ACCEPTABILITY OF CONTRACEPTIVE VAGINAL RING (NuvaRing ® ) AMONGST NURSES IN A MALAYSIAN TEACHING HOSPITAL Vijayaletchumi T, Harlina H Siraj, * Azmi MT, MA Jamil Department of Obstetrics and Gynaecology, * Department of Public Health Universiti Kebangsaan Malaysia Medical Center Objectives Results Conclusions References 1. Haymen NE. Medical history of contraception. New York, NY: Gamut Press, 1963. 2. Benagiano G, Bastianelli C, Farris M. Contraception today. Ann. NY. Acad. Sci.1092, 1-32 (2006) 3. Pharmacia & Upjohn Inc. International survey of birth control methods and what women want. Available at http://birthcontrolresources.com. 4. Bjarnadottir RI, Tuppurainen M, Killick SR. Comparison of cycle control with a combined contraceptive vaginal ring and oral levonorgestrel/ethinyl estradiol. Am J Obstet Gynecol 2002;186:389–395. 5. Roumen FJME, Apter D,Mulders TMT, Dieben TOM. Efficacy, tolerability and acceptability of novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Hum. Reprod.16,469-475 (2001. 6. Dieben TOM, Roumen FJME, Apter D. Efficacy, cycle control and user acceptability of novel combined contraceptive vaginal ring. Obstet.Gynecol.100,585-593 (2002) 7. Timmer CJ, Mulders TMT. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet 2000;39:233–42. 8. Efficacy and safety of contraception vaginal ring (Nuvaring) compared with a combined oral contraceptive: a 1- year randomized trial. Oddsson K, Leifels –Fishers et al. Contraception71 (2005) 176-82. 9. Milsom I, Lete I, Bjertnaes A et al. Effects on the cycle control and bodyweight of the combined contraceptive ring, Nuva ring versus an oral contraceptive containing 30µg ethinyl estradiol and 3mg drospirenone. Hum. Reprod. 21,2304- 2311 (2006.) 10. Jensen JT, Burke AE, Barnhart KT, Tillotson C, Messerle- Forbes M, Peters D. Effects of switching from oral to transdermal or transvaginal contraception on markers of thrombosis. Contraception78 (2008) 451-458. From puberty until menopause, women are faced with concerns about childbearing or its avoidance. The options that are available are sexual abstinence, contraception, or pregnancy otherwise. The history of contraception is a long one, dating to ancient times: however, the voluntary control of fertility is even more important in our current modern society 1 . The combined oral contraceptive pill was probably the most important discovery in the field of obstetrics and gynaecology during the last century, and is currently used worldwide by more than 100 million women 2 . However, because women are required to take a contraceptive pill every day, often for a number of years, many would welcome the availability of a hormonal method that is convenient to use and does not require daily oral intake. 3 Hence the need for other more convenient methods had been looked into more seriously in the recent. The other available methods are such as injectable (IM depo provera), injectable rods (Implanon ® ) or hormone releasing intrauterine devices (Mirena ® ). Unfortunately, these methods require administration by trained personnel and cannot be self administered. Hence came the innovation of a more easy and patient friendly method, NuvaRing ® . NuvaRing ® is the trade name for a combine hormonal contraceptive ring. It is a flexible plastic (ethylene-vinyl acetate copolymer) ring with an outer diameter of 54mm that releases an average 0.120mg etonogestrel and 0.015mg ethinylestradiol, respectively for 24 hours, over a period of 3 weeks. Each ring is intended for one cycle of use only, comprising 3 weeks of ring use and 1 week of ring free period. The efficacy of the ring is comparable with that of combined oral contraceptives 4,5 . However, the vaginal route of administration avoids hepatic first-pass metabolism and gastrointestinal interference, which allows lower doses of the hormones to be used 6 Furthermore, the vaginal ring achieves more uniform plasma hormone concentrations than the oral preparations 6 . In comparing NuvaRing ® to implanon, hormonal patch or oral contraception pills, NuvaRing ® has also shown to be more acceptable. In a direct comparison with users of a combined levonorgestrel containing oral contraceptive pills, ring users had a significantly lower rate of breakthrough bleeding (5% vs. 39%) 8 . Intended bleeding was better for all cycles with NuvaRing ® (55.2-68.5%) than that in combined contraceptive pills (35.6-56.6%), hence better cycle control 5 . However in term of body weight gain there was no clinically relevant difference between the two groups 9 . Roumen et al 4 in 2001 and Dieben et al 5 in 2002 studied the efficacy, tolerability, cycle control and user acceptability of NuvaRing ® . Both of them and another study by Oddsson et al 10 2005, had similar promising results. The ACCEPT study which is the most recent, is a Phase There was a low acceptability for a contraceptive vaginal ring among the nurses that need to be addressed urgently. Rate of acceptance was however high amongst nurses who completed the trial. The challenge is to correct the misconceptions as soon as possible. Otherwise vaginal contraceptive ring would not benefit those who in need of an efficient contraceptive. Methods A cross-sectional study was designed involving nurses who were randomly selected. In University Kebangsaan Malaysia Medical Center (UKMMC) for a period of 1 year months from October 2010 till September 2011. Approval for this study was granted by the hospital research committee. (FF-317-2010) The data was analyzed by using the Statistical Package for the Social Sciences (SPSS) version 17.0. Basic descriptive statistics and frequency calculations were performed on all the variables. Apart from mean, standard deviation, percentage, Pearson’s Chi- square test, independent t-test and comparison tests were used to analyze the data. P value of < 0.05 was considered statistically significant. Out of 422 nurses being selected, only 34 (7.7%) nurses agreed to participate in the clinical trial. 33 nurses were Malays and one was an aborigine (orang asli). 20 were from the non O&G field. 26.5% were in service for 10 years and they were the majority that joined the trial. Table 1: The parity of the nurses recruited in the clinical trial The menstrual cycles of the recruited nurses were regular menses except 6 nurses had irregular menses and only one nurse had heavy menses. Seven had dysmenorrheal. We took this as a baseline to see if the NuvaRing ® would make it worst. However due to the short term use of this ring ie for only 2 months, it was difficult to deduce much info in the menstrual changes. Figure 1: Bleeding pattern with NuvaRing ® observed in nurses recruited. 85.29% of nurses in the trial had appropriate withdrawal bleeding pattern (2 to 4 days ring free period). The remaining 14.71% had either early or late withdrawal bleeding. At baseline of our clinical trial, 21 nurses had practice contraception prior to NuvaRing ® . Seven (33%) nurses indicated that the oral contraceptive was their method of choice and six other chose coitus interruptus as their method of choice. Table 2: Side effects experience with the NuvaRing ® observed in the nurses recruited in the study. Table 3: Response towards NuvaRing ® 29 nurses that completed the study had no difficulty in the insertion or removal of the ring. Only three nurses felt that the ring was displaced after insertion, however there were no cases of ring falling out. A significant number of nurses did not have any sensation of the ring being in situ. Four nurses from the 34 that joined the trial dropped out due to the vaginal discomfort. However the ring did not hinder their sexual intercourse. In fact only two to three nurses or partner actually could feel the ring at sexual intercourse. 93.1% of the nurses that completed the trial were happy to continue with NuvaRing ® . All 29 nurses in this trial would Side effects Yes No Emotional disturbances Headache Acne Weight gain Nausea Dysmenorrhea Leucorrhoea Vaginal discomfort Dysperunea 0 2 3 1 2 0 2 3 1 34 32 31 33 32 34 32 31 33 Response Strongl y disagre e Disagre e Neithe r Agree Strongl y agree Easy insertion Easy removal Ring not felt after insertion Ring not felt during intercourse Ring not felt by partner during intercourse Those that would continue Those that would recommend to others 0 1 0 1 0 0 0 0 0 0 0 2 0 0 0 2 1 2 0 2 0 18 15 15 13 17 14 13 11 11 13 13 10 13 16 Parity n % Para 0 Para 1 Para 2 Para 3 Para 4 1 7 9 11 6 2.9 20.6 26.5 32.4 17.6 Inclusion criteria All nurses working in UKMMC Aged between 18 -40 years In good health Not using any hormonal contraception for the last 3 months Not planning pregnancy kin next 2 months Exclusion criteria Known or suspected pregnancy Undiagnosed vaginal bleeding History of migraine with focal neurological symptoms History of arterial or venous thromboembolism Hypersensitivity to active substance in Nuvaring