Breast-feeding and the return to ovulation in Durango, Mexico.

Twenty-nine breast-feeding mothers and 10 non-breast-feeding postpartum comparison mothers from a rural area of Mexico were followed longitudinally until ovulation resumed. A simple set of guidelines is described involving three obvious milestones for the breast-feeding mother to safely use the natural contraceptive benefit of breast-feeding. Those milestones are: the first vaginal bleeding episode, the initiation of supplementation, and the child's monthly birthday. In the absence of bleeding and supplementation, 100% of breast-feeding mothers remained anovular for 3 months postpartum, 96% for 4 months, 96% for 5 months, and 96% for 6 months. This suggests that, if a mother understands these three conditions, she can use breast-feeding alone as effectively as modern family planning methods for the prevention of pregnancy.

Mortality associated with sterilization: preliminary results of an international collaborative observational study.

Sterilization is the contraceptive method most widely used worldwide, yet the case-fatality rate of deaths attributable to sterilization is not known. We used data collected from 1971-1979 from 28 countries by Family Health International to estimate case-fatality rates. We adjusted these rates for individuals lost to follow-up. Of 41,834 sterilizations, 23 resulted in deaths temporally associated with the procedure used. The adjusted attributable case-fatality rates were 13.4 per 100,000 for interval procedures, 53.3 per 100,000 for postabortion procedures, and 43.4 per 100,000 sterilizations after vaginal delivery. Multiple factors contributed to the deaths, including pre-existing health problems, infection and anesthesia. Prevention of deaths resulting from sterilization depends on complete ascertainment of deaths associated with sterilization and careful investigation to determine preventable risk factors. We conclude that, overall, sterilization in these programs was conducted with very low attributable mortality.

PIP: Sterilization is the contraceptive method most widely used worldwide, yet the case-fatality rate of deaths attributable to sterilization is not known. In this study data was collected from 1971-79 from 28 countries by Family Health International to estimate case-fatality rates. Rates were adjusted for individuals lost to follow-up. Of 41,834 sterilizations, 23 resulted in deaths temporally associated with the procedure used. The adjusted attributable case-fatality rates were 13.4/100,000 for interval procedures, 53.3/100,000 for postabortion procedures, and 43.4/100,000 sterilizations after vaginal delivery. Multiple factors contributed to the deaths, including pre-existing health problems, infection and anesthesia. Prevention of deaths resulting from sterilization depends on complete ascertainment of deaths associated with sterilization and careful investigation to determine preventable risk factors. Overall, sterilization in these programs was conducted with very low attributable mortality.

Comparison of the safety of open and conventional laparoscopic sterilization.

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.

Menstrual pattern changes following minilap/Pomeroy, minilap/ring and laparoscopy/ring sterilization: a review of 5982 cases.

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.

First World standards versus Third World settings.

PIP: The 3rd world population programs supported by international agencies are being heatedly debated, and the conclusions reached are frequently confusing, extreme, and biased. The international agencies at the center of the debate must make numerous decisions, many of which have ethical implications. Such a wide range of opinions exist that it is becoming more and more difficult for agencies to maintain a balance. Consequently a maze of rules and regulations had proliferated in recent years. It is not clear whether these are meant to protect the user or the provider. Measures intended to safeguard family planning users in developing countries frequently do more harm than good. Complicated Western requirements for informed consent, meant to educate users and protect providers from malpractice suits, may be unrealistic in developing nations. It is mandatory to ensure that an individual is not treated against his/her will, but the informed consent forms for all contraceptive methods are becoming longer and more complicated. The most salient facts are completely lost or undermined in the profusion of information. Where the population is illiterate and unaccustomed to signing forms, this practice raises suspicion and creates mistrust. Comparing the relative risks and benefits of the many fertility control methods is both complicated and controversial, even among highly educated populations. It is most important to ensure that persons are not coerced into accepting family planning and that they have a clear understanding of the major consequences of the particular contraceptive they choose. This information needs to be communicated in a manner acceptable to the local culture. The use of modern equipment and gadgetry is tempting to both donors and recipients, but it is essential to evaluate carefully local conditions and capabilities before deciding whether these or simpler family planning methods are more appropriate. Another factor for consideration is the reluctance of physicians to revert to simple techniques once they have become accustomed to sophisticated methods. Reporting is a reasonable requirement for any agency to impose, but detailed and elaborate documentation requirements serve primarily to impose an additional burden on the program staff. Donor agencies that are sincerely concerned about the welfare of people in developing countries must make their assistance more meaningful. As the benefit of all foreign aid to the developing countries is constantly being negated by staggering population increases, it is essential that assistance for family planning programs be well managed.^ieng

Menstrual pattern changes following laparoscopic sterilization with different occlusion techniques: a review of 10,004 cases.

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.

A comparison of different laparoscopic sterilization occlusion techniques in 24,439 procedures.

This investigation assessed the safety and efficacy of five laparoscopic tubal occlusion techniques for female sterilization: electrocoagulation, the tubal ring via conventional and open laparoscopy, the prototype spring-loaded clip, and the Rocket clip. The 24,439 cases make up a data set collected by collaborating staffs at 64 institutions in 27 countries. The five techniques were compared with respect to six commonly evaluated parameters. Rates of surgical difficulties ranged from 2.4% to 12.5% (5.1% overall); rates of surgical complications, from 0.7% to 2.7% (1.7% overall); and rates of technical failures, from 0.6% to 1.0% (0.8% overall). Twelve-month life-table pregnancy rates were less than one per 100 women years. Prospective data on six menstrual parameters revealed that the menstrual cycles of the majority of women were unchanged after sterilization; for those who reported a change, approximately half experienced a change in one direction and half in the other direction. For example, one half reported an increase in the amount of menstrual flow, and one half reported a decrease in the amount of flow. The reported incidence of subsequent pelvic operations was less than 1% at each long-term follow-up. These data indicate that laparoscopic sterilization is safe and effective and that none of the studied techniques has a distinct advantage.

PIP: This investigation assessed the safety and efficacy of 5 laparoscopic tubal occlusion techniques for female sterilization: electrocoagulation, tubal ring via conventional and open laparoscopy, the prototype spring-loaded clip, and the Rocket clip. The 24,439 cases make up a data set collected by collaborating staffs at 64 institutions in 27 countries. The 5 techniques were compared with respect to 6 commonly evaluated parameters. Rates of surgical difficulties ranged from 2.4%-12.5% (5.1% overall); rates of surgical complications from 0.7-2.7% (1.7% overall); and rates of technical failures from 0.6-1.0% (0.8% overall). 12-month life-table pregnancy rates were less than 1/100 woman years. Prospective data on 6 menstrual parameters revealed that the menstrual cycles of the majority of women were unchanged after sterilization; for those who reported a change, approximately 1/2 experienced a change in 1 direction and the other 1/2 in the other. For example, 1/2 reported an increase in the amount of menstrual flow, and 1/2 reported a decrease. The reported incidence of subsequent pelvic operations was less than 1% at each longterm follow-up. These data indicate that laparoscopic sterilization is safe and effective and that none of the studies techniques has a distinct advantage.

Menstrual therapies in commonwealth Asian law.

PIP: This review of the application of abortion laws confines itself to the 900 million people--20% of the world's population--who live under the commonlaw tradition of the British Commonwealth. One of the historic ties to the British Commonwealth is the commonlaw tradition, which is reflected in reference to common leading cases and approaches taken to case precedents. There are 2 Commonwealth legal traditions concerning penal legislation, and they differ on an issue of major significance regarding abortion. Under English law, acting with the intention to procure an abortion whether a woman is pregnant or not is a crime. In Asian Commonwealth jurisdictions, and Pakistan, menstrual therapies are not as restricted as they may be in England. Menstrual therapy, a generic term, describes medical and surgical procedures performed on the uterus for diagnostic and therapeutic indications. This includes menstrual aspiration and the use of drugs as well as the more traditional dilatation and curettage. Diagnostic biopsy of the uterine lining may be indicated upon a variety of clinical grounds, including apparent infertility, dysfunctional bleeding, and suspected uterine cancer. Treatment of incomplete abortion is a common medical procedure and involves the operator in no liability under abortion laws. Uterine evacuation initiated for purposes of abortion in a woman known to be pregnant must conform to the abortion law of the jurisdiction, but some procedures will be undertaken before pregnancy can be diagnosed by the routinely available methods. A woman may occupy 1 of 3 positions: 1) she may clearly be pregnant; 2) it may be unclear whether she is pregnant or not; and 3) she may clearly not be pregnant. English abortion law applies to the first 2 positions but the Penal Code abortion provisions applies only to the 1st position. Thus, performing menstrual therapy in a woman in position 2 may be illegal abortion under English law (unless pregnancy would endanger her life or health) but not under the Penal Codes of the Commonwealth Asian jurisdictions. Menstrual therapy undertaken as a means of abortion in a case of proven pregnancy must conform to local abortion law, but menstrual therapy undertaken for another purpose need not conform to such a law. Without clear and compelling evidence of pregnancy in the individual case, the physician may proceed on the presumption that the woman is not pregnant. Any mistake of fact made in good faith constitutes a good legal defense.^ieng

Menstrual pattern changes following laparoscopic sterilization: a comparative study of electrocoagulation and the tubal ring in 1,025 cases.

This investigation compared the effects of the laparoscopic occlusive techniques of unipolar electrocoagulation and the tubal ring on subsequent menstrual patterns. The question of whether sterilization, in general, causes menstrual pattern changes is also addressed. The 1,025 cases constituted a data set collected by investigators at five institutions in five countries. After controlling for prior contraceptive use, the two techniques were compared with respect to menstrual cycle regularity, cycle length, flow duration, amount of flow, dysmenorrhea and intermenstrual bleeding. In this series, approximately 10% to 50% (depending on the menstrual parameter) of the menstrual pattern changes seen within six months following sterilization could be attributed to the discontinuation of the Pill or IUD at the time of sterilization. The majority of the women experienced no menstrual pattern changes following sterilization. There was no statistically significant difference between the two occlusion techniques in terms of the proportion of women who reported changes in any of their menstrual parameters. The theory that sterilization causes menstrual pattern changes rests on the hypothesis that the greater the degree of destruction of the uteroovarian vascular anastomosis (as with unipolar electrocoagulation), the greater the amount of subsequent menstrual pattern disturbance. Our findings suggest that this hypothesis is not valid.

PIP: This investigation compared the effects on subsequent menstrual patterns of both laparoscopic occlusive techniques of unipolar electrocoagulation (504 cases) and the tubal ring (KLI Falope Ring, 521 cases). 1025 cases were collected at 5 institutions in 5 countries. After controlling for prior contraceptive use, the 2 techniques were compared with respect to menstrual cycle regularity, cycle length, flow duration, amount of flow, dysmenorrhea, and intermenstrual bleeding. Most women experienced no menstrual pattern changes following sterilization. Approximately 10% to 50% (depending on the menstrual parameter) of the menstrual pattern changes seen within 6 months following sterilization could be attributed to the discontinuation of the pill or IUD at the time of sterilization. There was no statistically significant difference between the 2 techniques in terms of the proportion of women who reported changes in any of their menstrual parameters. The theory that sterilization causes menstrual pattern changes rests on the hypothesis that the greater the degree of destruction of the uteroovarian vascular anastomosis (as with unipolar electrocoagulation), the greater amount of subsequent menstrual pattern disturbance. Our findings suggest that this hypothesis is not valid.

A comparison of tubal ring and Madlener's techniques of tubal ligation in postpartum cases.

PIP: Compares Madlener's traditional technique and a new method of tubal ligation as sterilization procedures on postpartum women. The new tubal ring ligation procedure has been welcomed because of its nonreliance on electrocautery, a procedure which has proved to be unsafe. This study is based on the sterilization and follow-up of 300 postpartum women aged 21 to 40. Follow-up was carried out at day 7, at 6 months and at 1 year (78% of sample). Except for a minor surgical complication in 1 subject of each group, surgery was uneventful, averaging 7.9 and 9.0 minutes for tubal ligation and Madlener's technique, respectively. Postoperative complication, common to this type of surgery and unrelated to comparative aspects of the 2 surgeries were noted. Follow-up showed the commonest complaints to be backache, leukorrhea and general weakness. These symptoms, however, are very common in hospital patients. The incidence of backache, though, was significantly higher in the group of women sterilized by the tubal ring technique as compared with Madlener's. Neither group was significantly different in the incidence of postoperative menstrual irregularities; after 1 year the most common abnormality was excessive or scanty menstrual cycle. Pelvic findings showed a slight increase in the number of cervical erosions and endocervicitis in the tubal ring group as opposed to Madlener's; these findings, though, are only coincidental and have no bearing on the method of sterilization. The study also demonstrates that either method can safely be performed in postpartum women.^ieng

Tubal ring sterilization: experience with 10,086 cases.

The safety and efficacy of the Silastic ring were examined for interval, postabortion, and postpartum sterilizations. The study includes an in-depth analysis of 10,086 cases generated by 51 collaborating institutions in 23 countries. Failure of the tubal ring is studied via the life-table method, although follow-up is limited to a relatively short period. Difficulties encountered when applying the ring, particularly those resulting in technical failure, are explored in detail. Surgical complications, infection, menstrual irregularity and abnormal bleeding, and pelvic surgery following sterilization are discussed. Comparisons are made among various approaches to the fallopian tubes. Such data are found to be similar to those for other occlusion techniques, demonstrating the comparable safety and efficacy of tubal ring sterilization.

Laparoscopic and minilaparotomy female sterilisation compared in 15 167 cases.

Three methods of female sterilisation were compared in data from 23 countries: laparoscopy with occlusion by the tubal ring (7053 cases), minilaparotomy with occlusion by the tubal ring (3033 cases), and minilaparotomy with occlusion by the modified Pomeroy technique (5081 cases). The 12-month failure rate was 0.60 per 100 women for laparoscopy/ring and 0.30 per 100 women for minilaparotomy/Pomeroy. The surgical complication rate for laparoscopy/ring (2.04%) was more than twice that for minilaparotomy/Pomeroy (0.79%). The technical failure rate of minilaparotomy/Pomeroy was twice that of laparoscopy/ring, but the complication and method-failure rates were much lower. Failure and complication rates with minilaparotomy/ring were intermediate. For many women seeking sterilisation, a minilaparotomy procedure will be preferable to a laparoscopy procedure.

PIP: Three of the most commonly used techniques in clinical trials conducted by the International Fertility Research Program (IFRP) in 23 countries--7053 cases of laparoscopy/ring, 3033 cases of minilaparotomy/ring, and 5081 cases of minilaparotomy/Pomeroy--were studied to evaluate their efficiency and safety. Safety and effectiveness were based on the following variables: 1) surgical difficulties; 2) surgical complications; 3) technical failures; and 4) method failures. Overall surgical difficulty, rate of surgical complications, and technical failure rates were standardized for timing of sterilization (eg, interval, postabortion, and postpartum). Life table method was used in determining failure rates. The laparoscopy/ring technique had a 12-month failure rate of 0.60/100 women; minilap/Pomeroy had a failure rate of 0.30/100 women. The laparoscopy/ring technique had a surgical complication rate of 2.04%; minilap/Pomeroy had a corresponding rate of 0.79%. The technical failure rate of the minilap/Pomeroy method was twice that of laparoscopy/ring. Minilap/ring had intermediate failure and complication rates. In developing countries, minilaparotomy procedure is preferred over laparoscopy for women seeking sterilization because of its lower failure rate, safety, efficacy and ease in dealing with complications. The limitation of this study is that the series was not generated by a randomized comparative trial.

A comparative study of intra-amniotic saline and two prostaglandin F2alpha dose schedules for midtrimester abortion.

The efficacy, side effects, and complications of two intra-amniotic PGF2alpha dose schedules and the unaugmented intra-amniotic instillation of saline are compared. All three methods resulted in satisfactory rates of abortion within a relatively short period of time and within clinically acceptable rates of complications. Each method has its advantages and disadvantages. Further large comparative studies were needed.