current opinion: consensus statement on intrauterine contraception

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Commentary Current opinion Consensus statement on intrauterine contraception Roberto Rivera a, *, Kim Best b a Office of International Research Ethics, Family Health International, Research Triangle Park, NC 27709, USA b Field Information and Training Services, Family Health International, Research Triangle Park, NC 27709, USA Received 22 January 2002; accepted 28 January 2002 Abstract Forty-five experts from around the world attended a 1-day seminar in September 2001 in Chapel Hill, North Carolina, USA, to identify ways that they might collaborate to overcome unnecessary barriers to the use of intrauterine devices (IUDs). Seminar participants formed working groups that produced at least three specific recommendations relating to: training/performance improvement; service delivery improvement; general public information; and clinical and programmatic research. Key recommendations included: integrating reproductive health knowledge and skills into curricula for all healthcare professionals; reviewing and reinforcing with providers evidence-based guidelines for IUD use; encouraging evidence-based review of the IUD label and package insert; and conducting further research about IUD client eligibility, potential health benefits, acceptability among clients and providers, and use by HIV-infected women. At the meeting’s conclusion, a number of participants, representing the fields of research, policy, communications, donors, women’s advocacy, and medicine, expressed an interest in refining and acting upon the recommendations. Hosted by Family Health International, the meeting was supported by the Mellon Foundation. © 2002 Elsevier Science Inc. All rights reserved. Keywords: Intrauterine device (IUD); Sexually transmitted infections (STI); Pelvic inflammatory disease (PID); Training and performance; Health services research 1. Introduction The contemporary copper intrauterine device (IUD) is one of the safest, most effective, and least expensive con- traceptives available. It is a spectacularly effective, revers- ible contraceptive, rivaling female sterilization, injectables, and implants for pregnancy prevention. The IUD is conve- nient. Once inserted, it is nearly maintenance-free (except for monthly self-checks to locate the IUD string) for up to a decade. Only one follow-up visit to a healthcare provider after 1 month of use is suggested. The nonmedicated or copper IUD has no systemic side effects, can be safely used by breastfeeding women, and rarely produces complica- tions. It may offer noncontraceptive health benefits as well. Six out of seven studies suggest that the copper IUD pro- tects against endometrial cancer [1–7]. The levonorgestrel-releasing IUD offers the additional health benefits of substantially reducing menstrual blood loss and pain, and providing endometrial protection for women receiving estrogen replacement therapy during menopause or women receiving tamoxifen to treat breast cancer [8,9]. It has become quite clear that the IUD does not facilitate sexually transmitted infections (STIs) or increase the risk of infertility [10]. Bacteria are the culprits in the development of pelvic inflammatory disease (PID) and associated infer- tility, while an IUD (if present) is an innocent bystander. Any woman with a cervical infection, particularly gonor- rhea or chlamydia, is at greater risk of PID than an unin- fected woman, whether or not she is using an IUD. If no sexually transmitted bacteria are present at the time of IUD insertion, none can be pushed up into the uterus; thus, there is no IUD-related risk of PID. While IUDs are not the first contraceptive choice for nulliparous women (because of increased expulsion risk), they can be safely provided to such women without compromising fertility [11,12]. The World Health Organization’s (WHO) medical eligi- bility criteria for safe use of contraceptives state that inser- tion of a copper IUD in an HIV-infected woman or one who is at high risk of infection is not usually recommended [13]. However, recent research suggests that the IUD may be a * Tel.: 1-919-544-7040; fax: 1-919-544-7261. Contraception 65 (2002) 385–388 0010-7824/02/$ – see front matter © 2002 Elsevier Science Inc. All rights reserved. PII: S0010-7824(02)00304-9

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Page 1: Current opinion: Consensus statement on intrauterine contraception

Commentary

Current opinionConsensus statement on intrauterine contraception

Roberto Riveraa,*, Kim Bestb

aOffice of International Research Ethics, Family Health International, Research Triangle Park, NC 27709, USAbField Information and Training Services, Family Health International, Research Triangle Park, NC 27709, USA

Received 22 January 2002; accepted 28 January 2002

Abstract

Forty-five experts from around the world attended a 1-day seminar in September 2001 in Chapel Hill, North Carolina, USA, to identifyways that they might collaborate to overcome unnecessary barriers to the use of intrauterine devices (IUDs). Seminar participants formedworking groups that produced at least three specific recommendations relating to: training/performance improvement; service deliveryimprovement; general public information; and clinical and programmatic research. Key recommendations included: integrating reproductivehealth knowledge and skills into curricula for all healthcare professionals; reviewing and reinforcing with providers evidence-basedguidelines for IUD use; encouraging evidence-based review of the IUD label and package insert; and conducting further research about IUDclient eligibility, potential health benefits, acceptability among clients and providers, and use by HIV-infected women. At the meeting’sconclusion, a number of participants, representing the fields of research, policy, communications, donors, women’s advocacy, and medicine,expressed an interest in refining and acting upon the recommendations. Hosted by Family Health International, the meeting was supportedby the Mellon Foundation. © 2002 Elsevier Science Inc. All rights reserved.

Keywords: Intrauterine device (IUD); Sexually transmitted infections (STI); Pelvic inflammatory disease (PID); Training and performance; Health servicesresearch

1. Introduction

The contemporary copper intrauterine device (IUD) isone of the safest, most effective, and least expensive con-traceptives available. It is a spectacularly effective, revers-ible contraceptive, rivaling female sterilization, injectables,and implants for pregnancy prevention. The IUD is conve-nient. Once inserted, it is nearly maintenance-free (exceptfor monthly self-checks to locate the IUD string) for up toa decade. Only one follow-up visit to a healthcare providerafter 1 month of use is suggested. The nonmedicated orcopper IUD has no systemic side effects, can be safely usedby breastfeeding women, and rarely produces complica-tions. It may offer noncontraceptive health benefits as well.Six out of seven studies suggest that the copper IUD pro-tects against endometrial cancer [1–7].

The levonorgestrel-releasing IUD offers the additionalhealth benefits of substantially reducing menstrual bloodloss and pain, and providing endometrial protection for

women receiving estrogen replacement therapy duringmenopause or women receiving tamoxifen to treat breastcancer [8,9].

It has become quite clear that the IUD does not facilitatesexually transmitted infections (STIs) or increase the risk ofinfertility [10]. Bacteria are the culprits in the developmentof pelvic inflammatory disease (PID) and associated infer-tility, while an IUD (if present) is an innocent bystander.Any woman with a cervical infection, particularly gonor-rhea or chlamydia, is at greater risk of PID than an unin-fected woman, whether or not she is using an IUD. If nosexually transmitted bacteria are present at the time of IUDinsertion, none can be pushed up into the uterus; thus, thereis no IUD-related risk of PID. While IUDs are not the firstcontraceptive choice for nulliparous women (because ofincreased expulsion risk), they can be safely provided tosuch women without compromising fertility [11,12].

The World Health Organization’s (WHO) medical eligi-bility criteria for safe use of contraceptives state that inser-tion of a copper IUD in an HIV-infected woman or one whois at high risk of infection is not usually recommended [13].However, recent research suggests that the IUD may be a* Tel.: �1-919-544-7040; fax: �1-919-544-7261.

Contraception 65 (2002) 385–388

0010-7824/02/$ – see front matter © 2002 Elsevier Science Inc. All rights reserved.PII: S0010-7824(02)00304-9

Page 2: Current opinion: Consensus statement on intrauterine contraception

safe contraceptive method for appropriately selected HIV-infected women with continuing access to medical services[14].

Also in the IUD’s favor is the fact that, if used for at least2 years, it is the least expensive reversible contraceptive[15]. While the up-front costs of the device and its insertionare higher compared to other methods, the costs over timeare low.

With some 100 million users in more than 100 countries,the IUD is the most commonly used reversible contracep-tive in the world. However, it remains an underutilizedmethod in many countries, including the US. In the 1970s,nearly 10% of US women used an IUD; today, fewer than1% do so.

Health services research has shown that confusion aboutthe association between the IUD, PID, and infertility per-sists. Although unwarranted, such concerns make IUDs amethod of “last resort” for many providers. Health servicesresearch has also found that myths, such as the idea thatIUDs can migrate throughout the body, still abound. Mean-while, IUDs are paid scant attention in counseling sessions,and their mechanism of action is misunderstood. Manyproviders, particularly in developing world settings, lacksufficient training, equipment, and supplies to insert IUDs.

Extra bleeding and cramping sometimes associated withIUD use causes some potential users to reject the method.And some women’s advocates oppose IUDs because theyare controlled by providers. Nevertheless, many womenhappily and successfully use IUDs, and such women’s ex-periences are important to highlight as efforts proceed tocast the contemporary IUD in the positive light it deserves.

2. International experiences

It is important to recognize that the method’s popularitygreatly varies throughout the world and to ask the question:Why has the method been readily adopted and its usecontinued in some countries while it languishes in others?

Mexico is a case study of IUD success. In Mexico, wherethe contraceptive prevalence rate is 70%, 2.3 millionwomen use IUDs, which have consistently accounted forabout 20% of the contraceptive method mix over the last 15years. High acceptance of the IUD is mainly a result of thecounseling provided during antenatal care for pregnantwomen. In the year 2000, according to the Mexican Na-tional Population Council, 55% of all IUD users adopted themethod postpartum, after having chosen during antenatalcare to use it, and the continuation rate at 1 year was 75%.High acceptance of the IUD in Mexico also has been a resultof a concerted effort to reduce medical barriers in theofficial norms for service delivery in family planning.

In terms of policy, economics, epidemiology, and cul-ture, IUD use in Kenya is starkly different than that inMexico. Although national guidelines are not unnecessarilyrestrictive of IUD use by such factors as age, parity, and

parental or spousal consent, providers often chose to disre-gard the guidelines and restrict use anyway. Checklists torule out pregnancy in nonmenstruating women have notbeen made available or used widely. Government facilities,which provide reproductive health services for up to half ofthe population, lack staff trained to insert IUDs and func-tional referral systems. Equipment and supplies needed forIUD placement are inadequate; it is not unusual for clientsto be asked to pay for sterile gloves and to have to wait forIUD insertion until scarce specula can be sterilized. On theother hand, obtaining IUDs at nongovernmental facilities isprohibitively expensive for most Kenyan women.

STI prevalence is high in Kenya (tubal occlusion becauseof prior STIs accounts for over 75% of infertility); thus,providers are acutely concerned with the potential for intro-ducing bacteria into the uterus during IUD insertion. Pro-viders also avoid the method because it is easier to give outpills or offer injections than to insert an IUD.

Finally, rumors among Kenyan women have perpetuatedthe myth that their sexual partners can feel the IUD stringand that clandestine use of the method is impossible. Falserumors of IUD failure, movement to such areas as the brain,causing congenital malformations and infertility, coupledwith reports of side effects, discourage women from usingthe method.

IUD use in China is unique from that in both Mexico andKenya in that it is simultaneously robust and problematic. InChina, many women accept and like the IUD for its long lifespan, reversibility, high effectiveness, and because insertionis free. A wide variety of IUDs available in China now offerwomen a broad choice, yet different IUD types requiredifferent insertion and removal techniques and also vary inlife span. A recent assessment by the State Family PlanningCommission of China, supported by WHO’s Department ofReproductive Health and Research, found that providerswere not always knowledgeable about the life span of var-ious IUDs, which ones required replacement and when, orhow to counsel women about side effects or appropriatefollow-up care. In addition, IUD users were required to havean ultrasound check every 3 months to ensure the placementof the devices. According to evidence-based medical crite-ria, this requirement is unnecessary, very costly, and need-lessly exposes women to multiple ultrasound exams. Fur-thermore, the assessment revealed that providers did notroutinely check for STIs. To avoid the risk of PID that couldbe caused by inserting an IUD in the presence of bacteria,Chinese providers need more training to diagnose, treat, orrefer potential IUD clients with STIs.

3. Industry perspectives

The private sector’s recent introduction of the levonorg-estrel-releasing IUD to the world market has renewed in-terest in intrauterine contraception.

However, for a large pharmaceutical company the IUD is

386 R. Rivera, K. Best / Contraception 65 (2002) 385–388

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a relatively minor product, promising uncertain financialreturn on large investments to promote it, which is partic-ularly worrisome if the public is not already “friendly”toward the product. Liability issues, while not major con-cerns for modern IUDs, also make the private sector cau-tious. Such liability concerns keep companies from workingto revise product labels containing overly conservativewarnings about IUD use. Such conservative product label-ing is a key reason that physicians are reluctant to recom-mend the IUD. In the US, physicians tend not to recommendthe method primarily because of liability concerns, withlack of knowledge about the device and lack of IUD inser-tion skills also important barriers to prescribing the device[16]. Ortho-McNeil Pharmaceutical, which markets theCopper T 380A IUD (ParaGard) in the US, found in asurvey of about 100 IUD users that the number of womenwho had asked for the IUD themselves rose sharply between1996 and 1999 (from 33% to 54%). However, the number ofphysicians recommending the device (as reported by theIUD users) fell from 63% to 40% during that time period[Katherine LaGuardia, Ortho-McNeil Pharmaceutical, Inc.;personal communication].

Meanwhile, smaller companies that market IUDs havelacked resources to launch large and continuous promo-tions, although some limited promotions have been under-taken.

Contech Devices Pvt. Ltd., which markets the Copper T380A IUD in India, in 1997 conducted a $10,000 campaignto promote contraception, particularly IUD use, in the sub-urbs of Calcutta, India. As a result of the campaign, 7% (96)of some 1375 women visited by field workers later went togynecologists providing IUDs; half of those women (a totalof 48) ultimately were fitted with the devices. The campaignfeatured door-to-door visits by field workers, as well as IUDinformation dissemination through handbill distribution,billboards, newspapers, and informing potential users thatIUDs were available from 15 leading gynecologists in thearea. Had funds been available and the campaign beenextended geographically, the manufacturer concluded, thecampaign would have been even more effective.

4. Proposed recommendations

Throughout the world, tens of millions of couples wantto avoid pregnancy but are not using contraception. As aresult, some 75 million unwanted pregnancies occur eachyear, about 50 million of which are aborted [17]. The unmetneed for effective, safe, and acceptable contraception isexacerbated when women lack a range of contraceptivechoices. In contrast, clients offered a mix of methods aremore likely to obtain the contraceptive method they needand prefer and are more likely to continue using it [18].

Given that the IUD is a highly effective, safe, and con-venient contribution to the contraceptive method mix, it istime to provide women and their reproductive health pro-

viders with correct and up-to-date information about intra-uterine contraception. To this end, IUD seminar participantstook part in four working groups to address: improvingprovider training and performance; improving service de-livery; updating and disseminating information; and con-ducting more clinical and programmatic research.

The workshop sessions generated specific, practical, andactionable recommendations, listed below.

4.1. Improving provider training and performance

Y Integrate reproductive health/family planning knowl-edge and skills into curricula at schools for all health-care professionals, both at preservice and servicelevel. Update materials for textbooks, training curric-ula, and health professional associations.

Y Regularly update and disseminate to providers accu-rate information about IUDs.

4.2. Improving service delivery

Y Improve services by making referrals to skilled pro-viders, and offering IUDs through mobile units andcenters of excellence.

Y Review evidence-based guidelines (e.g., menses re-quirements, follow-up visits, side effect management,and number of visits required), then reinforce them toencourage changes in provider behavior.

Y Focus more on client concerns through better coun-seling and management of side effects, listening re-spectfully to clients, and addressing myths and fears.

4.3. Updating and disseminating information

Y Provide updated information to journalists, women’shealth advocates, and internet information specialists.

Y Create a task force to identify key positive messagesabout the IUD to share with the lay public. A univer-sal website, sanctioned by experts in the reproductivehealth field, could be established to provide to laymenconsistent, updated information about IUDs.

Y Identify a multicultural, global network of spokesper-sons, preferably satisfied IUD providers and users, toact as a “voice” in support of IUDs.

Y Review the IUD label and package insert. Evidence-based revisions reflecting the safety of contemporaryIUDs are needed to restore the confidence of provid-ers and clients. Media promotion of the IUD could belinked to revision in the package insert and productlabel.

Y Establish an annual IUD conference during whichnew data, positive messages, successes, and sugges-tions for additional research are discussed and sharedwith the media. Establish a Global Society of IUDContraception.

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4.4. Clinical and programmatic research

Clinical research is needed to:

Y Demonstrate the safety of IUD use in nulliparouswomen;

Y Determine whether simple checklists can be used pro-spectively to identify appropriate women for IUD usein settings with a high prevalence of STIs;

Y Demonstrate the safety of IUD use by HIV-infectedwomen, collect more data on the relationship betweenIUD use and viral shedding, and investigate whetherIUD users are at any greater risk than other women ofacquiring HIV; and

Y Investigate whether progestin-releasing IUDs reducethe incidence of PID.

Programmatic research is needed to test interventions tochange provider/client attitudes to IUD use, promote con-dom use among women at high risk of STIs, and removeIUD disincentives to providers in developing countries. It isalso needed to determine the most appropriate counselingfor women considering sterilization, ways to reduce IUDdiscontinuation due to pain and bleeding, and to what extentIUD-related costs affect method acceptability by both cli-ents and providers.

The meeting concluded with a number of participatingagencies, representing the fields of research, policy, com-munications, donors, women’s advocacy and medicine, ex-pressing an interest in further refining and acting upon therecommendations. Additional meetings will be organized toensure that the goal of overcoming IUD use barriers be-comes a reality.

Acknowledgments

The authors wish to acknowledge the following for par-ticipating in the seminar: Kirsi Armanto (USA), RodolfoAviles (El Salvador), Kim Best (USA), Elizabeth Bukusi(Kenya), Ward Cates (USA), Valda Chauncey (USA), Car-mela Cordero (USA), Vanessa Cullins (USA), JacquelineDarroch (USA), Satyaki De (India), Vicente Dıaz Sanchez(Mexico), Nguyen Dinh Loan (Vietnam), Mary Dolan(USA), Laneta Dorflinger (USA), David Grimes (USA),Guadalupe Guillen Dominguez (El Salvador), MichaelHarper (USA), Kamal Hazari (India), Krista House (USA),David Hubacher (USA), Elof Johansson (USA), MichaelKafrissen (USA), Mihira Karra (USA), Katherine La-Guardia (USA), Joanne Luoto (USA), Tapani Luukkainen(Finland), Noel McIntosh (USA), Kirsten Moore (USA),Charles Morrison (USA), Fatma Mrisho (Ethiopia), MelvaFager Okun (USA), Lilian Ramırez (Guatemala), Robert

Rice (USA), Roberto Rivera (USA), Gloria Salazar (Chile),Jim Shelton (USA), Jeffrey Spieler (USA), John Stanback(USA), Betsy Tolley (USA), Lalla Toure (USA), SandraWaldman (USA), Cari Weisberg (USA), and John Wilson(USA).

References

[1] Salazar-Martinez E, Lazcano-Ponce EC, Gonzalez Lira-Lira G, Es-cudero-De los Rios P, Salmeron-Castro J, Hernandez-Avila M. Re-productive factors of ovarian and endometrial cancer risk in a highfertility population in Mexico. Cancer Res 1999;59:3658–62.

[2] Sturgeon SR, Brinton LA, Berman ML, et al. Intrauterine device useand endometrial cancer risk. Int J Epidemiol 1997;26:496–500.

[3] Hill DA, Weiss NS, Voigt LF, Beresford SA. Endometrial cancer inrelation to intra-uterine device use. Int J Cancer 1997;70:278–81.

[4] Rosenblatt KA, Thomas DB. Intrauterine devices and endometrialcancer. The WHO Collaborative Study of Neoplasia and SteroidContraceptives. Contraception 1996;54:329–32.

[5] Parazzini F, La Vecchia C, Moroni S. Intrauterine device use and riskof endometrial cancer. Br J Cancer 1994;70:672–3.

[6] Castellsague X, Thompson WD, Dubrow R. Intra-uterine contracep-tion and the risk of endometrial cancer. Int J Cancer 1993;54:911–6.

[7] Shu XO, Brinton LA, Zheng W, Gao YT, Fan J, Fraumeni JF. Apopulation-based case-control study of endometrial cancer in Shang-hai, China. Int J Cancer 1991;49:38–43.

[8] Sivin I, Stern J. Health during prolonged use of levonorgestrel 20�g/d and the Copper TCu 380 Ag intrauterine contraceptive devices:a multicenter study. Fertil Steril 1994;61:70–7.

[9] Gardner FJ, Konje JC, Abrams KR, et al. Endometrial protectionfrom tamoxifen-stimulated changes by a levonorgestrel-releasing in-trauterine system: a randomized controlled trial. Lancet 2000;356:1698–9.

[10] Grimes DA. Intrauterine devices and infertility: sifting through theevidence. Lancet 2001;7358:6–7.

[11] World Health Organization. Improving access to quality care infamily planning: medical eligibility criteria for contraceptive use. 2nded. Geneva: World Health Organization, 2000. p. 1.

[12] Hubacher D, Lara-Ricalde R, Taylor DJ, Guerra-Infante F, Guzman-Rodriguez R. Use of copper intrauterine devices and the risk of tubalinfertility among nulligravid women. N Engl J Med 2001;345:561–7.

[13] World Health Organization. Improving access to quality care infamily planning: medical eligibility criteria for contraceptive use. 2nded. Geneva: World Health Organization, 2000. p. 9.

[14] Morrison CS, Sekadde-Kigondu C, Sinei SK, Weiner DH, Kwok C,Kokonya D. Is the intrauterine device appropriate contraception forHIV-1-infected women? Brit J Obstet Gynecol 2001;108:784–90.

[15] Trussell J, Leveque JA, Koenig JD, et al. The economic value ofcontraception: a comparison of 15 methods. Am J Public Health1995;85:494–503.

[16] Kooiker CH, Scutchfield FD. Barriers to prescribing the copper T380A intrauterine device by physicians. West J Med 1990;153:279–82.

[17] World Health Organization. World Health Day. Safe Motherhood.Prevent Unwanted Pregnancy. Online. Available at: http://www.who.into/archives/whday/en/pages1998/whd98_09.html.

[18] Pariani S, Heer DM, Van Arsdol MD. Does choice make a differenceto contraceptive use? Evidence from East Java. Stud Fam Plann1991;22:384–90.

388 R. Rivera, K. Best / Contraception 65 (2002) 385–388