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To investigate relative efficacy of intrauterine diclofenac and ibuprofen as adjuvants to intrauterine quinacrine for nonsurgical sterilization, a total of 900 women were systematically allocated to 2 monthly insertions of pellets of diclofenac (75 mg) or ibuprofen (55.5 mg) as adjuvants to intrauterine quinacrine (216 mg) in a rural private practice in West Bengal, India. All women were prescribed oral contraceptives for three months from first insertion. In the middle of the study increased care was taken to insert pellets at the fundus. There was no statistically significant difference found in cumulative life-table pregnancy failure rates at 36 months for women receiving diclofenac (2.7 +/- 0.82) or ibuprofen (3.4 +/- 0.89). Taking care to insert pellets at the fundus resulted in a decline of failures at 24 months from 4.4 +/- 0.92 to zero. Intrauterine administration of pellets of quinacrine (216 mg) plus diclofenac (75 mg) or ibuprofen (55.5 mg) with 3 months' oral contraception provides acceptable efficacy if pellets are inserted to the fundus.

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Two preliminary single-insertion clinical trials of the quinacrine pellet method of non-surgical female sterilization were compared. Both trials used transcervical application of quinacrine, 252 mg, and diclofenac, 75 mg, as pellets. In the first trial (21 April 1992 to 17 February 1993), 58 women received oral contraceptives for three months. In the second trial (19 February 1993 to 25 May 1994), 229 women received medroxyprogesterone acetate, 150 mg IM, at the time of quinacrine insertion. At 18 months, the life-table pregnancy failure rate per 100 women of the first trial was 8.6 (SE 3.7), whereas the failure rate for the medroxyprogesterone acetate group was 0.5 (SE 0.5), p<0.05. There were no serious complications or side-effects in either group. Larger confirming trials with random allocation and long-term systematic follow-up are needed to determine whether a single injection of medroxyprogesterone improves the efficacy of quinacrine.

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This paper was published in the wake of Pope John Paul II's encyclical 'Evangelicum Vitae', which condemns abortion and contraception. The author describes how, in the mid-1970's, the Vatican blocked the implementation of President Nixon's 'National Security Study Memorandum 200', which was intended to combat global overpopulation. The author explains that excessive population growth is considered threatening to U.S. security interests, and concludes that "papal security-survival along with the influence of fundamentalist Protestant opposition to birth control is now pitted against the U.S. and world security-survival."

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Much evidence suggests that demand for sterilization is a function of supply of surgical sterilization services in less-developed countries. If such services were greatly expanded, the number of procedures performed would grow dramatically. While the prevalence of sterilization is estimated to increase from 23.5% to 28.8% of married women of reproductive age in the 1990s, there will actually be 106,432,000 more couples of reproductive age at the end of this decade than at its beginning who use either no method or a far less effective method with much lower continuation rates than sterilization--nearly a 20% increase. To achieve a mean sterilization prevalence of 47% of married women of reproductive age in the less-developed world, as now seen in the Republic of Korea and Puerto Rico, the number of sterilizations would need to be more than double the current projection for the 1990s: 328,429,000 rather than 159,000,000. The quinacrine pellet method for nonsurgical female sterilization offers hope that this enormous shortfall in sterilization services can be overcome in this decade.

PIP: Around 23% of all married women of childbearing years in all developing countries combined have undergone sterilization. Male and female sterilization protects almost 50% of all contraceptive users from pregnancy. In India, sterilization provides protection for 70% of all contraceptive users and 31% of all married women of childbearing years. These figures in China are 49% and 37%, respectively. Together these 2 countries have 82% of all sterilization acceptors in developing countries. Across cultures acceptance of sterilization is high. Projected demand for sterilization during the 1990s ranges from 151,000,000 to 164,000,000. Using the middle projected number of 159,000,000, 2 scientists estimate that 47,849,000 new sterilizations would be needed just to keep the same prevalence of 23.5% and 49,332,000 to raise the prevalence to 28.8%. Family planning professionals should work to increase sterilization prevalence to at least the levels of the Republic of Korea (47.6%) and of Puerto Rico (46.8%). To increase prevalence to 47% of married women of childbearing age in developing countries during the 1990s, the number of sterilizations needed should actually be 437,938,000. Sterilization prevalence rates for 35-39 year old women in some developing countries have already exceeded 47% including the Republic of Korea (74%), Panama (62%), and China (60%). Surgical sterilization cannot realistically meet these needs. The quinacrine pellet method of nonsurgical female sterilization may be a viable option. It consists of 2 intrauterine administrations of 252 mg quinacrine a month apart during the proliferative phase of the menstrual cycle. This causes occlusion of the fallopian tubes. By the end of 1992, there may have been as many as 175,000 completed quinacrine nonsurgical sterilizations. Prostaglandins serve as adjuvants to this method. The success rate is 98-99%. It has caused no deaths and no serious complications. The cost of this method is US$.25.

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OBJECTIVE: To compare the findings of the case-control and cohort studies used to indict the Dalkon Shield (A.H. Robins Company, Inc., Richmond, VA) with the findings of the Dalkon Shield clinical trials. DATA IDENTIFICATION: All published reports on the Dalkon Shield were identified through MEDLARS system (United States National Library of Medicine) searches and by cross checking all references in these reports. The same approach was used to identify all case-control and cohort studies of the purported relationship between intrauterine devices (IUDs) and pelvic inflammatory disease (PID). STUDY SELECTION: Only studies of interval patients that included 50 or more women and 6 or more months of follow up that computed standard IUD event rates (rates of pregnancy and expulsion and removal for pain and bleeding) were selected for this study. All case-control and cohort studies identified were included except two case-control studies that included women with sterile chronic salpingitis. RESULTS: The 16 case-control and 2 cohort studies found or suggested that the Dalkon Shield increased the risk of PID. The 71 clinical trials of the Dalkon Shield show that when this device is inserted by an experienced clinician it is a safe and effective contraceptive method, comparable with other IUDs used at the time. There was no evidence of an increased risk of PID found in these clinical trials. CONCLUSIONS: This study offers convincing evidence that the indictment of the Dalkon Shield was a mistake. Additionally, this study shows that physician skill and experience is far more important to successful IUD insertion than previously recognized, a finding with considerable implications for IUD study designs and for marketing strategies.

PIP: 2 researchers searched MEDLARS databases for articles on clinical trials of the Dalkon Shield to compare the results of case control and cohort studies which identified its relationship with pelvic inflammatory disease (PID) with those of other clinical trials. They identified 71 useful reports. The results of clinical trials not used to incriminate the A.H. Robins Company, the manufacturer of the Dalkon Shield, showed that the Dalkon Shield was indeed safe and effective when inserted by a skilled and experienced clinician. In addition, the Dalkon Shield compared favorably with other IUDs. Further the pregnancy rate and removal rate for pain and bleeding matched those of other IUDs. Moreover the expulsion rate for the Dalkon Shield was better than that of other IUDs. In those studies that examined PID, the PID rates were essentially the same as the expected rates of other IUDs in their clinic populations. Besides, even though the case control studies suggested a considerable increased PID rates with the Dalkon Shield, increased rates of removals for pain and bleeding did not occur. Furthermore pregnancy and expulsion rates improved as did the skill and experience of the physicians who inserted the Dalkon Shield. In fact, the best rates occurred in trials conducted in centers where only a few clinicians inserted 1000 Dalkon Shields. For example, the removal rate for pain or bleeding was as low as 0.9%. This rate among inexperienced clinicians was as high as 27%. The fact that the litigation case against A.H. Robins used the results of the weaker case control studies rather than the superior randomized clinical trial resulted in removal of a safe and effective contraceptive. Further IUD studies should incorporate clinician skill as a variable to better assess the IUD's efficacy and safety.

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The Women's Health Study (WHS) was a large, widely accepted and influential case-control study of the relationship between the use of intrauterine contraceptive devices (IUDs) and pelvic inflammatory disease (PID). The data were collected at 16 hospitals in 9 cities across the U.S.A. from October 1976 through August 1978. The first paper on this research was published in 1981 and concluded that IUDs increase the risk of PID. The report cited an estimated RR (relative risk) of PID for current IUD users vs nonIUD users of 1.6 with a 95% confidence interval of (1.4, 1.9). However, careful examination of the report reveals that the data support conclusions antithetical to those at which the author arrived. When the second report on the WHS was published in 1983, it was anticipated that many of the shortcomings of the first report would be corrected, but they were not. In 1983 we undertook a complete reanalysis of the same WHS data using more appropriate criteria and the results were compared to the first two published reports. The reanalysis revealed an RR of 1.02 (0.86, 1.21) for current IUD users compared to noncontraceptors. The conclusion of the WHS should have been that IUDs do not increase the risk of PID.

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The transcervical quinacrine pellet method developed by Zipper and co-workers is potentially a much needed safe, inexpensive, and effective non-surgical method of female sterilization. This method utilizes an intrauterine device inserter to deposit 250 mg of quinacrine hydrochloride as pellets in the uterine cavity. No complications or side effects, other than temporary pain and oligomenorrhea, have been reported. Tetracycline has an established track record for safety. It also has been reported to have properties similar to quinacrine as a sclerosing agent, with potential as a non-surgical method using the quinacrine insertion technique. To expand the experience with quinacrine and to study tetracycline as an alternative, studies were undertaken under the auspices of the Indian Rural Medical Association in Calcutta, India. During the period 14 August, 1979 to 28 June, 1984, 414 women received three insertions of 200 mg of quinacrine. There were 29 failures and a three-year life table failure rate of 8.5. During the period 25 April, 1984 to 28 December 1984, 55 women received three insertions of 200 mg of tetracycline. By 1 June, 1986 there were 32 failures among the 55 cases for a failure rate of 58%. A more recent study using a single dose of 1000 mg of tetracycline also produced unacceptably high failure rates.

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This study lends support to others indicating the apparent safety and effectiveness of multiple transcervical insertions of quinacrine hydrochloride as pellets in 240 mg dosage to achieve permanent sterilization. In order to study the effects of the number of quinacrine pellet insertions and the site of placement of the pellets in the uterus of prehysterectomy volunteers, a scoring system of histological changes in the Fallopian tube was designed. Quinacrine pellets were deposited at the fundus using a straight inserter in 16 women, and at the cornua using a curved inserter in 17 women. Each group had at least five women receiving one, two or three insertions at one-week intervals. Results indicate that neither the number of insertions nor the place of deposition of the pellets affects the degree of tubal inflammation and fibrosis.

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No nation desirous of reducing its growth rate to 1% or less can expect to do so without the widespread use of abortion. This observational study, based on the experience of 116 of the world's largest countries, supports the contention that abortion is essential to any national population growth control effort. The principal findings are: Except for a few countries with ageing populations and very high contraceptive prevalence rates, developed countries will need to maintain abortion rates generally in the range of 201-500 abortions per 1000 live births if they are to maintain growth rates at levels below 1%. The current rate in the USA is 426 abortions per 1000 live births. Developing countries, on the other hand, are faced with a different and more difficult set of circumstances that require even greater reliance on abortion. No developing nation wanting to reduce its growth to less than 1% can expect to do so without the widespread use of abortion, generally at a rate greater than 500 abortions per 1000 live births. Widespread availability of abortion is a necessary but not sufficient condition to achieve growth rates below 1%. A high contraceptive prevalence is essential as well in order to achieve growth rates below 1%. A high contraceptive prevalence is a necessary but not sufficient condition to achieve population growth rates below 1%. A high rate of abortion (generally 201-500 or more abortions per 1000 live births in the developed and greater than 500 abortions per 1000 live births in the developing countries) is essential to achieve growth rates below 1%. The different and more difficult set of circumstances faced by developing countries that will necessitate even higher abortion rates than developed countries includes a young population with resultant rapidly growing numbers of young fertile women, poor contraceptive use-effectiveness, low prevalence of contraception, and poor or non-existent systems for providing contraceptives. These data show that high death rates of infants and children can moderate population growth rates--a most undesirable solution. The data in this report suggest that actual alternatives are high death rates of infants and children or widespread use of contraception and abortion. African nations tend to have the very lowest abortion rates and the very highest infant and child death rates. To avoid a world with deteriorating social, economic and political stability, with the concomitant loss of personal and national security, we must ensure that safe abortion is made available to all who wish to use this service.

PIP: Population control is an important but neglected social benefit of abortion. To examine this role, the outhors compared population growth rates and abortion (legal and illegal) incidence rates for the 116 largest countries in the world. These 116 countries were first ranked by their abortion rates into 4 groups: very high (greater than 500/1000 live births), high (201-500/1000), moderate (50-200/1000) and low (less than 50/1000). Then each of these 4 groups was ranked according to contraceptive prevalence: very high (60% or above), high (40-59%), moderate (15-39%), and low (less than 15%). Within each of the 16 groups, the countries were then ranked according to their population growth rate. The age distribution and mortality of children under 5 years of age were also considered for each country. The data indicate that where abortion and contraceptive prevalence rates are the highest and populations are the oldest, growth rates tend to be the lowest. As contraceptive prevalence decreases, the growth rate increases. The younger the population, the greater the growth rate. Where the abortion rate is very high with only modest use of contraception, a high growth rate can result. Thus, abortion is necessary but not sufficient to cause low growth rates. With the exception of a few countries with aging populations and very high contraceptive prevalence rates, developed countries need to maintain abortion rates in the range of 201-500/1000 if they are to maintain growth rates at levels below 1%. An even greater reliance on abortion--over 500/1000 live births--is required in developing countries to reduce population growth.

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Presented is a comparison of the safety of open and conventional laparoscopy. The 1400 cases make up a data set consisting of 1112 cases of open and 288 cases of conventional laparoscopy. The two techniques were compared with respect to three parameters commonly used to evaluate safety. For the open versus the conventional technique, the rates of surgical difficulties were 2.9 and 2.1%, respectively, rates of surgical complications were 1.4% for both techniques, and rates of technical failures were 0.2 and 2.0%, respectively. All the problems that led to technical failure were however, due to preexisting conditions. These data indicate that with respect to safety, the open technique is comparable with the conventional technique. However, the present data set cannot address the comparative risks of the infrequent but potentially life-threatening risks of major blood vessel laceration and viscus injury.

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Data on 36 611 singleton deliveries in Indonesia were used to contrast patient characteristics, obstetric history and pregnancy outcome for two birth weightgroups among women experiencing the best and poorest stillbirth rates, namely 3 000-3 499 g and less than 2 500 g, respectively. The low birthweight group was characterized by younger age at first marriage, rural residence, lower educational attainment, less antenatal care and poorer pregnancy outcome and infant survival. Both groups showed progressive anemia prevalence with increasing parity with lower hemoglobin levels for the low birth weight group. Stillbirth rates were particularly high (60.6 per 1 000 pregnancies) for the under 20 year olds in the lower birthweight group. The results suggest poorer maternal nutrition among women with lower educational achievement, higher energy expenditures among rural women, nutritional reserves depletion with increasing parity and competition between the teenager's nutritional needs for her own physical growth and fetal growth as factors in low birthweight and perinatal mortality.

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PIP: Knowledge of, attitudes toward, and use of contraception were investigated in a 1982 survey of 250 men living in Khartoum, Sudan. Interviews were conducted at mosques, marketplaces, a government office building, and a textile factory. 75% of respondents were ages 21-40. 92% of respondents expressed the belief that Khartoum is overcrowded, although this was attributed by 57% to rural-urban migration. Despite the fact that 85-95% linked overpopulation with social problems such as inflation, food shortages, and unemployment, 72% expressed a desire for 5 or more children. Only 30% of the men interviewed supported the concept of family size limitation, largely for economic reasons. The majority of those opposing family size limitation cited religious reasons. Attitudes toward child spacing were more favorable, with 80% indicating approval 59% of the men with wives at risk of pregnancy reported that they were using some form of contraception, but only 21% were using an effective method. Two-thirds of respondents reported that they do not discuss contraception with their spouse. 60% identified either the mass media or friends and relatives as their source of family planning information. Although 64% indicated an awarencess of where to obtain family planning services, only 2.8% had ever received services from a family planning clinic. 79% voiced an interest in more information on family planning, and 59% with wives of reproductive age wanted to use family planning services. Most respondents desired more information on sexual sterilization and, although surgical contraception is not available in Sudan, 10% said they would consider this method when they attained their desired family size. The belief that family size should be limited increased dramatically with education, from 9% among those with no formal schooling to 45% among men with 13 or more years of school. Men under 40 years of age had more favorable attitudes toward family planning than older men. Surprisingly, men interviewed at mosques had the most favorable attitudes whereas government employees were the most conservative. Overall, these fndings suggest that the present family planning clinic system in Sudan may be falling short of meeting the demand for information services.^ieng

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No nation wanting to reduce its growth rate to less than or equal to 1% can expect to do so without the widespread use of abortion. This study, based on the experience of 116 of the world's largest countries, supports the contention that abortion is essential to any national population growth control effort. Existing circumstances in developed countries have facilitated reduction of growth rates to less than 1%, with abortion rates generally in the range of 200 to 500 per 1000 live births. However, developing countries are faced with a different and more difficult set of circumstances that require even greater reliance on abortion. These obstacles include a young population with resultant rapidly growing numbers of young fertile women, poor contraceptive use-effectiveness, low prevalence of contraception, and poor or nonexistent systems for providing contraceptives. By virtue of their profession, physicians play a critical role in family planning and carry a special responsibility in ensuring that abortion services are available to all women who need them.

PIP: No nation wanting to reduce its growth rate to or=1% can expect to do so without the widespread use of abortion. This study, based on the experience of 116 of the world's largest countries, supports the contention that abortion is essential to any national population growth control effort. Existing circumstances in developed countries have facilitated reduction of growth rates to less than 1%, with abortion rates generally in the range of 200-500/1000 livebirths. However, developing countries are faced with a different and more difficult set of circumstances that require even greater reliance on abortion. These include a young population with resultant rapidly growing numbers of young fertile women, poor contraceptive use effectiveness, low contraceptive prevalence, and poor or nonexistent systems for providing contraceptives. By virtue of their profession, physiciansalpy a critical role in family planning and carry a special responsibility in ensuring that abortion services are available to all women who need them.

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Menstrual pattern changes experienced by 5982 women subsequent to sterilization by the techniques of minilap/Pomeroy, minilap/tubal ring and laparoscopy/tubal ring were tabulated. Controlling for prior contraceptive use, we examined data on the following six menstrual parameters at the time of sterilization compared to reports at follow-up visits 6 and 12 months after surgery: cycle regularity, cycle length, menstrual flow duration, amount of flow, dysmenorrhea and intermenstrual bleeding. Our findings suggest that minilap sterilization does not cause menstrual pattern changes.

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A comparison is made of menstrual pattern changes reported by 10,004 women undergoing interval and postabortion sterilization by the laparoscopic occlusive techniques of unipolar electrocoagulation, the tubal ring, the prototype spring-loaded clip, and the Rocket clip. Controlling for prior contraceptive use, the menstrual patterns in these women sterilized by the four techniques were compared with respect to six parameters: cycle regularity, cycle length, menstrual flow duration, amount of flow, dysmenorrhea, and intermenstrual bleeding. The majority of women reported no menstrual changes subsequent to sterilization. When changes were experienced, they occurred in equal proportions in opposite directions. Depending on the parameter, from 15% to 79% of the menstrual pattern changes seen within 6 months after sterilization in women who were using oral contraceptives or intrauterine contraceptive devices at the time of sterilization could be attributed to the discontinuation of those methods of contraception. There were no significant differences between the several occlusion technique groups with respect to the proportion of women who reported changes in their menstrual patterns after sterilization.

PIP: A comparison is made of menstrual pattern changes reported by 10,004 women undergoing interval and postabortion sterilization by the laparoscopic occlusive techniques of unipolar electrocoagulation, the tubal ring, the prototype spring-loaded clip, and the Rocket clip. Controlling for prior contraceptive use, the menstrual patterns in these women sterilized by the 4 techniques were compared with respect to 6 parameters: cycle regularity, cycle length, menstrual flow duration, amount of flow, dysmenorrhea, and intermenstrual bleeding. The majority of women reported no menstrual changes subsequent to sterilization. When changes were experienced, they occurred in equal proportions in opposite directions. Depending on the parameter, from 15%-79% of the menstrual pattern changes seen within 6 months poststerilization in women who were using OCs or IUDs at the time of sterilization could be attributed to the discontinuation of those contraceptive methods. There were no significant differences between the several occlusion technique groups with respect to the proportion of women who reported changes in their menstrual patterns after sterilization.

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