Free The Effects Of Hormonal Contraceptives On Renal Function Research Proposal Example

Introduction p. 3

Summary of Proposed Research p. 3
Literature Review p. 4-6
Research Questions p. 6
Statement of Methodology p. 6
Timescale p. 7
Bibliography p. 8
The Effects of Hormonal Contraceptives on Renal Function
1. Introduction:
Studies on the effects of hormonal contraception (HC) on renal outcome are scarce. As measured by renal function and albuminuria (Ahmed et al 2005), there has been some association between HC and an increase in microalbuminuria. Increased levels of albuminuria are indicative of vascular endothelial damage (Deckert et al 1989) and an increased risk for renal failure. Although there has been no evidence that the use of HC promotes renal failure, the studies to date have been conducted with diabetic (Ahmed et al 2005) or hypertensive (Ribstein et al 1999) subjects. The aim of this study is to follow a randomly selected group of women between the ages of 18 and 35 screened for no preexisting renal problems for a period of 4 years to evaluate the effects of HC on renal function.
2. Summary of Proposed Research:
Women require effective contraception for reproductive health. Current studies indicate there is no significant risk to diabetic or hypertensive patients with the use of the hormonal contraceptive depot-medroxyprogesterone acetate (DMPA). There are a number of other advantages to the use of DMPA, but there are no studies addressing the use of the contraceptive on a healthy population without symptoms of renal disease. This proposal is for an extended 4-year study to follow women across ethnic, age, and income demographics to determine if the use of DMPA is safe in terms of affecting renal function. As far as the use of oral contraceptives, studies on women ages 19 thru 35 demonstrates no significant affect in the mean of renal function tests (Ekhator et al 2014)( Taneepanichskul et al 2013). The choice of patients using DMPA as a contraceptive system was selected based on the ability to monitor and control administration. Depending on the patients to taken the medication daily in an oral form leaves too many variables in terms of time of day, other drugs taken jointly, missing dosage, and so on. Receiving the injection at the research center allows control of the injection time and monitoring of other measurements such as blood pressure. A short questionnaire will also be administered to ascertain if the patient feels there have been any changes that may be attributable to taking the DMPA. In addition, having the patients come into the center allows contact to be maintained and determined if the data from a subject needs to be rejected due to loss of contact.
Renin is a proteinase released by the kidney which raises blood pressure; this is achieved by activating angiotensin (Dictionary.search.yahoo.com (2015). Consequently, studies of the effects of hormonal contraceptives on renal function take into account the affect on blood pressure as well (Curtis et al 2006). Women considering the use of oral contraceptives containing estrogen should be cautioned concerning further elevation in systemic blood pressure. Consistent monitoring is recommended. Bonnema et al (2010) states that women with well-controlled hypertension can safely use combined hormonal contraceptives. While there are a number of other studies addressing the use of various contraceptive systems and multiple types of diseases, they are beyond the goal of this study. While hypertension may be a symptom of impaired renal function, monitoring the systolic blood pressures of the participants is a safety precaution in the event of a previously hidden condition.
3. Literature Review:
A study by Pietrzak et al 2007 directed the focus of the effect of transdermal hormonal birth control on female kidney patients. In the study, 10 kidney patients ages 22 to 36 years of age used the contraception system for a period of no less than 18 months. Stable graft function was determined for all patients. The patch released 20 μg of etinyl estradiol and 150 μg of norelgesromin daily. At the conclusion of the study, no patients were found to be pregnant. The use of the hormonal contraception system did not significantly influence serum creatinine, mean blood pressure, body mass index, or other biochemical parameters. While it was thought the relative contraindications to use of hormonal contraceptives of impaired liver function and arterial hypertension, it appears to be a highly effective method of contraception. It is possible the transdermal method diminishes possible drug interactions. In addition, it also influences the well-being of the patient, decreases the development of mild ovarian cysts, and regulates menstrual bleeding.
A similar study by Atthobari et al (2007) sought to determine if starting and stopping hormonal contraceptives would elicit changes in urinary albumin excretion (UBE), glomerular filtration rate, and blood pressure readings. The hormonal contraceptive used was administered either orally, by injection, or as a subcutaneous implant. It contained ethinyl estradiol and/or progestin. A sample size of 751 subjects was used under the age of 45. The findings indicated a rise in systolic blood pressure and diastolic blood pressure with an insignificant rise on other measures at the start of hormonal contraceptive use. Cessation in use resulted in a decreased in readings and kidney function was preserved. A limitation of the study was that none of the subjects was under the age of 28 and a high percentage were either currently smoking or had smoked when establishing baseline measurements. There was also the possibility bias was introduced by confounding by contraindication or indication for hormonal contraceptive use.
A paper titled “Contraception in Renal Transplant Recipient”(2012) discussed the use of depot medroxyprogesterone acetate (DMPA) formulated to be slowly released over a period of 12 weeks. It has a failure rate of less than 2% generally related to delay in receiving the injection. The immunosuppressive regiments of renal transplant patients do not appear to have any drug reactions with DMPA. Injectable DMPA is easy to use and highly effective. It is coitus independent, , reversible, and discreet. After 2 years of use, 70 percent of users experience amenorrhea which is acceptable and even desirable by many women. The ability to self-inject decreases risk of pregnancy due to delayed injections.
4. Research Questions
Ekhator (2014) conducted a study of oral contraceptives and not the use of DMPA. The results of the study recommend further animal researches and human studies to determine if oral contraceptives containing levonorgestrel and ethinylestradiol containing COCP negatively affect the function of the kidney. Also, investigation would be worthwhile on the affect on the function of the kidneys and other internal organs by other OCP (Al-Jomard and Al-Youzbaki 2012).
5. Statement of Methodology:
For effective research results, the number of participants should be significant. Doses of contraceptives should be safely administered in a controlled manner. Subjects will give written informed consent.
In a screening examination, the potential subjects will provide an interview for gathering data such as demographics, medical history, history of smoking, and so on. Measurements of weight, height, and blood pressure will be taken. To measure UBE, urine will be collected for two days and measured by nephlometry. Controls should be employed for confounding factors such as contraindication or indication for hormonal contraceptive use. Due to skewed distribution, logarithmic transformation will be applied for further analyses and the reported values converted back to the original scale using geometric means. To compensate for differences in population characteristics, the group will be tested for categorical variables by an X2 test and for continuous variables by Student’s t-test for non-impaired data.
6. TimescalePending university approval and assembling of the research team, the first six months of the project will be used for developing the research method, methods of analysis, and determination of the participants. The accumulation of the necessary equipment and personnel will take place concurrently.
After the data collection, participants will be followed every three months to maintain contact in a mobile society. Telephone interviews will attempt to collect information that would disqualify the participant from the study; i.e. cessation of the use of HC. Laboratory data collection will take place every 6 months for a period of 4 years. The research team will work with interested consulting associates for validation and determination of results. After finding results suitable for presentation, approval of the facility will be sought prior to release of the data compiled and the findings of the research.

References

ACOG Practice Bulletin No. 73: Use of Hormonal Contraception in Women With Coexisting
Medical Conditions. (2006). Obstetrics & Gynecology, 107(6), p.1453.
Ahmed, S., Hovind, P., Parving, H., Rossing, P., Price, D., Laffel, L., Lansang, M., Stevanovic,
R., Fisher, N. and Hollenberg, N. (2005). Oral Contraceptives, Angiotensin-Dependent
Renal Vasoconstriction, and Risk of Diabetic Nephropathy. Diabetes Care, 28(8),
pp.1988-1994.
Al-Jomard, S. and Al-Youzbaki, W. (2012). Effect of Combined Oral Contraceptive Pills on
Renal Function Tests. Iraqi J. Comm. Med, 4.
Atthobari, J., Gansevoort, R., Visser, S., de Jong, P. and de Jong-van den Berg, L. (2007). The
impact of hormonal contraceptives on blood pressure, urinary albumin excretion and
glomerular filtration rate. British Journal of Clinical Pharmacology, 63(2), pp.224-231.
Bonnema, R., McNamara, M. and Spencer, A. (2010). Contraception Choices in Women with
Underlying Medical Conditions. Am Fam Physician, 82(6), pp.621-628.
Contraception in renal transplant recipient. (2012). [policy change] Renal Guideline Committee.
Curtis, K., Mohllajee, A. and Peterson, H. (2006). Use of combined oral contraceptives among
women with migraine and nonmigrainous headaches: a systematic review.
Contraception, 73(2), pp.189-194.
Darney, P. (2012). HEALTH FROM TRUSTED SOURCES: Hormonal contraception. [online]
Health-fts.blogspot.com. Available at: http://health-fts.blogspot.com/2012/01/hormonal-
contraception.html [Accessed 20 Jan. 2015].
Deckert, T., Feldt-Rasmussen, B., Borch-Johnsen, K., Jensen, T. and Kofoed-Enevoldsen, A.
(1989). Albuminuria reflects widespread vascular damage. Diabetologia, 32(4), pp.219-
226.
Dictionary.search.yahoo.com. (2015). renin - Yahoo Dictionary Search Results. [online]
Available at:
https://dictionary.search.yahoo.com/search;_ylt=AwrBT4cCEL9U7ZoAZZlXNyoA;_ylu
=X3oDMTB0a21sbDFyBHNlYwNzYwRjb2xvA2JmMQR2dGlkA1NNRTc1NV8x?p=re
nin&.sep= [Accessed 21 Jan. 2015].
Ekhator, C., Omorogiuwa, A. and Akpamu, U. (2014). Effect of Combined Oral Contraceptive
Pills (COCP) Containing Levonorgestrel and Ethinylestradiol on Kidney Function.
Trends in Applied Sciences Research, 9(5), pp.269-274.
Fernandez-Fresnedo, G., Palomar, R., Escallada, R., de Francisco, A., Cotorruelo, J., Zubimendi,
J., de Castro, S., Ruiz, J., Rodrigo, E. and Arias, M. (2001). Hypertension and long-term
renal allograft survival: effect of early glomerular filtration rate. Nephrology Dialysis
Transplantation, 16(suppl 1), pp.105-109.
Inomata, S., Nakamoto, Y., Inoue, M., Itoh, M., Ohsawa, Y. and Masamune, O. (1989).
Relationship between urinary albumin excretion rate and renal histology in non-insulin-
dependent diabetes mellitus: With reference to the clinical significance of
microalbuminuria. Journal of Diabetic Complications, 3(3), pp.172-178.
Monster, T. (2001). Oral Contraceptive Use and Hormone Replacement Therapy Are Associated
With Microalbuminuria. Archives of Internal Medicine, 161(16), p.2000.
Oelkers, W., Foidart, J., Dombrovicz, N., Welter, A. and Heithecker, R. (1995). Effects of a new
oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the
renin-aldosterone system, body weight, blood pressure, glucose tolerance, and lipid
metabolism. J Clin Endocrinol Metab, 80(6), pp.1816–1821.
Pietrzak, B., Bobrowska, K., Jabiry-Zieniewicz, Z., Kaminski, P., Wielgos, M., Pazik, J. and
Durlik, M. (2007). Oral and Transdermal Hormonal Contraception in Women After
Kidney Transplantation. Transplantation Proceedings, 39(9), pp.2759-2762.
Ribstein, J., Halimi, J., du Cailar, G. and Mimran, A. (1999). Renal Characteristics and Effect of
Angiotensin Suppression in Oral Contraceptive Users. Hypertension, 33(1), pp.90-95.
Schunkert, H., Danser, A., Hense, H., Derkx, F., Kurzinger, S. and Riegger, G. (1997). Effects of
Estrogen Replacement Therapy on the Renin-Angiotensin System in Postmenopausal
Women. Circulation, 95(1), pp.39-45.
Taneepanichskul, S., Jaisamrarn, U. and Phupong, V. (2013). Effect of a new oral contraceptive
with drospirenone on vital signs, complete blood count, glucose, electrolytes, renal and
liver function. J. Med. Assoc. Thai, 90, pp.426-431.
Woods, J. (1988). Oral contraceptives and hypertension. Hypertension, 11(3_Pt_2), pp.II11-II11.