RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCEBANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTSFOR DISSERTATION

1 NAME OF THE CANDIDATEAND ADDRESS(IN BLOCK LETTERS)

SHAKUNTALA SURYAVOMSHI1st YEAR M.Sc. NURSING THE OXFORD COLLEGE OF NURSINGJ.P.NAGAR, 1ST PHASEBANGALORE

2 NAME OF THE INSTITUTION THE OXFORD COLLEGE OFNURSING J.P.NAGAR, BANGALORE

3 COURSE OF THE STUDY AND SUBJECT

M.Sc, NURSING IN OBSTETRICS AND GYNAECOLOGICAL NURSING

4 DATE OF ADMISSION 30th MAY 2008

5 TITLE OF THE TOPIC EFFECTS OF HUMAN TERATOGENS ON FETAL DEVELOPMENT

6. BRIEF RESUME OF THE INTENDED WORK:

“INFORMATION AND INVENTION ARE BETTER TOOLS FOR PREVENTION"

INTRODUCTION:

The word Teratogen is derived form the Greek “Teratos” means monster. A

teratogen is an agent that acts during embryonic & fetal development to produce

permanent alterations of structure and functions. Currently recognized teratogens

includes: chemicals, drugs, maternal infection, radiations etc. women commonly

ingest medications or drugs while pregnant and even expose to radio active

substances. The most common teratogenic effects attributed to drugs and give rise

to spontaneous abortion, congenital malformation, intra uterine growth retardation,

mental retardation and carcinogenesis. Fetal alcohol syndrome (FAS) consists of

multi system abnormalities and is caused by excessive intake of alcohol during

pregnancy. It has been widely reported that prenatal exposure to ionizing radiation

can interfere with embryonic and fetal development, depending on dose and

gestational age in which the exposure occurs. During pre-implantation stage

elevated doses of radiation can result in abortion, while lower doses may produce

genomic damage. Active & Passive smoking constitutes one of the most serious

problems like intra uterine growth retardation, intra uterine fetal death, premature

rapture of membranes and pre-term birth and can have deleterious effect on mother

and infant. Teratogenic effects of smoking are intra uterine growth retardation,

intra uterine fetal death, premature rapture of membranes and pre-term birth. If

pregnant women develop an infection during pregnancy it may cause multi organ

damage, incomplete limb development, cataracts, hearing loss cardiac

malformations1.

A study conducted on 9000 medical prenatal patients in Michigan revealed

that each woman received an average of 3.1% prescription of drugs other than

vitamins. A number of substantial pregnant women also abuse recreational drugs

during pregnancy2. This was supported by a study conducted found that 5.2% of

29494 women presenting ranging 5.2% presented for delivery in 202 Number of

California hospitals, were using one or more illicit drugs, including Amphetamine

Barbiturates, Coccaine, Methadone and opiods. Another 6.7% were using alcohol

and 8.8% populations of pregnant mothers were having habit of smoking cigarettes

prior to delivery. In most of the rural areas in India due to lack of knowledge

illiteracy and taboos, women are involved in alcohol consumption, tobacco

chewing, and ingestion of drugs, which are having teratogenic effects3.

The Government of India launched the “National Rural Health Mission” to

carryout necessary architectural correction in basic health care delivary system.

Recognized the importance of health in the process of economic and social

development and improving the qualities of life of people those residing in rural

areas mainly, the poor, women and children, the mission covers entire country. The

main function of N.R.H.M. in state is to provide fund for Asha, Programme

management unit, and up gradation of subcentre, Primary health centers and

community health centers, through integrated financial envelope. In community

health care delivary system the junior female health assistants (ANM) are gross

root level health workers. They are the mediators for health care delivary system

and community. By providing information, sharing knowledge and training them,

through the self instructional module to improve their knowledge, skill and

efficiency with regards to teratogenic effect on fetal development, which can

support their contribution to community 4.

6.1 Need for the study:

In the past, people were not aware of teratogens or its effects on fetal

development, due to the lack of knowledge, lack of advanced studies, and

technologies the infant morbidity and mortality rate were very high. Now we are in

the advanced world, with technology in support, and health care delivary system

accessible to all, we can be successful to prevent. Recent Health Statistical report

given by WHO birth defects are known to occur in 3.5% of all new borns

teratogens are the leading cause of infant mortality. A recent survey done in the

United States stated that more than 20% of are infant deaths due to effects of

teratogens. 7 to 10% of children will require extensive medical care to diagnose or

treat to diagnose or treat birth defects. Although significant progress have been

made in identifying teratogenic causes of some birth defects.

At global level fetal alcohol syndrome are 0.2 to 2 cases per 1000 live births,

comparable to or higher than other developmental disabilities, such as Down

syndrome or spinabifida. U.S. surgeons generally advise pregnant women to

abstain from alcohol use; congenital infection with cytomegalo virus is actually

more common in poorer communities. The incidence of Primary cytomegalo virus

infection in pregnant women in U.S. varies from 1% to 3%, Cytomegalo virus is

the more common cause of congenital infection in humans, and intra uterine

infection, Down syndrome are known cause of mental retardation. The use of

Tobacco products are exposure to second hand smoke during pregnancy has been

linked to low birth weight. Governor Mike Hucca bee of Arkansas citing studies

which attributes 10% of fetal death due to smoking mother. Gestational diabetes

affects 3 to 10% of pregnancy. Baby born with gestation diabetes are at more risk

of complications, like primary growth abnormalities and chemical imbalance,

which low down blood sugar5.

As per statistical information’s from Directorate of Health Services in Karnataka

from 1995 to 2001 due to congenital anomalies like spina bifida, hydrocephalus,

heart and circulatory system, cleft palate and cleft lip total number of deaths

reported are 7666.

In India congenital abnormalities are prevalent both in urban and rural area.

In the Governmental rural health set up, the junior female health assistants (ANM)

is the health functionary closest to the community, and play a pivotal role in

preventing perinatal mortality and morbidity. The junior female health assistants

(ANM) deals with aspects of health and family welfare, and her domain consists of

half a dozen villages – one of which is a sub center village. She functions at

various level, at one level she operates from the sub center where clients come for

services. At second level she will visits villages and homes contacting women,

children and men; providing services giving medicines tendering advice. At the

third level she is in touch with the primary health center community health center

and even District hospitals. At fourth level she is involved in survey / research

team and in record keeping, and also involved in providing the doorstep health and

family welfare services which can be made available at the field level, and to carry

out IEC (Information Education Communication) activities and collect

information7. Thus by educating junior female health assistants (ANMs) on effects

of human teratogens on fetal development can reduce congenital anomalies among

infants. Hence the researcher is interested to assess the knowledge on teratogenic

effects on fetal development and educate the junior female health assistants

(ANMs) to play a vital role in preventing.

6.2 REVIEW OF LITERATURE:

6.2.1 Studies related to effects of human teratogens on fetal development.6.2.2 Studies related to knowledge of health workers regarding teratogenic effect on fetal development.6.2.3 Studies related to effectiveness of self-instructional module.

6.2.1 Studies related to teratogenic effect on fetal development

Several drugs have teratogenic effect. This is supported by a study conducted

on the teratogenic risk of corbamazepine,(CBZ) is an antiepileptic drug that was

developed and marketed mainly for the treatment of epileptic seizures. In order

to quantify better the risks of exposure to CBZ during pregnancy, researcher

pooled data from prospective known to them. Researcher found in prospective

meta-analyses studies involving 1255 cases of exposure that CBZ therapy

increased the rate of congenital anomalies, mainly neural tube defects,

cardiovascular and urinary tract anomalies and cleft palate. CBZ may also

induce a pattern of minor congenital anomalies and developmental retardation,

and also appears to reduce gestational age at delivary. It concludes that, a

combination of CBZ with other antiepileptic drugs is more teratogenic than

CBZ monotherapy. In light of these results researchers recommend performing

a level 2 ultrasound and fetal echocardiography in women treated with CBZ

during pregnancy.8

It has been widely reported that prenatal exposure to ionizing radiation can

interfere with embryonic and fetal development depending on dose and

gestational age in which exposure occurs. In this review the main focus was on

the relevance of estimating the cumulative dose of radiation to the fetus and the

gestational age in which exposure occurs, to provide appropriate counseling to

pregnant women. This study was supported by several studies conducted on

animals as well as in human. In human studies, elevated doses produce adverse

outcomes depending on stage of development, as in animal studies.

Blastogenesis (up to 2 weeks) is associated with failure to implant or no

significant health effects. An Increased risk of malformation and growth

retardation can be observed for 2 to 7 weeks exposure (organogenesis stage)

while exposure at later stages (fetogenesis) is mainly associated with brain

damage. . (9)

Intake of alcohol during pregnancy leads to Fetal Alcohol Syndrome (FAS)

consists of multisystem abnormalities and is caused by the excessive intake of

alcohol. And FAS is most important human teratogenic condition known today.

Department of community oral health, Tygerberg, South Africa, conducts a study.

The purpose of this study was to analyze the craniofacial parameters of children

with FAS and compare with matched controls. Ninety children diagnosed with

FAS (45 females, 45males) and 90 controls were matched for age, gender, and

social class. The mean age of the FAS children was 8.9 years with controls slightly

older at 9.1 years this age difference was not significant (p=0.34). A standard

lateral cephalometric radiograph of each subject was taken. The radiographs were

digitized for 20 linear and 17 angular measurements. These 37 variables were

formulated to assess the size, shape, and relative position of three cranifacial

complexes :(1) the cranial base, (2) midface, (3) mandible. In addition, 9 variables

were computed to compare soft tissue profiles. The study showed that

measurements related to face height and mandibular size appear to be the most

important features when distinguishing FAS children. Overall, the FAS children in

the present study presented with vertically and horizontally underdeveloped

maxillae, features of long face syndrome with large gonial angles and short ramus

in relation to total face height. There was also a tendency for the development of

an anterior open bite, which appear to be compensated for by an increase in the

vertical dimension of the anterior alveolar process to bring the incisor teeth into

occlusion. The latter adaptation occurred mainly in the mandible.10

Maternal Hyperthermia during gestation can be teratogenic to the developing

fetus. Hyperthermia – induced malformations in structural abnormalities,

particularly in central nervous system, heart defects, hypodactyly and renal

anomalies. This is supported by a study conducted by medical genetics institute,

Steven Spielberg pediatric Research center, cedars-Medical center, Los Angeles

California 90048, USA. He demonstrated that the type of defects is related to the

timing of maternal hyperthermia that is cell death; membrane disruption vascular

description and placental infarction were all implicated in causing embryonic

damage.11

6.2.2 Studies related to the knowledge of health professional on effects of

human Teratogens on fetal development: -

Health professionals play a vital role in health care delivery system. By

educating the group of health professionals on effects of teratogens on fetal

development will help in preventing the same. This is supported by the studies

conducted by School Of Public Health –UMDNJ New Jersey Medical School –

University of Medicine and Dentistry of New Jersey USA12 revealed that there is a

need to educate health professionals in regards to fetal alcohol spectrum disorders

(FASD) across many health and allied health fields. Objective conduct evaluations

of educational programs designed to assess knowledge, attitudes and beliefs in

relation to fetal alcohol spectrum disorders. Methodology used for the same is over

a four months period using a common set of materials; pre and post test evaluation

comprised 20 questions on FASD recognition, diagnosis, treatment, and

prevention. It concludes that educational efforts in regards to FASD should be

sensitive to the various health professionals engaged in preventing, diagnosing and

treating FASD.

Nurses are one of the largest groups of healthcare professionals sharing in patient

care responsibilities, including caring for those who use and abuse psychoactive

substances. To evaluate the theoretical-practical knowledge acquired by nurses

their perceptions about alcohol users, quantitative, descriptive survey conducted in

Brazil by universidade federal De-Sao Paulo- Eescola Paulista De Medicina,

Brazil. This educational study conducted with 319 volunteers of nurses, revealed

that education which can bring about changes in the knowledge regarding use of

alcohol and its consequences with regard to offering adequate care management for

the patients who have problem with addiction to alcohol is important.13

6.2.3 Studies related to effectiveness of Self Instructional Module: -

Self-instructional module is an effective method of instructions. Self-

instructional module is an educational material, which helps the individual to learn

by self in a systematic way. Here in this individual will learn through shared

information, knowledge and study. This is supported by a study conducted on

effectiveness of Self Instructional Module among staff nurses in selected hospitals

in Bangalore on selected obstetric drugs. The results shows that the mean posttest

knowledge score 28(52%) with‘ t ‘ value 16.7 at <0.01 level of significance and

the findings reveals that the self-instructional module is an effective tool in

increasing the knowledge.14

Effectiveness of self-instructional module on pre-eclompsia among 50 female

health workers in primary health centers of selected districts in Tamilnadu. This

study revealed that it is an effective educational strategy in improving knowledge

of female health workers. The pre test knowledge score was 19.37 (mean pre- test

score x2 = 24.14) and the posttest score was 22.46 (mean Post test score X2=29.65).

This significant difference between the mean pre test and mean posttest results

were demonstrated by‘t ‘test (“t “49=8.179, p < 0.05). The finding suggests, that

the Self Instructional Module is effective method of instruction.15

STATEMENT OF THE PROBLEM:

A study to assess the effectiveness of self-instructional module, regarding effects

of human teratogens on fetal development among junior female health assistants

(ANMs).

6.3 OBJECTIVES OF STUDY:

6.3.1 To assess the knowledge of junior female health assistants (ANMs) on effects

of human teratogens on fetal development by pre test knowledge score.

6.3.2 To develop self-instructional module on effects of human teratogens on fetal

development.

6.3.3 To assess the effectiveness of self-instructional module by comparing the pre

and post- test scores.

6.3.4 To determine the association between selected variables.

6.4 HYPOTHESES OF THE STUDY

RESEARCH HYPOTHESES:

H1: There will be significant difference between the pre and post- test

knowledge scores of junior female health assistants (ANMs).

H2: There will be significant association between selected demographic

variables such as age, education, professional experience, source of information

and the pre test knowledge scores.

6.5 RESEARCH VERIABLES:

DEPENDENT VERIABLE: Knowledge.

INDEPENDENT VERIABLE: Self Instructional Module.

6.6 OPERATIONAL DEFINATIONS:

1. EFFECTIVENESS: In this study effectiveness refers to the extent to

which self-instructional module regarding effects of teratogens on fetal

development; achieve the desired effect in improving knowledge of Junior

female Health assistant’s as evident from increase in knowledge scores.

2. KNOWLEDGE: In this study knowledge refers to the correct response

from the respondent regarding teratogenic effect on fetal development as

elicited through a questionnaire.

3. HUMAN TERATOGENS in this study, it refers to selected agents such as

drugs, chemicals, radiations and maternal infections that acts during

embryonic and fetal development that produce permanent alterations of

structures and functions on the fetal development of organs.

4. Drugs: In this study, it refers to selected drugs or medications such as,

Aminoglycosides, Antimetabilite agents, Cocaine, Ethanol, Methimazole,

Lithium, Phenytoin that are strongly suspected or proven to be human

teratogens.

5. Chemicals: In this study it refers to selected chemicals like smoking;

alcohols that have the potent teratogenic effect on fetal development

6. Infections: In this study infection refers to selected maternal infections such

as Varicella, Rubella, and Cytomegalo viral infection that may pass to the

fetus and affect the fetal development.

7. Radiations: In this study it refers to, exposure of pregnant woman to the X-

rays; radioactive substances that can cause birth defects.

8. Selected Demographic Variables: It refers to Junior Female Health

Assistants age, education, professional experience and their source of

information.

9. Self Instructional Module:

Self-instructional module is a self-instructional material prepared in

English and Kannada regarding teratogenic effect on fetal development.

It consists of:

Effects of drugs

Effects of chemicals

Effects of radiation

Effects of maternal infection

Measures to prevent teratogenic effect on fetal development.

10.Junior Female health Assistants: Who have been trained for the period of

18 months, and working as junior female Health assistant at the rural PHCs

of Nelamangala.

11.Primary Health Center: PHCs of Nelamangala Taluk are: Nelamangala,

Maragondanahalli, Shivagange, Tadasighatta, Tyamagondlu, Dabaspet,

Manne PHU, Madalkote.PHU angala Taluk, Bangalore Rural District.

and total strength of junior female health assistants only 49 in numbers, at

present working.

6.7 ASSUMPTIONS:

Junior Female Health Assistants may have some knowledge on effects of

teratogens on fetal development.

6.8 DELIMITATIONS:

The Study is limited to rural PHCs Nelamangala Taluk only. Bangalore Rural

District.

7. MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

Junior female health assistants (ANM) at rural primary health centers are located in

Nelamangala Taluk .Bangalore rural district.

7.2 METHOD OF COLLECTION OF DATA:

Self administered questionnaire.

7.2.1 RESEARCH APPROACH

Quantitative approach.

7.2.2 RESEARCH DESIGN

Pre experimental -one group pre-test, post- test design.

7.2.3 SETTING OF THE STUDY

Study will be conducted in rural PHCs of Nelamangala, Bangalore rural district.

7.2.4 POPULATION

Junior female health assistants working in PHCs.

7.2.5 SAMPLE SIZE

The sample of the study consists of 49 ANM working in rural PHC at Bangalore

North (Nelamangala Taluk)

7.2.6 SAMPLING TECHNIQUE

Purposive sampling technique.

7.2.7 SAMPLING CRITERIA

INCLUSION CRITERIA:

Junior female health assistants working in Nelamangala Maragondanahalli,

Shivagange, Tadasighatta, Tyamagondlu, Dabaspet, Manne PHU, Madalkote.PHU

of rural PHCs, Nelamangala Taluk, Bangalore Rural District.

EXCLUSION CRITERIA:

Junior female health assistants who are on long leave and not available during

study.

7.2.8 TOOL FOR DATA COLLECTION

Self-administered questionnaire. It consists of two parts. Part I, and Part II.

Part I: Items on demographic variables like age education qualification, total year

of experience.

Part II: Knowledge item on teratogenic effect on fetal development.

7.2.9 DATA ANALYSIS METHOD:

The data analysis through descriptive and inferential statistics.

Descriptive statistics

Frequency, mean, mean percentage and standard deviation to describe

demographic variables.

Inferential statistics

Paired‘t’ test to compare pre and post test knowledge score.

X2 test will be used to find out the association between selected variables with

knowledge scores.

7.3 DOES THE STUDY REQUIRE ANY INTERVENTIONS TO BE CONDUCTED ON HUMANSYES

7.4 HAS THE ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR

INSTITUTION?

Permission obtained from the research committee of the Oxford College of

Nursing.

Authorities of primary health center Bangalore Rural dist.

Informed consent will be taken from the junior female health assistants who are

willing to participate in the study.

8. LIST OF REFERENCES: -

1 Chambulann, geofrey, Turnbulls obstetrics, Chin.Livenstone publishers 3rd

Edition

2 Piper and Colleagues (1987).

3 Wega and Colleagues (1993)..

4 Electronic Media - www.google.com

5 Electronic Media- www.who.com.

6 Statistical Information From DHS.

7 Electronic Media - www.google.com

8 Matalon S, Schechtman S, Goldweig G, Ornoy A, laboratory of Teratology,

Dept. of anatomy and cell biology Hebrew University Hadassah Medical School,

Jerusalem Israel.

9 Telefono Rosso Teratology information service. Department of OBG, Catholic

University,LargoAgostino Gemelli I, Rome, Italy

10 Naidoo S, Harris A, swanevelder S, Lombard C. Department of community

oral health, Tygerberg, South Africa.

11 Steven Spielberg pediatric Research center, cedars-Medical center, los Angeles

California 90048, USA

12 University of Medicine and Dentistry of New Jersey USA

13 universidatle federal De-Sao Paulo- Eescola Paulista De Medicina, Brazil

14 Sabitha Sibala, a study to Asses the effectiveness of self- instructional module

on selected obstetric drugs among staff nurses working in Jayanagar General

Hospital, Bangalore, 2005. Unpublished Master’s dissertation, Rajeev Gandhi

University of Health Sciences, Bangalore, India.

15 Revathy, effectiveness of self-instructional module on Pre-eclampsia among 50

female health workers in primary health centers of selected district in

Tamilnadu. Unpublished Master’s dissertation, Annamalai University,

Tamilnadu, India.

9. SIGNATURE OF THE STUDENT:

10.REMARKS OF THE GUIDE: The topic which is selected by the candidate, is

relevant and appropriate and it attempts to increase knowledge among junior

female health assistants on effects of human teratogens on fetal development

NAME AND DESIGNATION OF GUIDE:

11.1 GUIDE NAME AND ADDRESS: Prof G. Tilagavathy

Head of the Department Obstetrics and gynecological nursing The oxford college of Nursing J.P.Nagar, 1st Phase, Bangalore-560078.

11.2SIGNATURE OF GUIDE:

11.3 HEAD OF THE DEPARTMENT NAME AND ADDRESS: Prof.G.Tilagavathy Head of the Department Obstetrics and gynecological nursing The oxford college of Nursing 1st Phase, J.P.Nagar, Bangalore-560078.

11.4 SIGNATURE OF H.O.D. :

12.REMARKS OF PRINCIPAL :The topic selected is relevant as it empowers the junior female health assistants with the knowledge on effects of human teratogens

which in turn, reduces the morbidity and mortality occur due to effects of human teratogens.

13. SIGNATURE OF PRINCIPAL :

Dr. G. KASTHURI Principal/Professor, The oxford college of Nursing, 1st Phase, J. P. Nagar, Bangalore-560078.