Chapter 5 The Research Methods and Procedures
5.3 The analytic process
This study showed the participants with CuT380A rather than LNG-IUS were more likely to grow several organisms in their vagina. Though, with increase in the duration of use most of the clients in both groups had no growth in their cervix or vagina from both cultures. However, 33.3% of Copper T380A users compared to 5.3% of LNG-IUS users at 6 months cultured micro-organisms (i.e. had infection, which is the invasion and multiplication of micro-organism) when the high vaginal
51
swabs were reviewed and it was statistically significant, (p value <0.001). Therefore, the null hypothesis was hence rejected. Enrol and colleagues in their study showed that LNG-IUS was superior to Copper T IUD in limiting the prevalence of cervico-vaginal colonisation and infections.53 Even though the participants were not evenly distributed in their study, however this study appear to validate their findings.
Most recent studies from the literature did not compare both forms of long-acting reversible contraceptives in a longitudinal setting with almost equal client distribution but the assumption was that CuT380A are more likely to cause more growth of pathogenic organism since LNG-IUS contain hormones that inhibit bacterial growth. This was proven by the study by Lassard in 2007.49
CONCLUSION
The study revealed that the use of copper T380A intra-uterine contraceptive device could drastically alter the normal bacterial flora in the vagina of women and encourage the growth of a variety of pathogenic organisms which predispose the user to cervico-vaginal infections. More organisms persisted in the genital tract of women who use copper T380A compared to previous studies that revealed fewer organisms. A variety of organisms were also isolated in this study compared to studies which revealed fewer types. The most common organism from this study was coagulase negative staphylococcus which was different from most other studies.
It is a less virulent type of staphylococcus and usually seen with presence of foreign body in the human body like the IUD.
Levonorgestrel intra-uterine system, since it contains a hormonal drug, may be responsible for the tendency for the growth of lesser number of organisms and lower risk of cervico-vaginal infection in the study. Fewer number of organisms remained in the genital tract of women using LNG-IUS after prolonged use which may be due to the hormonal component of the device inhibiting bacterial growth.
This study also showed the common organisms prevalent in the genital tract of women in this study and because some are pathogenic, may be responsible for the infection among women with foreign body in their genital tract.
52
This study being a local one confirms the fact and findings from studies from other regions of the world that Copper T380A IUD is likely to increase growth of varied pathogenic bacteria and cause an increased risk of cervico-vaginal infections.
RECOMMENDATIONS
1. Women should be carefully selected and screened before insertion of IUD/IUS as a foreign body in their reproductive tract as it may promote growth of genital organisms, howbeit for a short period of use.
2. Women should be encouraged to practice healthy and safe perineal hygiene and sexual practices to prevent disruption and destruction of the normal protective commensals of the vagina while using IUD/IUS due to tendency for the device to be colonized by bacteria.
3. Women who are suspected to have clinical and or laboratory evidence of pelvic or genital infection should not have IUD/IUS inserted for contraception till they have been treated and certified to be free of infection.
4. Women who have previous use-related side effects such as pelvic infection from Copper T380A IUDs can be encouraged to change to LNG-IUS, which has reduced risk for pelvic infection as seen from this study.
5. Women who use Copper T380A should be encouraged to report any abnormality in the perineal health such as abnormal vaginal discharge, fever or severe pelvic pain. The device should be removed and the client treated;
and if could be encouraged to use LNG-IUS instead.
6. There is need to properly counsel women who use long acting reversible contraceptives such as Copper T380A and LNG-IUS to maintain healthy perineal hygiene, avoid multiple sexual partners, practice safe sex and avoid indiscriminate use of anti-microbial or immunosuppressive medication that may cause over-growth of genital pathogens.
7. Women should be counselled that use of Copper T380A or LNG-IUS may predispose to genital symptoms or infection and that the contraceptive benefit may be affected and delayed.
53 REFERNCES
1. Intra Uterine Devices (IUD). OPT. Options Sexual Health. 2011. Available at. https://www.optionsforsexualhealth.org/birth-control-pregnancy/birth-control-options/iuds. Retrieved February 1, 2015.
2. Better health Channel. Contraception-Intrauterine Devices(IUD), fact sheet.
2012. Available at.www.betterhealth.vic.goc.au. Retrieved March 30, 2015.
3. United Nations. World contraceptive use 2011. 2011. Available at:http://www.un.org/esa/population/publications/contraceptive2011/contrace ptive2011.htm.Accessed January 24th, 2017.
4. National Population Commission, Nigeria and ICF International. Nigeria Demographic and Health Survey 2013. Abuja and Rockville: NPC and ICF International; 2014. 565 pages.
5. Buhling KJ, Zite NB, Lotke P, et al. Worldwide use of intrauterine contraception: a review. Contraception 2014; 89:162.
6. Hurt kJ., Mattew WG., Jessica LB., Harold EF., Edward EW. The John Hopkins manual of gynaecology and obstetrics. In: 4th ed. Philadelphia:
Wolters Kluwer Health/Lippincott Williams & Wilkins; 2010:232.
7. Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group, ACOG. Committee Opinion No.539:
Adolescents and Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2012;120(4):983-988.
8. Black K, Lotke P, Buhling KJ, Zite NB. A review of barriers and myths preventing the more widespread use of intrauterine contraception in
54
nulliparous women. Eur J Contracept Reprod Health Care. 2012;17(5):340-350.
9. Mestad RE, Kenerson J, Peipert JF. Reversible Contraception Update: The Importance of Long-Acting Reversible Contraception. Postgrad Med.
2009;121(4):18-25.
10. Steenland MW, Tepper NK, Curtis KM, Kapp N. Intrauterine contraceptive insertion postabortion: a systematic review. Contraception. 2011;84(5):447-464.
11. Gabbe SG, Niebyl JR, Galan HL, Jauniaux ERM, Landon MB, Simpson JL, et al. Obstetrics: Normal and Problem Pregnancies, 6th edition. Philadelphia.
Elsevier Health Sciences; 2012. 643 pages.
12. Falcone T, Hurd W. Clinical Reproductive Medicine and Surgery.
Philadelphia. Elsevier Health Sciences; 2007. 323 pages.
13. Marnach ML, Long ME, Casey PM. Current Issues in contraception. Mayo Clin Proc. 2013;88(3):295-299.
14. Sonfield A. Popularity Disparity: Attitudes About the IUD in Europe and the United States. Guttmacher Policy Rev. 2007;10(4).
15. Gemzell-Danielsson K, Mansour D, Fiala C, Kaunitz AM, Bahamondes L.
Management of pain associated with the insertion of intrauterine contraceptives. Oxf J Hum Reprod Update. 2013;19(4):419-427.
16. Serrill MS. Law: A Panel Tries to Judge a Judge. Available at http://content.time.com/time/magazine/article/0,9171,952466,00.html.
Retrieved April 18, 2015.
55
17. Ugent MT. Intrauterine contraception: from silver ring to intrauterine contraceptive implant. Eur J Obstet Gynecol Reprod Biol. 2000;90(2):145-152.
18. National Institute for Health and Care Excellence. LARC(update), A summary of prescribing recommendations from NICE guidance. NICE.
September 2014.
19. Mirena (hormonal IUD). Available at http://www.drugs.com/mcp/mirena-hormonal-iud. Retrieved February 2, 2015.
20. Cervicovaginal Infections. Inst Fertil Genética Ingenes,2015. Available at
http://www.ingenes.com/en/first-steps/understanding-infertility/causes/tubaric-factors/cervicovaginal-infections/. Retrieved February 2, 2015.
21. Fortney JA, Feldblum PJ, Raymond EG. Intrauterine devices. The optimal long-term contraceptive method? J Reprod Med. 1999;44(3):269-274.
22. Grimes DA. Intrauterine device and upper genital tract infection. Lancet.
2000;356(9234):1013-1019.
23. Your IUD Causing Yeast Infections? Epigee Women "s health, 2015.
Available at http://www.epigee.org/is-your-iud-causing-yeast-infections.html. Retrieved April 18, 2015.
24. Ferraz do Lago R, Simoes JA, Bahamondes L, Camargo RPS, Perrotti M, Monterio I. Follow-up of users of intrauterine device with or without bacterial vaginosis and other cervicovaginal infections. Contracept J.
2003; 68:105-109.
56
25. History of IUD,2006. Contraceptive online. Available at http://web.archive.org/web/20060127085615/http://www.contraceptiononlin e.org/meetings/IUD/lynch/presentation_text.cfm?cme_activityid=47&show menu=1. Retrieved April 2015.
26. "Evolution and revolution: The past, present, and future of contraception".
Contraception Report. 2000 Feb; 10(6) :12. Retrieved April 2015.
27. Importance of intrauterine contraception. Available at http://www.escrh.eu/events/esc-events/4th-esc-congress-contraception-today,1996. Retrieved April 2015.
28. Treiman, K, Liskin, L, Kols, A, Rinehart, W. IUDs—an update. Popul Report. 1995;6:1-35.
29. Sivin I. Another look at the Dalkon Shield: meta-analysis underscores its problems. Contracept J. 1993;48(1):1-12.
30. Mintz, M. "A Crime Against Women. A. H. Robins and the Dalkon Shield.
Multinatl Monit. 1986;7(1).
31. Salem R. New Attention to the IUD: Expanding Women’s Contraceptive Options to Meet Their Needs. Popul Rep B. 2006;7.
32. World contraceptive use 2009. United Nations Population Division, Department of Economic and Social Affairs. Available at http://www.un.org/esa/population/publications/contraceptive2009/contracept 2009_wallchart_front.pdf. Retrieved April 2015.
33. Making decisions about contraceptive introduction: a guide for conducting assessments to broaden contraceptive choice and improve quality of care.
57
World Health Organization, Geneva 2002 (WHO/RHR/02.08). Retrieved April 2015.
34. O'Brien PA, Kulier R, Helmerhorst FM, Usher-Patel M, d'Arcangues C.Copper-containing, framed intrauterine devices for contraception: a systematic review of randomized controlled trials. Contraception. 2008 May;77(5):318-27.
35. Vasquez A, Jakobsson T, Ahrne S, Forsum U, Molin G. Vaginal Lactobacillus Flora of Healthy Sweedish Women. J Clin Microbiol.
2002;40(8):2746-2749.
36. Graver M, Wade J. The role of acidification in the inhibition of Neisseria gonorrhoeae by vaginal lactobacilli during anaerobic growth. Ann Clin Microbiol Antimicrob. 2011;10(8).
37. Matu MN, Orinda GO, Njagi ENM, Cohen CR, Bukusi EA. In vitro inhibitory activity of human vaginal lactobacilli against pathogenic bacteria associated with bacterial vaginosis in kenyan Women. Anaerobe.
2010;16:210-215.
38. Boris S, Barbes C. Role played by lactobacilli in controlling the population of vaginal pathogens. Microb Infect. 2000;2:543-546.
39. Al-Mushrif S, Jones BM. A study of the prevalence of hydrogen peroxide generating lactobacilli in bacterial vaginosis: The determination of H2O2 concentrations generated, in vitro, by isolated strains and the levels found in vaginal secretions of women with and without infection. J Obstet Gynaecol.
1998;18:63-67.
58
40. Aroutcheva A., Gariti D, Simon M, Shott S, Faro J, Simones JA, et al.
Defence factors of vaginal lactobacilli. Am J Obstet Gynecol.
2001;185(2):375-379.
41. "Mechanisms of the Contraceptive Action of Hormonal Methods and Intrauterine Devices (IUDs)". Family Health International. 2006. Available at http://www.fhi360.orgen/RH/Pubs/booksReports/methodaction.htm.
Retrieved April 2015.
42. International Contraception Access Foundation, ICA. LNG IUS , Training Manual for Family Planning. 2004. Available at http://www.ica-foundation.org/ICA%20_LNG_manual.pdf . Retrieved April 2015.
43. Haukkamaa M, Stranden P, Jousimies-Somer H, Siitonen A. Bacterial flora of the cervix in women using different methods of contraception. Am J Obstet Gynecol. 1986;154(3):520-524.
44. Kaliterna V, Kučišec-Tepeš N, Pejković L, Zavorović S, Petrović S, Barišić Z. An intrauterine device as a possible cause of change in the microbial flora of the female genital system. J Obstet Gynaecol Res. 2011;37(8):1035-1040.
45. Roy S. Nonbarrier contraceptives and vaginitis and vaginosis. Am J Obstet Gynecol. 1991;165(4 Pt 2):1240-1244.
46. Ceruti M, Canestrelli M, Condemi V, Piantelli, G., Depaolis, P, Amone, F, Tovogliari, D, Canestrelli M, Condemi V, et al. Methods of contraception and rates of genital infections. Clin Exp Obstet Gynecol. 1994;21(2):119-123.
47. Wahab SA., Altaieb S, Saleh A., Sakr E, Hamly AK., Hegab M, et al. Effect of Copper T intrauterine device on cervico-vaginal flora. Int J Gynaecol Obstet Off Organ Int Fed Gynaecol Obstet. 1985;23(2):153-156.
59
48. Kanat-Pektas M, Ozat M, Gungor T. The effects of TCu-380A on cervicovaginal flora. Arch Gynecol Obstet. 2008;277(5):429-432.
49. Lessard T, Simões JA, Discacciati MG, Hidalgo M, Bahamondes L.
Cytological evaluation and investigation of the vaginal flora of long-term users of the levonorgestrel-releasing intrauterine system (LNG-IUS).
Contraception. 2008;77(1):30-33.
50. Bariş II, Arman-Karakaya Y. Effects of contraception on cervical cytology:
data from Mardin City. Türk Patoloji Derg. 2013;29(2):117-121.
51. Sabah Abd Al, Kareem Al, Daniz TB, Shafaq, TB, Kareem Al, et al. Biofilm Formation on Intrauterine Device and Associated Infections. Iraqi Postgrad Med J. 2013;12(4):562-567.
52. Pillay B, Gregory AR, Subbiah M. Cytopathologic Changes Associated with Intrauterine Contraceptive Devices. A Review of Cervico-Viginal Smears in 350 Women. Med J Malays. 1994;49(1):74-77.
53. Erol O, Simavlı S, Derbent AU, Ayrım A, Kafalı H. The impact of copper-containing and levonorgestrel-releasing intrauterine contraceptives on cervicovaginal cytology and microbiological flora: a prospective study. Eur J Contracept Reprod Health Care Off J Eur Soc Contracept.
2014;19(3):187-193.
54. Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper- releasing (Nova T) IUDs during five years of use: A randomized comparative trial. Contraception. 1994;49:56-72.
55. Neale R, Knight I, Keane F. Do users of the intrauterine system (Mirena) have different genital symptoms and vaginal flora than users of the intrauterine contraceptive device? INT J STD AIDS. 2009; 20:423.
60
56. Jimoh AA. Complications of intrauterine contraceptive device(IUD) use at the University of Ilorin Teaching Hospital, Ilorin. Niger J Med.
2004;13(3):244-249.
57. Wright WA, Aisien AO. Pelvic inflammatory disease and the intrauterine contraceptive device. Int J Gynaecol Obstet. 1989;28(2):133-136.
58. Stanback J, Shelton JD. Pelvic inflammatory disease attributable to the IUD:
modeling risk in West Africa. Contraception. 2008;77(4):227-229.
59. Ladipo OA, Farr G, Otolorin E, Konje JC, Sturgen K, Cox P et al.
Prevention of IUD-related pelvic infection: the efficacy of prophylactic doxycycline at IUD insertion. Adv Contracept. 1991;7(1):43-54.
60. Arowojolu AO, Otolorin EO, Ladipo OA. Performances of copper T 380A and multiload copper 375/250 intrauterine contraceptive devices in a comparative clinical trial. Afr J Med Sci. 1995;24(1):59-65.
61. W. M Daniel. Biostatistics: A Foundation for Analysis in Health Sciences.
7th ed. New York: Wiley; 1999.
61 APPENDIX I INFORMED CONSENT
IRB Research approval number: __________ This approval will elapse on:
_____________
Title of research: Comparative study of cervico-vaginal bacterial flora changes in women using Cu-T380A contraceptive device versus LNG IUS in Ibadan: a two-centre, clinical comparative cohort study.
Researcher: This study is being conducted by Dr. B.C, Oranye a resident doctor in the department of Obstetrics &Gynaecology, University College Hospital, Ibadan.
The study is self-sponsored.
Purpose: The purpose of this study is to determine which type of contraceptive device changes the cervico-vaginal flora of women attending family planning clinic and thereby predispose them to cervico-vaginal infection or PID post- insertion.
Procedure of the research:
Women who are attending family planning clinic between the ages of 18-48years will be asked to participate in the study once they consent.
They will be required to answer some questions as truthfully as possible. A few of these questions may be personal, it is not to embarrass but rather ensure a thorough understanding of their answers. These women will be interviewed during which a thorough history will be taken and examination done in the family planning clinic before Intrauterine device insertion. They will be reviewed again at a month, 3months and 6months interval after insertion at the family planning clinic.
They will be asked some questions regarding their age, marital status, parity, previous obstetric history, the number of sexual partners, previous history of sexually transmitted infection, their HIV status, history of some behavioural lifestyles, like smoking, douching, presence of fever or abnormal vaginal discharge etc.
Further questions to be asked at each of the two visits after the intrauterine device insertion includes history of heavy vaginal bleeding, persistent fever, passage of foul
62
smelling vaginal discharge, severe abdominal pain, intrauterine device expulsion and history of treatment.
A swab sample each from the endo-cervix and posterior vaginal fornix using sterile swab sticks will be collected from participants at the family planning clinic before they have their intrauterine device inserted and at each 2 visits after the insertion and process using standard bacteriological methods.
The study is expected to last for the duration of 6 months within which time necessary specimen for both the pre and post IUD insertion is taken.
There are no risks expected from participating in this study apart from minor discomfort while taking the cervical and vaginal samples. The participation will not bear any direct financial costs by participating in this study.
The aim of this study is to determine if Copper T380A has a higher risk than LNG IUS to alter the normal cervico-vaginal flora and cause cervico-vaginal infection among users of IUDs in Ibadan.
It is crucial to ensure the women are assessed for the risk to developing cervico-vaginal infections before inserting a foreign body like the IUD into their genitals for the purpose of contraception or otherwise.
All information and data obtained from each subject will be will be coded and the patient’s names will not be used. It will be treated with utmost confidentiality.
However, institutions associated with proper conduct of research from UI/UCH Ethical Review Committee and ethics may have access to these records.
Your participation in this research is entirely voluntary and if you choose not to participate this will not affect your treatment in this hospital in any way. You can also choose to withdraw from the research at any time. Please note that some of the information that has been obtained may be used for reports and publication. During the course of the research, you will be informed of the result of your culture through your doctor and appropriate treatment given to you if ay pathogenic bacteria or micro-organism is cultured from you.
63 Statement of person obtaining informed consent:
I have fully explained this research to: ________________________________ and have given sufficient information, including the risks and benefits to make an informed decision.
DATE: _______________________________________
SIGNATURE _________________________________
NAME: _____________________________________
Statement of person giving consent:
I have read the description of the research or have had it translated into language I understand. I have also talked it over with the doctor to my satisfaction. I understand that my participation is voluntary. I know enough about the purpose, methods, risks and benefits of the research study to judge that I want to take part in it. I understand that I may freely stop being part of this study at any time. I have received a copy of this consent form and additional information sheet to keep for myself.
DATE:__________________________________
SIGNATURE:_______________________________
NAME: ___________________________________
WITNESS’ SIGNATURE: ___________________
WITNESS’ NAME: _______________________
The following individuals can be contacted concerning any questions about this research:
Chairman:
UI/UCH Ethical Review Committee Biode Building, 2nd Floor
Room T10, IMRAT, College of Medicine
64 Universityof Ibadan.
E-mail: [email protected] Oyo State
The Principal Investigator:
Name: Dr. Benjamin C. Oranye
Dept.: Obstetrics & Gynaecology, University College Hospital, Ibadan.
Phone no: 08059820755.
e-mail: [email protected]
65 APPENDIX II
(ENROLMENT VISIT-PROPOSED QUESTIONAIRE) QUESTIONAIRE ON THE SCREENING FOR CHANGES IN
CERVICOVAGINAL FLORA pre-INSERTION OF COPPER-IUD/ LNG-IUS I am Dr B.C. Oranye, a senior resident doctor in the Department of Obstetrics and Gynaecology, UCH, Ibadan. I am carrying out a study on the above topic. I request your co-operation in getting the following information about you. These shall be treated with utmost confidentiality.
Phone No: --- LNMP: --- Thanks