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Research Proposal: Risks of Smoking on Pregnant Women

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Introduction:

            There is growing evidence that smoking causes several health concerns, including cardio-vascular and respiratory diseases. There is a risk that health problems may arise due to smoking during pregnancy, given the rise in the number of health concerns arising from smoking.

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Prevalence of Smoking during Pregnancy:

The prevalence of smoking while pregnant varies markedly from country to country.​​ In certain countries, the prevalence rates imply that there has been a peak, and the decline has begun.​​ In other countries, however, the prevalence of smoking during pregnancy continues to climb, emphasizing that this increase is more in younger women. The discovery of research that has shown modest effectiveness in smoking prevention strategies during pregnancy is of greater significance (Cnattingius, 2004).

The prevalence of smoking during pregnancy in the United States of America experienced a 38 percent decrease in the time between 1990 and 2002. The prevalence of smoking during pregnancy in 2002 was 11.4%, compared to 18.4% in 1990. The decline in smoking prevalence during pregnancy varied across the country. The prevalence statistics, however, indicate a high prevalence of smoking among teenage and young expectant mothers​​ during pregnancy. (2004, by Mathews).

Risk Factors:

​​ Smoking during pregnancy has been described as the most significant preventable risk factor for unsuccessful pregnancy outcomes. In addition to increasing the risk of spontaneous abortions, ectopic pregnancies, placental previa, behaviour disorders, respiratory disorders, and infection in childhood, smoking during pregnancy is associated with foetal growth restriction, stillbirth, preterm birth, placental abruption, and sudden infant death syndrome (SIDS)​​ (Heilbronner, 2005).

Sudden Infant Death Syndrome:

The risk of​​ SIDS​​ due to smoking during pregnancy​​ was investigated by Shah, Sullivan, & Carter, 2006, using data from birth and death records in Georgia during the period from 1997 to 2000. They reported that​​ for as many as one in five cases of SIDS, smoking during pregnancy was responsible. It was found that smoking was responsible for two thirds of SIDS, taking into account the rate of SIDS in mothers who smoked during pregnancy. Such statistics are a matter of concern for SIDS due to smoking during pregnancy and become even more concerning when the well-accepted fact that SIDS and smoking during pregnancy are widely underreported and​​ mistakenly identified in birth records.

​​ Smoking during pregnancy is underreported, as it is a self-reported factor by expecting mothers​​ in birth certificates. Hence,​​ it is quite likely that the figure for smoking during pregnancy-related SIDS figures are higher than those based on such birth certificates. The very clear​​ association​​ between smoking and SIDS​​ deaths that occur up to one month after delivery can be attributed to continuing the smoking behavior even after delivery. It is seldom that mothers who have smoked during pregnancy stop after pregnancy (Buescher, 2002).​​ 

Hypothesis:

​​ These studies indicate that smoking during pregnancy could be responsible for many infant death. The death of infants is a matter of concern for the healthcare delivery system and society on the whole. Confirmation of the existing​​ evidence of earlier studies on the subject is extremely in reinforcing existing evidence.​​ This​​ study proposes to​​ confirm the hypothesis that​​ smoking during pregnancy increases the risk of​​ sudden infant death syndrome (SIDS).

​​ To ascertain smoking in pregnant mothers in a more reliable manner, the study will use hospital records. The historical record of the mother would be more reliably recorded​​ than in birth and death registrations. The study would be restricted to​​ two years,​​ using anyone hospital's medical records providing obstetrics and gynecological services.

Method:

The methodology used on any research study may not be free​​ of​​ errors;​​ however, the fundamental characteristics that should be present in any study include acceptability, feasibility, reliability, sensitivity to change, and validity, for it is only then that the findings of the stuffy become useful as evidence for application in healthcare. Hence these basic characteristics remain the guiding principles for this research study.​​ 

​​ The three commonly used research methodologies are qualitative, quantitative, and triangulation.​​ Qualitative research's essential strengths lie in its ability to provide a more realistic feel of the subject being evaluated; flexibility in data collection, data analysis, and interpretation; more effective interactivity with the subjects, and better descriptive capacity. Against these benefits are the disadvantages present in the qualitative methodology. It requires more duration; the likelihood of deviation from objectives; the researcher's subjectivity affects the conclusions drawn; high level of experience required in the researcher; the​​ conclusions are not very reliable, and is dependant on the investigative techniques.

Quantitative research methodology provides the key benefits of clearly and precisely defining the terms of the research problem; following the goals of the research study firmly; achieving higher levels of reliability in the data collected; and​​ eliminating or minimizing the possibility of subjectivity​​ in the findings, though it suffers from the disadvantages of inability to control the context and environment of the situation. The outcomes are limited to those specified in the research proposal.

​​ Triangulation employs both qualitative and quantitative research methodologies on the same research problem to enable cross-checking of the findings to increase the reliability of the findings. However, in triangulation, it is not uncommon that contradictory results are thrown up from the two methodologies' findings, making it difficult to conclude. Also, triangulation calls for an excellent understanding of the fundamental issues involved in the research being undertaken.

Considering all the advantages and disadvantages of the three research methodologies and the competence of the research team and the objectives of the research study, the research​​ study is designed on a quantitative basis. The reason for this is that a quantitative basis provides the means for effectively testing​​ the chosen​​ hypothesis​​ objectively by​​ the​​ relatively inexperienced research team, within the​​ limited time​​ frame available,​​ removing any subjective orientation through the more objective testing of the hypothesis.​​ Also, the objective of the research study is fixed and narrow. The objective is to test the hypothesis that smoking during pregnancy increases the risk of SIDS. In essence, this means​​ evaluating available data on SIDS and ascertaining smoking's impact during pregnancy on SIDS.​​ Such an approach​​ the research team believes will​​ increase the validity of the study being undertaken.​​ (Curwin, 2004).

Sampling Design:

​​ Two criteria have been considered in the sampling design to increase the validity and reliability of the study. The first criterion lies in the number of subjects. A very small sample size makes for reduced validity and reliability of the study. Simultaneously, a very large sample size makes the study unwieldy in data collection and analysis. It also​​ increases the cost of the study​​ (Kumar, R. 1999).

Keeping this in view, the sampling design will consist of examining the​​ medical records pertaining to SIDS​​ in a hospital​​ providing obstetrics and gynecological services​​ during 2005 and​​ 2006.​​ Such a period would provide an adequate sample size and not be too large for this study to handle. The hospital would be chosen from among the local hospitals willing to participate in the study. Using the available medical records, the history of smoking in the mother, including smoking during pregnancy, is likely to be more reliable than from other sources.​​ The years of 2005 and 2006 have been chosen to enable the findings to be as current as possible.

​​ The necessary actions for sanction and cooperation from the hospital administrative authorities would enable​​ the collection of the required data. The data collections would be executed in such a manner as not to interfere with the normal functioning of the hospital. For this purpose, the research team would​​ collect the required records from the record room and unobtrusively collect the relevant data.

Inclusion and Exclusion Criteria:

The inclusion criteria would be all​​ medical​​ records pertaining to​​ SIDS for the relevant period of years 2005 and 2006 in the hospital that has agreed to cooperate with the research study and has been chosen. Medical records before the year 2005 and after the year 2006 would be excluded from the study. The age of the pregnant women in the SIDS medical records would be recorded to evaluate the prevalence of SIDS and smoking during pregnancy to expand the research study's scope. However, it will have no bearing on the inclusion and exclusion criteria.

Data Collection:

​​ The need for data to provide answers to research questions lies in the importance of data and data collection. To provide the correct answers to these questions, the data collected and the sources from which the data is derived need to be provided the utmost attention. Inadequate attention to these variables may lead to incorrect and inadequate data that can not be compensated for by any amount of depth used in the subsequent study. Statistics is a two-legged subject: one is data collection and interpretation, the other is probability​​ (Gibson, W., 1997).

Data will be collected based on a data collection sheet. ​​ Please see Appendix – 1 for the questionnaire. The investigator's data sheet would be filled in by the research study from the​​ SIDS​​ medical records available at the medical records facility in the chosen hospital. Mutually convenient times would be fixed through​​ discussions with the administrative authorities of the concerned hospital. ​​ The investigator would collect the relevant medical records and fill up the data sheets and check for the data entry's correctness at the hospital​​ record maintenance facility.​​ Such an approach would allow for any clarifications.​​ This approach to the filling in the​​ data collection​​ is expected to give more exactness in the data collection.

Data Analysis:

The data collected will be first made suitable for analysis. The conversion of the data collected to numeric data would be affected. The data that has been quantified will be then be entered into a file in a statistics software program like SPSS or MS Excel. It will be double-checked for correct data entries. It will then be analyzed statistically using T-Test or Chi-Square to provide significant findings. Findings with limited significance will be mentioned in the results. Findings with no significance will be omitted. (Duncan, C., 2003).

​​ Since the research is not familiar with statistical methods and analysis, the guidance and assistance of the statistics professionals available will be made use of, and due acknowledgment is being made earlier and will be made when the study is presented.

Ethical Considerations:​​ 

The study will conform to all administrative and ethical considerations in all activities, which are part of the study. In the first place, letters seeking approval for conducting such the will be made out to the academic heads and​​ administrative heads of the academic institution through the concerned tutor for sanction. Only after receiving written sanction will the study continue.

The use of medical records brings into picture the ethical responsibilities of the research team. Several guidelines ensure ethical considerations, and the research team aims to ensure that all guidelines are maintained. In the first place, the appropriate ethical committee's necessary sanctions will be sought and received before starting the data collection procedures. The data collection would be such that the data collection elements do not involve any personal data to maintain the privacy of the record and the patient-physician relationship. Coding will be a part of the data collection tool to ensure this. In addition, all data collection records would be maintained in such a manner as prescribed by the ethics committee to ensure these records' safety. By taking such steps, the research team believes that all aspects of ethical consideration in health care research will be ensured (Bradburn, 2001).​​ 

Limitations:

The author acknowledges several limitations to the planned​​ research study. The study aims only at confirming the hypothesis that smoking during pregnancy enhances the risk of SIDS. This is a limited approach. The second​​ limitation is that the research is limited to one hospital, and hence the findings may not be applicable in a wider reference frame. The limitation to one hospital in one area severely limits the study's application to other geographical areas. Thus there is a limitation in the scope and applicability of the study. However, the research team believes that the narrow objective of confirming the enhanced risk of SIDS due to​​ smoking during pregnancy is not severely limited by the limitations acknowledged.

Appendix – 1

Data Collection Sheet

1. Record Code:     xxxxxx

2. Age:      xx Years

3. Smoking History​​      Yes/No

4. Smoking Stopped During Pregnancy  Yes/No

5. Smoking Continued During PregnancyYes/No

Literary References

 

  • Bradburn, N. M. 2001 'Medical privacy and research,'​​ The Journal of legal studies, vol. 30, no. 2, pp. 687-701.

  • Buescher, A. P. 2002, ‘Maternal Smoking and Infant Mortality in North Carolina,'​​ North Carolina Medical Journal,​​ vol. 63, no. 3. pp.​​ 107-109.

  • Cnattinguis, S. 2004, 'The epidemiology of smoking during pregnancy: smoking prevalence, maternal characteristics, and pregnancy outcomes,'​​ Nicotine & tobacco research, vol. 6 (Suppl), no.2, pp. S 125-140.​​ 

  • Curwin, J. 2004.​​ Quantitative Methods: A short course. United Kingdom: Thompson.

  • Duncan, C. 2003.​​ Advanced Quantitative Data Analysis. London: Open University Press

  • Gibson, W. 1997.​​ Commercial and Industrial Statistics.​​ London. Hodder Headline Plc.​​ 

  • Heilbronner, C. 2005, ‘What are the short, mid, and long term consequences of smoking during pregnancy?​​ Journal de gynecologie,​​ obstetrique et biologie de la reproduction, vol. 34 (Spec), No. 1, pp. 3S 390-446.

  • Kumar, R.​​ 1999.​​ Research Methodology: A step by step guide for beginners.​​ London: Sage Publications.

  • Mathews, T. J. 2004,​​ ‘Smoking During Pregnancy United States, 1990—2002’,​​ Morbidity & Mortality Weekly Report, vol. 53, no. 39, pp. 911-915.

  • Shah, T., Sullivan, K. & Carter, J. 2006, ‘Sudden infant death syndrome and reported maternal smoking during pregnancy’,​​ American Journal of Public Health, vol. 96, No. 10, pp. 1757-1759.

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