Factors associated with discontinuation rates of the Copper T380A IUD in a Peruvian public hospital

The objectives of this study were to evaluate performance and causes of discontinuation of the Copper T380A IUD by users at the Family Planning Service at Hospital Arzobispo Loayza in Lima, Peru, during a period of three years. The study included 3167 acceptors of the CuT380A attending the service during 1992-1994. IUDs were inserted during interval timing. Follow-up was at 1, 12, 24 and 36 months after insertion. The following events were recorded: number of pregnancies, expulsions and all causes of discontinuation. The cumulative rates per 100 woman-years using the life-table method was calculated. Also calculated were the relative risks for expulsion and for pregnancy. At the end of the study, 361 women had discontinued the method for various reasons, whereas 1667 women continued using the method. The lost-to-follow-up proportion increased over time from 35.9 per 100 woman-years for the first year to 38.2 for the third year. The cumulative discontinuation rate over three years was 22.6±1.3 (cumulative rate±standard error) per 100 woman-years. The cumulative pregnancy rate for three years was 1.2±0.4 per 100 woman-years, whereas the cumulative rate of expulsion was 4.9±0.4 for the first, 6.4 for the second and 6.8 for the third year. The main cause of discontinuation during the first year of use was expulsion (4.9 per 100 woman-years) followed by personal reasons (2.1 per 100 woman-years). At the end of the third year, the main cause was personal reasons (11.4) and the second cause was expulsion (6.8). A higher probability of expulsion, pregnancy and discontinuation for bleeding and/or pain was associated with age less than 20 years. In conclusion, the effectiveness of the CuT380A IUD after three years of use was 98.8 per 100 woman-years, whereas continuation was 39.2, and loss to follow-up increased over time.     

International experience with NORPLANT and NORPLANT-2 contraceptives

Experience encompassing more than 20,000 woman-years of use of NORPLANT capsules and 6,000 woman-years of trials of NORPLANT-2 rods is reviewed. Implant contraception repeatedly has been associated with low pregnancy rates and high continuation rates through five full years of use. Weight has proved to be a factor related to effectiveness. Women weighing less than 50 kg experienced cumulative five-year pregnancy rates well below 1 per 100, whereas the overall cumulative rate has been 3.5 per 100. Medical events reported during use that have led to discontinuation are analyzed from four large data sets.     

TCu 380A IUD: a reversible permanent contraceptive method in women over 35 years of age

OBJECTIVE: The objective of the study was to evaluate the performance of the TCu 380A IUD in women who had been using the device for more than 10 years and who were 35 years of age or more on completion of the 10th year of IUD use. METHODS: A total of 228 women who had an IUD inserted between 1987 and 1992 were included in the study. The cutoff date for analysis was January 31, 2004. Clinical performance was evaluated by life-table analysis. The mean age of women at 10 years of use was 38.8+/-0.4 years and mean parity was 2.2+/-0.08 (mean+/-SD). The duration of follow-up beyond 10 years ranged from 1 to 72 months. No pregnancy was observed in 366 woman-years of observation beyond 10 years of use. The main reason for discontinuation was removal of the device because the clients had previously been informed that the IUD was not approved for use beyond 10 years. This reason accounted for a gross cumulative 6 years discontinuation rate of 42.5 per 100 women beyond 10 years. The other main reasons for discontinuation beyond 10 years of use were surgical sterilization, menopause and expulsion with gross cumulative 6-year termination rates of 19.2, 11.0 and 21.2 per 100 women, respectively. The cumulative continuation rate beyond 10 years was 67.0 at the end of the first year of follow-up and 21.2 at the end of the sixth year. CONCLUSION: We found no evidence that the TCu 380A IUD loses its effectiveness after 10 years of use. RESULTS: The concept that women who have insertion of a TCu 380A IUD at the age of 25 years or older could use this IUD as a reversible but permanent method of contraception up to the menopause continues to be supported by the accumulation of evidence, although definitive evidence remains to be obtained.     

Oral contraceptive failures and body weight: findings in a large cohort study

This report looks at data from 17 032 women who took part in the Oxford Family Planning Association contraceptive study. Thirty-eight first accidental pregnancies occurred during 6779 woman-years of use of progestogen-only oral contraceptives (0.56 per 100) and 95 first accidental pregnancies occurred during 48 692 woman-years of combined oral contraceptive use (0.20 per 100). Although associations with age and parity were found, there was no evidence of any influence of body weight on the risk of accidental pregnancy with either form of oral contraceptive.     

Perfect-use and typical-use Pearl Index of a contraceptive mobile app

ObjectivesThe Natural Cycles application is a fertility awareness-based contraceptive method that uses dates of menstruation and basal body temperature to inform couples whether protected intercourse is needed to prevent pregnancies. Our purpose with this study is to investigate the contraceptive efficacy of the mobile application by evaluating the perfect- and typical-use Pearl Index.Study designIn this prospective observational study, 22,785 users of the application logged a total of 18,548 woman-years of data into the application. We used these data to calculate typical- and perfect-use Pearl Indexes, as well as 13-cycle pregnancy rates using life-table analysis.ResultsWe found a typical-use Pearl Index of 6.9 pregnancies per 100 woman-years [95% confidence interval (CI): 6.5–7.2], corrected to 6.8 (95% CI: 6.4–7.2) when truncating users after 12 months. We estimated a 13-cycle typical-use failure rate of 8.3% (95% CI: 7.8–8.9). We found that the perfect-use Pearl Index was 1.0 pregnancy per 100 woman-years (95% CI: 0.5–1.5). Finally, we estimated that the rate of pregnancies from cycles where the application erroneously flagged a fertile day as infertile was 0.5 (95% CI: 0.4–0.7) per 100 woman-years. We estimated a discontinuation rate over 12 months of 54%.ConclusionsThis study shows that the efficacy of a contraceptive mobile application is higher than usually reported for traditional fertility awareness-based methods. The application may contribute to reducing the unmet need for contraception.ImplicationsThe measured typical- and perfect-use efficacies of the mobile application Natural Cycles are important parameters for women considering their contraceptive options as well as for the clinicians advising them. The large available data set in this paper allows for future studies on acceptability, for example, by studying the efficacy for different cohorts and geographic regions.     

Initial UK experience of the levonorgestrel-releasing contraceptive intravaginal ring

A study was performed to establish the tolerance, acceptability and associated efficacy of a levonorgestrel-releasing intravaginal ring (IVR) in a sample of British women requiring contraception. This was achieved with an open non-randomized prospective study of 1710 women aged 18-40 years, recruited in 75 centers geographically spread around the UK using an IVR designed to release 20 g/day of levonorgestrel. Assessments were made at baseline, after 6 weeks, after 3 months and then 3-monthly. After initial insertion of the IVR, it was changed at 3-monthly intervals. A total of 1591 women were eligible for analysis, with 572 available after 12 months and 34 after 24 months of use. Life-table analysis revealed pregnancy rates of 5.1% and 6.5% at 12 months and 24 months, respectively. The IVR was rated as acceptable or very acceptable as a form of contraceptive by 60.7% of women at 12 months. The most common adverse events were menstrual disturbance, headache and vaginal discharge. No significant pattern of biochemical, hematological, microbiological or cytological abnormalities was found but vaginal erythematous lesions were noted at some centers. This IVR was found to be a generally well-accepted method of contraception with a failure rate comparable to some other progestogen-only methods. On this basis, further development of hormone-releasing intravaginal rings is justified.     

Mesigyna once-a-month combined injectable contraceptive: experience in Latin America

A phase III clinical study was carried out among 534 fertile Latin American women to evaluate cycle control, side effects, and contraceptive efficacy of a once-a-month combined injectable, Mesigyna, consisting of 50 mg norethisterone enanthate and 5 mg estradiol valerate. The pregnancy rate at 1 year was 0 per 100 woman-years for a total experience of 4688 woman-months. The overall discontinuation rate at one year was 17.9%. Discontinuation rate for bleeding problems was 5.1%. The Colombian women had a significant increase (p <0.001) in bleeding problems compared to other countries. The discontinuation rate for amenorrhea was 1.1%. There were no significant differences between the groups regarding discontinuation for other medical or non-medical reasons. Mean weight gain after one year of use was 1.02 kg. Mesigyna is an appropiate once-a-month injectable contraceptive for Latin American women since it is highly effective and its perception of normal menstrual bleeding is of importance in the Latin American population.     

Use effectiveness of the prentif cervical cap in private practice: A prospective study

Of two-hundred-sixty women seeking cervical cap contraception, exactly half subsequently used the Prentif cavity rim cap as their sole method of contraception. The one year continuation rate for these exclusive cap users was 56.7 per hundred. No major side effects related to the use of the Prentif cap were observed in the course of this study, involving 918 women-months in year 1. Pregnancy and dislodgement of the cap during use were the principal reasons for discontinuation of exclusive use, with gross rates of 19.1 and 12.9 per 100 at one year, respectively.     

Two-year performance of a Nestorone-releasing contraceptive implant: a three-center study of 300 women

A 2-year trial of a single Nestorone (NES) rod implant was conducted at three Latin American centers, each enrolling 100 women. We studied the safety, effectiveness and acceptability of this progestin-releasing contraceptive implant. Three pregnancies occurred, the last at 18 months of use. Because no pregnancies were expected in the first 18 months, the trial was halted. At that time, 224 women had completed at least 18 months of use, and 99 women had used the implant for more than 24 months. Few participants used adjunctive contraception between the time the study was halted and the time they had their implant removed. No additional pregnancies occurred before the removal of the last implant. The 2-year cumulative pregnancy rate was 1.7 per 100 with a Pearl index of 0.6 per 100 for the 2-year period. The 1-year and 2-year continuation rates were 80.5 and 66.7 per 100, respectively. Menstrual and medical disturbances were the principal reasons for discontinuation, followed by planned pregnancy. Headache and weight gain frequently led to discontinuation. The NES implant had little important effect on most clinical chemistry and lipid parameters. Over the study course, the mean change in hemoglobin was <1%. Slight modification of the design of this single 2-year implant, restoring features previously examined in clinical trials, is likely to improve its effectiveness. A single NES implant appears to provide acceptable contraception for women.     

A multicentred phase III comparative clinical trial of depot-medroxyprogesterone acetate given three-monthly at doses of 100mg or 150mg: 1. Contraceptive efficacy and side effects

Two dosages of depot-medroxyprogesterone acetate (DMPA), 100mg and 150mg given every 90 days, were compared in two groups of women with regard to effectiveness, reported complaints and reasons for discontinuation. A total of 1216 women were recruited into a seven-centre, multinational, randomized clinical trial. Follow-up was for a period of one year and resulted in a total of 5507 woman-months of experience of 100mg DMPA and 5429 woman-months of experience of the 150mg dose.The study showed little difference in efficacy and side effects between the two treatment groups. Two pregnancies occurred in women receiving 100mg DMPA giving a Pearl Index of 0.44 per 100 woman-years. None occurred in the 150mg group. There was no difference in the overall continuation rates between the two groups at one year, being 59.3% in the 100mg group and 58.8% in the 150mg group. Except for discontinuation of method use for amenorrhea, the rates of all medical and non-medical reasons given for discontinuation were comparable between the two treatment groups.Women's perception of lack of bleeding was reported as amenorrhea and resulted in discontinuation rates at 12 months for amenorrhea of 7.2% for women receiving 100mg of DMPA and 12.5% for those receiving the 150mg dose. Three centres, Alexandria, Karachi and Szeged, made the major contributions to this difference.     

Sexual and reproductive behaviour among single women aged 15-24 in eight Latin American countries: a comparative analysis

A comparative analysis of exposure to sexual activity, contraceptive use, conceptions, and pregnancy resolutions among single women aged 15-24 in eight Latin American countries is presented. Using data from Demographic and Health Surveys complete contraceptive and reproductive histories are constructed for single women aged 15-24 during the 5 year period preceding each survey. Pre-marital conception rates and overall and cause-specific life-table probabilities of contraceptive discontinuation are estimated. Pregnancy outcome and intention status of births are summarized. Trends in virginity, contraceptive protection, and conception rates for five sites are documented. In all eight countries, virginity accounts for over half of all single woman-years of exposure between age 15 and 24. The percentage of sexually active time protected by contraception is less than 20% in five countries, is about 30% in Peru and 50% in Brazil and Colombia. The contribution of condoms to contraceptive protection ranges from one-tenth to one-fifth. Pre-marital conception rates among sexually active single women range from 14.1 per 100 woman-years in Nicaragua to 25.8 in Bolivia. Most pre-marital conceptions ended in live birth, and births that are legitimized by marriage or cohabitation are more likely to be wanted. In five settings, virginity has fallen over time, especially in Northeast Brazil and Colombia, and uptake of condoms has increased faster than use of other methods. Because of pervasive declines in the protective effect of virginity, conception rates among single women in Latin America are rising. Contraceptive uptake, particularly of condoms, is increasing but not sufficiently to offset the decline in virginity.     

Rhythm: systematized chance-taking

The variations of the rhythm method of contraception and its inadequacy as a reliable method are discussed. Studies of women following the calendar method have shown a failure rate of 30 pregnancies per 100 women-years of use. Failure rates with the basal body temperature method have been observed to be lower than when the calendar method and basal body temperature method are combined (6.6 and 19.3 per 100 woman-years). Sufficient data does not yet exist to evaluate the cervical mucus method. The failure rates are higher than those found with oral contraceptives, IUDS, and occlusive methods. The development of methods to determine the post ovulatory phase of the menstrual cycle would enhance the rhythm method. It is concluded that methods which attempt to predict the ovulatory phase are not effective methods of birth control.     

Early experience in contraception with a new progestogen

This report combines the results of two related studies in the use of a new progestogen, 17 alpha-acetoxy-6 beta,11 beta-dichloro-19-norpregna-4,6-diene-3,20-dione. (GR2/1159, Glaxo Research Ltd.), as an oral contraceptive. In the first trial 22 women took 200 μg, twice daily for a total of 184 woman-months, and a series of haematological and biochemical variables were monitored. In the second, 115 women took 350 μg, once daily for a total of 927 woman-months.The main cause of discontinuation due to side effects was irregular menstrual bleeding which occurred equally in both studies, the rate of 28.2 per 100 woman-years being twice that for norethisterone (350 μg daily) in a similar population. Pregnancy rates were low, there being none in the first trial and a net rate of $\text{2.8}\text{100}$ woman-years in the second. There was one ectopic gestation. There were no important variations in blood pressure, body weight, blood cells, or in plasma proteins, prothrombin ratio, lipids, enzymes, glucose or electrolytes after taking this compound for six months continuously.     

Effectiveness of IUDs: a review

Large, multicenter, randomized trials of IUDs conducted between 1970 and 1986 encompass more than 50,000 woman-years of experience in the two-year interval following device insertion. Taken singly and collectively, these trials demonstrate that IUD failure rates are strongly affected by the age of participants, notably by the proportion of women under age 25 admitted to the studies. Individual trials and overall comparisons indicate further that: 1. Non-medicated devices such as the Mahua steel ring and Lippes loop D have pregnancy rates above 2 per 100 woman-years. 2. The first approved copper IUDs, the Copper 7 and the TCu 200, do not markedly differ in pregnancy rates from standard plastic devices with rates significantly above 2 per 100 woman-years. 3. Five more recent, widely used copper IUDs have had failure rates significantly below 2 per 100 woman-years in multicenter trials. The point estimate of the failure rate was less than 1 pregnancy per 100 woman-years for three of these IUDs. One copper-bearing device had a failure rate significantly below 1 per 100 woman-years. 4. Devices releasing either 25 mcg/day of progesterone or 2 mcg/day of levonorgestrel have had significantly higher failure rates than the more effective copper-releasing IUDs; however, devices releasing 20 mcg/day of levonorgestrel appear at least as effective as the most effective copper IUDs. Long-term IUD failure rates derived from straight assignment as well as randomized trials indicate 4-year gross cumulative failure rates do not exceed 10 per 100 for any of the standard copper devices or the Lippes loop D. Point estimates of the four-year gross cumulative pregnancy rates have been below 5 per 100 users in studies of the TCu 220C, the Nova T, the TCu 380A, and the MLCu 375.     

Norethisterone oenanthate as an injectable contraceptive: A study of patients discontinuing treatment

Two hundred and ninety-five women were enrolled in a study of norethisterone oenanthate (NET-OEN) as an injectable contraceptive. One hundred and twenty-four patients who discontinued this contraceptive have been studied in detail. The main reasons for use-related closures of method were menstrual abnormality (22 patients), minor side-effects (23 patients), personal reasons (22 patients) with 18-month life-table net discontinuation rates of 14.7/100 women, 13.5/100 women, 14.2/100 women respectively and an overall discontinuation rate of 49.2/100 women. There were no accidental pregnancies. The probability of discontinuing treatment was not affected by age, parity, time of starting treatment or previous contraception. Sixty-nine per cent of all discontinuations occurred in the first four months of treatment. There were no serious complications.     

Dillings自然避孕法的推广使用

观察300对育龄夫妇4516个妇女月连续使用Billings自然避孕法的避孕效果。用生命表法统计12个月和18个月时净累积停用率分别为14.57/百妇女和21.21/百妇女,续用率分别为85.43/百妇女和78.79/百妇女。因方法学本身引起的意外妊娠停用率较低,分别为1.02/百妇女和1.37/百妇女。本文认为除方法学意外妊娠外,其它原因引起的妊娠与使用者有关。只要进一步改进培训方法,调动受试者主观能动性和强调丈夫的合作,定能降低使用者引起的停用率,提高续用率。Billings自然避孕法效果可靠,无任何副作用,可进一步推广使用。     

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.     

Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. I. Contraceptive efficacy and side effects. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation

A multicentre clinical trial, including 19 centres in 13 countries, assessed the contraceptive efficacy and clinical acceptability of a Silastic 382 vaginal ring releasing 20 micrograms of levonorgestrel for at least 90 days. A total of 1005 women entered the study and 8176.74 woman-months of experience was gathered. The rate of intrauterine pregnancy at one year of use was 3.6 per 100 women (95% confidence interval 2.2-5.0), and of ectopic pregnancy, 0.2% (one case). The principal reasons for discontinuation were menstrual disturbances (17.2% at one year), vaginal symptoms (6.0%) and repeated expulsion of the ring (7.1%). The pregnancy rate with this 20 micrograms levonorgestrel-releasing vaginal ring compares favourably with that of a low estrogen combination oral contraceptive tested by WHO and is less than half that of a progestogen-only oral contraceptive in a WHO randomized study. It is concluded that the WHO intravaginal ring releasing an average of 20 micrograms of levonorgestrel per 24 hours is an effective method of contraception for at least one year of use.     

Phase IV study of the injection Norigest in Pakistan

A field study of the injectable contraceptive, norethisterone enanthate (NET-EN), was conducted in family planning clinics in Sind and Punjab provinces of Pakistan, to determine the acceptability and feasibility of providing NET-EN in government family planning clinics staffed by Family Welfare Visitors (FWVs). A total of 2147 women were recruited to the study, of whom approximately three-fourths had never previously used contraception. The overall discontinuation rate at one year was 78 per 100 women; the most common reason for discontinuation was bleeding disturbances, including amenorrhea, although returning to the clinic too late for an injection also accounted for a substantial proportion of the discontinuations. Given adequate training, FWVs were shown to be capable of providing NET-EN in family planning clinics, including managing the bleeding disturbances common with this method of contraception. No pregnancies were reported, demonstrating that the method is highly effective when used in a usual family planning clinic situation.     

Use-effectiveness of the condom in a selected family planning clinic population in the United Kingdom

A prospective study of the beneficial and adverse effects of different methods of contraception is in progress at 17 clinics run by the British Family Planning Association. The present report is concerned with the findings so far on the efficacy of the condom.

Overall, 62 accidental pregnancies have been observed among 2057 couples using this method of birth control during 1543 woman-years of exposure to risk, representing a use-effectiveness pregnancy rate of 4.0 per 100 woman-years.

It is concluded that there is little reason to encourage couples who are highly motivated towards family planning and who find the condom aesthetically acceptable to change to a more modern method of birth control with its attendant risks unless a very high degree of security is essential.