Clinical performance of the TCu 380A and TCu 220C IUDs in four developing country family planning clinics.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 220C (TCu 220C) intrauterine devices (IUDs) were evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at four collaborating research sites located in two developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the TCu 220C IUD at 12 months (0.3 and 0.8, respectively), although this difference was not statistically significant (p > 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. No statistically significant differences were observed in the frequency of experiencing menstrual disturbances (i.e., dysmenorrhea, intermenstrual pelvic pain or intermenstrual bleeding) between the two IUD groups. These data suggest that the TCu 380A and TCu 220C IUDs are both appropriate options for contracepting women. The TCu 380A IUD, however, may be a more appropriate option for those women wishing to space births over a longer period of time.

Women and family planning. "Now I will tell my daughters".

PIP: A Bolivian woman with three daughters became pregnant while practicing the rhythm method. Method failure occurred seven years after she bore her most recent child and prompted her, with her husband's consent, to obtain an unsafe abortion. The decision to abort the fetus was based upon her husband's lack of employment, the meager monthly income of US$45 which she earns, and the inability of her to continue working once pregnant. The abortion process consisted of a three-hour scraping/general cleaning which left the woman dizzy. She returned to the physician several days later, bloated and in pain, when the possibility of a perforated uterus was voiced and surgery conducted. The woman regrets having the abortion, for the couple wanted to bear a fourth child once they could afford it.^ieng

Use of the diaphragm without spermicides may be just as effective in preventing unwanted pregnancy.

PIP: Researchers are exploring ways of increasing the effectiveness and acceptability of the diaphragm. According to one Brazilian study, women tend to continue use of the diaphragm, with a higher rate of effectiveness, when it is used alone without spermicides. This may be due to convenience and cost. The retrospective study comparing 441 women who used diaphragms in conjunction with spermicides to 215 who used diaphragms alone demonstrated a significantly higher failure rate in the former group (9.8 per 100) than in the latter (2.8 per 100). There were also significantly more discontinuations for vaginal discharge and other medical reasons in the first group. The Coletivo Feminista Sexualidade e Saude in Sao Paulo, Brazil reports a high diaphragm acceptance rate with a high 1-year continuation rate (72%) among its clients. The clinic emphasizes adequate training of its clients in the use of the diaphragm, including follow up visits, which is important to the success of the method. Studies show that diaphragms used with spermicides also provide significant protection against sexually transmitted diseases. Women using this method are less likely (p .05) to have cervical gonorrhea (relative risk = .32) or trichomoniasis (relative risk = .24), or to be hospitalized for pelvic inflammatory disease.^ieng

Effectiveness of the diaphragm, used continuously, without spermicide.

The experience of 670 diaphragm users from three Brazilian clinics was retrospectively reviewed. Most of the subjects (441) followed the traditional method (TM) of using the diaphragm, only at the time of sexual intercourse and with spermicide. One third (215) used the diaphragm continuously (CU), without spermicide, removing it only at the time of their daily shower to wash it, with immediate re-insertion. The total pregnancy rate was 7.0 per 100 women-years for the whole group. Patient and total failure rate were significantly lower in the CU (0.6 and 2.8), in comparison with the TM sub-group (6.5 and 9.8). The discontinuation rate for urinary infection or other medical reasons was not greater in the CU group. Logistic regression analysis, including age, parity, number of abortions and of living children, years of schooling, whether living with a partner, presence of mild cystocele or retroverted uterus, and form of use of diaphragm (TM or CU), showed that only the TM of diaphragm use was positively associated to patients' and total failure rate.

PIP: In Brazil, a retrospective review of clinical records of diaphragm users from the Sexuality and Health Women's Collective in central Sao Paulo, the family planning clinic at the State University of Campinas, and a private practice in Belo Horizonte was performed to compare data on 215 women continuously using it without spermicide, except to clean it during a shower, with data on 441 women using it with spermicide only during sexual intercourse to determine diaphragm effectiveness. The patients' failure rate stood considerably higher among women using the diaphragm with spermicide (6.5 vs. 0.61; p .05). The method failure rate was just slightly higher in the diaphragm with spermicide users' group (3.53 vs. 2.2). 71.47% of all women continued use for 12 months, especially women continuously using the diaphragm without spermicide (84.84 vs. 63.28%; p .05). Women who used the diaphragm with spermicide were more likely to discontinue for vaginal discharge and for other medical and personal reasons than were those who continuously used it without spermicide (p .05). They were also more likely to be lost to follow up (16.4% vs. 6.43%; p .05). The logistic regression analysis indicated that diaphragm with spermicide use was positively linked to patients' and total failure (p = .042). These findings suggested that the messiness of diaphragm use with spermicide, its interference with sexual intercourse, and perhaps spermicide cost contributed to its high discontinuation and failure rates. The findings should raise interest in identifying means to improve acceptance of and use effectiveness of the diaphragm.

The dynamics of contraceptive use in Peru.

In 1986, the Demographic and Health Surveys project administered the first six-year calendar history of events that included women's contraceptive use and their reasons for discontinuation in experimental surveys in Peru and the Dominican Republic. In this report the experimental survey from Peru is examined to demonstrate how the calendar data can be used to calculate multiple increment-decrement life table rates of contraceptive discontinuation--including contraceptive failure, method switching, and abandonment of use--and of resumption of method use following discontinuation. These analyses reveal that nearly half of all Peruvian women who begin to use a method will stop using it within one year; 29 percent of women discontinue method use for nonpregnancy-related reasons within one year of initiating use. Women who switch methods do so frequently, and many will return to a method used previously, or move on to a third method. Women who become pregnant after abandoning contraceptive use have similar contraceptive-use patterns to women who experience a contraceptive failure.

PIP: An analysis of calendar data from January 1981 to interview date in 1986 (Demographic and Health Survey) on 1065 ever married Peruvian women who had ever used a contraceptive was used to show how researcher can use these data to calculate multiple increment-decrement life table rates of contraceptive discontinuation and renewed method use after discontinuation. 46.4% of women discontinued a method within 1 year. 29% discontinued a method for nonpregnancy related reasons within 1 year of use. Women who stopped using a method were more likely to switch directly to another method than not use any method. The risk of unplanned pregnancy was therefore low for these women. Women who discontinued use of a method but not switch directly to another method likely ceased having sexual intercourse, while others either ran out of supplies, were dissatisfied with the method, or could not find acceptable alternative methods. Regardless of the reason for not switching to another method after discontinuation, these women were at an increased risk of unplanned pregnancy. Women who discontinued a method and did not directly switch to another method were just as likely to return to the abandoned method as they were to switch to another method, but were likely to become pregnant before they returned to the abandoned method or switched to another method. Contraceptive use patterns of such pregnant women matched those of women whose contraceptives failed. Both groups of women tended to return to the method that failed. The considerable amount of method switching in a population may demonstrate either that women profit from a wide range of contraceptive choices or they cannot easily obtain and are not satisfied with currently available contraceptives. Since Peru had one of the weakest family planning programs in Latin America during the 1980s, the latter 2 reasons were most likely the case.

[Non-surgical female sterilization using quinacrine: efficacy of two insertions of quinacrine pellets]. / Stérilisation féminine, non chirurgicale avec l'emploi de quinacrine: efficacité de deux insertions de pellets de quinacrine.

In a group of 159 women at Santiago du Chili, fertility control by means of chemical occlusion of the utero-tubular junction was assessed. Two transcervical intra-uterine insertions of 216 mg of quinacrine, carried out at an interval of one month and associated with 50 mg of intra-uterine diclofenac and 150 mg of intra-muscular diclofenac resulted in a pregnancy rate after 12 months of 2.1 per 100 women and a Pearl index of 1.63 at 27 months after the sterilization process. The complications and adverse events appear to be similar to those which occur during insertion of an IUD and were minor and transient, disappearing within a few hours or at most 2 days after the procedure.

PIP: A group of 147 women participated in a study of outpatient tubal occlusion with quinacrine pellets at a hospital in Santiago, Chile. Six pellets, each containing 36 mg of quinacrine, were inserted transcervically into the uterus by means of a plastic tube in a procedure resembling IUD insertion. The women also received 50 mg of intrauterine diclofenac and 150 mg of intramuscular diclofenac. The initial procedure was carried out within the first postmenstrual cycle week, and was repeated at the same cycle phase on month later. No procedures were done within 42 postpartum days. The study women were 34.9 years old an average and had an average of 4.9 living children. Of the 159 patients who completed the two scheduled insertions, 140 were followed for 27 months and the other 19 were lost to follow-up. Three women became pregnant within two years. The Pearl index was 1.63 for 2198 woman-months. The percentages of pregnancies were 0.62 for the first year and 1.25 for the second year. None of the pregnancies was ectopic. One pregnancy was terminated by a medical abortion, and the patient was surgically sterilized. No abnormality was observed during laparotomy. The other two pregnancies terminated in normal delivery of healthy infants. Twenty women had adverse reactions during the 24 months of observation, but most were minor. No hospitalization or additional surgical procedures were required. Three women had post-insertion metrorrhagia, which lasted a maximum of two days.

Comparative study on the efficacy and acceptability of two contraceptive pills administered by the vaginal route: an international multicenter clinical trial.

The efficacy and acceptability of two widely used oral contraceptive tablets, one containing 250 mg levonorgestrel and 50 micrograms ethinyl estradiol and the other containing 150 micrograms desogestrel and 30 micrograms ethinyl estradiol, administered by the vaginal route were compared in 1055 women studied over 12,630 woman-months of vaginal contraceptive pill use. This multicenter clinical trial was performed in nine countries of the developing world by the "South to South Cooperation in Reproductive Health," an organization founded by scientists from the Third World working in the area of reproductive health, and the study was developed and coordinated by one of these centers. The findings of this study confirm the efficacy of both these tablets when administered by the vaginal route. Involuntary pregnancy rates at 1 year of 2.78 for subjects in the levonorgestrel group and 4.54 for subjects the desogestrel group showed no statistically significant difference between the two groups. However, total discontinuation rates of 47.01 for subjects in the levonorgestrel group and 56.33 for subjects in the desogestrel group showed a statistically significant difference between the two groups, and discontinuation rates attributable to prolonged bleeding of 0.6 for subjects in the levonorgestrel group and 3.2 for subjects in the desogestrel group were also significantly higher in the group of subjects using the desogestrel vaginal contraceptive pill. Blood pressure remained at admission values throughout treatment. A statistically significant weight increase from admission values occurred in both groups of subjects.

PIP: Efficacy and acceptability of 2 combined oral contraceptive pills administered vaginally are summarized. This is the 1st collaborative trial published by the South to South Cooperation in Reproductive Health. 1055 women participated in 12,630 cycles, in 9 countries, from June 1988 to May 1991. The pills were commercially available tablets containing 50 mcg ethinyl estradiol and 250 mg levonorgestrel (Schering AG, Sao Paulo, Brazil), or 30 mcg ethinyl estradiol and 15 mcg desogestrel (Organon, Sao Paulo, Brazil). Subjects were aged 17-39 younger and of lower parity from Mexico and Dominican Republic and older from Egypt and China. All had at least 1 pregnancy. 675 participated for 6 months, 470 for 1 year, 364 for 18 months, and 210 for 2 years. The 1-year discontinuation rate averaged 47.01% for the levonorgestrel group and 56.33% for the desogestrel group (p = 0.0061); 2-year discontinuation rates were 48.01% and 69.36, respectively, explained in part by higher involuntary pregnancy rates and prolonged bleeding rates in the desogestrel group. The most common medical reasons for stopping contraception were unplanned pregnancy, vaginal or vulval irritation, nausea, vaginal discharge and headache. Vaginal irritation was reported by 1%, 9 in each group. There were 32 pregnancies, 14 in the levonorgestrel and 18 in the desogestrel group. 17 were in missed pill cycles and the rest were method failures, 6 in the levonorgestrel group and 9 in the desogestrel group. The Pearl index varied from 0 in Nigeria to 12.24 in Mexico, and was 2.45 for levonorgestrel vs. 3.74 for desogestrel. There was a wide variation in discontinuation rates by center: Brazil and China had few, while many women from Dominican Republic, Mexico and Zambia left the study. Bleeding problems were common complaints, more so in the desogestrel group. There were 363 women with intermenstrual bleeding (only once in 80%), 148 with spotting (only twice in 65%). Bleeding duration was significantly less in pill cycles than baseline, pressure. Women gained an average of 1 kg over 2 years, more in the desogestrel group. The pregnancy rate of 2.78 is within the range reported for levonorgestrel rings.

[Comparative study of intrauterine devices: TCu380A and Flexigard]. / Estudo comparativo entre os dispositivos intrauterinos: TCu380A e Flexigard.

PIP: The Copper T 380A and the Flexigard intrauterine devices were evaluated for safety, efficacy, and continuation rates in parous women. The Flexigard is a new concept of IUD technology with regard to the affixing of the device to the uterine fundus, the flexibility of the device, and the total absence of a plastic frame. A total of 186 women were enrolled in the study: Group I contained 90 women using Flexigard, and Group II 96 women using TCu380A. All participants were healthy women with at least one living child, regular menstrual cycles, and without previous history of pelvic inflammatory disease and/or ectopic pregnancy. The IUDs were inserted in the first 10 days of the cycle, and subsequent examinations were carried out on day 15, and 3, 6, 9, 12, and 24 months after insertion. The patients were followed up for a total of 2622 and 2589 woman-months for TCu380A and Flexigard, respectively. There were 96 TCu380A and 95 Flexigard insertions. Medical reasons for discontinuation were: desire to get pregnant (1.1%), complaint of partner (1.1%), blood loss (1.1%) for Flexigard; and desire to get pregnant (5.2%), partner's complaint (1.9%), and loss of blood (1.0%) for TCu380A. There were five insertion failures out of 95 insertions with the Flexigard and none out of 96 insertions with TCu380A. The age, parity, and continuation rates showed no differences between devices. The main difference between the devices was that the complete expulsion rate for Flexigard was significantly higher (5.55%) than for the TCu380A (p 0.05). This high rate of complete expulsions for Flexigard was attributable to improper insertion of the device rather than to the expulsion of a properly fitted one.^ieng

Comparison of condom breakage during human use with performance in laboratory testing.

This paper combines results from a study of the determinants of condom quality and use conducted by The Population Council in two countries in the Caribbean with results from a condom breakage study conducted by Family Health International (FHI) in the United States. The studies, conducted two years apart, compared the breakage rates of condoms from the same lot during human use to their performance in laboratory test results. Breakage rates of 12.9% for Barbados, 10.1% for St. Lucia and 6.7% for the United States compared to passing ASTM laboratory tests suggest that existing laboratory tests as used with the current pass/fail standards are either not sufficiently sensitive or not well-defined to reliably predict condom performance during human use. The study also suggests that user behaviors and practices may be a factor in condom breakage. If the condom is to be an effective method against unplanned pregnancy and STD/HIV infection, and if consumer confidence is to be retained, condom breakage during sexual intercourse must be reduced.

PIP: Family Health International (FHI) in North Carolina sampled and tested 52mm contour condoms with a reservoir tip and silicone lubrication in November 1988 and March 1990. Condoms from this same lot were used in 2 human use studies conducted in 2 Caribbean countries and in the US. The Population Council conducted 1 human use study in Barbados and St. Lucia among 50 heterosexual male condom users from each country. FHI conducted the other study in the Research Triangle area of North Carolina among 50 heterosexual male condoms users. Condom breakage rates of the human studies were high (12.9% in Barbados, 10.1% for St. Lucia, and 6.7% for North Carolina) in comparison with other studies (1-7%). Breakage did not occur due to poor storage conditions or oil based lubricant use. The researchers thought that it occurred due to men misusing the condoms or other user behaviors and practices. This belief was supported by the differences in breakage between the Caribbean men and the US men. More men experienced multiple condom breakages than those who experienced only 1 breakage. Condoms used in the study were from the same lot which passed elongation and tensile strength standards of the American Society for Testing and Materials (ASTM) in both 1988 and 1990, but failed the International Organization of Standardization (ISO) airburst tests in 1988 and just barely passed in 1990. Apparently the standards are not sensitive enough to predict increases in condom breakage. These findings suggest that the ISO standard for airburst testing is a more accurate predictor of condom quality than the ASTM standards for tensile strength and elongation. Further the breakage rates are too high given the AIDS epidemic. Moreover high breakage reduces customer confidence. In conclusion, researchers need to conduct studies on sexual behavior and practices to determine their effect on condom breakage rates.

[Use of a monthly calendar for collecting retrospective data on contraception: an evaluation of the experimental field studies of the Demographic and Health Surveys (DHS)]. / Uso de un calendario mensual para recolectar datos retrospectivos sobre anticoncepcion: una evaluacion de los estudios de terreno experimentales de las Encuestas Demograficas de Salud (DHS).

A methodological experiment was conducted as part of the Demographic and Health Surveys (DHS) project to determine whether different approaches to measuring the same variables would yield similar results. The experiment consisted of the use of a new questionnaire, incorporating variants of many of the traditional approaches to the collection of demographic and health data. The experimental questionnaire was applied in 2 countries, Peru and the Dominican Republic at the same time as the standard survey. The most salient feature of this new questionnaire pregnancies, contraceptive practice, and postpartum, marriage, employment, and migration information. In this paper, the authors evaluate whether the use of the calendar in the experimental questionnaire improved the quality of the resulting information on contraception in the DHS surveys from the abovementioned countries. Specifically, the author determine whether the monthly calendar led to better estimates of contraceptive prevalence, failure, and discontinuation, and discuss the advantages and drawbacks of the calendar over the more standard approach. Results from this evaluation suggest that the major advantages of the calendar over the more standard questionnaire are 3-fold: it allows for more complete reports of use for periods prior to the survey; it allows for a detailed study of contraceptive use patterns; and it obtains information which is more internally consistent with other types of information. On the bases of these findings, the DHS project will include a calendar in the new standard questionnaire to be used in the 2nd round of surveys (DHS II).

Mini-pill in lactating women.

A non-comparative study of the progestogen-only oral contraceptive, norgestrel 0.075 mg, in breast-feeding women was conducted at the Centro de Investigaciones Regionales, Merida, Yucatan, Mexico. The study was designed to evaluate the overall acceptability and contraceptive efficacy of norgestrel in breast-feeding women. This report includes a survey of 200 women, all of whom were less than 26 weeks postpartum at admission; 113 were interval patients and 87 were postpartum. Follow-up visits were scheduled at 2, 6 and 12 months after admission. Overall, women experienced an increase in intermenstrual bleeding, amenorrhea, vaginal discharge and breast discomfort. The discontinuation rate at 12 months was 32.5 and the corresponding lost to follow-up rate was 22.5; this is a measure of acceptability. The 12-month life-table rate for pregnancy was 3.4 with a standard error of 2.0. Three women discontinued use of the mini-pill due to accidental pregnancy. One pregnancy was attributed to user failure and the woman conceived 9 months after entering into the study; the other two were attributed to method failure, one woman conceived 3 months after admission and the other conceived 6 months after admission.

[Demographic trends: birth spacing]. / Tendencias demográficas: intervalo intergenésico.

Two studies to measure children spacing in western metropolitan Santiago are compared. The first (1984-85) surveyed a sample of 687 mothers and the second 1,000. Deliveries took place at San Juan de Dios and Félix Bulnes hospitals (both state-finance) which provide medical care for medium and low income groups. Long spacing (5 years or more) accounted for the highest proportion of non-first born children (33.8% in 1984-85 with a significant increase to 40.1% in 1988) while short spacing (under 2 years) accounted for 19.2% in 1984-85 and 21.8% in 1988 (not significant). Mean birth weights were over 3,200 g in every spacing group. Despite the low illiteracy rate, predominant urban origin and having at least one child born before, high proportions of children were conceived despite the use of contraceptive measures (19.7% in 1984-85 and 22.5% in 1988). This contraceptive failure was less frequent among children born after longer spacings.

PIP: Results are compared of 2 studies of child spacing undertaken in public maternity hospitals serving middle and lower income populations in the western area of Santiago, Chile. The 1st study surveyed 687 mothers of live-born infants in 1984-85, while the 2nd surveyed 1000 mothers in February-May 1988. All mothers had at least 1 older child. The surveys were undertaken in the 72 hours following delivery. In the 1984-85 and 1988 studies respectively, the birth interval was under 24 months for 19.2 and 21.8%; 24-35 months for 18.9 and 16.0%; 36-47 months for 16.9 and 13.1%; 48-59 months for 11.2 and 9.0%; and 60 months or more for 33.8 and 40.1%. The increase in birth intervals over 60 months was statistically significant. The average birth weight increased from 32.. g to 3330 g between the 2 studies, but the difference was not significant. The average birth weight increased for all birth intervals. The proportion of infants weighing under 2500 g at birth was 5.8% in 1984-85 and 6.9% in 1988. The proportions of mothers who became pregnant despite using a contraceptive method in 1984-85 and 1988 respectively were 28.0 and 30.7% for birth intervals of 24 months or less, 18.3 and 23.1% for intervals of 24-59 months, and 16.8 and 17.5% for intervals of 60 months or more. 22.5% of all infants in the 1988 survey were conceived while their mothers were using a contraceptive method. The factors involved in this apparently high rate, whether related to availability of family planning services, user knowledge, or method efficacy, should be identified and corrected.

Analysis of sterilization failure in Brazil.

A study of 13,423 female sterilization procedures performed from 1981 to 1984 in Rio de Janeiro, Brazil, was conducted to determine the level of sterilization failure. The lifetable cumulative failure rate was 0.54 at 12 months per 100 initial sterilizations, increasing to 1.04 at 48 months. Results of a multivariate analysis indicated that the differential in the rate of sterilization failure by woman's age at sterilization at 12 and 24 months was statistically highly significant. However, the differential rate of failure by the other variables such as whether sterilized during a training period, number of sterilizations per surgeon per day, and year of sterilization were not statistically significant.

PIP: To determine the level of sterilization failure, an analysis of the 13,423 female sterilization procedures carried out in 1981-84 at a primary care center in Rio de Janeiro was performed. 97% of these procedures were performed with a laparoscope, and a band was used for 98% of occlusions. 144 women reported a pregnancy after their sterilization procedure; of these, 22 were defined as occurring before the surgery (luteal phase) and were excluded from the life-table analysis. The cumulative failure rate was 0.54/100 sterilizations at 12 months and 1.04/100 procedures at 48 months. Parity, method of sterilization, and occlusion technique were not correlated with sterilization outcome. However, logistic regression analysis indicated that the rates of sterilization failure at 12 and 24 months were consistently lower for older women (age 30 years and above) than women in the 17-29-year age group. (p0.01). The number of sterilizations performed per day was also a factor in sterilization failure, but this association was not statistically significant. 5.7% of the sterilization failures resulted in ectopic pregnancies. Overall, these findings are comparable to the failure rate in other countries. The occurrence of 22 luteal phase pregnancies in this study highlights the importance of thorough preoperative counseling and examination. It is recommended that contraception should be used in the cycle prior to sterilization to reduce this risk.

[The most common choices for those desiring to practice contraception]. / As opções mais comuns para quem deseja praticar a anticoncepção.

PIP: Major contraceptive methods are listed along with their effectiveness, advantages, disadvantages, side effects, and recommendations for correct use serving as a guide to nurses. The prolongation of lactation causes less than 40 pregnancies per 100 women, it is natural, but the time of return to fertility is not sure, usually its safety lasts only 3 weeks, thus subsequently other methods are needed. Periodic abstinence includes the rhythm or calendar method (25-30 pregnancies per 100 women) and the basal temperature method (7-15 pregnancies). No medicine or device is needed, they are approved by the Catholic Church, but they require instruction for correct practice, and the rigorous observation of 6 menstrual cycles. The index of failure of the ovulation method is 5-10 pregnancies, and it requires the observation of the cervical mucus of 6 cycles, just like the more effective (4 pregnancies) sympto-thermic method. The failure rate of the contraceptive pill is 0.5-0.8 pregnancies, but even serious side effects (thromboembolitic diseases) can occur. The intrauterine device is fairly effective (2-3 pregnancies), but its fitting requires medical assistance. Female and male sterilization are also effective (0.1 and 0.9 pregnancies, respectively). Other methods in decreasing order of effectiveness are: diaphragm (2-10 pregnancies), spermicides (5-35 pregnancies), condom (7 to 13-15 pregnancies), vaginal sponge (9-27 pregnancies), and coitus interruptus (20-40 pregnancies).^ieng

[Norplant: a new alternative in family planning]. / Norplant: una nueva alternativa en planificacion familiar.

PIP: The Norplant system is a long-acting hormonal contraceptive method for women which offers high efficacy. The active principal is levonorgestrel, a progestin widely used in oral contraceptives. The Norplant system is in use in various countries including the US, the Dominican Republic, Colombia, Brazil, Chile, Sweden, and Denmark. Norplant consists of silastic capsules containing levonorgestrel which are inserted subdermally in the arm. The progestin is released in constant form from the moment of implantation. 50 mcg are released daily during the first year and approximately 30 mcg are released in subsequent years. Norplant is effective for at least 5 years if a set of 6 capsules is used. Norplant II, consisting of 2 capsules used for 3 years, has come into use more recently. The cumulative pregnancy rate after 5 years of use by 992 women was 2.7/100 continuous users. The annual pregnancy rate was generally less than .5%. No other reversible method has demonstrated the same level of effectiveness during such prolonged periods of use. The mechanism of action is based on inhibition of ovulation in about 50% of cycles, thickening of cervical mucus, and endometrial suppression. Norplant users may present some adverse effects such as menstrual irregularities, amenorrhea, nausea, dizziness, or headaches, but these symptoms are less frequent than with other hormonal methods. Menstrual irregularity is the most frequent secondary effect and the principal cause of termination of use. The secondary effects are generally acceptable. Follow-up during the period of effectiveness of the implants is simple and infrequent. Norplant is an excellent contraceptive choice for women who do not desire pregnancy but do not wish to use a definitive contraceptive method. Once the implant is removed, fertility rapidly is restored.^ieng

[Surgical sterilization: 10 years' experience]. / Esterilización quirúrgica: experiencia en 10 años.

PIP: A sample of 1003 records of surgical sterilizations was studied from among the 9400 performed between July 1972-June 1982 at a university hospital in Nuevo Leon, Mexico. 12 patients were aged 15-19, 104 were 20-24, 244 were 25-29, 291 were 30-34, 267 were 35-39, and 85 were 40-45. Not all patients met the recommended conditions of being at least 25 years old and/or having at least 3 pregnancies. 11.6% of the patients were sterilized because of psychiatric problems, multiparity, 2 previous cesarean sections or on request of the spouse. 95.5% of the women were married, 2.1% were single, 1.6% lived in free union and .8% were widowed. 14.0% were illiterate, 57.7% had incomplete primary educations, 19.3% had completed primary school, 2.5% had incomplete secondary or technical schooling, and .3% had professional studies. 27 women had had 0-2 pregnancies, 336 had 3-5, 336 had 6-8, 198 had 9-11, and 106 had 12 or more. The maximum number of pregnancies was 20 and the average was 7.1/woman. 6 women had preoperative hemoglobin levels of 6.0 g or less, 12 had 7.0 g, 44 had 8.0, 119 had 9.0 g, 756 had 10.0, and 566 had 11.0 g or higher. Transfusions were given to all women with less than the minimum level of 10.0 g. 460 of the operations were postpartum, 334 were transcesarean, and 209 were interval procedures. 696 operations were done by the Pomeroy method, 52 by modified Pomeroy, 27 by fimbriectomy, 16 by salpingectomy, and 2 by the Uchida method. Among laparoscopic methods, 82 were done by cauterization and 128 with Yoon rings. 392 postpartum and 286 transcesarean operations were performed using the Pomeroy technique, while 82 interval sterilizations were done using cauterization and 107 using Yoon rings. Epidural anesthesia was used in 457 postpartum and 325 transcesarean procedures, while general anesthesia was used in 175 interval sterilization. There were few transoperative complications. There were 2 cases of failure to achieve salpingoclasy, 4 cases of hemorrhage, 1 case of burning of the visceral wall, 1 case of anesthetic accident, and 12 cases of other complications. Among postoperative complications there were 15 cases of abdominal pain, 1 each of fever and infection, and 1 of other complication. There was 1 pregnancy among the 1003 cases. All the procedures were performed by physicians in training.^ieng

Cross of Lorraine and Cross of Caravaca: new IUD's with low expulsion rates.

The Cross of Caravaca and Cross of Lorraine IUDs with double horizontal bar design were developed in an attempt to reduce expulsion and removal rates for pain and bleeding encountered with other IUDs. The devices were manufactured in radio-opaque plastic bearing copper wire or sleeves on the top arm. The Cross of Lorraine has the upper arm shorter than the lower arm whereas in the Cross of Caravaca the shorter is the lower arm. 748 women had insertion of the Cross of Caravaca and 412 had insertion of the Cross of Lorraine. For the Cross of Caravaca 486 women completed 1 year of use, 392 completed 2 years and 310 completed 3 years. For the Cross of Lorraine, 268 women completed the 1st year, 205 the 2nd, and 150 women completed 3 years of use. The combined number of observed months of use for the 2 devices at the end of 3 years was 24,963. Accidental pregnancy rates at the end of 3 years were 1.13% for Caravaca and 3.48% for Lorraine. Expulsion rates at the end of 3 years were nil for the Cross of Lorraine and 1.16% for the Cross of Caravaca. Pain and bleeding were the most common causes of termination for medical reasons, bleeding accounting for termination in 1.66% of Lorraine users at the end of 3 years of use and 2.75% of Caravaca users. Pain accounted for termination in 3.14% of Caravaca users and 2.02% of Lorraine users. Incidence of infection was 0.42% and nil for Caravaca and Lorraine users respectively. Total discontinuation rates at the end of 3 years were 25.39% for Caravaca and 16.67% for Lorraine.

[Comparative clinical trial of two models of copper IUDs in Campinas: the T-Cu 200 and the Multiload-Cu 250]. / Estudo clinico comparativo de dois modelos de anticoncepcionais com cobre em Campinas: o T-Cu 200 e o Multiload-Cu 250.

PIP: The clinical performance of the Multiload-Cu250 (ML-Cu250) copper intrauterine device (IUD), not previously available in Brazil, was compared to that of the T-Cu200, an IUD widely in use. 742 IUD acceptors were enrolled in a prospective randomized study, 292 of whom received the ML-Cu250 and 292 of whom received the T-Cu200. An analysis of age and parity showed no significant differences between the 2 groups. Results were very good with both devices, with continuation rates of more than 90% at 12 months and more than 85% at 18 months. There were no significant differences between the 2 IUDs after 18 months of use. It was concluded that these 2 devices do not present statistically significant differences in their performance and that the 2 IUDs should both be made available to the Brazilian population. The ML-Cu250 should be tested in larger clinical trials to confirm the good performance presented in this study.^ieng

[Evaluation of a type of biomedicated IUD (model Copper 7 200) in a family planning clinic]. / Avaliacao de um tipo de dispositivo intra-uterino biomedicado (modelo "7 de cobre 200") em uma clinica de planejamento familiar.

PIP: In October 1978, 95 patients were inserted with a model 7 Cu 200 IUD at the Family Planning and Human Reproduction Clinic of the Federal University of Minas Gerais, Belo Horizonte, Brazil. Patients varied in age between 16 and over 40, the great majority being in the age group 21-30, and in parity between 1 and over 4, the majority with parity over 4. Most patients, or 76.19%, had previously used OC (oral contraception); 84 of the original 95 patients were followed up at 1, 6, 12, and 18 months after insertion of the device. Continuation rate was 86.7%; there were 36 cases, or 42.85%, of menstrual disorders, mostly hypermenorrhea; 8.23% of patients complained of pain, and 16.47% of discomfort. There was 1 ectopic pregnancy, or a Pearl index of 0.82%, 12 expulsions, or 9.88% of cases, and 1 case of pelvic inflammatory infection. There was 1 removal for hemorrhage, and 2 removals on request from the patients. Hemoglobin levels were measured in 7 patients before insertion and after 14 months, and changes were not significant. These results show that the device was well tolerated and side effects and complications were minimal.^ieng

A prospective multicentre trial of the ovulation method of natural family planning. II. The effectiveness phase.

A five-country prospective study was undertaken to determine the effectiveness of the ovulation method of natural family planning. After successful completion of a teaching phase of three cycles, 725 subjects entered a 13-cycle effectiveness phase and contributed 7514 cycles of observation. The overall cumulative net probability of discontinuation for the effectiveness study after 13 cycles was 35.6%, 19.6% due to pregnancy. Pregnancy rates per 100 woman-years calculated using the modified Pearl index were as follows: conscious departure from the rules of the method, 15.4; inaccurate application of instructions, 3.5; method failure, 2.8; inadequate teaching, 0.4; and uncertain, 0.5.

PIP: A 5 country prospective study was undertaken to determine the effectiveness of the ovulation method of natural family planning. 869 subjects of proven fertility from 5 centers (Auckland, Bangalore, Dublin, Manila, and San Miguel) entered the teaching phase of 3-6 cycles; 765 (88%) completed the phase. 725 subjects entered a 13-cycle effectiveness phase and contributed 7514 cycles of observation. The overall cumulative net probability of discontinuation for the effectiveness study after 13 cycles was 35.6%, 19.6% due to pregnancy. Pregnancy rates per 100 woman-years calculated using the modified Pearl index were as follows: conscious departure from the rules of the method, 15.4; inaccurate application of instructions, 3.5; method failure, 2.8; inadequate teaching, 0.4; and uncertain, 0.5. Cycle characteristics included: 1) average duration of the fertile period of 9.6 days, 2) mean of 13.5 days occurred from the mucus peak to the end of the cycle, 3) a mean of 15.4 days of abstinence was required, and 4) a mean of 13.1 days of intercourse was permitted. Almost all women were able to identify the fertile period by observing their cervical mucus but pregnancy rates ranged from 27.9 in Australia and 26.9 in Dublin to 12.8 in Manila. Continuation was relatively high ranging from 52% in Auckland to 74% in Bangalore.