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Biomedical subjects

C B Champion

Publications and source records attributed to C B Champion.

13 recordsLinked to original sources

Prevention of IUD-related pelvic infection: the efficacy of prophylactic doxycycline at IUD insertion.

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.

Administration, Oral↗

A comparative clinical trial of the TCu 380A, Lippes Loop D and Multiload Cu 375 IUDs in Indonesia.

The Copper T 380A (TCu 380A), Lippes Loop D (LLD) and the Multiload Cu 375 (MLCu 375) IUDs were evaluated for safety and efficacy in a multicenter randomized clinical trial in Indonesia. A total of 2992 women were enrolled into the study and data for 2845 women were analyzed (147 cases did not meet protocol criteria). Although study IUDs were randomly assigned, LLD users in this study were older and of higher parity than TCu 380A and MLCu 375 users. The 24-month gross cumulative life-table pregnancy rates for TCu 380A, LLD and MLCu 375 users were 1.2, 2.2 and 2.7, respectively. The 24-month expulsion rates for TCu 380A, LLD and MLCu 375 users were 6.7, 7.5 and 5.3, respectively. Overall, 24-month continuation rates were 85.5%, 85.0% and 85.4% for the respective device groups. Differences in both gross and age- and parity-adjusted life-tables rates for the major outcome variables were not statistically significant at 24 months postinsertion. The study suggests that the TCu 380A, LLD and MLCu 375 IUDs seem to be safe and effective contraceptive options for Indonesian women.

Adolescent↗

Insertional pain and other IUD insertion-related rare events for breastfeeding and non-breastfeeding women--a decade's experience in developing countries.

The possible effect of breastfeeding on intrauterine device (IUD) insertion events was investigated. Analysis included a total of 6493 women who enrolled in multicenter IUD clinical trials over a ten-year period. Findings indicate that breastfeeding exerts a protective effect on the incidence of moderate to severe insertional pain and reduces the need for cervical dilatation to facilitate insertion. The pain protection effect was most evident in breastfeeding women who were still in lactational amenorrhea. Subjects with amenorrhea, both breastfeeding and non-breastfeeding, had a significantly lower incidence of pain at IUD insertion than the corresponding menstruating subjects. This effect may be related to a higher secretion of beta-endorphin in the breastfeeding and lactational amenorrheic subjects.

Breast Feeding↗

Performance of the copper T-380A intrauterine device in breastfeeding women.

The effect of breastfeeding on performance of the TCu-380A IUD was evaluated using data derived from multicenter clinical trials. Insertion events for breastfeeding women (N = 559) and non-breastfeeding women (N = 590) were compared as well as discontinuations of IUD use through six months following insertion. Results indicate that breastfeeding women inserted with a TCu-380A are more likely than non-breastfeeding women to have a smooth, pain-free insertion, few postinsertion bleeding and pain problems, and a high rate of continuation of IUD use. There were no uterine perforations reported from either group of women.

Adult↗

A 3-year evaluation of the TCu380Ag and the Cu-7.

The TCu380Ag and the Cu-7 intrauterine devices (IUDs) were evaluated in a randomized comparative clinical trial. A total of 198 women who had not recently been pregnant entered the trial in Manila, Philippines and were followed-up through 3 years postinsertion. The 36-month follow-up rates were impressively high at 80.3 for TCu 380A users and 76.7 for users of the Cu-7. Although the two IUDs demonstrated statistically similar termination rates, the findings suggest a higher efficacy for the TCu380Ag. Gross cumulative life-table pregnancy rates were 0.0 and 4.5 for the TCu380Ag and Cu-7, respectively, at 3 years. Overall 3-year continuation rates were 74.3 and 64.9 for users of the respective devices.

Actuarial Analysis↗

A three-year evaluation of TCu 380 Ag and multiload Cu 375 intrauterine devices.

A randomized, comparative, multicenter clinical trial of TCu 380Ag and Multiload Cu 375 intrauterine devices (IUDs) was conducted. Safety and acceptability were evaluated through three years following insertion in 884 patients. The two IUDs were similar with respect to all event rates. Thirty-six month life table pregnancy rates were 0.6 per 100 TCu 380Ag users and 1.8 per 100 Multiload Cu 375 users. Continuation rates were 67.4 and 61.4 per 100 users of the respective devices at three years after insertion.

Adolescent↗

Cervical dilatation in interval insertion of an IUD. Who requires it and does it lead to a high expulsion rate?

Cervical dilatation is occasionally performed to facilitate IUD insertions in difficult-to-insert cases. Patient characteristics associated with the need for dilation and whether dilation is associated with an increased risk of early expulsion of the IUD have rarely been studied. This analysis, using the extensive international IUD data base developed and maintained by Family Health International, is intended to answer these questions. This case-control analysis revealed that nulliparous women as well as women who had used oral contraceptives or an IUD in the previous month were more likely to require cervical dilatation at IUD insertion. Breastfeeding women, on the other hand, were less likely to require cervical dilatation to facilitate IUD insertion. Hypotheses are generated from this analysis that need to be tested in future studies. The six- and 12-month gross cumulative life-table expulsion rates and other pertinent termination event rates (e.g., accidental pregnancies and removals due to bleeding and pain) were not found to be higher for women with cervical dilatation than for women without.

Age Factors↗

Pregnancy following minilaparotomy tubal sterilization--an update of an international data set.

Seventeen pregnancies were reported from an international tubal sterilization data set comprising 1,862 minilaparotomy cases between 1978 and 1984. Of these 17, seven (41.2%) were diagnosed as luteal phase pregnancies. Of the 10 pregnancies due to sterilization failure, one was an ectopic pregnancy which occurred much later (20 months poststerilization) than the intrauterine pregnancies (10 months or less). Poststerilization pregnancy risk was greater among gravid women (those undergoing sterilization at the time of abortion or soon after childbirth) than among non-gravid women (those undergoing interval sterilization). These findings are, in general, consistent with those of previous studies using a much larger data set of primarily laparoscopic sterilizations. Pregnancies occurred with every type of mechanical tubal occlusion techniques included for study (the tubal ring, the Rocket Clip, the Secuclip and the Filshie Clip), and a frequently reported reason for failure was incorrect placement of the device. No pregnancies occurred in women sterilized with the non-mechanical Pomeroy/modified Pomeroy techniques. Findings of this analysis suggest that in minilaparotomy sterilization, for the mechanical tubal occlusion techniques to be as effective as the Pomeroy/modified Pomeroy techniques, more care and skill are required for the operator.

Adult↗

Technical failures in female sterilization using the tubal ring: a case-control analysis.

To delineate characteristics of women predisposing to sterilization technical failures, we performed an analysis of 20 technical failures that occurred during tubal ring procedures and 80 control ring procedures matched on planned surgical approach and study site. None of the women had recently been pregnant (interval procedures). The odds ratios (ORs) were elevated for women wearing an IUD in the three months prior to sterilization (OR = 5.0, 90% confidence interval [CI] 2.2, 11.2) and for women with a history of spontaneous abortion (OR = 4.3, 90% CI 1.8, 9.8). A history of pelvic inflammatory disease (PID) and/or current evidence of PID was strongly associated with technical failure (X2 = 25.0, p less than 0.001). The combined effect of any two of these three factors increased the risk synergistically. We examined these factors prospectively and confirmed the elevated risks (relative risk [RR] = 5.0, 5.5 and 22.7 for recent IUD wearing, spontaneous abortion history and history/evidence of PID, respectively). The prospective analysis also found that previous abdominal surgery is associated with technical failure (RR = 6.7).

Abdomen↗

A study of delta intrauterine devices in Ankara, Turkey.

Delta devices, modifications of standard Lippes Loop D and TCu 220C IUDs, were designed for postpartum insertion. A study of the Delta T and the Delta Loop was conducted at Hacettepe University School of Medicine in Ankara, Turkey. The IUDs were randomly allocated to 246 immediately postpartum women (less than 10 min postplacenta). Twelve-month expulsion rates were low for both devices; 3.7 for Delta Loop users and 7.6 for Delta T users.

Female↗

A comparative study of topical anesthesia for laparoscopic sterilization with the use of the tubal ring.

A study of 300 women undergoing sterilization via standard or open laparoscopy was conducted at Siriraj Hospital in Bangkok, Thailand; one aspect of the study was designed to determine whether application of topical anesthesia to the fallopian tubes reduces the degree of pain experienced by the patient. The use or nonuse of topical anesthesia was randomized for all cases. Overall, data from this study indicate that application of topical anesthesia to the fallopian tubes tends to diminish surgical pain of patients sterilized by use of either the standard laparoscopy or the open laparoscopy approach and that pain in the recovery period is also reduced for open laparoscopy patients.

Administration, Topical↗

IUDs and PID: a comparative trial of strings versus stringless devices.

An international multicentered clinical trial was designed to determine the possible role of intrauterine device (IUD) marker strings in the etiology of pelvic inflammatory disease (PID). A total of 1265 women were admitted and randomly allocated to receive either a standard TCu200 IUD or a TCu200 IUD without marker strings. These patients were followed-up through 12 months postinsertion. No statistically significant differences were found between the two groups of IUD users with respect to the incidence of PID or other types of infection or inflammation. The 12-month life table termination rates and overall continuation rates were also similar for users of the respective devices, with the exception of removal rates for bleeding/pain, which were significantly higher in the strings group than in the stringless group. However, the number of bleeding/pain complaints ever reported during the study were not statistically different in the two study groups. The study results indicate that the IUD string does not play an important role in the etiology of PID associated with the use of IUDs.

Adult↗