Brief resume of the intended work



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Rajiv Gandhi University of Health Sciences, Karnataka,

Bangalore.

PROFORMA SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

DISSERTATION PROPOSAL

A STUDY TO ASSESS THE EFFECTIVENESS OF STRUCTURED TEACHING PROGRAMME REGARDING TERATOGENS AND THEIR EFFECTS AMONG ANTENATAL WOMEN RESIDING AT UTTARAHALLI, BANGALORE CITY”.



SUBMITTED BY,

Mrs. DHANAM.M,

1ST YEAR M.Sc NURSING,

BHAGATH COLLEGE OF NURSING,

#60, UTTARAHALLI MAIN ROAD,

UTTARAHALLI HOBLI,

BANGALORE- 560061.

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore.

PROFORMA SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1



Name of the Candidate and Address

DHANAM.M,

1ST YEAR M.Sc NURSING,

BHAGATH COLLEGE OF NURSING,

#60, UTTARAHALLI MAIN ROAD,

UTTARAHALLI HOBLI, BANGALORE: 560061.


2

Name of the Institution

Bhagath College of Nursing.


3

Course of study and subject


1ST Year M.Sc Nursing,

Obstetrics and Gynaecological Nursing.



4

Date of admission to Course

01/10/2011


5

Title of the Topic

“A Study to Assess the Effectiveness of Structured Teaching Programme Regarding Teratogens and their Effects Among Antenatal Women Residing at Uttarahalli, Bangalore city.”


6

Brief resume of the intended work:

6:1 Need for the study

6:2 Review of literature

6:3 Objectives of the study

6:4 Operational definitions

6:5 Hypothesis of the study

6:6 Assumptions

6:7 Delimitations of the study

6:8 Pilot study

6:9 Variables



Enclosed


Enclosed

Enclosed


Enclosed

Enclosed


Enclosed

Enclosed


Enclosed

Enclosed

7


Materials and Methods

7:1 Source of data- Data will be collected from antenatal women

Residing at Uttarahalli, Bangalore city.

7:2 Method of collection of data: Structured knowledge questionnaire.

7:3 Does the study require any investigation or interventions?

Yes.


7:4 Has ethical clearance been obtained from our institutions?

Yes, Ethical committee’s report is here with enclosed.




8

List of references

Enclosed

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore.

PROFORMA SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1

Name of the Candidate and Address


DHANAM.M,

1ST YEAR M.Sc NURSING,

BHAGATH COLLEGE OF NURSING,

#60, UTTARAHALLI MAIN ROAD,

UTTARAHALLI HOBLI, BANGALORE: 560061.


2

Name of the Institution


Bhagath College of Nursing.

3

Course of Study and Subject


1st Year M.Sc Nursing,

Obstetrics and Gynaecological Nursing.



4

Date of Admission to Course


01/10/2011

5

Title of the Topic

“A Study to Assess the Effectiveness of Structured Teaching Programme Regarding Teratogens and their Effects Among Antenatal Women Residing at Uttarahalli, Bangalore city.”





6. BRIEF RESUME OF THE INTENDED WORK
INTRODUCTION
"An ounce of prevention is worth a pound of care."

-Benchemin Franklin

Pregnancy is a unique, exciting and often joyous time in a woman's life, as it highlights the woman's amazing creative and nurturing powers while providing a bridge to the future. Pregnancy comes with some cost, however, for a pregnant woman needs also to be a responsible woman so as to best support the health of her future child. The growing fetus depends entirely on its mother's healthy body for all needs. Consequently, pregnant women must take steps to remain as healthy and well nourished as they possibly can. Pregnant women should take into account the many health care and lifestyle considerations1.


A teratogen is a drug or other substance capable of interfering with the development of an embryo fetus that may lead to birth defects or developmental malformations. The presence teratogenic materials in your lab do not mean that you have been exposed or are likely to experience teratogenic or embryo toxic effects. All chemicals including teratogens can be handled safely but some require more care in handling than others.

A teratogen is an agent, which can cause a birth defect. It is usually something in the environment that the mother may be exposed to during her pregnancy. It could be a prescribed medication, a street drug, alcohol use, or a disease present in the mother which could increase the chance for the baby to be born with a birth defect. About 4 to 5 percent of birth defects are caused by exposure to a teratogen2.


Once the egg is fertilized (conception), it takes about six to nine days for implantation to occur. Once the fertilized egg is connected to the uterus, a common blood supply exists between the mother and the embryo. In other words, if something is in the mother's blood, it can now cross over to the developing fetus. Teratogens are thought to have the ability to affect the fetus up to 10 to 14 days after conception.
During the development of a baby, there are certain organs forming at certain times. If a teratogen has the potential to interfere with the closure of the neural tube, for example, the exposure to the teratogen must occur in the first 3.5 to 4.5 weeks of the pregnancy, since this is when the neural tube is closing. There are some organ systems that are sensitive to teratogens throughout the entire pregnancy, such as the central nervous system. The central nervous system is the baby's brain and spine. One teratogen that affects the central nervous system is alcohol. Alcohol, at any time during the pregnancy, has the potential to cause birth defects and health problems in the baby, since the central nervous system is sensitive to teratogens the entire nine months of gestation.
A “teratogen” is any exposure that can cause harm to an unborn or breastfeeding baby. Teratogens can be alcohol, prescription/non-prescription medications, illegal drugs, vaccines, illnesses, environmental exposures, occupational exposures, or maternal autoimmune disorders3.
Every woman has a 3-5% risk of having a baby born with a birth defect. Some teratogens will increase that risk, depending upon when in the pregnancy a woman has the exposure, the dose and route ofexposure.
We know that 25% of all recognized pregnancies end in miscarriage. The risk of a miscarriage drops to 10% in your eighth week. Some teratogens will increase this risk, but it is dependent upon the type and amount of the exposure as well as the timing in the pregnancy.

6.1 NEED FOR THE STUDY

Before you were born I carried you under my heart. From the moment you arrived in this world until the moment I leave it, I will always carry you in my heart."


Author: Mandy Harrison

Exposure to teratogens can result in a wide range of structural abnormalities such as cleft lip, cleft palate, dysmelia, anencephaly, ventricular septal defect. Exposure to a single agent can produce various abnormalities depending on the stage of development it occurs. Specific birth defects are not characteristic of any single agents.


It is estimated that 10% of all birth defects are caused by prenatal exposure to a teratogenic agent. These exposures include, but are not limited to, medication or drug exposures, maternal infections and diseases, and environmental and occupational exposures. Teratogen-caused birth defects are potentially preventable. Studies have shown that nearly 50% of pregnant women have been exposed to at least one medication during gestation. An additional study found that of 200 individuals referred for genetic counseling for a teratogenic exposure, 52% were exposed to more than one potential teratogen4.
The World Health Organization estimates that about 50% of all fertilized ova are lost within the first three weeks of development, and that 15% of all clinically recognizable pregnancies end in spontaneous abortions. Birth defects are known to occur in 3-6% of all newborns. They are the leading cause of infant mortality in the United States, accounting for more than 20% of all infant deaths. Seven to ten percent of all children will require extensive medical care to diagnose or treat a birth defect. And although significant progress has been made in identifying the etiology of some birth defects, approximately 65% have no known or identifiable cause. Polygenic, multifactorial and synergistic interactions of teratogens fall into this category.
However, it is extremely difficult to make accurate estimates of exposure risk due to the large number of pharmaceutical, industrial and agricultural chemicals which increases the risk of exposure to multiple agents and their potential synergistic effects, and human genetic heterogeneity which contributes greatly to the individual level of threshold susceptibility. It was previously believed that the mammalian embryo developed in the impervious uterus of the mother, protected from all extrinsic factors. However, after the thalidomide disaster of the 1960s, it became apparent and more accepted that the developing embryo could be highly vulnerable to certain environmental agents that have negligible or non-toxic effects to adult individuals5.
A review published in 2010 identified 6 main teratogenic mechanisms associated with medication use: folate antagonism, neural crest cell disruption, endocrine disruption, oxidative stress, vascular disruption and specific receptor- or enzyme-mediated teratogenesis.
The study was conducted on alcohol as a teratogen which causes placental hypoxia and foetal development to examine the causes of variability in the effect of maternal drinking on the foetus, with particular reference to the pattern, frequency and duration of the period of drinking, differences in maternal, foetal and placental metabolism of ethanol/acetaldehyde, and genetic factors. There seems to be an association between the teratogenic effect, hypoxia and oxidative stress, the molecular mechanism involved and the range of effects. The review sums ups the evidence that could explain some of the abnormalities in the brain development that could be related to behavioural problems observed in individuals with foetal alcohol spectrum disorder. This suggests that alcohol consumption produces failures in the normal migration of radial cells, from which the rest of the brain cells would eventually develop6.
The study was conducted on association of genotoxic and teratogenic effects induced by cyclophosphamide. Intact rat embryonic and placental tissues were found to have a characteristic ratio of cells with different degrees of DNA fragmentation. The genotoxic effect of cyclophosphamide was shown to be accompanied by a quantitative deviation from the control group established ratio of different cell types. A relationship was found between the abnormal ratio of different cell types in the embryonic and placental tissues and the occurrence of embryonic morphological abnormalities. The antimutagen afobazole (1, 10, and 100 mg/kg) was ascertained to be able to lower genotoxic effects in the embryonic and placental tissues and their related malformations. It is presumed that it is promising to use DNA damage index in the embryonic and placental cells as a biomarker of the course of embryogenesis and as a basis for devising an indicator test for rapid screening of potential teratogens7.
When the investigator worked as a staff nurse in a hospital, the researcher witnessed a pregnant women delivered a baby with cardiac defect. While taking the detail history of her, the researcher came to know that the basic reason behind that is more exposure to alcohol during pregnancy. So the researcher thought to assess the knowledge of antenatal women and educate them regarding the teratogens and its effects during pregnancy. So that they can reduce the risk of complications and ensure safety in pregnancy and having a healthy baby, and can build up a healthy nation as today’s children are tomorrow’s citizens.

6.2 REVIEW OF LITERATURE
Review of literature provides basis for future investigation, justifies the need for replication, throws light up on feasibility of the study and indicates constraints of data collection and help to relate findings of one another. The scope of literature review should be broad enough to allow the reader to become familiar with the research problems and narrow enough to include predominantly relevant sources.


  1. Review related to prevalence of teratogens during pregnancy

The study was conducted on potential cardiac teratogens by department of pediatrics. This review is a series of the authors' studies designed to test the hypothesis that administration of trichloroethylene, dichloroethylene , their metabolites, and related compounds are responsible for fetal cardiac teratogenesis when given to pregnant rats during organogenesis. Identification of teratogenic compounds will allow more accurate assessment of environmental contaminants and public health risks. Maternal and fetal variables showed no statistically significant differences between treated and untreated groups. When treated with TCAA the increased cardiac defects, as compared to controls, do not preclude the involvement of other metabolites as cardiac teratogens, but indicates TCAA as a specific cardiac teratogen8.


The study was conducted on mycophenolate as a new teratogen by department of public health. Mycophenolate is an immunosuppressant drug that is teratogenic in rats and rabbits. Reports of malformations in 13 offspring of women exposed to MMF in pregnancy raise concern that MMF is also a human teratogen. We report an additional child with malformations following prenatal exposure to MMF and review the other 13 reports. We identified a Cambodian male born at 31 weeks' gestation to a mother who had been treated for lupus nephritis with MMF from before conception to 12 weeks' gestational age. While case reports have limited value in identifying human teratogens, the unusual distribution of malformations among the 14 reported exposed offspring identifies a phenotype suggesting that MMF is likely a human teratogen9.
The study was conducted on metronidazole appears not to be a human teratogen. As is the case with many drugs, physicians often hesitate to use it during pregnancy, particularly in the first trimester. A review of the nearly four decades' worth of published literature on metronidazole use in pregnant women indicates that it is not teratogenic, regardless of the trimester in which it is used. On the other hand, a number of published studies indicate that bacterial vaginosis and trichomoniasis are associated with preterm birth and low birth weight. Treatment of these conditions with metronidazole during pregnancy may decrease the incidence of preterm birth and low birth weight, thus potentially decreasing the complications that can result from prematurity during pregnancy and after childbirth prevent the urinary stress incontinence10.


  1. Review related to complications of teratogens during pregnancy

The study was conducted on human teratogens by national center on birth defects and developmental disabilities. The prescription of known teratogenic medications requires a careful balance between allowing women access to medications that they might need and avoiding unnecessary exposure to these medications during pregnancy because of their devastating fetal effects. Isotretinoin, a potent human teratogen, is of particular concern because of its widespread use among reproductive-aged women and the dramatic increase in use from 1992 through 2000. A revised risk management system was implemented in 2002 because of concerns about the continued occurrence of isotretinoin-exposed pregnancies. However, the recent approval of three generic versions of isotretinoin in the US has further complicated risk management and raises concerns that use might increase further if the lower cost of generics serves to increase accessibility10.


The study was conducted to evaluate whether computerized clinical decision support can increase primary care providers provision of family planning services when prescribing potentially teratogenic medications. The result shows that the Both CDS systems were associated with slight increases in provision of family planning services when potential teratogens were prescribed, without a significant difference in improvement by CDS complexity. Because CDS was not repeated, 13% of the times that PCPs received CDS they substituted another potential teratogen. PCPs reported significant improvements in several counseling and prescribing practices. The multifaceted group reported a greater increase in the number of times per month they discussed the risks of medication use duringpregnancy. The simple CDS system was associated with greater clinician satisfaction11.
The study was conducted on Piperidine alkaloids are acutely toxic to adult livestock species and produce musculoskeletal deformities in neonatal animals. These teratogeniceffects include multiple congenital contracture deformities and cleft palate in cattle, pigs, sheep, and goats. Poisonous plants containing teratogenic piperidine alkaloids include poison hemlock, lupine, and tobacco. There is abundant epidemiological evidence in humans that link maternal tobacco use with a high incidence of oral clefting in newborns; this association may be partly attributable to the presence of piperidine alkaloids in tobacco products. In this review, we summarize the evidence for piperidine alkaloids that act as teratogens in livestock, piperidine alkaloid structure-activity relationships and their potential implications for human health12.


  1. Review related to effects of teratogens on fetus

The study employed qualitative approach and investigated the effects of teratogenic agents on the life of the developing human beings. Qualitative researchers seek to gather answers and information from the events they see and hear from people and read from literature. The unborn child, although seemed to be protected, comfortable in the womb environment is not completely immuned to some external and internal influences surrounding the mother that can cause serious and debilitating effects at different developmental stages of the individual. Literatures reviewed explained the negative effects of teratogenic agents on both prenatal and postnatal lives. Most literature reviewed indicated that the danger of structural defects caused by teratogens is greater in embryonic stage. Studies also showed that the teratogenic agents can be disastrous to the developing human being from the moment of conception to birth and/or through life. The study reported two, teratogenic cases13.

The study was conducted on teratogens and its effects by Mycophenolate mofetil (MFM) is an immunosuppressant agent used in organ transplantation, rheumatoid arthritis and lupus nephritis. Experimental data show that doses roughly equivalent to those used clinically in transplant patients may cause fetal resorption and malformations in pregnant rats and rabbits. There are limited data regarding the use of MFM in pregnant women. The human experience is based on 9 case reports, 1 case series, and 2 registry data. The most frequent structural anomalies described in 12 newborns exposed to MFM were as follows: microtia, auditory canal atresia, cleft lip and palate, micrognathia, hypertelorism, ocular coloboma, short fingers, and hypoplasic nails. The distinctive and unique phenotype associated with MFM exposure during pregnancy raised the hypothesis that MFM may be a real teratogenic drug. Appropriate recommendations to prevent this possible new embryopathy are given14.


  1. Review related to prevention of teratogen exposure associated complications.

The study was conducted on intrauterine exposure to teratogens.There is very little data linking the use of immunomodulating agents following solid organ transplantation in pregnant women with specific congenital anomalies in the offspring. Here we report on a late preterm infant with multiple, nonsyndromic, congenital anomalies including microtia/anotia, cleft lip and palate, micrognathia, ocular hypertelorism, microphthalmia and cataracts, complex congenital heart disease, rib anomalies, and intestinal malrotation. The similarity of the complex anomalies in our case to other reported cases suggests that the abnormalities are likely due to mycophenolate mofetil alone or in combination with other immunosuppressive medications taken by the mother during pregnancy15.

The study was conducted on potential teratogenic effects during pregnancy. We report on a case of a multiple congenital anomalies in a newborn infant whose mother was on allopurinol treatment through the pregnancy. The pattern of congenital anomalies that was noted in our patient was similar to the pattern described in a number of published reports following mycophenolate mofetil treatment during pregnancy. The anomalies present in our patient include: diaphragmatic hernia, unilateral microtia and absence of external auditory canal, micrognathia, microphthalmia, optic nerve hypoplasia, hypoplasia of the corpus callosum, unilateral renal agenesis, pulmonary agenesis, and cleft lip and palate. Since both allopurinol and mycophenolate mofetil act by disrupting purine biosynthesis and given the similarities in anomalies seen after prenatal exposure, we suggest that allopurinol should also be considered a teratogen16.


The study was conducted on broad spectrum of teratogenic effects. A newborn female infant born to a woman on immunosuppressive medications including mycophenolate mofetil for a renal graft secondary to lupus nephritis presented with congenital diaphragmatic hernia and additional findings of microtia, esophageal atresia with tracheoesophageal fistula, cleft palate, congenital heart defect, digital anomalies, and dysmorphic facial features. To date, this is the only human report of CDH in an infant with prenatal exposure to MMF, although the manufacturer's package insert alludes to animal studies with a broad spectrum of malformations, including CDH. Thus, a teratogenic exposure can mimic a known Mendelian genetic syndrome, and caution is urged in presuming a genetic etiology for infants with potential teratogenic exposure to relatively new drugs with limited published animal data17.

6.3 OBJECTIVES OF THE STUDY


  1. To assess the knowledge of antenatal women regarding the Teratogens and their effects.




  1. To develop and conduct a structured teaching programme among antenatal women regarding the Teratogens and their effects.



  1. To evaluate the effectiveness of structured teaching programme among antenatal women regarding the Teratogens and their effects by posttest.



  1. To find out the association between knowledge level and selected demographic variables of antenatal women.

6.4 OPERATIONAL DEFINITIONS

1. Assess: Assess refers to the critical analysis and evaluation or judgement of the status or quality of Teratogens and their effects among antenatal women.

2. Effectiveness: Effectiveness refers to the difference which is expected in the knowledge score values of the antenatal mothers regarding teratogens and its effects.
3. Structured teaching programme: It is a planned systematic information, instruction or training giving to a person or a group regarding the Teratogens and their effects.
4. Teratogen: A teratogen is a drug or other substance capable of interfering with the development of an embryo fetus that may lead to birth defects or developmental malformations.
5. Antenatal women: Is a women who is carrying viable products of conception in the womb till birth between the reproductive age group of 20-35 years.

6.5 HYPOTHESIS OF THE STUDY
H1: There will be statistically significant association between antenatal women knowledge regarding Teratogens and their effects and selected demographic variables.

H2: There will be statistically significant difference between pre and post test knowledge scores of antenatal women regarding Teratogens and their effects.




6.6 ASSUMPTIONS:

  1. Antenatal women may have some knowledge regarding the teratogens and their effects.

  2. Antenatal women’s knowledge regarding the teratogens and their effects can be measured by using a structured knowledge questionnaire.

  3. Antenatal women’s knowledge regarding teratogens and their effects can be improved by structured teaching programme.

6.7 DELIMITATIONS OF THE STUDY

  1. The study is limited only to antenatal women who are at the age between 20-35Yrs.

  2. The study is limited only to antenatal women who are residing at Uttarahalli, Bangalore city.

  3. The study is limited only to antenatal women who are able to read and write Kannada or English.

6.8 PILOT STUDY:

The study will be conducted with 6 samples. The purpose to conduct pilot study is to find out the feasibility for conducting the study and design on plan of statistical analysis.



6.9 VARIABLES:

Variables are qualities, properties or characteristics of persons, things or situations that change or vary and are manipulated or measured in research.



  • Dependent variables: Knowledge level of antenatal women regarding the teratogens and their effects.

  • Independent variables: Structured Teaching Programme

  • Extraneous variable: Age, parity status, educational status, occupation, source of information.

7. MATERIAL AND METHODS:

7.1 SOURCE OF DATA:

The data will be collected from all antenatal women who are residing at Uttarahalli, Bangalore.



7.1.1 RESEARCH DESIGN

The research design adopted for this study is Pre experimental in nature. One group pretest- posttest design.



7.1.2 RESEARCH APPROACH:

Evaluative research approach



7.1.3 SETTING OF THE STUDY:

The study will be conducted at Uttarahalli, Bangalore city.



7.1.4 POPULATION:

All the antenatal women who meet all the inclusion criteria and are residing in Uttarahalli, Bangalore.



7.2 METHODS OF COLLECTION OF DATA (INCLUDING SAMPLING PROCEDURE):

The data collection procedure will be carried out for a period of one month. The study will be conducted after obtaining permission from the concerned authorities. The investigator collects data from antenatal women by using a structured knowledge questionnaire regarding the teratogens and their effects.

The data collection instrument consists of following sections

Section A: Demographic Data

Section B: Questions related to the knowledge of antenatal women regarding the teratogens and their effects.

7.2.1 SAMPLING TECHNIQUE:

Non-probability convenience sampling will be used to select the antenatal women who are residing at Uttarahalli, Bangalore city.



7.2.2 SAMPLE SIZE:

Sample consists of 60 antenatal women who are residing at Uttarahalli, Bangalore city.



SAMPLING CRITERIA:

7.2.3 INCLUSION CRITERIA:

  1. Antenatal women who are residing at Uttarahalli, Bangalore city.

  2. Antenatal women who are at the age between 20-35 Years.

  3. Antenatal women who are available at the time of study.

  4. Antenatal women who are able to read and write Kannada or English.

  5. Antenatal women who are willing to participate in the study

7.2.4 EXCLUSION CRITERIA:

  1. Antenatal women with contagious diseases.

  2. Antenatal women who are selected for pilot study.

  3. Antenatal women with hearing disabilities.

  4. Antenatal women with loss of vision.

7.2.5 TOOLS FOR DATA COLLECTION:

A structured knowledge questionnaire is used to collect the data from the antenatal women.



7.2.6 DATA ANALYSIS METHOD:

The data collected will be analyzed by using descriptive and inferential statistics



Descriptive statistics:

Frequency and percentage for analysis of demographic data and mean, mean percentage and standard deviation will be used for assessing the level of knowledge.



Inferential statistics:

Chi-square test will be used to find out the association between knowledge of antenatal women and selected demographic variables. Paired‘t’ test will be used for assessing the effectiveness of Structured Teaching Programme.



7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INVESTIGATIONS TO BE CONDUCTED ON PATIENTS OR HUMANS OR ANIMALS?

Since the study is pre experimental in nature, investigation or interventions are required.



7.4 ETHICAL CLEARENCE:

Yes, ethical committee’s is here with enclosed. The main study will be conducted after the approval of research committee of the college. Permission will be obtained from the head of the institution. The purpose and details of the study will be explained to the study subjects and assurance will be given regarding the confidentiality of the data collected.



LIST OF REFERENCES (VANCOUVER METHOD FOLLOWED)

  1. Jessica Evert, Introduction to Pregnancy, British medical journal, 2005 August 12, Available from: http://www.mentalhelp.net.



  1. Grace Addison, The Secret to a Healthy and Beautiful Pregnancy, Ezine Articles 2010 August 8, Available from: http://ezinearticles.com.



  1. Teratogens and their effects, 1998 April 15, Available from: http:// www.chw.org/display/PPF/DocID/22924/router.asp.



  1. Introduction to teratogens, 2009 December 1, Available from: http://www.ehow.com.



  1. Jago Holmes, Teratology, 2009 August 23, Available from: http://en.wikipedia.org/wiki/Teratology. Available from: http://www.ncbi.nlm.nih.gov




  1. Bosco CDiaz E. Placental hypoxia and foetal development versus alcohol exposure in pregnancy. 2012 Mar-Apr;47(2):109-17. Available from: http://www.ncbi.nlm.nih.gov



  1. Shreder OVShreder EDDurnev ADSeredenin SB. Association of genotoxic and teratogenic effects induced by cyclophosphamide. Available from: http://www.ncbi.nlm.nih.gov



  1. P D Johnson, B V Dawson, and S J Goldberg. Potential cardiac teratogens. 1998 August; 106(Supple 4): 995–999. Available from: http://www.ncbi.nlm.nih.gov



  1. Anderka MT, Lin AE, Abuelo DN, Mitchell AA, Rasmussen SA. Reviewing the evidence for mycophenolate mofetil as a new teratogen. . 1997; 5(5): 326–335. Available from: http://www.ncbi.nlm.nih.gov



  1. Barbara J. Struthers. Metronidazole Appears Not to Be a Human Teratogen. 2009 Jun; 149A (6):1237-40.Available from: http://www.ncbi.nlm.nih.gov/pubmed.



  1. Honein MA, Moore CA, Erickson JD. Can we ensure the safe use of known human teratogens? 2004; 27(14):1069-80. Available from: http://www.ncbi.nlm.nih.gov/pubmed



  1. Schwarz EBParisi SMHandler SM. Clinical Decision Support to Promote Safe Prescribing to Women of Reproductive Age.  Koren GCohen EDShevchik GJFischer GS. 2012 Mar 11; 293(1-3):53-8. Available from: http://www.ncbi.nlm.nih.gov



  1. Green BTLee STPanter KEBrown DR. Human and food animal teratogens. 2012 Feb 2, Available from: http://www.ncbi.nlm.nih.gov



  1. The Effects of Teratogens on the Health of Developing Human Beings. 23-25th July, 2008, Available from: http://www.ncbi.nlm.nih.gov



  1. Parisi MA, Zayed H, Slavotinek AM, Rutledge JC. Broad spectrum of teratogenic effects. 2009 Jun; 149A (6):1237-40. Available from: http://www.ncbi.nlm.nih.gov/pubmed



  1. Merlob P, Stahl B, Klinger G. Tetrada of the possible mycophenolate mofetil embryopathy. 2009 Jul;28(1):105-8, available from: http://www.ncbi.nlm.nih.gov



  1. Jackson P, Paquette L, Watiker V, Randolph L. Intrauterine exposure to mycophenolate . 2009 Jun;149A(6):1231-6. Available from: http://www.ncbi.nlm.nih.gov



Signature of the Candidate



Remarks of the Guide




Name and Designation of

11.1 Guide

11.2 Signature

11.3 Co-Guide

11.4 Signature

11.5 Head of Department

11.6 Signature





12.1 Remarks of the Chairman &

Principal



12.2 Signature




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