dissertation - Rajiv Gandhi University of Health Sciences

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS
OF
DISSERTATION
SECOND TRIMESTER
ULTRASONOGRAPHIC DETERMINATION OF UMBILICAL
COILING INDEX AND ITS CORRELATION WITH PERINATAL
OUTCOME
Submitted by
Dr. AYISHA S KAZI
M.B.B.S.
POST GRADUATE STUDENT IN
OBSTETRICS AND GYNAECOLOGY (M.S)
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
ESIC-MC-PGIMSR, RAJAJINAGAR
BANGALORE
1
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1
Dr. AYISHA S KAZI
P.G IN OBSTETRICS AND GYNAECOLOGY,
ESIC-MC-PGIMSR, RAJAJINAGAR
NAME OF THE CANDIDATE
AND ADDRESS
(in block letters)
BANGALORE
2.
NAME OF THE INSTITUTION
3.
COURSE OF STUDY AND SUBJECT
4.
DATE OF ADMISSION TO COURSE
5.
TITLE OF THE TOPIC
6.
ESIC-MC-PGIMSR, RAJAJINAGAR
BANGALORE.
M.S. IN OBSTETRICS & GYNAECOLOGY
01-06-2012
“SECOND TRIMESTER
ULTRASONOGRAPHIC
DETERMINATION OF UMBILICAL
COILING INDEX AND ITS CORRELATION
WITH PERINATAL OUTCOME”
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
APPENDIX-II
7
MATERIALS AND METHODS
APPENDIX-IIA
7.1 SOURCE OF DATA
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
2
8.
LIST OF REFERENCES
9.
SIGNATURE OF THE CANDIDATE
10.
REMARKS OF THE GUIDE
11
NAME AND DESIGNATION
(in Block Letters)
APPENDIX - III
It will be a useful studyip proved statistically
significant in identifying risk fetuses early in
the antenatal period so that early therepeutic
measures can be initiated to improve the
prognosis
11.1 GUIDE
Dr. SUJATA PRABHUM.D.
Professor,
Department of Obstetrics and Gynecology,
ESIC-MC-PGIMSR, RAJAJINAGAR
BANGALORE
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY)
-
11.4 SIGNATURE
-
Dr. RENUKA RAMAIAHM.D.
Professor and Head
Department of Obstetrics and Gynecology
ESIC-MC-PGIMSR, RAJAJINAGAR
11.5 HEAD OF DEPARTMENT
BANGALORE
11.6 SIGNATURE
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12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL
3
12.2 SIGNATURE
APPENDIX-I
6. BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR THE STUDY:
Umbilical cord is the structure connecting fetus to placenta.It consists of 3 blood vessels
and has characteristic screw shaped coils.The cause, role and mechanism of coiling is not
known1.Antenatally coiling can be determined sonographically.2Studies have established
correlation between third trimester Umbilical coiling index (UCI)and postnatal UCI(true UCI)
withadverse perinatal outcome like preterm labor,IUGR,IUD,fetaldistress.In the present study; at
18-22 weeks Period of gestation,antenatal UCI(aUCI) determined at routine fetal anatomy survey
scans and its association with perinatal outcome studied. If there exists a significant correlation,
abnormalaUCI at 18-22 weeks POG can be used as an early predictor of adverse perinatal
outcome.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
The umbilical cord is life line of fetus as it supplies water, nutrients and oxygen to the
growing fetus.
Its three blood vessels pass along the length of the cord in helical / coiled
fashion.The helical fashion of these umbilical vessels is known as ‘Spiral Course’. A coil is
defined as complete 3600 spiral course of umbilical vessel around the Wharton’s Jelly.3
4
Coiling of umbilical vessels develops as early as 28 days after conception and is present in about
95% of fetuses by 9 weeks of conception.The helices may be seen by ultrasound as early as first
trimester.4
The number of twists seen in first trimester is roughly the same as seen in term cords. Since
lengthening of cord occurs from the fetal end, perhaps coiling of cord represent a long term record
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of fetal well being.
The antenatal UCI is compared with true UCI results obtained after birth. A statistically significant
correlation between aUCI(antenatal UCI) and true UCI was found with p value <0.0016
The UCI measured in second trimester is useful in predicting the birth of small for gestational age
infant and may serve as a marker for subsequent growth restriction.7
The hypo coiling of umbilical cord during the late second trimester of pregnancy suggests the risk
of preterm delivery is high, and hence delivery of low birth weight neonates and admission to
NICU is high.8
APPENDIX –IC
6.3 AIMS AND OBJECTIVES OF STUDY
1. To study antenatal umbilical coiling index at second trimester (18-22 weeks of gestational age)
2. To correlate antenatal second trimester umbilical coiling index with perinatal outcome.
3. To analyse if antenatal second trimester umbilical coiling index measurement could predict
adverse perinatal outcome
7.0 MATERIALS AND METHODS
APPENDIX-II A
7.1 SOURCE OF DATA
This study is being conducted at ESIC-MC-PGIMSR,RAJAJINAGAR,BANGALORE
Study Design : Prospective analytical study design.
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Study Period
: 18 Months (November 2012 toMay 2014)
APPENDIX-II B
7.2 METHOD OF COLLECTION OF DATA: It is a prospective study conducted at department
of Obstetrics and Gynecology,ESIC-MC-PGIMSR,Rajajinagar,Bangalore.
100 booked singleton pregnancies fulfilling the below mentioned inclusioncriteria, attending
regular Antenatal check up and willing for institutional deliveries will be evaluated
ultrasonographically for umbilical coiling index at the time of routine fetal anatomical survey.
INCLUSION CRITERIA

Maternal age between 18-35 years.

Primigravida.

Intrauterine Singleton live pregnancy.

Fetal anatomic survey at 18-22 weeks period of gestation.

Willing for Institutional delivery at ESIC-MC-MODEL HOSPITAL.
EXCLUSION CRITERIA

Multigravida .

Multifetal gestation.

Anomalous fetus.

Single umbilical artery.

Pre existing maternal diseases like Hypertension, Diabetes, Chronic renal disease.

Smoking andDrug abuse.
Procedure of Study: 100 consecutive primigravida fulfilling the inclusion criteria are recruited
into the study. They are booked at antenatal clinic at first trimester. Maternal Demographic
characteristics recorded and routine antenatal investigations
performed. Gestational age and
expected day of confinement are calculated as defined by 280 days from last menstrual period,
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andfirst trimester scan with less than 7daysdiscrepancy. They are emphasized on importance of
regular antenatal visits.
Second trimester fetal anatomic sonographic survey is done at 18-22 weeks of gestational age.
Pregnancies with singleton live fetus with absence of gross anomalies are included in the study.
Placental implantation site, volume of amniotic fluid recorded. The measurement of umbilical
coiling index is done by2-5 Mhz abdominal transducer (PHILIPS HD 6,C5-2)as proposed by
Degani et al.The distance in centimeters between two adjacent coils is measured from inner edge of
arterial or venous wall to the outer edge of next coil along ipsilateral side of umbilical cord. The
umbilical coiling index defined as reciprocal of distance between two adjacent coils. Normal UCI
is 0.2+/- 0.1,complete coils in 1cm,which means 1 coil in every 5 cms. UCI of less than 0.17 and
greater than 0.37 is defined as hypocoiled and hypercoiledrespectively.UCI between 0.17-0.37 are
defined as normocoiled.
Later they are followed up every 4 weeks till 28 weeks gestation, fortnightly till 36 weeks and
weekly till term. During this period any antenatal complications and fetal well being addressed.
At the onset of labor, admission NST recorded. Continuous intrapartum monitoring of maternal
vitals and fetal well being is done.Intrapartum factors like fetal heart rate abnormality,meconium
stained liqor,mode of delivery noted.Neonatal factors like APGAR,birthweight, admission to
NICU noted.Placenta and umbilical cord are examined macroscopically for type of
placenta,itsweight,attatchment,length and number of vessels in the cord noted.
The antenatal UCI is correlated with each of fetal characteristic to determine if any relation exists
between them after statistical analysis.
Statistical Analysis Done by :

Positive and negative predictive value,likelihood ratios and 95 % confidence limits to
evaluate the strength of association between antenatal UCI and Perinatal outcome.

P value less than .05 regarded as statistically significant
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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


Requires ultrasonographic evaluation :done by using Philips
HD-6 ,C5-2,2-5 MHz abdominal transducer to calculate the antenatal UCI
Cardiotocography as an admission procedure.
APPENDIX-III
8. LIST OF REFERENCES
1.
Strong TH. Jarles DL. Vega JS et al. Umbilical coiling index. Am. J. Obstet Gynecol.1994 ;
170 : 29-32.
2.
Garry CF.KennethJL.StevenLB.JohnCH.DwightJR.CatherineYS.Williams
obstetrics.23rdedition.United states of America.McGraw Hill;2010
3.
Gupta S. Faridi MM .Krishnan J. Umbilical coiling index. J. Obstet. Gynecol India 2006 ;
56 (4) : 315-319.
4.
Lacro RV.Jomes KL.Benirschke K.
The umbilical cord twist: Origin, direction and
relevance. Am. J. ObstetGynecol1987 ; 157 : 833-8.
5.
TH strong junior.JP Elliott., TG Radon.Non coiled umbilical blood vessels,a new marker for
fetus at risk.Obstetrics and gynecology1993;81(3):409-411.
6.
MladenP.SriramCP.StephenTC.Rebecca N .Baergen et al.Assessment of umbilical cord
coiling during the routine fetal sonographic anatomic survey in the second trimester.Journal
ultrasound Med 2005;24:185-191.
7.
Shimon D. ZviL.IsraelS.RonG.GonenO.Early second trimester low umbilical coiling index
predicts small for gestational age fetuses.J ultrasound med2001;1183-1188.
8.
Yun SJ. Dong KJ. GuiseraL.Thesonographic umbilical cord coiling in late second trimester
of gestation and perinatal outcome.Intl Journal of Medical Sciences2011;8(7):594-598.
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PROFORMA
NAME:
NAME OF SPOUSE:
AGE:
DATE OF ADMISSION:
IP NUMBER:
DATE OF DISCHARGE:
ADDRESS:
LMP:
EDD:
DEPARTMENT/UNIT:
PRESENT HISTORY:
OBSTETRIC HISTORY:
MENSTRUAL HISTORY:
PAST HISTORY:
H/O HYPERTENSION/DIABETES/CHRONIC RENAL DISEASE
FAMILY HISTORY: H/O HYPERTENSION/DIABETES/CONGENITAL
ANOMALIES / MULTIPLE GESTATION
GENERAL EXAMINATION
HEIGHT:
WEIGHT:
PULSE:
BLOOD PRESSURE:
PALLOR:
ICTERUS:
EDEMA:
BREAST:
THYROID:
CVS:
RS:
PER ABDOMEN:
FUNDAL HEIGHT:
LIE:
PRESENTATION:
LIQOR:
FHS:
PELVIC EXAMINATION: P/S :
P/V:
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INVESTIGATIONS:
HEMOGLOBIN:
RBS:
URINE MICROSCOPY/ALBUMIN/SUGAR:
HIV:
HbsAg:
VDRL:
OGCT:18-22 WEEKS
OGCT:28-32 WEEKS
GESTATIONAL AGE ACCORDING TO SONOGRAPHY:
GESTATIONAL AGE ACCORDING TO LMP:
GESTATIONAL AGE ACCORDING TO FIRST TRIMESTER SONOGRAPHY:
ULTRASOUND OF ABDOMEN AND PELVIS:FOR CONFIRMATION OF
PREGNANCY/DATING SCAN/FETAL ANOMALY SURVEY/UMBILICAL COILING
INDEX(UCI)
CARDIOTOCOGRAPHY/NON STRESS TEST:
LABOR MONITORING:PARTOGRAM ENCLOSED
DELIVERY NOTES:MODE OF DELIVERY
WEIGHT:
LIQOR:COLOUR
AMOUNT:
BABY:APGAR SCORE
SEX:
1”
5”
GESTATIONAL AGE IN WEEKS:
ADMISSION TO NICU:
PLACENTA:WEIGHT:
ABNORMALITIES IF ANY:
UMBILICAL CORD: LENGTH:
NO OF VESSELS:
COMMENT
ON
a UCI AND PERINATAL OUTCOME:
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ATTATCHMENT:
CONSENT FORM
I ----------------------------------------- C/o ------------------------------------- age ------------- give my
free and voluntary consent to be included in the above mentioned clinical study. I have been
explained to my full satisfaction the nature and purpose of treatment and possible complications by
one of the treating doctors, Dr.----------------------------------------. During the course of the study, I
also give my full voluntary consent to undergo any blood or radiological investigation and any
other relevant investigation and clinical photography required for the study. I will abide by the
prescribed medication regimen and other instructions. I will present myself/ patient at the
designated time and place in the hospital during study follow-up. During the course of the study I
will immediately inform about any adverse events related to my treatment. I will give my
cooperation to the concerned treatment doctor and the hospital staff. I give my consent for
publication of the results of the study. I will not seek any reward or compensation for the study. I
have been explained that I can withdraw from the study at any time of my own will without any
adverse effect on my treatment. I also give my voluntary consent to be enrolled in either treatment
group (drug or placebo as the case may be) depending upon the randomized allocation.
Signature/Thumb Impression
Date and Time
Patient’s Name or Parent’s / Guardian’s Name
-------------------------------------------------------------------------------------------------
Name of witness( )----------------------------------- -----------------------------------
Name of Doctor (Dr.)--------------------------------
---------------------------------
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FORM F
[See Proviso to Section 4(3), Rule 9(4) and Rule 10(1A)]
FORM FOR MAINTENANCE OF RECORD IN RESPECT OF PREGNANT WOMAN BY
GENETIC CLINIC/ULTRASOUND CLINIC/IMAGING CENTRE
1. Name and address of the Genetic Clinic/Ultrasound
Clinic/Imaging Centre.
2. Registration No.
3. Patient’s name and her age
4. Number of children with sex of each child
5. Husband’s/Father’s name
6. Full address with Tel. No., if any
7. Referred by (full name and address of Doctor(s)/Genetic
Counseling Centre (Referral note to be preserved carefully with
case papers)/self referral
8. Last menstrual period/weeks of pregnancy
9. History of genetic/medical disease in the family (specify)
Basis of diagnosis: (a) Clinical (b) Bio-chemical (c) Cytogenetic (d) Other
(e.g. Radiological, ultrasonography etc. specify)
10. Indication for pre-natal diagnosis
A. Previous child/children with:
Chromosomal disorders Metabolic disorders Congenital anomaly Single gene disorder
Mental retardation Haemoglobinopathy Sex linked disorders Any other (specify)
B. Advanced maternal age (35 years)
C. Mother/father/sibling has genetic disease (specify)
D. Other (specify)
11. Procedures carried out (with name and registration No. of Gynaecologist/Radiologist/Registered
Medical Practitioner) who performed it.
………………………………………………………………………………..
Non-Invasive
(i) Ultrasound …………………………………………………………………………………………………………..
(Specify purpose for which ultrasound is to done during pregnancy)
[List of indications for ultrasonography of pregnant women are given in the important Notes]
Invasive
Amniocentesis Chorionic Villi aspiration Foetal biopsy
Cordocentesis Any other (specify)
12. Any complication of procedure – please specify
13. Laboratory tests recommended [Strike out whichever is not applicable or not necessary]
Chromosomal studies Biochemical studies
Molecular studies Preimplantation genetic diagnosis
14. Result of
(a) Pre-natal diagnostic procedure (give details)…………………………………………………………………….
(b) Ultrasonography Normal/Abnormal
(Specify abnormality detected, if any).
15. Date(s) on which procedures carried out.
16. Date on which consent obtained. (In case of invasive)
17. The result of pre-natal diagnostic procedure was conveyed to ….………………..….on …………….………
18. Was MTP advised/conducted?
19. Date on which MTP carried out.
Date: Name, Signature and Registration number of the
Place Gynaecologist/Radiologist/Director of the Clinic
DECLARATION OF PREGNANT WOMAN
I, Ms. ________________ (name of the pregnant woman) declare that by undergoing ultrasonography
/image
scanning etc. I do not want to know the sex of my foetus.
Signature/Thump impression of pregnant woman
DECLARATON OF DOCTOR/PERSON CONDUCTING ULTRASONOGRAPHY/IMAGE SCANNING
I, __________________ (name of the person conducting Ultrasonography/image scanning) declare that
while
conducting ultrasonography/image scanning on Ms. ___________ (name of the pregnant woman), I have
neither detected nor disclosed the sex of her foetus to any body in any manner.
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Name and signature of the person conducting Ultrasonography/image scanning/Director or owner of genetic
clinic/ ultrasound clinic/imaging centre.
Important Notes are given in back side P.T.O.
Important Note:(i) Ultrasound is not indicated/advised/performed to determine the sex of foetus except for
diagnosis of sex-linked diseases such as Duchenne Muscular Dystrophy, Haemophilia A & B
etc.
(ii) During pregnancy Ultrasonography should only be performed when indicated. The following is
the representative list of indications for ultrasound during pregnancy.
(1) To diagnose intra-uterine and/or ectopic pregnancy and confirm viability.
(2) Estimation of gestational age (dating).
(3) Detection of number of fetuses and their chorionicity.
(4) Suspected pregnancy with IUCD in-situ or suspected pregnancy following contraceptive
failure/MTP failure.
(5) Vaginal bleeding / leaking.
(6) Follow-up of cases of abortion.
(7) Assessment of cervical canal and diameter of internal os.
(8) Discrepancy between uterine size and period of amenorrhoea.
(9) Any suspected adenexal or uterine pathology / abnormality.
(10) Detection of chromosomal abnormalities, foetal structural defects and other
abnormalities and their follow-up.
(11) To evaluate foetal presentation and position.
(12) Assessment of liquor amnii.
(13) Preterm labour / preterm premature rupture of membranes.
(14) Evaluation of placental position, thickness, grading and abnormalities (placenta
praevia, retroplacental haemorrhage, abnormal adherence etc.).
(15) Evaluation of umbilical cord – presentation, insertion, nuchal encirclement, number of
vessels and presence of true knot.
(16) Evaluation of previous Caesarean Section scars.
(17) Evaluation of foetal growth parameters, foetal weight and foetal well being.
(18) Colour flow mapping and duplex Doppler studies.
(19) Ultrasound guided procedures such as medical termination of pregnancy, external
cephalic version etc. and their follow-up.
(20) Adjunct to diagnostic and therapeutic invasive interventions such as chorionic villus
sampling (CVS), amniocenteses, foetal blood sampling, foetal skin biopsy, amnioinfusion,
intrauterine infusion, placement of shunts etc.
(21) Observation of intra-partum events.
(22) Medical/surgical conditions complicating pregnancy.
(23) Research/scientific studies in recognized institutions.
Person conducting ultrasonography on pregnant women shall keep complete record thereof
in the clinic/centre in Form – F and any deficiency or inaccuracy found therein shall
amount to contravention of provisions of section 5 or section 6 of the Act, unless contrary
is proved by the person conducting such ultrasonography.
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