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 HealthUniversiti 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.

11. Sarah ML, Mathieu L et al. Adolescents’ willingness to use contraceptive vaginal ring. Canada J Obstet Gynecol 2011:353–360.

12. Carey AS, Chiappetta L, Tremont K, et al. The contraceptive vaginal ring:femal adolescents ’ knowledge, attitudes and plans for use. Contraception 207;76:444-50.

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 society1. 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 women2. 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 contraceptives4,5. However, the vaginal route of administration avoids hepatic first-pass metabolism and gastrointestinal interference, which allows lower doses of the hormones to be used6 Furthermore, the vaginal ring achieves more uniform plasma hormone concentrations than the oral preparations6.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 control5. However in term of body weight gain there was no clinically relevant difference between the two groups9. Roumen et al 4 in 2001 and Dieben et al 5in 2002 studied the efficacy, tolerability, cycle control and user acceptability of NuvaRing®. Both of them and another study by Oddsson et al102005, had similar promising results. The ACCEPT study which is the most recent, is a Phase IV trial to assess compliance, side effects, overall acceptability and intent to continue use of the method. The study is focused on the acceptability of the vaginal ring among female undergraduate or graduate students and is still recruiting samples of students in University of Chicago. Hence till date there are many studies on the efficacy and acceptability as well of comparison of NuvaRing® with the other contraception. However most of this study was done in the European countries. My attempt is to assess the acceptability rate for NuvaRing® amongst nurses in UKMMC and secondly to determine the reasons fo acceptance, refusal, reasons for discontinuation / continuation and finally percentage of NuvaRing® users after two months. We hope by doing so we may be able to reflect on the perception and acceptability of NuvaRing® in the general population.

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 recommend it to their family and friends. Five nurses discontinued the trial after the 1 st month. One nurse discontinued due to increase pervaginal discharge, the other 4 discontinued as they claimed that after insertion there still felt the sensation of the ring vaginally and felt uncomfortable due to that. The cost of NuvaRing®was not the main cause of discontinuation. Only one nurse felt that it was expensive and it may be a cause to discontinue. After two cycles of use NuvaRing®, out of the 29 nurses that completed the trial, 27 nurses (93.1%) perceived it as the suitable contraception for them and were keen to continue the usage. All the 29 nurses that completed the trial would recommend it to their friends and family.All the 34 nurses did not think the cost of NuvaRing® was a reason to discontinue the usage and were willing to pay the price to buy it in the pharmacy after the trial had completed

Side effects Yes NoEmotional disturbancesHeadacheAcneWeight gainNauseaDysmenorrheaLeucorrhoea Vaginal discomfortDysperunea

023120231

343231333234323133

Response Strongly disagree

Disagree Neither Agree Strongly agree

Easy insertionEasy removalRing not felt after insertionRing not felt during intercourseRing not felt by partner during intercourseThose that would continueThose that would recommend to others

0101000

0000200

0212020

18151513171413

11111313101316

Parity n %Para 0Para 1Para 2Para 3Para 4

179

116

2.920.626.532.417.6

Inclusion criteriaAll nurses working in UKMMCAged between 18 -40 yearsIn good healthNot using any hormonal contraception for the last 3 monthsNot planning pregnancy kin next 2 months

Exclusion criteriaKnown or suspected pregnancyUndiagnosed vaginal bleedingHistory of migraine with focal neurological symptomsHistory of arterial or venous thromboembolismHypersensitivity to active substance in Nuvaring