Prevention of IUD-related pelvic infection: the efficacy of prophylactic doxycycline at IUD insertion. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Effect of prophylactic antibiotics on morbidity associated with IUD insertion: results of a pilot randomized controlled trial. IUD Study Group. Prophylactic antibiotics for suction curettage abortion: results of a clinical controlled trial. Preventing IUCD-related pelvic infection: the efficacy of prophylactic doxycycline at insertion. Pelvic inflammatory disease and intrauterine devices: prophylactic antibiotics to reduce febrile complications. A prospective, double-blind, placebo-controlled trial of a single dose of azithromycin on postoperative wound infections in plastic surgery. A randomized clinical trial of prophylaxis for vacuum abortion: 3 versus 7 days of doxycycline. Prophylaxis with doxycycline (Vibramycin) in colorectal surgery.
It is believed that much of the small increased risk for developing pelvic inflammatory disease (PID) associated with the use of an intrauterine device (IUD) appears to be caused by bacterial contamination of the endometrial cavity at the time of insertion. Previous research suggests that use of prophylactic antibiotics immediately prior to IUD insertion may reduce the risk of developing PID. This paper presents results from a randomized clinical trial of 1485 women in Ibadan, Nigeria evaluating the effectiveness of 200 mg of doxycycline (versus placebo) given orally at the time of IUD insertion in reducing the incidence of PID during the first three months of IUD use. Rate of PID infection in the doxycycline-treated group was not significantly lower than that in the placebo-treated group. The rate of unscheduled IUD-related visits to the clinic also was not significantly lower among the doxycycline-treated group. However, the incidence of PID was low (21 cases) for both study groups. Aseptic conditions during IUD insertion, follow-up visits with short intervals to monitor health, and treatment of opportunistic infections may have reduced the potential of PID within this population. The value of antibiotic prophylaxis before insertion of an intrauterine device (IUD) remains uncertain. We undertook a triple-masked, randomised, placebo-controlled trial to find out whether such prophylaxis reduces the rate of IUD removal within 90 days.
                11 clinic sites in southern California enrolled women who requested IUD insertion and were at low risk of sexually transmitted infection according to self-reported medical history. We randomly assigned 1985 participants either 500 mg azithromycin or placebo capsules of identical appearance taken about 1 h before insertion of a Copper T 380A IUD. 118 women did not have an IUD inserted. We followed up 1833 of the remaining 1867 (98%) participants for at least 90 days after insertion.
                The rate of IUD removal for any reason other than partial expulsion was 3.8% (35/918) in the antibiotic group and 3.4% (31/915) in the placebo group (relative risk 1.1 [95% CI 0.7-1.8]). The two treatment groups sought medical attention with equal frequency (mean 38 visits per 100 women). During the 90 days after IUD insertion, only one woman from each assignment group had salpingitis, as defined by established criteria.
                Prophylaxis with azithromycin did not affect the likelihood that a woman would retain her IUD at 90 days or the frequency of postinsertion medical attention. In appropriately screened women, the risk of upper-genital-tract infection is negligible after IUD insertion, with or without the administration of prophylactic antibiotics. The efficacy of administering an antibiotic prior to IUD insertion to reduce the risk of introducing an upper genital tract infection during the procedure has not yet been established. Two double-blind randomized studies conducted in Africa comparing a 200 mg prophylactic dose of doxycycline with a placebo did not conclusively identify a reduced risk of post-insertion pelvic inflammatory disease (PID). A clinical trial of comparable design is currently under way in the US. This multi-site trial will evaluate whether use of an antibiotic prior to insertion reduces the risk of IUD removal for all medical reasons, including upper genital tract infection, within the first three months after insertion. This paper reports on the pilot phase of this study, which was designed to test the protocols and data collection instruments in advance of the full-scale clinical trial. A total of 447 prospective IUD (TCu-380A) users were randomly assigned to receive either a 200 mg dose of doxycycline or a placebo one hour before IUD insertion. 3.6% (8/219) of participants who received the antibiotic had the device removed for medical reasons (infection, bleeding, cramping, etc.) within three months post-insertion compared to 4.5% (10/223) of participants who received the placebo. This reduction in the removal rate was not statistically significant given the limited size of the pilot study (RR = 0.81; 95% CI 0.28-2.29). Only two subjects, one from each treatment group, met the diagnostic criteria for acute PID. The overall three-month retention rate was 91.8% for the antibiotic group and 89.7% for the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS) The prophylactic use of 300 mg doxycycline at the time of an abortion was evaluated in a randomized controlled trial. In the group with negative chlamydia screening results, only two (0.4%) of 502 patients who received prophylactic treatment developed pelvic infection, compared with 15 (3.0%) of 497 patients who received placebos (p = 0.001). The same effectiveness was found in women with positive chlamydia screening results. Vomiting was the major side effect of the medication and could limit its use. A simulation of selective prophylaxis in women with negative chlamydia screening results showed that its selective use in patients with a history of gonorrhea or in nulliparous women with multiple sex partners could be nearly two thirds as effective as general prophylaxis. Most of the small increased risk in pelvic inflammatory disease (PID) associated with the intrauterine contraceptive device (IUCD) appears to be caused by bacterial contamination of the endometrial cavity at the time of insertion. This randomized clinical trial of 1813 women in Nairobi, Kenya, assessed the effectiveness of 200 mg of doxycycline given orally at the time of insertion in reducing the occurrence of PID. The rate of this infection in the doxycycline-treated group was 31% lower than that in the placebo-treated group (1.3 and 1.9%, respectively; RR 0.69; 95% CI 0.32 to 1.5). The rate of an unplanned IUCD-related visit to the clinic was also 31% lower in the doxycycline-treated group (RR 0.69; 95% CI 0.52 to 0.91). Although the significance level (P = 0.17) for the reduction is PID does not meet the conventional standard of 0.05, the results may be suggestive of an effect. Moreover, the reduction in IUCD-related visits (P = 0.004) not only represents an important decrease in morbidity but also substantiates the reduction found for PID. Further studies are needed to corroborate these results. Consideration should be given to the prophylactic use of doxycycline at the time of IUCD insertion as an approach to preventing PID and other IUCD-related morbidity. In the present study, we tried to determine whether IUD insertion related PID and febrile complications could be prevented by prophylactic use of antibiotics. We studied 300 patients who were admitted to our family planning clinic for IUD contraception. Of these, 150 patients received prophylactic Doxycycline (group 1) and the second 150 received no therapy (group 2). Five cases experienced fever with or without leucocytosis and none required hospitalization. PID was observed in one woman in each group. Positive culture (gonorrhea) was obtained in one woman who was then treated by relevant antibiotics; the other woman required hospitalization for two days. The overall infection rates for group 1 and 2 were 2.1% and 2.9%, respectively and this difference was not significant. The incidence of PID infection and febrile complications was found to be very low for both groups when compared to other studies, suggesting that aseptic conditions with proper insertion reduce the risk of infection. Over a 9-month period from September of 1991 to May of 1992, 339 patients were included in a randomized, double-blind, placebo-controlled study using azithromycin as the prophylactic agent to determine whether it effects a clinically meaningful reduction in postoperative surgical infections in plastic surgery. Azithromycin was given as prophylaxis in 171 patients and placebo in 168 patients. The study medication was a single oral dose taken at 8 P.M. the day before surgery. The patients were followed up for a minimum of 4 weeks after surgery. The patients who received wound infection prophylaxis had 5.1 percent infections compared with 20.5 percent in the placebo group (p = 0.00009). Eighty percent of all wound infections were first seen after discharge, explaining why plastic surgeons might overlook their infectious complications. There was a significant reduction in postoperative complications (p = 0.04) and in the additional use of antibiotics postoperatively (p = 0.007) in the prophylaxis group. Subgroup analysis showed a significant reduction in surgical infections in breast surgery (p < 0.05) and reconstructive surgery with flaps (p < 0.05). No effect of the prophylactic regime was demonstrated in patients undergoing secondary surgery for cleft lip and palate disease. To estimate prospectively whether reducing oral doxycycline prophylaxis from 7 to 3 days increases the incidence of endometritis after elective first-trimester vacuum abortion.
                We randomized 800 women requesting first-trimester abortion to two study groups: 1) 100 mg of doxycycline administered orally twice a day for 7 days or 2) 100 mg of doxycycline orally twice a day for 3 days followed by an oral placebo twice daily for the last 4 days. Doxycycline was prescribed immediately after surgery.
                There were no statistically significant differences in age, race, gravidity, parity, number of previous abortions, current gestational age, and history of previous pelvic infection, chlamydia, or intrauterine device use. Women in the doxycycline plus placebo group were more likely to have had a history of gonorrhea (3.3% versus 0.8%, P =.42) or chlamydia (7.0% versus 4.3%, P =.18). The 66.3% of enrollees returning for 2-week examinations were distributed similarly between study groups and were similarly compliant in self-reported pill taking (mean 97.5%). The study groups did not differ in the incidence of postoperative symptoms or examination findings suggesting infection. One patient in the doxycycline-only group developed endometritis and was treated as an outpatient.
                Shortening oral doxycycline prophylaxis from 7 to 3 days had no adverse effect on the incidence of postabortion infection. A prospective randomized double-blind study comprising 118 patients was performed to evaluate the effects of doxycycline as a prophylactic antimicrobial in elective colonic surgery. Fifty-eight patients were treated and 60 were controls. 200 mg of active substance or placebo was given 4-6 hours before operation and 100 mg daily for the next five postoperative days. Levels of doxycycline in serum and tissues were determined and related to the MIC-values of the contaminants. A significantly lower incidence of abdominal wound sepsis, intra-abdominal complications and septicaemia was found in the doxycycline group (12.4%) compared to the controls (45%). The positive effects were most pronounced in the non-contaminated cases, and especially in the cases with negative wound culture at operation. In order to evaluate the effect of prophylaxis in clinical routine an open study comprising 182 patients was carried out. In the group of patients receiving adequate prophylaxis (159 patients) the abdominal wound sepsis rate was 8.1%. 11 other patients who had received doxycycline preoperatively for some time because of intra-abdominal infection developed wound sepsis in 63.4%. In 12 patients where incomplete or no prophylaxis was given, the wound sepsis rate was 33.2%. The frequency of abdominal septic complications did not differ between non-contaminated, 10.9%, and contaminated operations, 13.8%, partly because of the topical application of ampicillin in some of the patients belonging to the latter category. Preoperative treatment with doxycycline because of some intra-abdominal was evidently the single risk factor associated with a high septic complication rate. No adverse ecological effects were seen during the 19 months study.
Use of either doxycycline 200 mg or azithromycin 500 mg by mouth before IUD insertion confers little benefit. While the reduction in unscheduled visits to the provider was marginally significant, the cost-effectiveness of routine prophylaxis remains questionable. A uniform finding in these trials was the low risk of IUD-associated infection, with or without use of antibiotic prophylaxis.