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Biomedical subjects

R Amatya

Publications and source records attributed to R Amatya.

At least 19 recordsLinked to original sources

Twelve-month comparative multicenter study of the TCu 380A and ML 250 intrauterine devices in Bangkok, Thailand.

The long-term effectiveness of the copper-bearing intrauterine device (IUD) has been documented. This paper reports 12-month results from a multiyear comparative study of the Copper T (TCu) 380A and Multiload (ML) 250 IUD in Bangkok, Thailand, among 1396 women. Continuation of the assigned IUD was relatively high after 12 months of use, with continuation rates of 90.17 and 87.54 per 100 women, respectively. Whereas the accidental pregnancy rate was higher for the ML 250 IUD than for the TCu 380A IUD (1.0 and 0.2 per 100 women, respectively), this difference was not considered statistically significant (p < 0.69). The rate of IUD expulsion was significantly higher among women using the ML 250 IUD than for women using the TCu 380A IUD (4.61 and 2.40 per 100 women, respectively, p = 0.05).

Adult

Non-physician insertion of IUDs: clinical outcomes among TCu380A insertions in three developing-country clinics.

Insertion of IUDs by trained non-physicians is increasing. This secondary analysis of TCu380A IUD acceptors collected at clinics in Nigeria, Turkey and Mexico involved 367 women; 193 insertions were performed by physicians and 174 by non-physicians. Women having their IUD inserted by a non-physician were more likely to experience a pain-free insertion, but also likelier to have the IUD removed for bleeding and pain or to experience an expulsion than women who had their IUD inserted by a physician. Early discontinuation rates were similar between the two groups. Overall continuation rates were statistically higher for IUDs inserted by physicians only at the Mexico site. Trained non-physicians can probably safely insert the TCu380A IUD. Appropriate competency-based training is required to limit the number of expulsions and removals for bleeding and pain by non-physicians.

Adult

Results of a pilot study of the time to azoospermia after vasectomy in Mexico City.

In a joint pilot study by Family Health International (FHI), AVSC International, and the Instituto Mexicano del Seguro Social (IMSS), information was gathered on the determinants of azoospermia following vasectomy on 38 healthy men who chose vasectomy for contraception. The time and number of ejaculations associated with loss of sperm motility and loss of sperm eosin vital staining were also evaluated. "Azoospermia" was defined on the basis of two consecutive azoospermic semen samples collected at least 3 days apart. The single decrement life table method was used to calculate weekly gross cumulative life table rates for the time to azoospermia, zero motility, and zero viability. The Kaplan-Meier method was used to calculate the product-limit estimates of the cumulative rates for the total number of ejaculations to azoospermia, 0% motility and 0% viability. The median time to azoospermia was 10 weeks and at the end of week 20, the life table rate (+/- standard error) was 93.0 (+/- 6.30) weeks/100 men. The median number of ejaculations to azoospermia was between 25 and 30, and the cumulative rate (+/- standard error) at 60 ejaculations reached 94.5 (+/- 5.16)/100 men.

Adult

Safety, functionality and acceptability of a prototype polyurethane condom.

Male condoms made from synthetic materials offer an alternative to latex condoms that may be more acceptable to users, thereby potentially resulting in more protected acts of intercourse. A prospective, noncomparative clinical study was conducted to evaluate the safety of using certain polyurethane materials to make condoms. Fifty-one healthy, contracepting, mutually monogamous couples were recruited between June 30 and November 24, 1993 to use a prototype roll-on polyurethane condom developed by Family Health International. Couples were to use the condoms for 10 consecutive acts of vaginal intercourse over a 4-week period. Baseline and postexposure genital examinations, including colposcopy for female participants, were performed. Fifty couples completed the study requirements and 517 acts of intercourse occurred using the condoms. Two adverse events were reported: irritation of introitus in a female participant and a small irritated erythematous lesion on a male participant's penis. Neither event was considered to be serious and both were resolved without treatment. Breakage and slippage rates were similar to those reported for latex condoms. These results suggest that polyurethane condoms represent a safe, functional and acceptable alternative to latex condoms.

Adult

An evaluation of the copper-T 380A IUD's safety and efficacy at three African centers.

The use of intrauterine devices in Africa is low compared with other contraceptive methods such as oral contraceptives. This study, coordinated by Family Health International, evaluated the clinical performance (safety and efficacy) of the TCu 380A IUD in three African centers, respectively, in Cameroon, Egypt, and Nigeria from 1986-1989. The 12-month unintended pregnancy rates were low for all three centers, ranging from none to 1.6 per 100 women. The 12-month discontinuation rates for all reasons ranged from 8.8 to 26.9 per 100 women. Statistically significant differences were observed among clinics for discontinuation rates for bleeding and/or pain and for planned pregnancy. The overall performance of the TCu 380A IUDs was considered satisfactory. Thus, the limited use of IUD in Africa could be due to the lack of accessibility, lack of information about, and confidence in the method rather than to documented clinical performance.

Cameroon

Clinical performance of the TCu 380A and Lippes Loop IUDs in three developing countries.

The clinical performance of the Copper T 380A (TCu 380A) and the Lippes Loop intrauterine devices (IUDs) were evaluated for 12 months in a group of 710 women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at three collaborating research sites located in three developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the Lippes Loop IUD at 12 months (0.7 and 2.1 per women, respectively). Although this difference was not statistically significant (p = 0.25), it is similar to findings from other studies. The 12-month cumulative removal rate due to personal reasons was significantly different (1.4 and 0.0, respectively, p = 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, medical reasons, planned pregnancy or investigator's choice. A statistically significant difference (p = 0.03) was observed in the number of TCu 380A IUD users experiencing dysmenorrhea (26.1%) during the 12-month study period, compared to Lippes Loop IUD users (18.8%).

Adolescent

Clinical evaluation of Norplant in Kumasi, Ghana.

A non-comparative study of the Norplant contraceptive subdermal implant system was conducted in Kumasi, Ghana. A total of 100 acceptors were enrolled in the clinical trial, which began in 1987. There were no pregnancies during the first two years of use. Only nine post-insertion medical problems were reported during the first two years of use. One woman in this study requested removal for menstrual pattern changes through two years of use. As assessed through user-satisfaction questionnaires administered at approximately six months of use, there has been an overall positive user experience with Norplant in this study. Although the sample size in this study is small, our results seem to be consistent with other studies and it appears that Norplant offers an effective, safe and acceptable method of contraception for Ghanaian women.

Adult

Contraceptive efficacy of the Copper T380A and the Multiload Cu250 IUD in three developing countries.

The clinical performance of the Copper T380A (TCu380A) and the Multiload 250 (MLCu250) intrauterine devices (IUDs) were evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at four collaborating research sites located in three developing countries. The gross cumulative life-table pregnancy rate of the TCu380A IUD was significantly lower than the rate with the MLCu250 IUD at 12 months (0.5 and 1.2, respectively, p < 0.01). No statistically significant differences between the two study IUDs were found with regard to IUD expulsion or IUD removal due to bleeding/pain, personal reasons, medical reasons, or planned pregnancy. TCu380A IUD users were more likely to report experiencing increased dysmenorrhea (p < 0.01) or intermenstrual pelvic pain (p < 0.01) than were MLCu250 IUD users. However, few of these users discontinued use of their assigned IUD because of having experienced menstrual bleeding disturbances or intermenstrual pelvic pain. These data indicate that the TCu380A IUD may be a better option than the MLCu250 IUD for women wishing to practice highly effective long-term birth control without having to resort to hormonal methods.

Adult

An analysis of the personal reasons for discontinuing IUD use.

The objective of this study was to evaluate possible factors associated with discontinuing use of TCu 380A IUDs due to personal reasons among 2748 users. Overall, a total of 88 subjects discontinued using the TCu 380A IUD within 12 months postinsertion for personal reasons. The most common reasons were planned pregnancy (32%) and husband or family opinion against IUD use (26%). The gross cumulative 12-month life table discontinuation rate for all personal reasons was 4.0 per 100 women. Having no education and/or living in a rural area were the sociodemographic characteristics associated with an increased risk of discontinuation for personal reasons. Effective and regular counseling about IUD use, especially among illiterate women, may help prevent IUD discontinuations related to personal reasons.

Attitude

Contraceptive efficacy of the Copper T 380A and Copper T 200 intrauterine devices: results from a comparative clinical trial in six developing countries.

The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 200 (TCu 200) intrauterine devices (IUDs) was evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a multicenter randomized clinical trial at one site in each of six developing countries. The pregnancy rate with the TCu 380A IUD was significantly lower than the pregnancy rate with the TCu 200 IUD at 12 months (0.5 and 2.6 per 100 women, respectively, p < 0.01). No statistically significant differences between the two study IUDs were found with regards to expulsion or removals due to bleeding/pain, personal, medical, or planned pregnancy. The TCu 380A IUD did not have a disproportionately higher incidence of side effects such as intermenstrual bleeding or pain, inflammations or infections, or insertion-related events compared to the TCu 200 IUD. TCu 380A IUD users, however, were significantly more likely to report increased dysmenorrhea than were TCu 200 IUD users. The performance of the TCu 380A IUD in preventing pregnancy during this trial indicates that this IUD may be a better option than the TCu 200 IUD for women wishing to practice effective, long-term, reversible birth control without having to resort to hormonal methods.

Contraception

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

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

Adolescent

The effect of husband counseling on NORPLANT contraceptive acceptability in Bangladesh.

A pilot study of the effect of husband counseling on NORPLANT contraceptive acceptability was conducted at four family planning clinics in Bangladesh. The study objectives were to compare discontinuation rates and user satisfaction among acceptors whose husbands received counseling about the method versus those who did not. Of a total 617 subjects enrolled in the study which began in 1988, about two-thirds (408) of the husbands were counseled at admission or at the one-month follow-up visit while the remainder of the husbands (209) were not counseled. Follow-up visits were scheduled at one and six months after NORPLANT implants insertion, and every six months thereafter until the close of the study in 1991. Some evidence was found that counseling husbands of NORPLANT implants acceptors may reduce discontinuation rates. At the end of 36 months, a difference of 10 percentage points in total discontinuation rates was observed between the husband-counseled group (32 per 100 women) and the husband-not-counseled group (42 per 100 women). The husband counseling had the most impact at clinics with higher discontinuation rates. Based on Cox's proportional hazards regression model results, the hazard for discontinuation among the acceptors in the husband-not-counseled group. Satisfaction with NORPLANT implants did not differ between the two groups. Although these results are not striking, they do suggest a potential positive effect of husband counseling on NORPLANT contraceptive accept-ability. In future studies, the counseling of husbands should be more intensive and standardized.

Adolescent

Clinical evaluation of the TCu 380A IUD at six Latin American centers.

Compared with other contraceptive methods such as sterilization and oral contraceptives, the prevalence of IUD use in Latin American countries is relatively low. This study evaluated the clinical performance of the TCu 380A IUD in six Latin American clinics to determine whether its performance was a determining factor in its low prevalence, and to provide efficacy and safety data based on local data sets to Latin American service providers. The 12-month unintended pregnancy rate ranged from 0.0 to 1.7 per 100 women and the 12-month discontinuation rates for all reasons, from 3.3 to 21.0 per 100 women. Statistically significant differences in discontinuation rates were observed among clinics, and could be explained, in part, by the different sociodemographic and clinical characteristics of women attending the clinics. The overall performance and acceptability of the TCu 380A IUD was considered satisfactory and comparable to those reported from other countries. Thus, the low prevalence of IUD use in Latin America is probably related to barriers to its use rather than its clinical performance.

Adult

Fresh gas flow and carbon dioxide rebreathing in a low pressure semi-open anaesthesia system.

We have constructed a simple system for field anaesthesia by using a Farman entrainer and a semi-open circuit to convert a draw-over apparatus to a continuous flow air/O2 system. Compressed O2 was the driving gas for the entrainer; fresh gas (FG) delivered to the semi-open circuit was a mixture of O2, entrained air and anaesthetic vapour. The purpose of this study was to examine FG flow rate and CO2 rebreathing during intermittent positive pressure ventilation (IPPV). A non-rebreathing inflation valve (Laerdal) placed at the end of the expiratory (efferent) limb of the circuit vented both expiratory gas and excess FG. Ambient air IPPV was applied through the Laerdal valve from a self-inflating bag or ventilator. Since this circuit is functionally similar to a T-piece, the gas from the efferent limb (340 ml, containing FG) entered the lungs first. If tidal volume was larger than 340 ml the balance was ambient air. Minute ventilation of the lungs with efferent limb gas was defined as Veff. Respiratory gas was sampled at the endotracheal tube and the CO2 tension was measured with a NIHON-KOHDEN CO2 analyzer. Thirty-seven adult patients having intra-abdominal or pelvic surgery under general tracheal anaesthesia were studied. Four FG flow rates (5.7, 8.0, 9.3, and 10.4 L.min-1), corresponding to driving gas pressures of 40, 60, 80, and 100 mmHg, were introduced in random order. Although inspired CO2 was detected at FG flow rates of 5.7-9.3 L.min-1, there were no differences in PETCO2 among the four groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult

Anaesthesia services and the education of anaesthetists in Nepal: a model for sustainable development?

In 1985 the University of Calgary in Canada and Tribhuvan University in Kathmandu, Nepal Jointly established the Diploma in Anaesthesiology (DA) programme in Nepal. To evaluate the impact of the DA Programme and provide a data base for long-term planning we conducted a national survey in 1992. We sought to describe anaesthesia manpower and workloads, and to make an inventory of facilities, equipment, and supplies in different sized hospitals. Twenty-seven hospitals providing surgical services were included, nine inside and 18 outside the Kathmandu valley. Seventeen of the 21 respondent hospitals had at least one specialist anaesthetist. The results identify both strengths and weaknesses in Nepal's anaesthesia services and provide important guidelines for planning. When the DA course was launched there were only seven specialist anaesthetists in Nepal. The shortage of anaesthetists was an important factor limiting surgical services, and after DA graduates were posted to zonal (50 bed) and regional (150-200 bed) hospitals the surgical case loads doubled. There are now about 40 specialist anaesthetists in the country, of which half are DA graduates, but many hospitals have only one anaesthetist. That isolation, plus lack of continuing education (CME), are important factors threatening quality of care. Recognizing the singular role of the DA programme in alleviating Nepal's shortage of anaesthetists, we conclude that it should be renewed and strengthened to meet the needs of the next decade. Techniques commonly used at the zonal level: regional, draw-over, and total IV anaesthesia, should be stressed. At the same time fresh initiatives are required in CME and higher education for the renewal of teaching staff.(ABSTRACT TRUNCATED AT 250 WORDS)

Anesthesia

Anaesthesia training and development in Nepal 1985-1990.

In 1985 a diploma program in anaesthesia was established in Kathmandu, Nepal, as a joint venture between the Institute of Medicine in Kathmandu and the University of Calgary. Development of the program and of the specialty in the capital city of Kathmandu was continuously documented during the next five years by local and visiting faculty. In 1990 teams of two Nepali and one Canadian anaesthetist also conducted a survey of each of the seven 50-100 bed zonal hospitals which did not previously have a trained anaesthetist and which are now staffed by graduates of the diploma program. In 1985 Nepal, with a population of 16 million, had seven trained Nepali anaesthetists all of whom worked in two hospitals in Kathmandu. By the end of 1989, 19 physicians had graduated. Seven of these continue to work in Kathmandu hospitals, nine work in zonal hospitals throughout the country and two are taking higher anaesthesia training in the United Kingdom. Additional Nepali anaesthetists have returned from training abroad, and the Society of Anaesthesiologists of Nepal, which joined the World Federation of Societies of Anaesthesiologists in 1988, now has 34 members. An annual anaesthesiology symposium is held, and weekly clinical meetings are organized in the major hospitals in Kathmandu. Anaesthetists who work in the zonal hospitals have limited supplies of drugs and equipment and opportunities for continuing medical education are virtually nonexistent.(ABSTRACT TRUNCATED AT 250 WORDS)

Anesthesia Department, Hospital

Re-evaluation of the Farman entrainer in a low-pressure system for field anaesthesia.

The aim of this project was to develop a portable anaesthesia system that was compatible with modern anaesthesia practice under field conditions, when compressed gas supplies are limited. We assembled and evaluated a low-pressure plenum system, based upon the Farman entrainer, which was adaptable to spontaneous, assisted or intermittent positive pressure ventilation (IPPV). The entrainer was tested using a low flow of compressed gas, O2 at 1-3 L.min-1. We measured the fresh gas flow (FGF) and O2 concentrations (F1O2) delivered at various source gas flow rates (O2 flow), and with various breathing circuits. Entrainment ratio, FGF, and F1O2 were highly dependent upon resistance to flow in the different breathing circuits. With a wide bore T-piece the air/O2 entrainment ratio was 6:1, and the F1O2 was 0.3. When circuit resistance was higher, e.g., with the Bain circuit, air entrainment and FGF were reduced, but F1O2 was higher. Because it offered the lowest resistance, the T-piece circuit was selected for a clinical trial.

Anesthesia, Inhalation

A low-pressure portable anaesthesia system for field use: clinical trials.

This is a report of our experience with a portable anaesthesia system that was developed for use under field conditions, when compressed gas supplies are limited. We first assembled and bench-tested a low-pressure plenum system, based upon the Farman entrainer. The entrainer required a low flow of compressed gas, O2 at 1-2 L.min-1, and generated a low-pressure mixture of O2 and air which was directed through an Oxford miniature vaporizer, a non-return valve, and a widebore T-piece circuit. With this system we anaesthetized 24 patients with intermittent positive pressure ventilation (IPPV) and nine patients breathing spontaneously. During IPPV, the circuit resembled a T-piece and provided effective gas exchange with a FGF of 1.2 times minute ventilation. Inspiratory and expiratory valves were arranged so that the spontaneous mode was non-rebreathing, and FGF was adjusted to equal minute ventilation. The system was very economical, using 1-2 L.min-1 O2 and 20-25 ml.hr-1 liquid halothane to produce a FGF of 6-10 L.min-1, an FIO2 of 0.33, and FIhal of 1-1.5 per cent. We have demonstrated that this is a versatile, safe, and economical system, compatible with the practice of modern inhalational anaesthesia under field conditions. It can be readily assembled from commercially available components.

Adult