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

1 / NAME OF THE CANDIDATE
AND ADDRESS
(in block letters) / Dr. VIDHYALAKSHMI R
P.G IN OBSTETRICS & GYNAECOLOGY,
ADICHUNCHUNAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
2. / NAME OF THE INSTITUTION /

ADICHUNCHANAGIRI INSTITUTE OF

MEDICAL SCIENCES, B.G.NAGARA.
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 / “PLACENTAL THICKNESS : IT’S CORRELATION WITH SONOGRAPHIC GESTATIONAL AGE AND FOETAL WEIGHT AND COMPARISON WITH ACTUAL BIRTH WEIGHT”
6. / BRIEF RESUME OF INTENDED WORK
6.1  NEED FOR THE STUDY
6.2 REVIEW OF LITERATURE
6.3 OBJECTIVES OF THE STUDY / APPENDIX-I
APPENDIX-IA
APPENDIX-IB

APPENDIX-IC

7 / MATERIALS AND METHODS
7.1  SOURCE OF DATA
7.2 METHOD OF COLLECTION OF DATA : (INCLUDING SAMPLING PROCEDURE IF ANY)
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER ANIMALS, IF SO PLEASE DESCRIBE BRIEFLY.
7.4 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3 / APPENDIX-II
APPENDIX-IIA
APPENDIX-IIB
YES
APPENDIX-IIC

YES

APPENDIX-IID
8. / LIST OF REFERENCES /

APPENDIX - III

9. / SIGNATURE OF THE CANDIDATE /
10. /

REMARKS OF THE GUIDE

/ Knowledge of the gestational age and foetal weight is essential for management of any obstetric case.
11 / NAME AND DESIGNATION
(in Block Letters)
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


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 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.

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.

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.

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

·  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


APPENDIX-IID

PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL

SECTION A
a / Title of the study / “PLACENTAL THICKNESS : ITS CORRELATION WITH GESTATIONAL AGE AND FOETAL WEIGHT AND COMPARISON WITH ACTUAL BIRTH WEIGHT”
b / Principle investigator
(Name and Designation) / Dr. VIDHYALAKSHMI R
P.G IN OBSTETRICS AND GYNAECOLOGY,
ADICHUNCHUNAGIRI INSTITUTE OF
MEDICAL SCIENCES.B.G NAGARA,
MANDYA DISTRICT -571448
c / Co-investigator
(Name and Designation) / Dr. SUNANDA KULKARNI M.D.
Associate Professor,
Department of Obstetrics and Gynecology
AIMS, B.G. Nagara-571448
d / Name of the Collaborating
Department/Institutions / DEPARTMENT OF RADIOLOGY
e / Whether permission has been obtained from the heads of the collaborating departments & Institution / YES
Section – B
Summary of the Project /

APPENDIX - I

Section – C
Objectives of the study /

APPENDIX - I

Section – D
Methodology /

APPENDIX - II

A / Where the proposed study will be undertaken / DEPARTMENT OF O.B.G.,
S.A.H. & R.C., B.G.NAGARA
B / Duration of the Project /
18 MONTHS
C / Nature of the subjects:
Does the study involve adult patients?
Does the study involve Children?
Does the study involve normal volunteers?
Does the study involve Psychiatric patients?
Does the study involve pregnant women? / YES
NO
NO
NO
YES
D / If the study involves health volunteers
I.  Will they be institute students?
II.  Will they be institute employees?
III.  Will they be Paid?
IV.  If they are to be paid, how much per session? / NO
NO
NO
NO
E / Is the study a part of multi central trial? / NO
F / If yes, who is the coordinator?
(Name and Designation)
Has the trail been approved by the ethics Committee of the other centers?
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.
II. The drug is marketed in India but not for the indication in which it will be used in the study
III. The drug is only used for experimental use in humans.
IV. Clearance of the drugs controller of India has been obtained for:
  Use of the drug in healthy volunteers
  Use of the drug in-patients for a new indication.
  Phase one and two clinical trials
  Experimental use in-patients and healthy volunteers. / NA
NA
-
NA
NA
NA
NA
NA
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
I / Does any agency have a vested interest in the out come of the Project? / NO
J / Will data relating to subjects /controls be stored in a computer? / NO
K / Will the data analysis be done by
-  The researcher?
-  The funding agent / YES
NO
L / Will technical / nursing help be required form the staff of hospital.
If yes, will it interfere with their duties?
Will you recruit other staff for the duration of the study?
If Yes give details of
I.  Designation
II.  Qualification
III.  Number
IV.  Duration of Employment / NO
NO
NO
NA
M / Will informed consent be taken? If yes
Will it be written informed consent:
Will it be oral consent? Will it be taken from the subject themselves?
Will it be from the legal guardian? If no, give reason: / YES, CONSENT WILL BE TAKEN FROM THE PATIENT
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

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.