Efficacy, acceptability, and clinical effects of a low-dose injectable contraceptive combination of dihydroxyprogesterone acetophenide and estradiol enanthate.

A total of 1,904 women, aged 15-38, used an injectable contraceptive combination of 90 mg dihydroxyprogesterone acetophenide with 6 mg estradiol enanthate, given once during each menstrual cycle between the 7th and 10th day, and preferably on the 8th day of the cycle, for a total of 17,576 cycles. Of these 1,904 women, 1,197 completed 12 cycles of use of the injectable combination. One subject became pregnant during the trial, resulting in a cumulative pregnancy rate of 0.07%. Principal reasons for discontinuation were personal, non-medical reasons, such as lost to follow-up, no longer wished to continue, protocol violation, desire to change to another contraceptive method, moved away, or other personal reasons. Mean weight of 1,901 subjects at admission to the trial was 53.5 +/- 0.2 kg and this increased to 54.3 +/- 0.3 kg after 12 cycles of use. Approximately 50% of subjects experienced menstrual bleeding similar to normal throughout the study period. The most frequent menstrual abnormality was irregular bleeding, experienced by approximately one-third of subjects.

New data show Norplant effective for 7 years.

PIP: According to research conducted in Chile, the Dominican Republic, Egypt, Finland, Singapore, Thailand, and the US, the levonorgestrel contraceptive implant Norplant offers up to 7 years of effective protection from pregnancy. The research involved two independent studies of 1210 women aged 18-40 in the seven countries using soft-tubing as well as hard-tubing Norplant implants. Overall, results indicated that cumulative 7-year pregnancy rates among Norplant users are comparable to rates among women who have been surgically sterilized. Moreover, among women ages 18-33 the 7-year Norplant pregnancy rates are comparable to the median rates of tubal sterilization methods for women of the same age and duration of use. For women ages 34 and older, without regard to weight at admission, the 7-year effectiveness of soft-tubing Norplant equals or surpasses that of tubal sterilization.^ieng

Can you bet your life on a condom?

PIP: A number of studies have demonstrated that when used consistently and correctly, both male and female condoms prevent unplanned pregnancy and the spread of sexually transmitted diseases (STDs). For example, in a study of US navy personnel who reported having vaginal intercourse with prostitutes who had a high prevalence of gonorrhea, none of the 29 men who reported using condoms during their sex acts contracted gonorrhea or nongonococcal urethritis. However, 14% of the 499 nonusers became infected. The preponderance of evidence from 10 studies of high-risk populations in 7 countries where both the level of condom use and HIV infection were prospectively measured showed the consistent use of male condoms to protect against HIV acquisition in the range of 50-100%. Additional evidence in support of condom use comes from two studies involving HIV-discordant couples. A European study of 123 such couples who consistently and correctly used condoms found that no HIV-uninfected partner became infected with HIV by their partners. Similarly, 1 of 42 seronegative partners in HIV-discordant couples in Haiti became infected with HIV after having consistently used condoms. In both of these studies, 7-14% of couples who used condoms either consistently or not at all became infected. Since the government of Thailand began promoting 100% condom use among prostitutes and their clients, there has been a decline in both the level of curable STDs reported to clinics and HIV prevalence among Thai military recruits. Male and female condoms are effective even under typical imperfect conditions, and their consistent use should be encouraged at every opportunity.^ieng

Comparative study of safety and efficacy of IUD insertions by physicians and nursing personnel in Brazil.

To assess whether trained nursing personnel could provide IUD services as safely and effectively as physicians in Brazil, an experimental study was conducted at the main clinic of the Center for Research on Integrated Maternal and Child Care in Rio de Janeiro. From November 1984 through April 1986, a total of 1,711 women who requested IUD insertion at the clinic were randomly assigned to have a Copper-T 200 IUD inserted by one of the clinic's 11 physicians or 13 nurses. All of the physicians and nursing staff members who provided these services had taken the Center's standard clinical family planning training course. Of 860 insertions attempted by the physicians and nurses, 1.3% and 3.3%, respectively, were unsuccessful. Statistically, this difference was very significant (P < 0.01). Also, mainly because the cervix was small and undilated, nulliparous women had a relatively high insertion failure rate of 8.0%, as compared to 1.5% for primiparas and 1.0% for multiparas. The overall rate of complications at insertion was 1.8%, these complications including diaphoresis, vomiting, syncope, cervical laceration, and one case of perforation of the uterus; no significant difference was found between the complication rates for insertions performed by physicians as compared to nurses. However, 9.0% of the study subjects reported severe pain during IUD insertion, with significantly higher percentages reporting pain if the IUD was inserted by a physician, or if the subject was nulliparous, had preinsertion symptoms, or had a history of pelvic inflammatory disease (PID) or sexually transmitted disease (STD). It was also found that the nurses had a dramatically high insertion failure rate (11.6%) with nulliparous subjects, while the physicians' failure rate with such subjects was a significantly lower 3.4%. No significant difference was found in the groups served by nurses and physicians with regard to postinsertion complaints or termination of use within 12 months of insertion. These findings suggest that future training, besides preparing nursing personnel in IUD insertion, should emphasize preparation in taking the client's medical history and diagnosing existing medical symptoms that could be associated with IUD insertion complications. In addition, if a nulliparous woman requests an insertion, it should be performed by a physician or more experienced nursing staff member with close medical supervision. Because of high rates of reported pain at insertion, such women, as well as those with medical symptoms associated IUD insertion complications and those with a history of PID or STD, should be considered candidates for extra care and counseling.(ABSTRACT TRUNCATED AT 400 WORDS)

PIP: In the mid-1980s in Brazil, health workers randomly assigned 1711 women aged 15-48 requesting IUD insertion at the Center for Research on Integrated Maternal and Child Care clinic in Rio de Janeiro to have the Copper-T 200 IUD inserted by a physician or by a nurse. The study aimed to determine whether trained nurses could perform as safe and effective IUD insertions as physicians. Insertion failure was more common when performed by nurses than physicians (3.3% vs. 1.3%; p = 0.005). Severe pain at insertion was more common during physician insertions than nurse insertions (10.8% vs. 7.1%; p = 0.008) and in women who had menstrual bleeding, bleeding, dysmenorrhea, or pelvic pain than in women lacking these preinsertion symptoms (14.2% vs. 7.8%; p 0.001). History of pelvic inflammatory disease (PID) or a sexually transmitted disease (STD) increased the likelihood of severe pain at insertion (14.5% vs. 8.5%; p = 0.022). Nulliparous women were more likely to experience insertion failure than parous women regardless of provider, especially for nurse insertions (11.6% vs. 1.6%; p 0.01). The higher failure rate among nurses was probably due to a higher proportion of nulliparous women in the nurse insertion group (17.2% vs. 13.6%; p 0.05). The overall IUD use-effectiveness rate at 12 months was 98.8% (98.6% for physicians and 99% for nurses). The cumulative IUD continuation rate at 12 months was slightly better for nurse insertions than for physician insertions (75.2% vs. 74.4%). There were no significant differences between termination rates regardless of reason (pregnancy, expulsion, or removal) between physicians and nurses. The increases in complaint rates between preinsertion and postinsertion were the same for both physicians and nurses (25.8% and 25.1%, respectively). These results indicate the need to emphasize taking the client's medical history and diagnosing existing medical symptoms that are possibly linked to IUD insertion complications. Physicians or more experienced nurses should insert an IUD in nulliparous women. More counseling and care are needed for women with IUD insertion complications and those with a history of PID or STD.

Recent experience with and future directions of contraceptive implants and injectable contraceptives.

Subdermal implantable contraception has been the most important addition to contraceptive technology in the past 2 decades. The Norplant system is only the first of a new family of long acting methods of high effectiveness, high acceptability, and prompt reversibility. The main advantage of the second generation implant systems, to be available soon, is the reduction in the number of implants, which greatly facilitates insertion and removal. However, great improvement in bleeding control is not to be expected. Large and carefully designed epidemiological studies have contributed to clear the main objections to the US Food and Drug Administration (FDA) approval of depot medroxyprogesterone acetate (DMPA) as an injectable contraceptive. New progestin-only, long acting injectables are being tested, but significant improvements over existing methods are difficult to foresee, although every alternative is welcome. Monthly combined injectables have been in great demand, at least in China and Latin America, because of better bleeding control. Improved combined monthly injectables, less estrogenic and more progestin dominated, have been developed and are being introduced in several countries and should soon replace the old monthly injectables. Contraceptive implants and injectables have shown to be an important addition to the contraceptive options available to women throughout both the developing and developed world.

Desogestrel-ethinylestradiol, an oral monophasic contraceptive. Clinical and lipid metabolic effects: a 5-year experience.

A comparative study of 5 years' duration using desogestrel (DSG), levonorgestrel (LN), and norethindrone (NET), combined with ethinyl estradiol (EE), was conducted. A total of 4499 cycles on DSG-EE, 3691 on LN-EE (1980 on triphasic and 1711 on monophasic schemes) and 1680 on NET-EE was evaluated. A contraceptive efficacy of 100% was obtained in all the groups. Minimal side effects were observed. In particular, body weight in those women on DSG-EE did not show noticeable changes and headaches were minimal. No alterations on blood pressure readings or on the routine laboratory tests were noticed in any of the groups. There was a significant increase in high-density lipoprotein-c (HDL-c) in women on DSG-EE. There was no change in NET-EE, and a significant decrease in women on LN-EE in both schemes. Changes in LDL-C, very low density lipoproteins, triglycerides, total lipids, total cholesterol, and glucose were not significant, although there was some increase at 60 cycles on triglycerides on those women on DSG-EE and on NET-EE. At the end of 5 years, 76% of women continued on DSG-EE. They indicated their satisfaction with this method.

Lactation and contraception.

The contraceptive effect of breastfeeding has been quantified in population-based surveys, and decreases in breastfeeding would require increase in contraceptive practice in order to keep total fertility in check. A consensus was recently achieved on the use of lactational amenorrhea for family planning. Lactational amenorrhea during nearly-full breastfeeding for the first six months postpartum can be considered an appropriate complement to contemporary family planning methods. It is especially useful when compliance and continuation with other contraceptive methods are poor. Physicians have often undervalued the contraceptive effectiveness of lactational amenorrhea, yet obstetricians and gynecologists are ideally placed to promote both breastfeeding and family planning. They have unique opportunities to influence both hospital practices and societal perceptions regarding breastfeeding.

PIP: The contraceptive effect of breastfeeding has been quantified in population-based surveys, and decreases in breastfeeding would require increases in contraceptive practice in order to keep total fertility in check. A consensus was recently achieved on the use of lactational amenorrhea for family planning. Lactational amenorrhea during nearly- full breastfeeding for the 1st 6 months postpartum can be considered an appropriate complement to contemporary family planning methods. It is especially useful when compliance and continuation with other contraceptive methods are poor. Physicians have often undervalued the contraceptive effectiveness of lactational amenorrhea, yet obstetricians and gynecologists are ideally placed to promote both family planning and breastfeeding. They have the opportunity to influence both hospital practices and societal perceptions regarding breastfeeding. (author's)

Prospective experience with a levonorgestrel implant--Norplant.

PIP: The clinical trial of a longacting levonorgestrel implant, Norplant, as a reversible method of contraception in 2 outpatient clinics of 2 hospitals in Colombia, has had very promising results. In almost 400 acceptors, with thus far more than 2600 woman-months, the pregnancy rate has been nil. Results of the 1st 300 cases are summarized, illustrating 2 sites of insertion--the inner region of the left arm and the left scapular region, both of which present some advantages. Secondary effects and other parameters are analyzed, including irregular bleeding and amenorrheas. Finally, some comments are made in relation to site, extraction, acceptability, and future use of the method. (author's) modified^ieng

Long-term experience with Norplant implants in international clinical trials.

Norplant subdermal implants containing levonorgestrel were used for contraception and compared with the Copper T, Model T Cu 200, during 42 months of use in an open study in Chile, the Dominican Republic, and Finland. Among 324 women enrolled for the implant regimen, there were no pregnancies in the 1st 2.5 years, and 2 by the end of 42 months. 1st segment net and gross cumulative pregnancy rates were 0.7 and 1.2/100 respectively, at 3.5 years. Cumulative pregnancy rates for the T Cu 200 group were 2.9, net and 3.5/100, gross at 42 months. More than 1/2 of the implant acceptors, 51.6/100 were continuing use at 3.5 years, somewhat above the continuation rate of the T Cu acceptors, 43.5/100, but not significantly so.

User's perception of the contraceptive vaginal ring: a field study in Brazil and the Dominican Republic.

PIP: The basis for this report is home interviews of users of the contraceptive vaginal ring and the pill from urban and rural clinics in 2 provinces in the Dominican Republic and clinics from 2 towns and a large city in Brazil. Dominican ring users were significantly more likely to be older than pill users, to have more schooling, and have partners with more education. 6% were illiterate and 75% had only elementary education. 1/10 of the ring users reported having had problems with insertion of the ring and 1/5 had problems removing it. It may be worthwhile to try a narrower, more flexible model that may be easier to insert and remove. 1 out of every 6 users reported vaginal odor, 1 out of 8 reported having felt the ring move in their vagina, and 1/3 were aware of the ring at some time. About 1/2 the women in each country said the ring had changed color during use, and about 1/2 of those who reported the change did not like it. It became light gray and looked dirty. Correction may improve acceptance. 10% reported having expelled the ring. Twice as many ring users reported having menstrual problems. Ring and pill users both reported headaches, vaginal discharge, menstrual pain, and increased libido. A large proportion of ring and pill users experienced decreased duration and amount of menstrual bleeding, which was seen more as a beneficial than a negative effect. The same can be said for weight gain, which was "linked" by 89% of the women in the Dominican Republic. 64% of ring users and 67% of pill users described thier respective method as good or very good. Detailed instructions should accompany the final model. They should say that it is alright for the ring to be any place within tha vagina for it to be effective.^ieng

Two years' experience with two levonorgestrel-releasing intrauterine devices and one copper-releasing intrauterine device: a randomized comparative performance study.

A randomized comparative performance study of two levonorgestrel intrauterine devices (IUDs) and a copper (Nova-T) IUD (Leiras, Turku, Finland) was performed at two clinics in Finland and one in Brazil. The 24-month cumulative event rates per 100 women are reported. Six thousand woman-months of use were recorded with the levonorgestrel IUD and 3000 with the Nova-T device. Pregnancy rates at 2 years of use were 0.6 and 0 with the two levonorgestrel IUDs and 3.3 with the Nova-T IUD. Removal rates because of bleeding and/or pain were low with all three IUDs: 7.5, 7.6, and 7.1, respectively, at 24 months. Recordings of the number of days of bleeding showed significantly fewer days of bleeding during use of the levonorgestrel IUDs than the Nova-T IUD from the second month of use onward, until the end of the second year. No infections were recorded in association with use of the levonorgestrel IUDs, and only one termination because of infection was recorded for the Nova-T IUD. The continuation rates of use at 24 months were 66.6, 60.7, and 71.9 for the two levonorgestrel IUDs and the Nova-T IUD, respectively; the differences were not statistically significant.

Trials of the ovulation method of natural family planning.

PIP: The concept of utilizing changes in cervical secretion offers a potentially simple method of natural family planning. A detailed international trial has been conducted to test the effectiveness of the method. 5 centers are involved: Auckland; Bangalore; Dublin; Manila; and San Miguel. The observations provide an indication of the value and success of the method. They also reveal interesting variations between the different centers and between various socioeconomic classes. The work was divided into a teaching phase and an effectiveness phase. The initial phase was designed to teach individual women how to recognize the symptoms in cervical mucus, and it usually covered the first 3 complete cycles. The subjects were ovulatory, of proven fertility, less than 39 years, nonlactating, and with a history of a menstrual cycle of between 23 and 35 days. Data were collected from the patient and returned to the organizers for analysis. Comparisons were then made between different centers on the 2 study phases. In the teaching phase 94% of the women could soon recognize and record their own cervical mucus symptoms. Many women could understand the principle of the method within the 1st teaching cycle. Almost 90% of the subjects completed the teaching phase, and 7% discontinued for various reasons, including 1.3% who failed to learn the method, and 5% who became pregnant. The average number of days of abstinence by the method was 17 in the 3rd teaching cycle, a high proportion of the length of the average menstrual cycle. After the teaching phase, 725 subjects were studied in an effectiveness phase which lasted for 13 cycles. More than 7500 cycles were analysed. High rates of method failures were found in the 2 most socially developed centers, Auckland and Dublin. Pearl rates for method failure ranged from 9.4/100 women years in Auckland to 1.1 in Manila and 0 in Bangalore and San Miguel. The accumulative probability of discontinuation after 13 cycles was 35.6%, more than half of this figure being due to pregnancy. Detailed pregnancy rates/100 woman years, using the modified Pearl Index, were found to be 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 reasons 0.5. Subjects were not selected randomly.^ieng

[Postplacental application of 5 different types of intrauterine devices]. / Aplicación postplacenta de cinco tipos diferentes de dispositivos intrauterinos.

PIP: 5 different types of IUDs were used in 1020 women after placental expulsion: T Cu220 in 101 cases; Lippes Loop in 407 cases; T Cu200 in 180; Progestasert in 196; and the Multiload 250 in 136. IUD insertion was accomplished by 3 different techniques: manual, with Forester's forceps, and with an experimental applicator. There were more expulsions and more pregnancies when the applicator was used. Expulsion and pregnancy rates were higher with the Progestasert. The T Cu220C showed the lowest number of expulsions and pregnancies and the highest continuation rate. Removals for medical reasons were similar among all IUD types. (author's modified)^ieng

[Comparative clinical study of 5 barrier methods]. / Estudio clínico comparativo de cinco métodos de barrera.

PIP: The effectiveness and acceptability of 5 barrier methods of contraception were investigated in 171 males and 407 women. They chose the use of ovules with 0.4 mg phenylmercuric acetate; foaming tablets with mephengol; 60 mg ovules with nonoxynol 9, 5.8%; and polymeric sponges with nonoxynol 9 at different concentrations. Anticonceptive effectiveness was evaluated by the Pearl's Index; the lowest rating (6.0) was for the preservative. In decreasing order came mephengol tablets (33.4), phenylmercuric ovules (33.0), nonoxynol ovules (60.7), and polymeric sponges (52.8-120.0). In general the acceptability was low. Discontinuation of spermaticides was due to unreliability; dissatisfaction was the reason for discontinuation of the preservatives and sponges. There were no important side effects. Some couples using foaming tablets reported a sensation of heat as the tablet was dissolving and 2 users reported a bad vaginal odor. After favorable initial acceptance of these methods, final acceptance was low, possibly due to the association with intercourse and direct manipulation of the genitals. (author's)^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.

[Analysis of 52 pregnancies with intrauterine devices]. / Análisis de 52 embarazos con dispositivo intrauterino.

PIP: This study presents the clinical evalaution of 52 pregnancies in IUD users. 76.9% were between 17 and 30 years of age, and 61.5% had 2 or less deliveries. 48 of the 52 women wore a Lippes Loop device; the majority of pregnancies had occurred within the 1st 12 months after IUD insertion. In 18 cases the device strings were visible; in 6 of these cases the device was removed by pulling the string; 2 women aborted and 4 delivered at term. There were, in total, 21 spontaneous abortions, or 45.7% of cases, 7 premature deliveries, or 15.2% of cases, and 18 deliveries at term of 39.1% of cases. There were 2 ectopic pregnancies. After delivery only 7 women, or 13.5%, requested insertion of another IUD; 34.6% preferred hormonal contraception, 26.9% chose tubal sterilization, and 25% chose local contraception.^ieng

Vasectomy in Guatemala: a follow-up study of five hundred acceptors.

PIP: 500 of the 1576 men vasectomized in the Asociacion ProBienestar de la Familia program between January 1977 and December 1979 were interviewed 12-36 months after vasectomy. 99.4% were married or lived in consensual unions, average age at the time of operation was 36, and average number of children was 3.9. More were highly educated than the general population and 78.2% were Catholic. Primary reasons for undergoing vasectomy included limitation of family size (61.2%), economic considerations (23.6%), avoidance of female contraceptives considered to be harmful (5.4%), relieving the wife of the burden of contraception (4.8%), and other (5.0%). 52.4% chose vasectomy over female sterilization because it is simpler, faster, and less risky. Primary source of referral was friend or relative. 79.4% reported prior use of contraception: 54.4% pills, 13.6% IUD, 12.3% condom, 7.8% vaginal methods, and 11.9% other. Most wives favored the operation. 40% reported discomfort in the 1st few days, primarily pain or inflammation of the testicles, 15% lost time from work, and 47 (9.4%) reported problems 1 month after the operation. Most men considered their general health, sex drive, and marital relations to be unchanged or improved. Only 73.8% had postoperative sperm checks; in 1.9% the check was positive. In 9 of the 500 cases (1.8%) the wife became pregnant. 97.4% said they had never regretted having the operation and 93.2% would recommend the operation to others. Further analysis indicated that satisfaction was not a function of sociodemographic characteristics, attitudes toward the clinic, postoperative discomfort, or wife's attitude. Dissatisfaction stemmed from failure of the operation or perceived negative effect of the operation on one's health or sex life.^ieng