Low risk of infection from IUD use shown
Do concerns about infection post-insertion of intrauterine devices (IUDs) lead your clinic to use prophylactic antibiotics prior to insertion, or perhaps even dampen use of the reversible contraceptive altogether?
Findings from a large multi-center U.S. study might lead to a better appreciation for the birth control method.1 Study results show that for women who are screened for infection risks, the risks remain low following IUD insertion, regardless of whether prophylactic antibiotics are administered.
Today's IUDs are extremely safe, and infection is almost unseen, says David Grimes, MD, vice president of medical affairs at Family Health International in Research Triangle Park, NC. Because IUDs offer such a high level of safety, the use of prophylactic antibiotics appears unwarranted, observes Grimes, one of the study's investigators.
Opinions have varied concerning use of prophylactic antibiotics. Since the risk of infection attributable to IUDs lasts only a few weeks following insertion,2,3 some have argued that antibiotics would reduce such risks.
Two previous studies didn't resolve this question. In a randomized trial in Nairobi, Kenya, pelvic inflammatory disease (PID) rates for the first month after IUD insertion were 1.3% for women who received doxycycline vs. 1.9% for those who received a placebo.4 A similar study in Ibadan, Nigeria, found no benefit of doxycycline.5
The findings from the Kenyan study led manufacturers in the United States to mention prophylactic antibiotics in their package labeling, although it was unclear whether the findings would apply to American women, Grimes says. The National Institute of Child Health and Human Development in Bethesda, MD, provided funding for the U.S. trial to assess the value of antibiotic use in this population.
Pilot study aided design
A pilot study conducted before the full-scale trial proved beneficial in overall operation of the study, says lead author Terri Walsh, MPH, research manager with the California Family Health Council in Los Angeles. Through the pilot study, investigators determined that azithromycin, a newer antibiotic, would serve as a more appropriate prophylactic than doxycycline. The early study also served to establish ongoing working relationships with the 11 Los Angeles County clinics involved in the full- scale trial.
More than 300 clinicians carried out IUD insertions or provided follow-up for study participants. Clinicians assessed risk of sexually transmitted infection through women's self-reported medical histories, and all women were screened for cervical infections from chlamydia and gonorrhea. A total of 1,985 participants were randomly assigned to receive two 250 mg capsules of azithromycin or two placebo capsules before insertion of a Copper T 380A IUD.
A total of 1,867 women received an IUD following treatment assignment; 118 women did not participate because they changed their minds or contraindications were identified before insertion. Of the remaining 94%, 933 received azithromycin, and 934 received a placebo. At least 90 days of follow-up information was maintained for about 98% of both groups.
Investigators set the primary outcome measure as removal of the IUD for any reason other than partial spontaneous expulsion within 90 days of insertion. The secondary outcome measure was use of medical services, defined as unscheduled clinic visits as well as gynecological complaints received during follow-up visits that would have necessitated care.
At 90 days, 92.7% of women who received the antibiotic and 93.2% of those who took placebo capsules still had their IUD in place. Only one woman in each assignment group had salpingitis (inflammation of one or both fallopian tubes) that met the study's diagnostic criteria. The rate of IUD removal for any reason other than partial expulsion was 3.8% in the antibiotic group and 3.4% in the placebo group.
Participants in the two groups sought medical attention for gynecological complaints with the same degree of frequency: 38 visits per 100 participants during the first 90 days post-insertion. The most frequent complaints were concerns about IUD position and symptoms of lower genital tract infection. Providers found clinically significant disorders at 47% of visits by women in the antibiotic group and 42% of visits by women in the placebo group.
Good continuation rates
When study enrollment began in August 1992, investigators knew they would encounter a cautious environment for IUD use, Walsh says. With results of the study now in, perhaps providers will re-evaluate their position on the contraceptive device.
Researchers found that about 80% of women still had their IUDs at one year, she notes. With this level of method satisfaction, perhaps the trend will begin to reverse in IUD usage.
"The IUD is extremely effective, indeed almost effective as tubal sterilization, and a good bit cheaper and safer," Grimes says. "The IUD has suffered some bad press in this country. This will hopefully be a step in the right direction." (For more on the renaissance of the IUD, see Contra cep tive Technology Update, February 1998, p. 17. For more on IUDs and HIV-1-infected women, see OB/GYN Update, enclosed in this issue.)
References
1. Walsh T, Grimes D, Frezieres R, et al. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Lancet 1998; 351:1,005-1,008.
2. Farley TM, Rosenberg MJ, Rowe PJ, et al. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 1992; 339:785-788.
3. Lee NC, Rubin GL, Ory HW, et al. Type of intrauterine device and the risk of pelvic inflammatory disease. Obstet Gynecol 1983; 62:1-6.
4. Sinei SK, Schulz KF, Lamptey PR, et al. Preventing IUD-related pelvic infection: the efficacy of prophylactic doxycycline at insertion. Br J Obstet Gynaecol 1990; 97:412-419.
5. Ladipo OA, Farr G, Otolorin E, et al. Prevention of IUD-related pelvic infection: the efficacy of prophylactic doxycycline at IUD insertion. Adv Contracept 1991; 7:43-54.
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