th week of gestation from foetal kidney length measurement”, Ultrasound Obstetrics & Gynecology, 2002: 19, 592-597
[5] Nahid Yusuf, Fauzia Moslem, Jasmine Ara Haque, “Foetal Kidney Length: Can be a new parameter for determination of gestational age in 3rd trimester”, The Journal of Teachers Association, 2007:20(2) 147-150
[6] Kyosun Kim, Jeong Hee Park, “Measurement of Foetal Kidney Size and Growth Using Ultrasonography”, Korean Journal, 1995: 14(4), 454 - 459
[7] Harris L. Cohen, et.al., “Normal Length of Fetal Kidneys: Sonographic study in 397 obstetric patients”, AJR: 1991: 545-548
[8] Bertagnoli L, Lalatta F, Gallicchio R, et al., “Quantitative characterization of the growth of the foetal kidney”, JCU, 1983: 1(1), 349-356
[9] O’Brien GD, Queenan JT, Campbell S., “Assessments of gestational age in the second trimester by real-time ultrasound measurements”, Journal of Obstetrics and Gynaecology, 1981: 134, 540-545
[10] Hadlock F, Harrist R, Deterk, et al., “A prospective evaluation of foetal femur length as predictor of gestational age”, Journal of Ultrasound Medicine, 1983: 2, 111
9 / Signature of the candidate
10 / Remark of the guide
Gestational age assessment is very important before termination of pregnancy to prevent iatrogenic prematurity. The routine parameters like BPD,FL,HC,AC are not accurate in later weeks of gestation. But fetal kidney length measurement is accurate in all periods. This is not affected in IUGR babies thus making it a good parameter for gestational age assessment throughout pregnancy and in IUGR babies.
11 / Name and designation
11.1 Guide / Prof. Dr. Nirmala Shivalingiah
MBBS,M.S OBG
Professor & Unit Chief,
Dept. of OBG,
KIMS, Bangalore - 560 004
11.2 Signature
11.3. Co-guide (if any) / Dr. Srinivasa Babu
MBBS,M.D Radiology
Professor & Head,
Department of Radiodiagnosis,
KIMS, Bangalore – 560 004
11.4 Signature
11.5 Head of the Department / Prof. Dr. Vasantha Kumar
MBBS, M.S OBG, DGO
Professor and Head,
Department of OBG
KIMS, Bangalore 560 004
11.6 Signature
12 / 12.1 Remarks of the dean and director
12.2 Signature