RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
SYNOPSIS
OF
DISSERTATION
"UMBILICAL CORD COILING INDEX
AND PERINATAL OUTCOME"
Submitted by
Dr. NIVEDITA S. PATIL
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 CANDIDATEAND ADDRESS
(in block letters) / Dr. NIVEDITA. S. PATIL
P.G IN OBSTETRICS AND 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 / 02-06-20085. / TITLE OF THE TOPIC / “UMBILICAL CORD COILING INDEX AND PERINATAL OUTCOME”
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 / MATARIALS 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
NO
APPENDIX-IIC
YES
8. / LIST OF REFERENCES /APPENDIX - III
9. / SIGNATURE OF THE CANDIDATE /10. /
REMARKS OF THE GUIDE
/ IF THE COILING INDEX IS ABNORMAL NECESSARY STEPS MAY BE TAKEN TO IMPROVE THE HEALTH OF THE NEONATE11 / NAME AND DESIGNATION
(in Block Letters)
11.1 GUIDE / Dr. SUNANDA. R. KULKARNI M.D.
Professor,
Department of Obstetrics and Gynecology,
AIMS, B.G. Nagara-571448
11.2 SIGNATURE OF THE GUIDE
11.3 CO-GUIDE (IF ANY) / -
11.4 SIGNATURE / -
11.5 HEAD OF DEPARTMENT / Dr. S. VIJAYALAKSHMI, M.D , D.G.O
Professor and Head
Department of Obstetrics and Gynecology
AIMS, B.G. Nagara-57144811.6 SIGNATURE
12 / 12.1 REMARKS OF THE CHAIRMAN
AND PRINCIPAL
12.2 SIGNATURE
APPENDIX-I
6.BRIEF RESUME OF THE INTENDED WORK:
APPENDIX –I A
6.1 NEED FOR THE STUDY:
This study is done to known whether abnormal umbilical cord coiling index is related to adverse perinatal outcome.
APPENDIX –I B
6.2 REVIEW OF LITERATURE
The umbilical cord is the 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.1 The helical fashion of these umbilical vessels is known as ‘Spiral Course’.1 A coil is defined as complete 3600 spiral course of umbilical vessel around the Wharton’s Jelly.1
The coiling property of cord vessels was described by Berengarius in 1521. the total number of coils for any particular cord is belived to be established in early gestation.2,3 In 1954, umbilical coiling was first quantified by Edmonds4 who divided the total number of coils by the umbilical cord length in centimeters and called it “The Index of Twist”. He assigned positive and negative scores to clockwise and anticlockwise coiling respectively.
Later, Strong et. al.,5 simplified by eliminating these directional scores and named it “The Umbilical Coiling Index”. An abnormal umbilical coiling index includes both hypocoiled cords (i.e., cords with umbilical coiling index < 10th centile) and hypercoiled cords (i.e., cords with umbilical coiling index > 90th centile). An abnormal umbilical coiling index (UCI) has been reported to be related to adverse fetal outcome.6-9
The study was done to know whether abnormal umbilical coiling index is related to adverse perinatal outcomes. 107 umbilical cords were examined and umbilical coiling index was calculated. The outcome measured were intra uterine growth retardation meconium staining, birth weight, apgar score, ponderal index. They concluded that hypocoiled cords were associated with low apgar score, low birth weight and meconium staining.1
The study of 100 cords was carried and umbilical coiling index was calculated by dividing the total number of complete vascular coils in given cord by the total length of the cord in centimeters. It was concluded that the cords with < 10th percentile of umbilical coiling index had higher incidence of growth retardation, fetal distress and meconium staining.5
The study was done to correlate the perinatal outcome with the umbilical coiling index. About 130 umbilical cords were studied and the umbilical coiling index was calculated by dividing number of coils in the cord by the total length of cord in centimeters. It was concluded that the cords having umbilical coiling index 5th percentile (hypocoited cords) were associated with low apgar score, intrauterine death and small for date babies. The cord with umbilical coiling index of 95th percentile i.e., hypercoiled were associated with meconium staining, intra uterine growth retardation, low apgar score.10
The study was carried out to evaluate perinatal outcomes in neonates with hypocoiled and hypercoiled cords. 802 cords were studies, umbilical coiling index was calculated and it was concluded that hypocoiled and hypercoiled were associated with low birth weight, low apgar score, meconium staining, intra uterine growth retardation.9
Umbilical cords of 885 patients were studied in a cross sectional study design. The umbilical coiling index was determined as the number of complete coils divided by the length of cord in centimeters, blinded for pregnancy outcome. Odds ratio and their 95% confidence intervals were calculated to evaluate associations between undercoiling and overcoiling and adverse pregnancy outcome, using multiple logistic regression. It was concluded that undercoiling and overcoiling of the umbilical cord are associated with increased risk for adverse perinatal outcome.11
APPENDIX –IC
6.3 AIMS AND OBJECTIVES OF STUDY
To correlate the perinatal outcome with the umbilical coiling index.
APPENDIX-II
7.0 MATERIALS AND METHODS
APPENDIX-II A
7.1 SOURCE OF DATA
This study is being conducted at Sri Adichunchanagiri Hospital and Research Centre, B.G. Nagara. The source of data for the study are patients from this hospital admitted in the labour room meeting the inclusion criteria.
Study Design : Cross sectional study design.
Study Period : 24 Months (June 2008 to May 2010)
APPENDIX-II B
7.2 METHOD OF COLLECTION OF DATA
INCLUSION CRITERIA
· Healthy women with term gestation irrespective of parity.
· Singleton pregnancy.
· Live baby.
· Delivery both vaginal and lower segment caesarean delivery.
EXCLUSION CRITERIA
· Twin gestation
· Preterm deliveries
· Intrauterine deaths
· Women with diseases like cardiac diseases, diabetes, severe hepatic impairment, renal impairment, pregnancy induced hypertension, recent severe asthmatic attack etc.
· Rh negative pregnancy.
· Malpresentations.
· Anamalous baby.
· Placental condition like placenta previa, abruptio placenta etc.
Procedure of Study :
Healthy women with term gestation with singleton pregnancy, irrespective of their parity, who are in active labour and are admitted to labour room are taken for the study. The patient is observed in 2nd and 3rd stage of labour. After separating the baby from the umbilical cord, the cord is tied and cut as close to placenta as possible. The umbilical cord is measured in its entirety, including the length of placental end of the cord and the umbilical stump of the baby. The number of the complete coils or spirals are counted from the neonatal end towards the placental end of the cord and expressed per centimeters. After this umbilical coiling index is calculated, by dividing the total number of coils, by the total length of cord in centimeters.
Normal Umbilical coiling index = 0.17
Umbilical coiling index < 10th centile = < 0.07 = hypocoling
Umbilical coiling index < 90th centile = > 0.30 = hypercoiling
After calculating the umbilical coiling index, perinatal factors like meconium staining, fetal weight, apgar score, ponderal index is correlated with it. Thus the effect of umbilical coiling on the perinatal outcome is carried out.
Statistical Analysis Done by :
· Proportions
· Odds ratio
· Multiple logistic regression
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
NO
APPENDIX-III
8. LIST OF REFERENCES
1. Gupta S, Faridi MMA, Krishnan J. Umbilical coiling index. J. Obstet. Gynecol India 2006 ; 56 (4) : 315-319.
2. Van Dijk CC, Franx A, De Latt MWM et al. The umbilical coiling index in normal pregnancy. J. Matern Fetal Neonatal Med 2002 ; 11 : 280-3.
3. Machin GA, Ackerman J, Gilbert BE. Abnormal umbilical cord coiling is associated with adverse perinatal outcomes. Pediatr Dev. Pathol 2000 ; 3 : 462-71.
4. Edmonds HW. The spiral twists of the normal umbilical cord in twins and in singletons. Am. J. Obstet Gynecol. 1954 ; 67 : 102-20.
5. Strong T.H., Jarles D.L., Vega J.S. et al. Umbilical coiling index. Am. J. Obstet Gynecol. 1994 ; 170 : 29-32.
6. Lacro R.V., Jomes K.L., Benirschke K. The umbilical cord twist : Origin, direction and relevance Am. J. Obstet Gynecol 1987 ; 157 : 833-8.
7. Strong T.H, Finberg H.L, Mattox J.H. et al. Antepartum diagnosis of non-coiled umbilical cords. Am. J. Obstet Gynecol 1994 ; 170 : 1729-33.
8. Ercal T, Lacin S, Altuoyurt S et al. Umbilical coiling index : Is it a marker for fetus at risk? Br. J. Clin Pract 1996 ; 50 : 254-6.
9. Rana J, Ebert GA, Kappy KA. Adverse Perinatal outcome in patients with an abnormal umbilical coiling index. Obsete Gynecol 1995 ; 85 (4) : 573-7.
10. Pudmanabhan L.D., Mhaskar R, Mhaskar A. Umbilical vascular coiling and the perinatal outcome. J. Obstet Gynecol India 2001 ; 51 (6) : 43-44.
11. Monique. W.M., de Laat, Arie Franx et al., Umbilical coiling index in normal and complicated pregnancies. Obstet and Gynecol 2006 ; 107 : 1049-1055.
APPENDIX-IID
PROFORMA APPLICATION FOR ETHICS COMMITTEE APPROVAL
SECTION A
a / Title of the study / “UMBILICAL CORD COILING INDEX AND PERINATAL OUTCOME”b / Principle investigator
(Name and Designation) / Dr. NIVEDITA. S. PATIL
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. R. KULKARNI, M.D.
Professor,
Department of Obstetrics and Gynecology
AIMS, B.G. Nagara-571448
d / Name of the Collaborating
Department/Institutions / NA
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 studySection – D
MethodologyA / 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 /
24 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
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
NA
NA
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 I
Ethical clearance has been accorded.
Chairman,
P.G Training Cum-Research Institute,
A.I.M.S., B.G.Nagara.
Date :
PS : NA – Not Applicable
14