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Chinese women in Shanghai who delivered vaginally and who chose to use an IUD for contraception received a Copper T-380A IUD inserted vaginally within 10 minutes after delivery of the placenta (i.e., immediate postplacental insertion, IPPI). Among them, 97.7% were primipara. The women were randomly divided into two groups: IUD inserted by hand and IUD via ring forceps. The follow-up rate of six months was 95.2%. Using Tietze's life table method and log rank test, the expulsion and other discontinuation rates were compared at three and six months postinsertion between these two different insertion techniques. Expulsions were the main reason for discontinuation. The six-month gross cumulative expulsion rates were 13.3 and 12.7 per 100 women in the hand-insertion group and ring forceps-insertion group, respectively. Discontinuation rates for medical removals (bleeding/pain) were 2.1 and 1.0 in these two groups, respectively. Neither of the differences was statistically significant (p > 0.05). No uterine perforation, infection or pregnancy occurred. The results suggest that these two different insertion techniques do not significantly affect discontinuation rates in vaginal IPPI using the TCu 380A, and the TCu 380A appears to be suitable for postpartum insertion in Chinese women. Other relevant issues, such as breastfeeding and IUD placement in uterine cavity, are also analyzed and discussed in this report.

PIP: During October 1993 to October 1994, in Shanghai, China, 910 women who delivered vaginally at 13 medical centers and requested IUD contraception were randomly allocated to the group in which the TCu 380A was inserted by hand (470) or to the group in which it was inserted by ring forceps (440) within 10 minutes after delivery of the placenta. This was the first birth for 97.7% of the women. The 6-month follow-up rate was 95.2%. 3-month and 6-month expulsion rates as well as rates for medical and non-medical removals between the two insertion techniques were not significantly different (p 0.05). For example, the 6-month gross cumulative expulsion rate was 13.3% for the hand-insertion group and 12.7% for the ring forceps-insertion group. The discontinuation rate for medical removals (e.g., bleeding, pain) was 2.1% for the hand-insertion group and 1% for the ring forceps-insertion group. The IUD expulsion rate was higher in non-breast feeding women than in breast-feeding women (22.4% vs. 11.9%; p 0.05). No woman in either group suffered from uterine perforation or an infection. No woman conceived. In conclusion, the two different IUD insertion techniques do not have a significant influence on discontinuation rates in vaginal immediate postplacental insertion using the TCu 380A.

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Recent epidemiologic studies have suggested that tubal sterilization (TS) may lead to an increased incidence of subsequent hysterectomy but a decreased risk of ovarian cancer. This review evaluates the nature and magnitude of these two relationships, which should be of great concern and interest to women, clinicians and the administrators of family planning programs. The positive relationship between TS and subsequent hysterectomy is more likely to be of a motivational rather than biological nature, and a considerable number of unnecessary hysterectomies after TS could be avoided by changing the attitudes of physicians and women. The inverse relationship between TS and ovarian cancer appears causal, although the exact biological mechanisms remain to be clarified. Theoretically, this non-contraceptive beneficial effect of TS could be used as a primary preventive measure to curb the incidence of the highly fatal ovarian cancer. However, a number of medical, ethical, and economic questions attending use of a generally irreversible contraceptive procedure as a preventive measure must first be answered. The issue of whether TS is associated with any long-term sequelae, and, if so, whether the association is of a cause-and-effect nature or a by-product of time passage and aging of the woman, should be addressed by well-designed studies.

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This paper reviews the historical development of the IUD, describing the challenges and successes, and attempts to offer a balanced perspective for family planning service workers today. Modern IUDs are an important component of family planning services and an excellent contraceptive choice for properly screened women, providing contraception that is safe, effective, long lasting and cost effective. Potential research strategies for the future are also discussed.

PIP: Although there are 100 million current IUD users on a global level, unwarranted apprehension about the device's safety persists on the part of both service providers and potential acceptors. Much of this concern is based on experiences with IUDs such as the Dalkon Shield that are no longer in use and unsubstantiated assertions emerging from past IUD research (e.g., the existence of an IUD-pelvic inflammatory disease link). The development of medicated copper IUDs has renewed confidence about the effectiveness and safety of this form of contraception. The Copper T 380A, Multiload Copper-375, Nova-T, and levonorgestrel-releasing IUD are expected to be the pillars of IUD contraception for the 1990s and beyond, although high production and distribution costs are jeopardizing widespread use in developing countries. Current research is focused on reducing expulsions and medical removal rates through innovative design modifications. At this point, there is sufficient data from prospective multicenter clinical trials to enable evaluation of rare side effects. There is a need, however, to widen the scope of research activities to focus on users' needs and expectations and the impact of sociocultural context. Educational campaigns directed both at the public and the medical community would help to dispel remnants of misinformation.

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PIP: The author reviewed available study findings in the literature to evaluate the merits, disadvantages, and unsettled issues of progestin-only contraceptive pills (POPs) and the newly developed levonorgestrel-releasing (LNG) IUD. The mechanism of POP action and the brands marketed are first considered, followed by discussion of safety considerations, efficacy and compliance, side effects, clinical acceptability, continuation patterns, the advantages of using POPs, current use, and issues to be addressed. The author then discusses the LNG IUD in sections on its mode of action, studies used for evaluation, safety considerations, clinical performance, noncontraceptive effects, and use perspectives and issues to be addressed. The benefits of POPs outweigh their risks, especially for lactating and/or postpartum women, with available information suggesting that POPs are at least as safe as, if not safer than, combined oral contraceptives (COCs). The incidence of nonmenstrual systemic side effects in POP users, such as headaches, nausea, vomiting, and dizziness, tend to be milder, and their incidence may have been overreported in previous studies. However, for POPs to be as effective as COCs, strict compliance is required. Moreover, compared to COCs, POPs are more likely to cause menstrual disturbances in the first few months of use.^ieng

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This review focuses on the safety, efficacy, pros and cons of tubal sterilization procedures performed during the puerperium period while the woman is still in hospital. Findings from four previous reviews are synthesized, and the results published in more recent literature are evaluated. The review finds that tubal sterilization performed while the woman is still on the delivery table, or during a woman's early puerperium while she remains hospitalized, is operationally easy and medically safe, and does not adversely affect lactation. However, reported pregnancy rates are generally higher in puerperal tubal sterilization than in interval sterilization, especially when the mechanical tubal occlusion technique is used. The Pomeroy method, and its modifications via minilaparotomy, is highly recommendable. On the other hand, electrocoagulation via laparoscopy is associated with high efficacy, but a potentially increased risk of complications and difficulties in tubal reversal. Tubal sterilizations can be easily and safely performed at cesarean delivery in selected cases. Tubal sterilization performed during puerperium has a number of advantages over short-acting contraceptive methods, which require strict compliance, for postpartum use. However, candidates for puerperal tubal sterilization need to be carefully screened and counseled, since post-sterilization regret is more likely to occur. Unsettled issues for puerperal tubal sterilization and a number of practical problems that need to be addressed before initiation of a puerperal tubal sterilization program in a maternity clinic/hospital are discussed.

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Clinical trials have consistently shown that the IUD that releases 20 micrograms levonorgestrel daily (LNG-IUD-20) has a contraceptive efficacy comparable to, if not surpassing, the Copper T380 and the Multiload Copper-375 IUDs. The focus of this review is the device's non-contraceptive effects--the beneficial ones, such as reduction of menorrhagia, a therapeutic effect on dysmenorrhea, and prevention of ectopic pregnancy, as well as the deleterious ones, such as amenorrhea, spotting and irregular bleeding, hormonal side-effects, and functional ovarian cysts. Also discussed are the possibility of a preventive effect on pelvic inflammatory disease, the effects of the IUD on postpartum/lactating women, fertility return after removal and other safety issues. In general, the LNG-IUD-20's non-contraceptive benefits are substantive, carry important medical and public health implications, and far outweigh the device's deleterious effects, which are either medically mild or transient in nature, and can usually be managed satisfactorily by counseling. A better understanding of these effects, both beneficial and deleterious, of this hormone-releasing IUD should lead to more effective patient counseling, which, in turn, should improve user quality of life, minimize unnecessary removals, and maximize continuation of use.

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The use of multiple clips for the occlusion of the Fallopian tubes has been reported in interval laparoscopic sterilization, but the circumstances leading to the performance of the multiple-clip procedure and its effects on safety and efficacy have not been carefully studied. A data set from international multi-center clinical trials of Filshie clips and Wolf (Hulka) clips was used to examine the possible reasons for performing this procedure for 102 women. Their complications, complaints, and surgical and post-surgical events before discharge and during one month of follow-up were compared with those of the 408 women whose tubes were occluded by single clip. Results indicate that multiple clips were most often used when surgical difficulties (and to a much lesser degree, tubal and/or mesosalpingeal injury) were encountered during the sterilization procedure. No increased risk of short-term complications or complaints (including pelvic pain) was found at one-month follow-up for those patients who received multiple clips.

PIP: Occlusion of the fallopian tubes by use of clips has been widely practiced. In some cases the use of multiple clips has been reported, but the reasons for selecting the multi-clip method over the single-clip procedure are not clear. In this retrospective study, data from international records on clip usage was examined for possible answers for selecting single versus multiple clips. Also reported are the complications, complaints, and surgical and post-surgical events. These studies noted that laparoscopic sterilization was performed and that either the Filshie clips or Wolf (Hulka) clips were used in 17 international centers. 79 (3.3%) of 2366 women noted in the records who had the Filshie clip inserted also had multiple clips inserted. With regard to the Wolf clip, 23 (3.7%) of 623 women also had multiple clips inserted. In this study, 102 women occluded by multiple clips were matched with 4 women each (for a total of 408 women) who had a single-clip occlusion procedure. Surgical difficulties in the multiple-clip group were evident. In 72 women (70.6%), surgeons had difficulties in occluding the tubes; in 11 women (10.8%), in grasping the tubes; and in 5 women (4.9%), in finding the tubes. After comparing multiple- and single-clip patients, no significant differences could be identified. Difficulties during the laparoscopic sterilization procedure tended to be the main reason for selection of multiple clips. No increased risk in short-term complications or complaints were reported.

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Tubal sterilization is the world's most commonly used contraceptive method. Even a small proportion of women incurring poststerilization regret would translate into a large number of sufferers. In this review, we examine recent reports on the incidence of, and the risk factors for, posttubal sterilization regret in women and requests for sterilization reversal in both developed countries and less-developed countries. We also consider the implications of our findings in the practical prevention of poststerilization regret and requests for sterilization reversal, and discuss methodological issues.

PIP: Used by approximately 138 million women of reproductive age, tubal sterilization is the world's most popular contraceptive method. Some women, however, regret having undergone the procedure. Curious about the incidence of, and the risk factors for post-tubal sterilization regret in women, as well as requests for sterilization reversal in both developed and developing countries, the authors searched literature through the Popline and Medline databases published on the subject since 1980. Review of studies' findings indicate that poststerilization regret is limited to a small number of women, regardless of their cultural backgrounds or the development stage of the country in which they reside. Young age at sterilization is an universally strong risk factor for regret, while remarriage is a strong risk factor for request of reversal, especially in developed countries and some African countries where remarriage is common. The death of an infant or child is an important risk factor for regret and desire for reversal in less-developed countries. Careful and thorough counseling by service providers is the key to preventing poststerilization regret and request for the reversal of sterilization. It is recommended that service providers avoid making the sterilization decision for women, avoid performing sterilizations immediately after delivery and concurrently with other surgical procedures in "high risk" women, and when practical, use a tubal occlusion technique for sterilization such as clips or rings which causes the least damage to fallopian tubes. The authors close in affirming that sterilization clients should regard the sterilization procedure as irreversible, yet physicians should perform it as if the procedure may one day need to be reversed.

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This retrospective analysis was conducted to determine whether IUD users are good candidates for laparoscopic sterilization using the tubal ring and the Filshie clip. The data set used for the analysis came from international multicenter clinical trials involving 1235 women who were sterilized by the tubal ring and 1892 women sterilized by the Filshie clip. Results indicate that former IUD use is not associated with an increased risk of surgical injuries, including uterine perforation, major complications, or postoperative infections, for either of these tubal occlusion techniques. The risk of a sterilization procedure ending in technical failure (defined as switching to laparotomy and/or a tubal occlusion technique not originally planned) among tubal ring cases was greater for former IUD users than for non-IUD users. However, this may be related to a center effect. Nine of the 10 ring cases with technical difficulties were successfully switched to electrocoagulation, and the operator did not have to resort to an unintended laparotomy. The incidence of surgical difficulties among the Filshie clip cases was also higher in former IUD users, but all of these difficulties were safely overcome without changing the tubal occlusion method. These findings lead us to believe that, in general, a woman's IUD use should not generally be a reason for an experienced service provider to hesitate in performing an interval laparoscopic sterilization using a mechanical tubal occlusion technique.

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Although intrauterine devices (IUDs) are a highly cost-effective contraceptive method, they have been unfortunately associated with increased risk of pelvic inflammatory disease (PID). However, new studies, including a 1992 World Health Organization (WHO) report, have demonstrated that there is little evidence of a causal link between IUD use and PID. IUD-related risk of PID is increased only during a short period following insertion, and exposure to STDs is probably the major determinant of PID risk for IUD users. Furthermore, no increased risk of PID use has been demonstrated with long-term IUD use. This paper examines the evidence, focusing on the 1992 WHO study, and looks to the future with suggestions for IUD research and programmatic approaches in the hope of vindicating the IUD's reputation and broadening the indications for its use.

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A newer generation of IUDs that includes the Copper T-380A/Ag (TCu-380A/Ag) IUDs and the Multiload Copper-375 (MLCu375) IUDs has been developed and marketed. The high efficacy of these IUDs in preventing accidental pregnancies has been equated to that of oral contraceptives and even sterilization. However, the reduction of two other IUD-related pertinent events, namely, expulsion and medical removal due to bleeding and/or pain, has been less impressive. Therefore, efforts are continuing to develop new IUDs. In this paper, the authors review the physical structures of six new IUDs: the CU-SAFE, Cu-Fix, Ombrelle, Fincoid, and Multiload Mark II IUDs, and the intracervical fixing device (ICFD). The clinical performance of the first four devices is also evaluated. Independent, noncomparative studies suggest that all of the four new IUDs may perform as well as, or even better than, the TCu-380A IUD in terms of expulsions and medical removals attributable to bleeding and/or pain. However, we deem these results tentative, and emphasize the need for multi-center, randomized comparative clinical trials with larger sample sizes and long-term follow-up.

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Good counseling and better selection of candidates would result in the intrauterine device's (IUD) safer use. Age and parity of the IUD acceptor do not seem to be associated with an increased risk of pelvic inflammatory disease (PID). The newer generation of copper- and hormone-releasing IUDs are associated with improved safety and efficacy.

PIP: The IUD is a very safe and effective contraceptive method for women in a mutually monogamous relationship. The 8-year pregnancy rates for the Copper T 380A IUD is 2.3%. Studies in the late 1960s and early 1970s suggested that IUDs caused pelvic inflammatory disease (PID). These studies may have been subject to methodological flaws (e.g., use of inadequate controls, such as users of methods protecting against PID [e.g. barrier methods] and failure to control for likely confounding variables [e.g., sexual behavior]). Recent large scale prospective studies tend to report low PID rates in IUD users (e.g., 7-year rate, 2.6% for the levonorgestrel releasing and a copper releasing IUDs). The risk of PID is highest within the first 20 days postinsertion, especially in women using a unmedicated IUD. The copper IUD has been modified to better conform to the uterine cavity throughout the menstrual cycle, thus, reducing the likelihood of bleeding and pain. Another new copper IUD likely to reduce bleeding and pain has 6 copper sleeves on 1 filament polypropylene thread. The knot at the thread's end is implanted into the myometrium at the fundus. The LNG-IUD releases a daily dose of 20 mcg levonorgestrel. It can be used effectively for 5 years. Amenorrhea and/or hormonal side effects contribute to its lower continuation rate than copper releasing IUDs. Providers must assess the risk of sexually transmitted diseases, conduct a pelvic exam, and counsel clients before IUD insertion. Only when IUD users experience symptoms do follow-up visits result in a significant cost saving. In the best interest of the client and to reduce discontinuation, counseling should address life style, user perspective, culture, possible increased risk of genital infection associated with nonmonogamous sexual behavior, and side effects.

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Among the limited number of reports on progestin-oral contraceptives (POCs), noncomparative studies conducted at family planning clinics have been the most often reported. This research trend will probably continue. Generally, noncomparative studies address a number of practical issues on POC use, and such studies have made important contributions to the understanding of this contraceptive modality. However, some studies have presented results that are either difficult to extrapolate for potential users or conflict with other findings. This article reviews several studies and suggests ways to improve the study methodology. Well-conceived, -executed, and -analyzed noncomparative studies can cost-effectively address a number of practical issues of POC use that have not been adequately addressed. Additional topics with programmatic utility, such as the effect of local background variables on POC acceptability, and the place of POCs in the ever-increasing contraceptive spectrum, are also discussed.

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With recent studies repeatedly showing results clearing the IUDs from their formerly suspected role in causing pelvic inflammatory disease (PID), very likely IUD use will further increase worldwide. While most previous IUDs have been withdrawn from the US market during the 1980s, newer and more effective IUDs have subsequently been developed; and some, marketed. Four of these devices will probably become the pillars for future IUD contraception worldwide. This review evaluates the relative performance and safety of these four devices. Consistent findings have proven the Copper-T 380A (Ag) and the Multiload-375 (MLCu375) IUDs to be safe with high and long-lasting efficacy. The Nova-T IUD showed favorable results in some studies, but showed deteriorated efficacy after three years of use in others; more studies are needed. Studies show that the IUD that daily releases 20 micrograms levonorgestrel (LNG-20) is associated with the highest efficacy in preventing accidental pregnancy among the four devices, but it has a uniquely high medical removal rate because of amenorrhea. This steroid-releasing device could be a high-performance IUD if this type of medical removal can be reduced through patient counseling devised according to local cultural background.

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The demand for postpartum sterilisation (performed within 42 days after delivery), is increasing both in developed and developing countries. The incidence of regret after postpartum sterilisation is important, but it could be minimised by carefully screening risk factors. Using trained paramedical personnel to perform postpartum sterilisation via minilaparotomy where physicians are in short supply appears to be safe and acceptable, under close medical supervision. Including postpartum sterilisation information in the antenatal counselling services effectively strengthens postpartum services and simultaneously helps to minimise subsequent regret.

PIP: Family Health International reviews data from Demographic and Health Surveys (DHS) in 25 developing countries and the literature to identify programmatic issues of postpartum tubal sterilization and then makes recommendations based on the findings. More than 66% of all contraceptive users in Thailand undergo tubal sterilization within 3 months after their last delivery, indicating that Thailand likely leads the world in postpartum sterilization. The demand for postpartum sterilization (i.e., postpartum women not wanting anymore children) in developing countries ranges from 24% in Africa to 62% in Latin America and the Caribbean. It is safest when done within 7 days after delivery. Even though many studies indicate that postpartum sterilization has no adverse effects on lactation, others show that delayed postpartum sterilization does affect lactation, suggesting a need to promote early postpartum sterilization. Many studies indicate higher regret among women undergoing postpartum sterilization, especially after a Cesarean section, than among those undergoing interval sterilization. Careful screening for regret risk factors (e.g., decision for sterilization not made by the woman and changes in patient characteristics after sterilization, such as divorce or child death) would diminish regret. Health workers should also provide accurate information about postpartum sterilization during prenatal care visits. Some specialists assert that postpartum sterilization is likely more cost-effective than temporary methods (e.g., oral contraceptives and injectables), because they necessitate repeated stock. In many areas of developing countries, experienced physicians are not available to perform postpartum sterilizations, so trained paramedical personnel perform sterilizations via minilaparotomy. In Thailand, for example, trained nurse-midwives perform postpartum sterilizations with few complications, and women and physicians are satisfied with their performance.

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Immediate postplacental insertion (IPPI) of the intrauterine device (IUD) has been practiced in China for at least 17 years. This presentation reviews and integrates the clinical experiences of IPPIs at five Chinese centers. The stainless-steel ring IUD was the most commonly used device for this procedure. Our review indicates that: (a) IPPIs-both after vaginal delivery and at cesarean section-are medically safe and effective in preventing accidental pregnancies (given careful patient selection), and (b) the one-year life-table expulsion rates of IUDs inserted at cesarean section are lower than the rates for vaginal insertions after normal delivery. This review also discusses other issues, such as factors influencing expulsion rates. Generally, IPPIs, whether performed via vagina or cesarean section, seem to be a method of choice for postpartum contraception. Some findings are, however, tentative; thus, further studies are needed.

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This evaluative review focused on the performance and safety of the Dutch-made Multiload copper IUD, primarily the Multiload-375 (MLCu-375) model which has a longer life expectancy (5 or more years) than the Multiload-250 (MLCu-250) model, usually cited for a life expectancy for three years. This copper-medicated IUD differs from the copper-T IUDs in shape and insertion technique. The review shows that (a) the MLCu-375 IUD seems to be slightly less effective in preventing pregnancies than TCu-380A IUD. Its efficacy is comparable to that of the Nova-T by two to three years of use; (b) the MLCu-250 IUD is similarly effective to TCu-200 but may be slightly less effective than TCu-220C; (c) no consistent differences were detectable in expulsion rates or in removal rates for bleeding/pain between the Multiload IUDs and comparative Copper-T IUDs; (d) the Multiload IUDs may perform better in nulliparous women than the T-shaped devices; (e) no or a very low incidence of uterine perforation is associated with insertions of the Multiload IUD; (f) ectopic pregnancy risks are similarly low in Multiload IUD users as in Copper-T-380A users; and (g) pelvic inflammatory disease (PID) risks are similarly low in Multiload IUD users as in users of T-shaped copper IUDs.

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Little is known of the factors associated with expulsion of intrauterine devices (IUD). We conducted a nested case-control study to examine the risk factors for copper T IUD expulsion using data from a multicenter international clinical trial. We included 70 cases with expulsion and 1,536 controls, and we examined a variety of characteristics of the IUD wearers. The proportional hazards model showed that young maternal age, abnormal amount of menstrual flow and dysmenorrhea before IUD insertion are risk factors for copper T IUD expulsion. The risk of expulsion steadily increased as age decreased, and as the severity of dysmenorrhea increased.

PIP: Data on 70 women who experienced expulsion of a copper releasing IUD were compared with data on 1536 women who still retained a copper releasing IUD to determine risk factors for IUD expulsion and calculate the magnitude of the association. The 18-40 year old women were part of an international multicenter clinical trial. Adolescents were at a 5.5 (unadjusted crude odds ratio) higher risk of IUD expulsion than women of at least 35 years old. The risk of expulsion decreased with age (odds ratio [OR] = 2.1 for 20-29 year olds and 1.1 for 30-34 year olds). Women whose menstrual flow was higher than normal were also at greater risk of IUD expulsion (OR = 2.4). The risk was the same for women who experienced severe pain during menstruation (OR = 2.4). The proportional hazards regression analysis showed maternal age (adjusted hazard ration = 5.4 for teenagers), amount of menstrual flow (2.4 for abnormal flow), and dysmenorrhea (1.8 for severe menstrual pain) were risk factors for expulsion of the copper releasing IUDs. Further, the trend test revealed a significant dose response pattern between maternal age and IUD expulsion (p .001) and between dysmenorrhea and expulsion (p = .011). The small sample size of nulliparous women (1 case and 7 controls) limited the ability of the analysis to identify parity as a risk factor which has been identified as a risk factor in other studies. In conclusion, these findings indicated that maternal age, amount of menstrual flow, and severe pain during menstruation are risk factors for expulsion of copper releasing IUDs.

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The progestin-only oral contraceptive (POC) is not a widely-used method of contraception, possibly due to competition from other contemporary contraceptive methods or misunderstanding and prejudices among clients and/or service providers. Because of its underuse, the POC, as a contraceptive method, is under-studied. This article evaluates the general merits of the POC and its disadvantages relative to combined oral contraceptives (COCs) and other contraceptive methods, specifically during the postpartum period and particularly for breastfeeding women. We find that the POC appears to be a safe and acceptable contraceptive method for postpartum women who are fully or nearly fully breastfeeding at six months postpartum or when menstruation returns. The POC could be considered for use at any time by non-breastfeeding postpartum women. The need for empirical studies of the POC is also discussed.

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An increasing number of case-control studies are being performed in the developing world. This paper describes the difficulties and advantages the author has experienced in conducting a hospital-based case-control study in the Republic of Korea testing the hypothesis of whether vasectomy is associated with subsequent cardiovascular disease. This experience should provide a useful reference for researchers planning studies using a similar approach in an Asian setting.

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