Download appendix - iii

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS
OF
DISSERTATION
“PLACENTAL THICKNESS : IT’S CORRELATION
WITH SONOGRAPHIC GESTATIONAL AGE AND
FOETAL WEIGHT AND COMPARISON WITH
ACTUAL BIRTH WEIGHT”
Submitted by
Dr. VIDHYALAKSHMI R
M.B.B.S.
POST GRADUATE STUDENT IN
OBSTETRICS AND GYNAECOLOGY (M.S)
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES,
B.G.NAGARA-571448
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
Dr. VIDHYALAKSHMI R
P.G IN OBSTETRICS & GYNAECOLOGY,
ADICHUNCHUNAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
1
NAME OF THE CANDIDATE
AND ADDRESS
(in block letters)
2.
NAME OF THE INSTITUTION
3.
COURSE OF STUDY AND SUBJECT
M.S. IN OBSTETRICS & GYNAECOLOGY
4.
DATE OF ADMISSION TO COURSE
31ST JULY 2013
5.
TITLE OF THE TOPIC
6.
7
ADICHUNCHANAGIRI INSTITUTE OF
MEDICAL SCIENCES, B.G.NAGARA.
“PLACENTAL THICKNESS : IT’S
CORRELATION WITH SONOGRAPHIC
GESTATIONAL AGE AND FOETAL
WEIGHT AND COMPARISON WITH
ACTUAL BIRTH WEIGHT”
BRIEF RESUME OF INTENDED WORK
APPENDIX-I
6.1 NEED FOR THE STUDY
APPENDIX-IA
6.2 REVIEW OF LITERATURE
APPENDIX-IB
6.3 OBJECTIVES OF THE STUDY
APPENDIX-IC
MATERIALS AND METHODS
APPENDIX-II
7.1 SOURCE OF DATA
APPENDIX-IIA
7.2 METHOD OF COLLECTION OF
DATA : (INCLUDING SAMPLING
PROCEDURE IF ANY)
APPENDIX-IIB
7.3 DOES THE STUDY REQUIRE ANY
INVESTIGATION OR INTERVENTIONS
TO BE CONDUCTED ON PATIENTS OR
OTHER ANIMALS, IF SO PLEASE
DESCRIBE BRIEFLY.
YES
APPENDIX-IIC
7.4 HAS ETHICAL CLEARENCE BEEN
OBTAINED FROM YOUR INSTITUTION
IN CASE OF 7.3
YES
APPENDIX-IID
8.
LIST OF REFERENCES
APPENDIX - III
9.
SIGNATURE OF THE CANDIDATE
1
10.
REMARKS OF THE GUIDE
11
NAME AND DESIGNATION
(in Block Letters)
Knowledge of the gestational age and foetal
weight is essential for management of any
obstetric case.
11.1 GUIDE
Prof. Dr. SUNANDA KULKARNI, M.D.
Associate Professor,
Department of Obstetrics and Gynecology,
AIMS, B.G. Nagara-571448
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY)
Dr. B. MALLIKARJUNAPPA, M.D. R.D
Associate professor,
Department of Radiology,
AIMS, B.G. Nagara-571448
11.4 SIGNATURE
11.5 HEAD OF DEPARTMENT
Prof. Dr. S. VIJAYALAKSHMI, M.D , D.G.O
Professor and Head
Department of Obstetrics and Gynecology
AIMS, B.G. Nagara-571448
11.6 SIGNATURE
12
12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL
The facilities required for the investigation
will be made available by the college
Dr. M.G SHIVARAMU MBBS, MD
PRINCIPAL,
AIMS, B.G. NAGARA.
12.2 SIGNATURE
2
APPENDIX-I
6.BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR THE STUDY:
A healthy baby at term is the product of three important factors: a healthy mother,
normal genes, and good placental implantation and growth. It is clear that a normally
functioning placenta is critical for normal fetal growth and development1,2. The human placenta
develops with the principal function of providing nutrients and oxygen to the fetus3. Adequate
fetal growth and subsequent normal birth weight depends on the efficient delivery of nutrients
from the mother to the fetus via normally functioning utero-placental organ4. It is clear that
normal development of placenta during gestation is necessary for supporting of a healthy
fetus5.
On the other hand, any impairment in its development may have a profound impact on
fetal development and pregnancy outcome3. The prediction of growth restricted pregnancies
from placental size is based on the fact that diminished placental size precedes fetal growth
restriction6. Foetal weight estimation is an important aspect of obstetric management because a
large proportion of perinatal mortality is related to birth-weight7.
Ultrasound measurement of placental thickness is a relative simple, reproducible and
clinical useful way to evaluate the placental size8-10.
Placental thickness also appears to be a promising parameter for estimation of
gestational age of the fetus as several studies have reported a linear increase in placental
thickness with gestational age11-13.
The gestational age is of utmost importance in the interpretation of biochemical tests
such as the screening for the expanded maternal serum biomarkers (Human Chorionic
Gonadrotrophin, Alfa Foeto protein and the oestrogen and progestrone levels) for the risk
3
assessment of various foetal anomalies, in evaluating the foetal growth by distinguishing the
normal from the pathological foetal development. This allows obstetrician to institute measures
that will optimize the foetal outcome14.
When an anomaly is detected, the interventional modality, which is used, is influenced
by the gestational age. Virtually, all the important clinical decisions, which include caesarean
section, elective labour induction, etc, depend on the knowledge of the gestational age.
Although there is a broad range, normal placental thickness is approximately 1 mm per
week of gestation. As a general rule, the placenta thickness in millimeters should be equal to
the gestational age in weeks, +/- 10mm15.
Placenta less than 2.5 cm thick at term is associated with intrauterine growth retardation
of the fetus, preeclampsia, prematurity, fetal malformations or trisomy, small for date fetus and
neonatal high heamoglobin16,17.
Placenta more than 4 cm thick at term is associated with gestational diabetes,
intrauterine infections and hydrops foetalis18.
Thus the subnormal placental thickness for the corresponding gestational age should be
evaluated for any disease condition19.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
Ohagwu CC, Abu P.D, Ezeokeke VO and Ugwu AC. (Jan 2009) studied 666 pregnant
Nigerian women were studied by ultrasound. The result of the study showed that there was a
fairly linear increase in the placental thickness with gestational age. The maximum mean
placental thickness of 45.09  6.37 mm was recorded at 39 week of gestation. There was also a
strong positive correlation between estimated fetal weight and placental thickness20.
4
Aremu Ademola Adegoke, Atanda Oluseyi Olaboyede (May 2013) conducted a cross
sectional study of 300 consecutive singleton pregnancies who were scanned at term gestational
age. They concluded that 2d prenatal ultrasound measurement of placental thickness is a true
reflection of the actual placental weight and volume and a positive predictor of the birth
weight. A thickness less than 20mm at term is statistically associated with low birth weight21.
Durnwald Celeste, Mercer, Brian (Dec. 2004) conducted a cross sectional study,
placental thickness was evaluated in 167 women in viable singleton concluded that placental
thickness varies with gestational age and is thinner for anterior placenta in 2nd and 3rd trimester.
There was a stepwise increase in PT (Mean  SD) with increasing gestation age for 1st, 2nd, 3rd
trimester respectively22.
P. Mital, N. Hooja, K. Mehndirahta (2002) conducted a study on 600 normal antenatal
women of all gestational age. In their study upto 21 weeks of gestation the near placental
thickness was slightly higher than the gestational age. From 22 weeks to 35th week of gestation
the placental thickness almost matched the gestational age in weeks there after the placental
thickness was lower by 1-2 mm. It was observed that the placental thickness gradually
increased from 15mm at 11 weeks to 37.5 mm at 39 weeks23.
Elchalal, Ezra, Levi, Bar-oz (Jan. 2000). Placental thickness was determined by routine
sonographic examination throughout the pregnancy in 561 normal singleton pregnancy. A
linear increase of placental thickness was found to correlate with gestational age throughout the
pregnancy. No correlation was found between placental thickness and maternal age or parity8.
Anupama Jain, Ganesh Kumar, U Agarwal, S Kharakwal et al. reported that the value
of mean placental thickness increases with advancing gestational age and almost matched the
gestational age from 27 to 33 weeks24.
5
In a study done by Carolyn M. Salafia, Elizabeth Maas, John M. Thorpe, Barbara
Eucker (December 2004) Placental thickness has a strong positive correlation with BPD and
AC with both parameters having identical relationship with placental thickness. Sub normal
placental thickness for a particular gestational age may represent a sign of intrauterine growth
retardation therefore recommended that measurement of placental thickness be routinely
carried out during obstetric ultrasound scan25.
T Karthikeyan, Ramesh Kumar Subramanium, WMS john, Prabhu K (July 2012)
observed that the maximum mean PT in the 1st, 2nd, 3rd and the combined trimesters were
16.5 mm, 23.78 mm, 35.81 mm and 28.49 mm There was a strong positive correlation between
PT and GA, with the correlation coefficient values for the 1st, 2nd and 3rd trimesters being r =
0.609, r = 0.812 and r = 0.814 respectively. There was a significant positive correlation
between PT and BPD, AC, FL, ABC, HC and FW also. They concluded that PT can be used as
a predictor of the GA. The subnormal PT for the corresponding GA should be evaluated for
any disease condition19.
N. Shwartz, E. Wang, S. Parry (November 2012) studied 1909 singleton pregnancies.
Mean placental diameter (SGA<10, P<0.001; SGA<5, P=0.002) and thickness (SGA<10,
P<0.006; SGA<5,P=0.065) were significantly smaller in SGA pregnancies. 2D placental
measurements taken in midgestation are significantly associated with the incidence of SGA27.
APPENDIX –IC
6.3 AIMS AND OBJECTIVES OF STUDY
1. To correlate placental thickness with gestational age and foetal weight sonographically.
2. To evaluate placental thickness, measured at the level of insertion of the umbilical cord,
as a parameter for estimating gestational age of the fetus.
3. To compare the estimated fetal weight as derived by the fetal growth parameters and
placental thickness with actual birth weight after delivery.
6
APPENDIX-II
7.0 MATERIALS AND METHODS
APPENDIX-II A
7.1 SOURCE OF DATA
Study Design
: Cross sectional study
Study Period
: January 2014 to August 2015(18 months)
The study will be conducted on women with uncomplicated pregnancy between 27
completed weeks to term gestation who were unequivocal about their LMP in Sri
Adichunchanagiri Hospital and Research Centre, B.G. Nagara, from January 2014 to August
2015.
APPENDIX-II B
7.2 METHOD OF COLLECTION OF DATA
SAMPLE SIZE
1. Singleton gravidae attending labour room between 27 completed weeks to term gestation in
the above hospital
INCLUSION CRITERIA
1. Singleton pregnancies
2. Between to term gestation
3. Known last menstrual period
4. A history of regular menstruation
EXCLUSION CRITERIA

Gestational diabetes

Hypertension (systemic hypertension and pregnancy induced hypertension)

Anemia
7

Polyhydramnios, oligohydramnios

Foetal anomalies

Placenta praevia, placental anomalies, poor visualization of placenta, cord anomalies.

Multiple pregnancies

Irregular menstrual cycles

Last menstrual period not known
APPENDIX-II C
7.3 Does the study require any investigation or intervention to be conducted on the
patients or animals, if so please describe briefly
YES
Investigation :

USG
8
APPENDIX-IID
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
“PLACENTAL THICKNESS : ITS
CORRELATION WITH GESTATIONAL
AGE AND FOETAL WEIGHT AND
COMPARISON WITH ACTUAL BIRTH
WEIGHT”
Dr. VIDHYALAKSHMI R
P.G IN OBSTETRICS AND GYNAECOLOGY,
ADICHUNCHUNAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
a
Title of the study
b
Principle investigator
(Name and Designation)
c
Co-investigator
(Name and Designation)
d
Name of the Collaborating
Department/Institutions
e
Whether permission has been obtained from
the heads of the collaborating departments &
Institution
Dr. SUNANDA KULKARNI M.D.
Associate Professor,
Department of Obstetrics and Gynecology
AIMS, B.G. Nagara-571448
DEPARTMENT OF RADIOLOGY
YES
Section – B
APPENDIX - I
Summary of the Project
Section – C
APPENDIX - I
Objectives of the study
Section – D
APPENDIX - II
Methodology
A Where the proposed study will be undertaken
B Duration of the Project
DEPARTMENT OF O.B.G.,
S.A.H. & R.C., B.G.NAGARA
18 MONTHS
C Nature of the subjects:
Does the study involve adult patients?
YES
Does the study involve Children?
NO
Does the study involve normal volunteers?
NO
Does the study involve Psychiatric patients?
NO
Does the study involve pregnant women?
YES
9
D If the study involves health volunteers
I. Will they be institute students?
NO
II. Will they be institute employees?
NO
III. Will they be Paid?
NO
IV. If they are to be paid, how much per
NO
session?
E Is the study a part of multi central trial?
NO
F If yes, who is the coordinator?
(Name and Designation)
NA
Has the trail been approved by the ethics
Committee of the other centers?
NA
If the study involves the use of drugs please
indicate whether.
I. The drug is marketed in India for the
indication in which it will be used in the study.
-
NA
II. The drug is marketed in India but not for
the indication in which it will be used in the
study
NA
III. The drug is only used for experimental use
in humans.
NA
IV. Clearance of the drugs controller of India
has been obtained for:
NA
 Use of the drug in healthy volunteers
 Use of the drug in-patients for a new
indication.
NA
 Phase one and two clinical trials
 Experimental use in-patients and healthy
volunteers.
10
G How do you propose to obtain the drug to be
used in the study?
-
Gift from a drug company
-
Hospital supplies
-
Patients will be asked to purchase
-
Other sources (Explain)
NA
H Funding (If any) for the project please state
-
None
-
Amount
-
Source
-
To whom payable
NO
Does any agency have a vested interest in the
I
NO
out come of the Project?
Will data relating to subjects /controls be stored
J
NO
in a computer?
Will the data analysis be done by
K
-
The researcher?
YES
-
The funding agent
NO
L Will technical / nursing help be required form
NO
the staff of hospital.
If yes, will it interfere with their duties?
NO
Will you recruit other staff for the duration of
NO
the study?
If Yes give details of
I.
Designation
II.
Qualification
III.
Number
IV.
Duration of Employment
NA
11
M Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent?
YES, CONSENT WILL BE TAKEN FROM
Will it be taken from the subject themselves?
THE PATIENT
Will it be from the legal guardian? If no, give
reason:
N Describe design, Methodology and techniques
APPENDIX II
Ethical clearance has been accorded.
Chairman,
P.G Training Cum-Research Institute,
A.I.M.S., B.G.Nagara.
Date :
PS : NA – Not Applicable
12
APPENDIX-III
8. LIST OF REFERENCES
1. Kliman HJ. Behind every healthy baby is a healthy placenta. In: Berman MR, ed.
Parenthood Lost. Westport, CT: Bergin & Garvey; 2001: 130–131.
2. Vintzileos AM, Tsapanos V. Biophysical assessment of the fetus. Ultrasound Obstet
Gynecol 1992; 2: 133–143.
3. Suri S, Muttukrishna S, Jauniaux E. 2D-ultrasound and endocrinologic evaluation of
placentation in early pregnancy and its relationship to fetal birthweight in normal
pregnancies and pre-eclampsia. Placenta. 2013 Jun 8. DOI:10.1016/j.placenta. 2013.05.003.
[Epub ahead of print]
4. Azpurua H, Funai EF, Coraluzzi LM, Doherty LF, Sasson IE, Kliman M, et al.
Determination of placental weight using two-dimensional sonography and volumetric
mathematic modeling. Am J Perinatol. 2010; 27(2): 151- 5. DOI:10.1055/s-0029-1234034.
5. Salafia CM, Zhang J, Miller RK, Charles AK, Shrout P, Sun W. Placental growth patterns
affect birth weight for given placental weight. Birth Defects Res Clin Mol Teratol. 2007;
79(4): 281-8.
6. Wolf H, Oosting H, Treffers PE. A longitudinal study of the relationship between placental
fetal growth measured by ultrasonography. Am J Obstet Gynecol. 1989; 161: 1140-5.
7. Watson WJ, Soisson AP, Harlass FE. Estimated weight of the fetus: Accuracy of ultrasound
vs clinical examination. J. Reprod. 1988; 33: 369-71.
8. Elchalal U, Ezra Y, Levi Y, Bar-Oz B, Yanai N, Intrator O, Nadjari M. Sonographically
thick placenta: a marker for increased perinatal risk – a prospective cross-sectional study.
Placenta. 2000; 21(2-3): 268-72.
9. Chen M, Leung KY, Lee CP, Tang MH, Ho PC. Placental volume measured by 3
dimensional ultrasound in the prediction of fetal alphathalassemia: a preliminary report.
Ultrasound Obstet Gynecol. 2006; 28(2): 166-72.
13
10. Hafner E, Metzenbauer M, Höfinger D, Munkel M, Gassner R, Schuchter K, et al. Placental
growth from the first to the second trimester of pregnancy in SGA-foetuses and preeclamptic pregnancies compared to normal foetuses. Placenta. 2003; 24(4): 336-42.
11. Hoddick WK, Mahony BS, Callen PW, et al. Placental thickness. J Ultra Med. 1985; 4(9):
479-82.
12. Jauniax E, Ramsay B, Campbell S. Ultrasonographic investigation of placental
morphologic characteristics and size during the second trimester of pregnancy. Am J Obstet
Gynecol. 1994 Jan; 170(1 Pt 1): 130-7.
13. Tongsong T, Boonyanurak P. Placental thickness in the first half of pregnancy. J Clin
Ultrasound. 2004 Jun; 32(5): 231-4.
14. Callen PW. Ultrasonography in Obstetrics and Gynaecology.5th ed. Philadelphia: Elsevier,
a division of Reed Elsevier India Limited; Chapter 7 – USG evaluation of foetal biometry &
abnormal growth. 2002 ; 225-65.
15. Callen PW. Ultrasonography in Obstetrics and Gynaecology.5th ed. Philadelphia: Elsevier,
a division of Reed Elsevier India Limited; Chapter 19– placenta and umbilical cord 2002 ;
721-728.
16. Graanum PAT, Hobbins JC, “The Placenta”. Radiol Clin North Am, 1982; 20-353.
17. Hoogland HJ, de Haan J, Martin eB. "Placental size during early pregnancy and fetal
outcome: A preliminary report of a sequential ultrasonographic study". Am J Obstet
Gynecol. 1980; 138: 441-443.
18. Benrishke K, Kaufmann P. Anatomy and pathology of the umbilical cord and major foetal
vessels.2nded. New York: Springer- Verlag;. Chapter 29, pathology of human placenta.
1998; 319-77.
19. T.Karthikeyan T, Subramaniam R.K, Johnson WMS, Prabhu K. Placental thickness and its
correlation to gestational age and foetal growth parameters – A cross sectional
ultrasonographic study. Journal of clinical and Diagnostic Research 2012 December; 6(10):
1732 – 5.
14
20. Ohagwu, CC, Abu, PO, Ezeokeke, UO and Ugwu, AC. “Relationship between placental
thickness and growth parameters in normal Nigerian foetus”. African Journal of
Biotechnology, Vol. 8 (2): 133-138.
21. Aremu Ademola Adegoke, Atanda Oluseyi Olaboyede, Adeomi Adeleye Abiodun.
Newborn birth weight and placental parameters in normal human pregnancies. J pharm
biomed sci. 2013 May (Supplement 1); 30(30): S23-S27.
22. Durnwald, Celeste, Merceri, Brain. “Ultrasonic estimation of placental thickness with
advancing age : 635”. American Journal of Obstetrics and Gynecology. Vol. 191(6),
Supplement, Dec. 2004, Ps178.
23. Mital P, Hooja N, Mehndiratta. "Placental thickness - a sonographic parameter for
estimating gestational age of the fetus". Ind J Radiol Imag. 2002; 12: 4: 553-554.
24. Anupama Jain, Ganesh Kumar, Agarwal U, Kharakwal S. "Placental thickness -a
sonographic indicator of gestational age". Journal of obstetrics and gynaeco/ogy of India.
2001; 51: 3: 48-49.
25. Schwartz N, Wang E, Parry S. Two dimensional sonographic placental measurements in
small for gestational age infants. Ultrasound Obstet Gynecol .2012; 40: 674 – 697.
15
PROFORMA
Sl.No. :
Name of the Patient
Address
:
:
Date
:
Age
:
I P no :
DOA :
Booked / Unbooked / Booked Else Where
H/o-Ammenorhoea
History of Present Pregnancy :
1. Trimester
:
Morning Sickness
_______ Yes/No
Bleeding PV
_______ Yes/No
Any Other
_______
2. Trimester:
Quickening
_______
3. Trimester:
Bleeding PV
_______
Symptoms of PET
_______
Any other
_______
Obstetric history:
Married life:
Primigravida
Consanguinity
Menstrual history:
A.O.M.:
Past Menstrual cycles:
L.M.P.:
E.D.D:
Past History:
1. Diabetes
:
2. Hypertension
:
3. Tuberculosis
4. Epilepsy
:
5. Congenital deformity
:
6. Operations
:
7. Traumatic injuries
:
Family History:
Personal History:
Diet:
Appetite:
Bowel/Bladder:
16
Sleep:
General Physical Examination:
Gait:
Pallor:
P.R.:
B.P.:
Temperature:
Height:
Weight:
Breast:
Thyroid:
Spine:
Systemic Examination:
C.V.S
Pedal edema:
R.S:
Per Abdomen:
Inspection:
Uterus Size:
Pendulous abdomen/Flanks
Palpation:
Uterine Size:
Contractions/10 mins:
A.G:
S.F.H:
E.F.W
Fundal Grip:
Lie:
Umbilical Grip:
Attitude:
Pelvic Grip I:
Presentation:
Pelvic Grip II:
Position:
Number of fifths palpable:
Auscultation:
USG: BPD
Hc
Ac
Fl
AFI
EFW
GEST AGE
PLACENTAL THICKNESS :
Baby:
Weight:
Apgar Score: 1min
Congenital Anomalies:
17
5min