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A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception

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A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception
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  Original research article A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception ☆ , ☆☆ David K. Turok  a, ⁎ , Shawn E. Gurtcheff  a  , Erin Handley  b , Sara E. Simonsen  b ,Christina Sok  a  , Patricia Murphy c a   Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, UT 84132-2209, USA  b  Division of Public Health, Department of Family and Preventive Medicine, University of Utah Health Sciences Center, Salt Lake City, UT 84132, USA c College of Nursing, University of Utah Health Sciences Center, Salt Lake City, UT 84132, USA Received 17 March 2010; revised 27 May 2010; accepted 1 June 2010 AbstractBackground:  This study evaluates the willingness of women presenting for emergency contraception (EC) to enroll in a study offering thecopper intrauterine device (IUD) or oral levonorgestrel (LNG) and follows up the two groups for 6 months after EC administration tocompare use of an effective method of contraception. Study Design:  This prospective observational study offered these two methods to women presenting for EC. The primary outcome was useof an effective method of contraception 6 months after presenting for EC. Results:  Thirty-four women (60%) chose oral LNG and 23 (40%) chose the copper IUD. One month after presenting for EC, 21 (96%) of 22in the IUD group were still using the IUD and all 22 were using an effective method of contraception (efficacy ≥ 92%). In the LNG group, 13(52%) of 25 were using an effective method of contraception (p b .001). At 6 months, 9 (69%) of 13 IUD users and 11 (52%) of 21 oral LNGEC users were using an effective method (p=NS). Conclusion:  Women presenting for EC were willing to enroll in a study offering the copper IUD or oral LNG.© 2010 Elsevier Inc. All rights reserved.  Keywords:  Emergency contraception; IUD; Oral levonorgestrel; Pilot study 1. Introduction The vast majority of the 3.1 million unintended pregnancies in the United States each year result fromsituations where contraception was used imperfectly or not at all [1]. Emergency contraception (EC) is a woman's onlyreliable option for preventing pregnancy after unprotectedintercourse. Currently in the United States, there are threeapproaches to EC. The use of combined oral contraceptiveshas been shown to be less effective and associated with moreadverse effects than high-dose oral levonorgestrel (LNG) [2].Thus, oral LNG has become the most frequently usedmethod of EC and is administered within 5 days of unprotected intercourse. Use of this method has not reducedabortion rates [3,4], but the third rarely pursued option,inserting a copper IUD, may do so.The demand for EC signifies a tremendous unmet  public health need for more reliable and more effectivecontraception. The copper IUD has 2 distinct advantagesover oral LNG for EC: the greatest efficacy of any methodof EC (pregnancy rates of   ≤ 0.2%) [5,6] and continuedhighly effective contraception for over a decade. The useof the copper IUD for EC is supported by a CochraneReview on the subject  [7], the American College of Obstetricians and Gynecologists [8], and several other  professional organizations and authors [9 – 15]. Despitethese endorsements, US family planning providers havenot embraced this practice nor has it been evaluated instudies performed in this country. Offering women desiringEC a highly effective long-term method of birth control Contraception 82 (2010) 520 – 525 ☆ This research was supported by an anonymous foundation. DavidTurok receives research support in the form of product from DuramedPharmaceuticals and has served on an advisory board for Bayer Healthcare. ☆☆ The findings from this report were presented as a poster at Reproductive Health 2009 in Los Angeles, CA, USA, in September 2009. ⁎ Corresponding author. Tel.: +1 801 581 8995; fax: +1 801 585 5146.  E-mail address:  David.Turok@hsc.utah.edu (D.K. Turok).0010-7824/$  –  see front matter © 2010 Elsevier Inc. All rights reserved.doi:10.1016/j.contraception.2010.06.001  has great potential to reduce unintended pregnancy andwarrants careful evaluation in the United States, which isthe developed country with the highest rate of unintended pregnancy and abortion.Planned Parenthood Association of Utah (PPAU) isUtah's main distributor of EC increasing distribution of oralLNG from 11,263 to 52,083 doses per year from 2000 to2006 [16]. In 2007, after the medication was availablewithout a prescription, PPAU still dispensed 38,921 doses.Because of the wide use of EC distributed by a centralsupplier who is also capable of inserting IUDs, PPAU is anideal place to conduct studies of the copper IUD versus oralLNG for EC. The purpose of this study is twofold. First, thisstudy seeks to evaluate the ability to recruit women presenting for EC to a trial of the copper IUD vs. oralLNG and to design future studies evaluating use of long-termcontraception in this group. Second, the study will comparethe use of effective methods of contraception one and sixmonths after women present for EC. 2. Materials and methods Women aged 18 – 45 years presenting for EC at a singlePPAU clinic were offered participation in this prospectiveobservational study. Participants chose either oral LNG or the copper IUD for EC. Either method was provided to the patient without charge. The following exclusion criteria wereemployed: current pregnancy, pelvic inflammatory diseaseor a septic abortion within the past 3 months, gonorrhea or chlamydia infection in the last 60 days, current behavior suggesting a high risk for pelvic inflammatory disease(multiple sexual partners without the use of a barrier methodfor STI prevention), allergy to copper or Wilson's disease(for participants selecting copper IUD), allergy to LNG (for  participants selecting LNG EC) and abnormalities of theuterus that distort the uterine cavity including leiomyomas,mucopurulent cervicitis, an IUD already in place, genital bleeding of unknown etiology, ovarian, cervical or endome-trial cancer, or a small uterine cavity ( b 6 cm).The primary outcome was use of an effective method of contraception 6 months after presenting for EC. Effectivemethods were defined as having a pregnancy rate of less thanor equal to 8% per year with typical use [17] and includedoral contraceptive pills, the combined hormonal contracep-tive patch and vaginal ring, depomedroxyprogesteroneacetate, etonorgestrel contraceptive implants, IUDs, andsterilization. Secondary outcomes measured were pregnan-cies, abortions, use of a highly effective method of contraception (IUDs, etonorgestrel contraceptive implant,or sterilization), repeat oral LNG EC use, and patient satisfaction with the chosen EC method. Participantsselecting the IUD were assessed for IUD expulsion, perforation, and removal. Oral LNG was dispensed as per the PPAU protocol for EC which is in accordance with statelaws and regulations.At the enrollment visit, a questionnaire was completedassessing baseline demographics, current method of contra-ception, obstetric history, prior sexually transmitted infec-tions, reasons for EC need, and time from unprotectedintercourse to EC request. All participants had a urine pregnancy test (Quickvue®+ One-Step hCG combo test,Quidel Corporation) and a urine test for gonorrhea andchlamydia (Aptima® Combo 2 assay, Gen-Probe). After completing the informed consent process and instructions, participants received their choice of oral LNG 1.5 mg as asingle-dose or insertion of a copper T-380 IUD by theclinician staffing the clinic that day. All IUDs were inserted by nurse practitioners with extensive experience in IUDinsertion. Participants who had an IUD placed werecounseled according to clinic protocol to check their stringsafter each menstrual episode to verify that the IUD was stillin place. If the subject was unable to feel the strings, saw theIUD come out, had a fever ( N 100.5°F), had pelvic pain that did not respond to ibuprofen, or had an abnormal vaginaldischarge, she was instructed to call the clinic and schedulean immediate appointment.Participants who selected oral LNG were informed that it works best if it is taken as soon as possible after unprotected intercourse and that it is preferable to take themedication within 72 h of unprotected intercourse but it hasan effect up to 120 h later. They also received informationon the common side effects of oral LNG and wereinstructed to check a home urine pregnancy test if theyhad not had their menses by the expected date. At thisinitial visit, oral LNG users were offered written informa-tion about other contraceptive methods, including barrier methods, combined hormonal methods, progestin-onlymethods and IUDs.Prior to leaving the clinic, an appointment was made for a follow-up visit in 4 weeks. Participants were called on theday prior to the follow-up appointment as a reminder. At this visit, a urine pregnancy test (Quickvue+ One-Step hCGcombo test, Quidel Corporation) was performed and participants were also asked if they had had a pregnancydiagnosed in the intervening period and the outcome of any pregnancy that occurred. A brief questionnaire wascompleted at this time addressing current use of contracep-tion, the presence or absence of abnormal discharge, fever or pain, and whether any infections or adverse events haveoccurred in the intervening period. In addition, thefollowing information was also obtained: repeat use of EC, number of sexual partners since EC use, condom usage,and satisfaction of the method chosen. Participants who hadthe IUD inserted were asked if they had an expulsion or removal. During this visit, women who selected the IUDwere asked if they had palpated the IUD strings and aspeculum exam was performed to check for proper  placement of the IUD strings. Participants with a positive pregnancy test at any time during the course of the studyreceived pregnancy options counseling and appropriatereferrals for pregnancy termination or obstetric care. 521  D.K. Turok et al. / Contraception 82 (2010) 520  –  525  Participants who did not return for their 1 month follow-upwere contacted by telephone. Those who were unreachableat any of the three phone numbers provided (after fiveattempts at each number) received a reminder letter with theinvestigator's phone number. Clinic records were alsoassessed to see if participants had called or returned for care.Finally, if we were unable to contact people or obtaininformation on current contraceptive use after the abovemethods were exhausted, we attempted to find a current  phone number using an online search service (www.MelissaData.com) [18]. Six months after their initial presentation for EC, participants were contacted by phone to complete a finalquestionnaire. This assessed the same information as theone-month follow-up as well as satisfaction with the methodof EC they used and their current method of contraceptionwith a five-point Likert scale (1=very unsatisfied, 2=unsat-isfied, 3=neutral, 4=satisfied and 5=very satisfied). IUDexpulsions and removals were documented by this telephonequery. The same methods were employed to contact allavailable participants.A power calculation was performed with a two-sidedalpha value of .05, power of 0.90 and the assumption that for every 20 women choosing oral LNG for EC, one wouldchoose the copper IUD. The primary outcome of use of aneffective method of contraception 6 months after presentingfor EC was anticipated to occur 30% of the time in oralLNG users and 80% of the time for copper IUD users. Thiswould have required sample sizes of 220 in the oral LNGgroup and 11 in the copper IUD group. Anticipating a possible loss to follow-up of 20%, our sample size wasincreased to 264 subjects in the oral LNG group and 13 inthe copper IUD group. However, once the study beganenrollment, we found that among women willing to participate in the study, the ratio of participants was 1.5oral LNG users to 1 IUD user. With this information, thesample size required was 29 in the oral LNG group and 19in the copper IUD group. An additional 20% were added toeach group allowing for loss to follow-up. The primaryoutcome of use of an effective method of contraception at 6months was analyzed using a chi-square test. Secondaryoutcomes were analyzed using a chi-square test andFisher's Exact test where appropriate. Data analysis was performed utilizing Stata 10 statistical software (StataCorp,College Station, TX, USA). This study was approved bythe Institutional Review Board of the University of Utah(IRB#00023111) and Planned Parenthood Federation of America Medical Affairs Department. As the copper IUDis not Food and Drug Administration (FDA) approved for EC, we received Investigational New Drug (IND) approval,and the study was conducted per FDA guidelines regardingan IND and in compliance with the Federal Food, Drug,and Cosmetic Act and the implementing regulations (Title21 of the Code of Federal Regulations). This trial wasregistered in the Clinical Trials Data Bank (http:// clinicaltrials.gov). 3. Results Over a 12-week period from April 21, 2008, to July 14,2008, 57 women who presented to a single PPAU clinicrequesting EC agreed to participate in this study. Thirty-four of these women (59.6%) chose oral LNG and 23 (40.4%)chose the copper IUD. All participants received their chosenmethod of EC within 120 h of unprotected intercourse, andthe groups were similar in the interval of time fromunprotected intercourse to EC administration. Baselinecharacteristics of the study participants are presented inTable 1. All urine pregnancy testing at presentation revealednegative results. Three participants tested positive for chlamydia at presentation, two in the oral LNG group andone in the IUD group. All three of these women and all of their known partners were treated with azithromycin 1 gorally. There were no reported infectious complications,specifically symptoms of or treatment for pelvic inflamma-tory disease, though one of the Chlamydia-positive partici- pants in the oral LNG group was lost to follow-up. Themajority of women presented within 24 h of unprotectedintercourse, and 23 (40.4%) of the 57 women were not usinga method of birth control at the time they presented for EC.Among participants who were using a method of contracep-tion at study entry, the options used in order of decreasingfrequency were male condoms, combined hormonal meth-ods, withdrawal, or depomedroxyprogesterone acetate.Outcome data are presented in Table 2. One month after initially presenting for EC, there were no pregnancies in Table 1Baseline data for oral LNG vs. copper IUD EC studyVariable Oral LNGn=34 (59.6%)Copper IUDn=23 (40.4%) p a  Mean (S.D.) Mean (S.D.)Age 23.0 (±4.7) 24.7 (±6.7) .263 n  (%)  n  (%) p  b Race/ethnicity .636White, non-Hispanic 20 (58.8) 15 (65.2)Hispanic 11 (32.4) 6 (26.1)Asian 3 (8.8) 1 (4.4)Hawaiian/PacificIslander 0 (0.0) 1 (4.4)Income .096 b $20,000 22 (64.7) 17 (73.9)$20,000 – $40,000 12 (35.3) 4 (17.4)$40,001 – $60,000 0 (0.0) 2 (8.7)Insurance status .927Private insurance 7 (20.6) 4 (17.4)Medicaid 3 (8.8) 3 (13.0)Self-pay 22 (64.7) 15 (65.2)Missing 2 (5.9) 1 (4.4) Nulligravity .209Yes 16 (47.1) 7 (30.4) No 18 (52.9) 16 (69.6)Percentages may not add up to 100% due to rounding. a  Two-sample  t   test with equal variances.  b Chi-square and Fisher's Exact tests.522  D.K. Turok et al. / Contraception 82 (2010) 520  –  525  either group. The 1-month follow-up rate was 82.5%, withdata available for 25 of 34 women in the oral LNG group and22 of 23 in the IUD group. One month after presenting for EC, 20 (90.9%) of 22 in the IUD group were still using thecopper IUD. Of the two women who had the IUD removed,one had cramping and one had heavy bleeding and cramping. Neither woman was using a regular method of contraceptionthough one reported she was not sexually active. In the LNGgroup, 13 (52.0%) of 25 were using an effective method of contraception (p b .001). These results remain statisticallysignificant even if all the women who were lost to follow-upin the oral LNG group were assumed to be using an effectivemethod of contraception. This would increase the number of women using an effectivemethod of contraception in theoralLNG group to 22 (64.7%) of 34 vs. 20 (90.9%) of 22 in theIUD group, p=.001. In addition, no women in the oral LNGgroup were using a highly effective method of contraception.The difference between the two groups for the number of women using a highly effective method of contraception wasalso statistically significant (p b .01) at 1 month. There wereno infections or complications requiring hospital admissionin either group. There were no perforations or expulsions inthe IUD group.Six months after presenting for EC, 22 (64.7%) of the 34oral LNG users were able to be contacted for follow-up, and13 (56.5%) of 23 in the IUD group. In the oral LNG group,13 (59.1%) of 22 were using an effective method vs. 9(69.2%) of 13 of IUD users. Fig. 1 depicts the use of effective contraception by women in the 2 groups at 1 and 6months. The groups differed in use of a highly effectivemethod of contraception (actual use-effectiveness  ≥ 98%)with this occurring in 1 (4.5%) of 22 women in the oralLNG group and 8 (61.5%) of 13 women in the IUD groupwho continued with their IUD (p b .001). There were noexpulsions in the copper IUD group. Five of the 13 womenin the IUD group had had the IUD removed by 6 months.Of these, one stated the reason was bleeding, two stated thereasons were bleeding and cramping/pain, and twoadditional women reported just cramping/pain. Throughthe 6-month course of the study, there were two pregnanciesreported in the oral LNG group and no pregnancies in theIUD group.During the 6 month follow-up phone call, we surveyed participants regarding their level of satisfaction using afive-point Likert scale. At 6 months, 21 (95.5%) of 22women in the oral LNG group and 8 (61.5%) of 13 in theIUD group reported that they were satisfied or verysatisfied with the method of EC they had chosen (p=.019).However, at this time, 17 (76.5%) of 22 and 11 (84.6%) of 13, respectively, said they were satisfied or very satisfiedwith the method they were currently using (p=.4). In theLNG group, satisfaction with contraceptive method at 6months was reported by 10 of 12 users of combinedhormonal contraception (oral contraceptive pills, the contra- Table 2Outcome data for oral LNG and copper IUD EC studyVariable Oral LNGn=34 (59.6%)Copper IUDn=23 (40.4%) p a  n (% ) n (% ) 1-month follow-up Available for follow-up 25 (73.5) 22 (95.7)Using effectivecontraception13 (52.0) 20 (90.9) .004Using highlyeffective contraception0 (0.0) 20 (90.9)  b .001 6-month follow-up Available for follow-up 22 (64.7) 13 (56.5)Using effectivecontraception13 (59.1) 9 (69.2) .7Using highlyeffective contraception1 (4.5) 8 (61.5)  b .001Satisfaction with ECmethod chosen21 (95.5) 8 (61.5) .019Satisfaction with current contraceptive method  b 17 (76.5) 11 (84.6) .4IUD expulsion N/A 0 (0.0)IUD removal N/A 5 (38.5)Pregnancy 2 (9.1) 0 (0.0) NS a  Chi-square and Fisher's Exact tests.  b The method at 6 months may have been different from thesrcinal method.Fig.1.Use of effective* and highly effective** methods of contraception at 1 and 6 months by type of EC used (oral levonorgestrel vs. copper T IUD).*Effective methods of contraception were defined as having a pregnancyrate of less than or equal to 8% per year with typical use and included oralcontraceptive pills, the combined hormonal contraceptive patch andvaginal ring, depomedroxyprogesterone acetate, etonorgestrel contracep-tive implants, IUDs, and sterilization. **Highly effective methods weredefined as having a pregnancy rate of less than or equal to 1% per year with typical use and included IUDs, the etonorgestrel contraceptiveimplant, and sterilization.523  D.K. Turok et al. / Contraception 82 (2010) 520  –  525  ceptive patch or ring), five of eight users of male condomsand one woman each who were using the levonorgestrelIUD and spermicide. In the IUD group, satisfaction withcontraceptive method at 6 months was reported by 7 of 8 women who continued with the copper IUD, 1 womanusing the contraceptive ring and 3 of 4 woman using malecondoms. Of note, in the oral LNG group, the medicationwas used again for EC in 5 (20.0%) of 25 in the first monthafter enrolling in the study and 5 (22.7%) of 22 in Months 2to 6. Repeat EC use occurred in women who declinedcontraception at their initial EC visit or did not use their method consistently. 4. Discussion More women who chose an IUD over oral LNG were stillusing effective contraception at 1 and 6 months of follow-up.In addition, there were no pregnancies in the IUD group. Theappeal of using IUDs for EC is that it facilitates use of one of the most effective contraceptive methods for the highest risk group of people (those presenting for EC). In spite of the fact that 38.5% of women had the IUD subsequently removed,there was still a significant difference in the number of women using highly effective, long-acting contraception at 6months (61.5% of IUD users vs. 4.5% of oral LNG users, p b .001). While the difference in use of an effective methodof contraception at 6 months (69.2% of IUD users vs. 59.1%of oral LNG users) was not statistically significant, it may beclinically significant, especially when applied to a large population with a high unintended pregnancy rate. In asimilar study with a large sample size a similar differencemay be statistically significant. The small sample size in thisstudy was designed to detect a large difference in the use of an effective method of contraception 6-months after  presenting for EC. As a result, this study lacked power todetect more subtle, but clinically important, differences inthis outcome.Recent studies looking at prescription refill rates inhormonal contraceptive users suggest that long-term contin-uation rates are poor, with less than 35% of pill usersconsistently refilling their prescriptions by one year  [19,20].The high discontinuation rates of oral contraceptive pill usersadds to their diminished efficacy versus an IUD; improvedcontinuation of more effective methods leads to lessunplanned pregnancy.Despite the preliminary nature of this study and the smallsample size, this study provides important information about women's willingness to choose a long-acting reversiblemethod for EC. Women request EC after unprotectedintercourse resulting from method failure or omission.Thus, we anticipated some EC users would be willing toaccept the IUD as an EC method due to its superior efficacyand the added benefit of long-term highly effectivecontraception. However, we did not anticipate almost equal proportions of women choosing the IUD as oral LNG. In our initial sample size calculations, we assumed that for every 20women who chose oral LNG for EC, there would be onewoman who chose an IUD. Yet, women enrolled in thisstudy actually chose an IUD much more frequently, with 1.5who chose oral LNG for every 1 who chose an IUD. Whileour study is not adequately powered to assess differences between the women who chose the IUD and women whochose oral LNG, this is promising preliminary information todirect future study.A major limitation of the study was loss to follow-up.Despite at least five attempts to contact each participant at the three contact phone numbers and the address werequested, our 6-month follow-up was poor. This highlightsthe need to alter strategy for future studies but also informsappropriate sample size calculation to ensure adequate power for subsequent research. Future efforts will include participants who can provide more reliable follow-up, morefrequent contact, and greater participant reimbursement.Another limitation is that only a minority of the 2473women who presented for EC during the study time periodwere offered participation in the study, and we do not havespecific data on the number of those offered participationrelative to those who accepted. The popularity of a drive-through window for provision of EC and the fact that anexperienced IUD inserter was not always in the cliniclimited our ability to offer the study to the majority of  participants. In addition, one barrier we did not address inthis study was that of cost, as both emergency contra-ceptives were provided to study participants at no charge.The decision process regarding whether to use an IUD, andif obtained whether to continue with it, may be highlyinfluenced by whether or not patients pay for the device.This is an important consideration in this study where over one-third of those who selected the IUD had it removed by6 months. High removal rates will adversely affect theoverall cost-effectiveness of this strategy. However, con-cerns over cost of an IUD may be mitigated with the advent of lower cost IUDs. In addition, the cost of the IUD needs to be compared to the cost of repeat doses of LNG EC, other methods of contraception and the potential cost of abortionor pregnancy care.In summary, more women chose a copper IUD for ECthan had been anticipated. Women that chose an IUD for ECwere much more likely to be using a highly effectivecontraceptive at follow-up despite relatively high discontin-uation rates of the IUD. Long-term loss to follow-up was amajor limitation in this pilot, and planning for a moredefinitive study must involve improved strategies tominimize loss to follow-up. Acknowledgments The authors wish to thank the staff of the PlannedParenthood Association of Utah's West Valley Clinic for their outstanding service to the women of Utah and their cooperation with this study. 524  D.K. Turok et al. / Contraception 82 (2010) 520  –  525
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