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A comparative clinical trial of Copper T 220 C and Alza T IPCS 52 intrauterine devices in Thai women.

Two IUDs (Copper T 220 C and Alza T IPCS 52) were comparatively studied by randomized insertions in 200 Thai women who attended the Family Planning Clinic at the Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University. Point estimates of the pregnancy rate and rate of removal for bleeding and pain at 18 months were lower for the copper device than for the Alza T IPCS 52, but neither these nor any other pertinent event rates reached statistical significance. Study of the Alza device was halted before the completion of 2 years because reports from other centres indicated an unacceptable pregnancy rate beyond 2 years.

Adolescent↗

Menstrual blood loss, haemoglobin and ferritin concentration of Beijing women wearing steel ring, VCu 200, and TCu 220c IUDs.

Menstrual blood loss (MBL), serum ferritin and whole blood cyanmethemoglobin were measured at pre- and 1, 3, 6, 12, 18 and 24th postinsertion cycles in 60 women wearing the Steel Ring, the Copper V (VCu 200) or the Copper T (TCu 220c). The MBL, incidence of menorrhagia and iron deficiency anemia were lower among users of the Steel Ring than among users of the Copper V and T. Anemia occurred later and the duration of menstruation was shorter with the Steel Ring than with the Copper T. There were no statistically significant differences between the Copper V and T.

Anemia↗

The use of vaginal ultrasound to identify copper T IUDs at high risk of expulsion.

A total of 235 women who had a TCu 380A IUD inserted had a vaginal ultrasound scan performed to identify if the IUDs were correctly placed in the uterine fundus. Women identified as having a misplaced IUD had it removed. The remaining women were compared to 201 women who had an IUD inserted and had no ultrasound evaluation, matched by age and parity. Women were followed-up for one year. Gross cumulative discontinuation rates and continuation rates were calculated by life table analysis. Comparison between groups was done by the Gehan test. The study group had 34 IUDs removed because they were misplaced according to the established criteria. The expulsion rate was significantly higher in the control group, also influencing the continuation rate which was lower in the same group. Of the 34 women who had their IUD removed because it was not correctly placed, only 22 requested and had another IUD inserted. The removal of IUD determined by an ultrasound to be incorrectly placed significantly decreased expulsion rates. However, many IUDs may have been removed unnecessarily, probably resulting in many women not returning to the clinic or deciding to use another contraceptive method.

Adult↗

Multicenter, double-blind, comparative clinical study on the efficacy and acceptability of a monthly injectable contraceptive combination of 150 mg dihydroxyprogesterone acetophenide and 10 mg estradiol enanthate compared to a monthly injectable contraceptive combination of 90 mg dihydroxyprogesterone acetophenide and 6 mg estradiol enanthate.

Healthy, regularly menstruating women, aged 14-38 years, were enrolled in a comparative, double-blind, phase III, clinical trial to evaluate the contraceptive efficacy and acceptability of a combination of 90 mg dihydroxyprogesterone acetophenide with 6 mg estradiol enanthate compared to the commercially available contraceptive combination of 150 mg dihydroxyprogesterone acetophenide with 10 mg estradiol enanthate. Subjects received the contraceptive combination intramuscularly, between the 7th and 10th day of each menstrual cycle, during 12 consecutive menstrual cycles. Approximately 60% of the subjects in both groups completed the study. Principal reasons for discontinuation were personal, nonmedical reasons. Principal medical reasons for discontinuation were menstrual-related, irregular bleeding being the most frequent. Differences in menstrual patterns between the two groups did not lead to differences in discontinuation rates. Three contraceptive failures occurred during the trial, one in Group A (90/6 mg) and two in Group B (150/10 mg), indicating that the lower dose formulation is at least as efficient as the higher dose.

Adolescent↗

Introductory study of the once-a-month, injectable contraceptive Cyclofem in Brazil, Chile, Colombia, and Peru.

An introductory trial with the injectable contraceptive Cyclofem was carried out in Brazil, Chile, Colombia, and Peru, with participation by 3,183 women. Women were followed-up for up to 2 years of use and the data were evaluated by life table analysis. A total of 29,676 women-months were accumulated for up to 2 years. No pregnancies were observed in the 2 years. The discontinuation rates for amenorrhea in the first year ranged from 3.4 in Brazil to 8.1 in Colombia, and for menstrual disturbances from 5.1 in Chile to 9.2 in Brazil. The discontinuation rates for other medical reasons ranged from 7.8 in Brazil to 26.3 in Colombia, and for personal reasons from 17.2 in Chile to 23.5 in Brazil. Continuation rates ranged from 42.3 in Colombia to 52 in Chile. In the second year of observation the rates of discontinuation were lower than those observed in the first year, with the exception of personal reasons in Brazil, which were the same as those observed in the first year. Continuation rates ranged from 19.4 in Brazil to 36.8 in Chile. The comparison of reasons for discontinuation in selected clinics showed that the rate for amenorrhea in one clinic in Chile was more than three times that in others and in Peru was seven times more in one clinic than in another. Regarding menstrual disturbances, in Peru one clinic presented a rate three times higher than the others. The main reasons for discontinuation due to other medical reasons were headache and weight gain. In conclusion, Cyclofem presented a high contraceptive efficacy and an acceptable rate of continuation and discontinuation for up to 2 years in the four countries.

Adult↗

Norplant consensus statement and background review.

This review has highlighted the attributes of a very important new method of contraception. The signatories to this document agree that, with the provision of appropriate information and instruction for the user, Norplant is a good contraceptive choice to be made available worldwide in family planning programs that have the resources for appropriate training and counseling. The signatories to this document are acting in their own personal capacity and not as representatives of any particular organization.

Contraceptive Agents, Female↗

Continuation rates of long-acting methods of contraception. A comparative study of Norplant implants and intrauterine devices.

Following adverse widespread publicity in the United Kingdom and the United States, it is commonly believed that discontinuation rates for the contraceptive implants Norplant in the UK are high. We have compared discontinuation rates between new intrauterine device (IUD) users (253 women) and new Norplant implant users (502 women) over 33 months following the introduction of Norplant implants among a population of women attending the same clinic and counseled in the same manner by the same group of providers. Women choosing the IUD were slightly older and were more likely to be changing their contraceptive method because of dissatisfaction with their current method. Nor plant implant users were more likely to have completed their families. Continuation rates for Norplant implants were significantly higher than for IUD at 12, 18, and 24 months after insertion. At 24 months, continuation rates for Norplant implants were 72% compared with rates of 55% for IUD users. Higher continuation rates may be related more to factors associated with the providers than with the users of these two long-acting methods.

Adult↗

Depressive symptoms and Norplant contraceptive implants.

Women enrolled in a multicenter prospective study were evaluated to identify any possible relationship between depressive symptoms and the use of contraceptive implants. Women choosing Norplant implants (n = 910) were evaluated before starting this contraceptive and were reinterviewed at 6 months and 2 years. Women who continued the method had lower depressive symptom scores before initiating Norplant implants than did the women who discontinued the method or who were lost to follow up. Among the continuing Norplant implant users, the mean scores were similar before starting Norplant and at 6 months (7.9 vs 7.7). The strongest overall predictor of the depressive symptom score was relationship satisfaction. At 24 months, the subgroup of continuing users with decreased relationship satisfaction had an increase in depressive symptom score, but those with stable or improved relationships had stable depressive symptom scores. The subjects with the highest (i.e., worst) scores at enrollment demonstrated improved scores during follow-up. These results are reassuring for women who are concerned that Norplant use may adversely affect their mood.

Adolescent↗

Depressive symptoms and Depo-Provera.

Women enrolled in a multicenter prospective study were evaluated to identify any possible relationship between depressive symptoms and the use of contraceptives. Women choosing Depo-Provera (n = 495) were evaluated before starting these contraceptives and were reinterviewed 1 year later. Women who continued the method had lower depressive symptom scores at baseline than did the women who discontinued the method or who were lost to follow-up. Among the continuing Depo-Provera users, the depressive symptom scores improved slightly at 1 year (7.4 vs 6.7). Those subjects with the highest (i.e., worst) scores at enrollment demonstrated improved scores at follow-up.

Adolescent↗

The comparative trial of TCu 380A IUD and progesterone-releasing vaginal ring used by lactating women.

The objective of this paper was to compare the efficacy, acceptability, safety, and bleeding pattern of TCu 380A intrauterine device (IUD) and progesterone-releasing vaginal ring used by breastfeeding women. The study population included 97 breastfeeding women using IUD and 100 women using vaginal ring. Of the IUD users, no insertion failure, perforation, or accidental pregnancy occurred in 12 months. There was one IUD expulsion. There were no discontinuations of IUD due to medical reasons other than expulsion. The total discontinuation rate was 2.3%. In the ring group, no accidental pregnancy occurred. The major reasons for discontinuation were ring use-related problems and vaginal problems. The total discontinuation rate was 65.4% within 1 year. The frequency of any one complaint among the ring users was higher than that among the IUD users. There were no differences in the proportion of women having no sexual activity and in the weight of their babies between the two groups. Compared with the IUD users, the median number of bleeding/spotting (B/S) episodes and B/S days of the vaginal ring users were fewer; consequently, the mean length of B/S-free interval was longer in all four reference periods; the mean length of B/S episode and segment were the same; the occurrence of amenorrhea was more frequent; in contrast, the proportions of normal bleeding patterns were fewer. The frequencies of prolonged bleeding, frequent bleeding, and infrequent bleeding patterns did not differ between the two groups. The percentage of irregular bleeding was fewer only in the first two reference periods. It is concluded that the TCu 380A IUD and progesterone-releasing vaginal ring used by breastfeeding women are safe and effective. The higher discontinuation rate of the ring users was mainly because of use-related problems. Breastfeeding women with TCu 380A IUD had better tolerance and acceptability. The TCu 380A IUD does not, but the progesterone-releasing vaginal ring does, suppress the recovery of ovarian function. However, once return of menstruation occurred, there were no differences in bleeding patterns between the two contraceptive methods.

Administration, Intravaginal↗

Introduction of cyclofem once-a-month injectable contraceptive in Mexico.

A large introductory study of Cyclofem, a once-a-month injectable contraceptive, was conducted in three Mexican provinces. A total of 3457 healthy women participated: 640 women from rural areas (community-based component) and 2817 women from urban and suburban areas (health center-based component). A total of 20,316 women-months of treatment experience were accumulated during a one year period. Cyclofem proved its use-effectiveness (pregnancy rate of 0.03%) and its safety under routine service conditions of family planning facilities in Mexico. The overall life table continuation rate at 1 year was 26.1%. Higher continuation rates were observed in the community-based component (36.6%) as compared to the health center component (23.7%). The most common reason for method discontinuation was change of address. Only 15% of the discontinuations were attributable to the injectable contraceptive method, with the overall 1 year discontinuation rate for bleeding problems (including amenorrhea) was < 11%. These observations underscore the importance of appropriate counseling and follow-up measures, providing convenient access to repeat injections, and other service delivery issues related to continuation of Cyclofem. The results of this trial have once again demonstrated that Cyclofem is a highly effective method with an acceptable side effect profile. In addition, the study provided the elements for its approval by local health authorities and its inclusion into the Ministry of Health Family Planning Program.

Adolescent↗

Reasons for contraceptive discontinuation in women 20-39 years old in New Zealand.

To estimate the frequency and the medical and nonmedical reasons for discontinuation of oral contraceptive (OC), intrauterine device (IUD), and injectable depot medroxyprogesterone acetate (DMPA) use, data from a cohort of experienced contraceptive users in New Zealand are reported. The current analysis consists of 2469 OC, 2072 IUD, and 1721 DMPA users followed over a period of 5 years. The percentage of women who discontinued the use of the method within 24 months after entry into the cohort were 42%, 44%, and 48%, respectively, for OC, IUD, and DMPA; these differences were not statistically significant. The most common reasons given for discontinuing a contraceptive method, regardless of which method was in use, were the desire to conceive, patient preference, no longer needing contraception, and vasectomy. Among the medical reasons, menorrhagia and intermenstrual bleeding were the reasons for discontinuing use of the method in 1.5 and 1.1 times per 100 women-years among DMPA users and in 1.8 and 4.7 times per 100 women-years among OC users. Pelvic pain and infection were reasons for discontinuing contraceptive method, respectively, 4.4 and 4.3 times per 100 women-years among IUD users. In conclusion, the present study confirms, in this New Zealand population, the high discontinuation rate of contraceptive methods reported elsewhere. In contrast with previous suggestions, in this study, irregular bleeding was not an important medical reason for discontinuation of DMPA use.

Adult↗

The LEM device in an immediate postpartum contraception program.

Experience with the LEM intrauterine device in an immediate postpartum program at the Jose Fabella Memorial Hospital, Manila, Philippines, is reported. During a 6-month period, the LEM was inserted in 1359 women immediately after normal term deliveries. The early expulsion rate was high, but removals for bleeding or pain were minimal. Pregnancy rates during the second 6 months of use were higher than those reported previously for postpartum insertions of the LEM device.

Adult↗

Experience with two different medicated intrauterine devices: a comparative study of the Progestasert and Nova-T.

A comparative study of the Progestasert (UPS) and the Nova-T in 326 randomly selected women was carried out. The observation period was 1 year. The over-all continuation rates for the two types of intrauterine devices (IUDs) were similar. The expulsion rate for the Nova-T (9.2%) was considerably higher (P = 0.001) than that for the UPS (1.2%). Medical removals for bleeding/pain were more frequent (P = 0.028) for the UPS (15.4%) as compared with the Nova-T (6.1%). The pregnancy rate for the UPS (Pearl index = 4.8) was insignificantly higher than that for the Nova-T (Pearl index = 2.8). Two of the pregnancies in the UPS group were ectopic. No significant changes in the reactive immunoglobulins (IgA, IgG, or IgM) were observed in either of the groups. Our results indicate that neither of these two IUDs is preferable to the already existing medicated IUDs, such as the Copper T or the Copper 7.

Adult↗

Concentrations of copper in human secretions and weight of the copper wire during the 4 to 7 years after insertion of a Cu-IUD (intrauterine device).

The useful life span of the two most commonly used copper intrauterine devices (Cu-IUDs) (Gravigard and Cu-T) was investigated in a long-term study up to 90 months after insertion. Minor differences between the two types of devices were found that, however, probably do not contribute to a diverging contraceptive efficacy with time. To be able to ensure maximal contraceptive effect, the authors suggest on the basis of the present data that the time of use not exceed 5 to 6 years.

Adolescent↗

The peritoneal reaction to the translocated copper intrauterine device in women and female rats.

The observation of a very severe peritoneal reaction to translocated copper-bearing devices in five women necessitated operative removal. Three Copper-T (Ortho Gyne-T, Ortho, Saunderton, High Wycombe, England) and two Copper-7 (Gravigard, Searle, High Wycombe, England) devices were involved. Similarly severe peritoneal reactions were noted in 90% of female rats who had small-sized modified copper devices inserted into their peritoneal cavities. In a control group of rats with the same device but without a copper wire, mild adhesions were observed in the majority (85%), and none had a severe peritoneal reaction. It seems evident that the severe peritoneal reaction is induced by the copper wire in both women and female rats.

Animals↗

Clinical experience with the GYNE-T 380 postpartum intrauterine device.

OBJECTIVE: The insertion of conventional intrauterine devices (IUDs) during the 1st 10 days after delivery is associated with a high rate of expulsions. DESIGN: The GYNE-T 380 (Ortho Pharmaceutical [Canada] Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no. 2 catgut to the top of the IUD (GYNE-T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the uterine fundus. PATIENTS, PARTICIPANTS: This modified IUD was evaluated in a phase II trial involving 190 women at four clinical sites. MAIN OUTCOME MEASURES: There were no pregnancies during the 1st year of the study. The continuation rate was 74 per 100 women and a life table expulsion rate of 9.6 and 13.3 per 100 women was observed at 6 and 12 months, respectively. RESULTS: Complications associated with the insertion and the use of this IUD were minimal. Large scale trials evaluating this IUD are in progress.

Equipment Design↗