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Biomedical subjects

I Batár

Publications and source records attributed to I Batár.

At least 19 recordsLinked to original sources
PubMed2002

Five-year clinical experiences with NOVA T 380 copper IUD.

In an open, single-group, phase III clinical trial of 5 years, the clinical performance of NOVA T 380 was investigated in three centers. The device having a higher copper surface of 380 mm(2) is a modification of NOVA T. A total of 400 voluntary women were enrolled in the study. The mean age was 31.4 years (SD 5.5) with the minimum of 18 and the maximum of 44 years. At the end of the study, 211 women had passed the 60-month visit. Cumulative discontinuation rates at the end of the first and the fifth year calculated by Kaplan-Meier estimates, were respectively as follows: pregnancy 0.5 and 1.9, expulsion 1.3 and 4.1, bleeding 4.4 and 14.0, pain 1.3 and 4.2, removal for other medical reason 1.4 and 6.4, planning pregnancy 0.8 and 13.5, and removal for other personal reason 2.4 and 11.9 per 100 users. Neither ectopic pregnancies nor episodes of pelvic inflammatory diseases (PIDs) occurred. One perforation was recorded; the calculated rate is 0.3 per 100 women (first year). The continuation rate was 88.3 and 52.5 at 1 and 5 years, respectively. In conclusion, the 5-year performance of NOVA T 380 was good compared to other "high-loaded" copper devices. Safety was acceptable over the entire study period.

Adolescent↗
PubMed2000

Immediate postabortal insertion of the frameless IUD: review of current experience.

Experience with the frameless Gynefix intrauterine device (IUD) for immediate postabortal insertion is growing. Reports confirm that the design characteristics of the frameless IUD (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness and high continuation rates. Insertion is easy and safe in the hands of trained providers and appears to be as reliable and effective as when inserted at interval. The results suggest that the frameless IUD may be an important new and affordable option to prevent repeat abortion.

Abortion, Induced↗
PubMed1999

Two-year clinical experience with Nova-T 380, a novel copper-silver IUD.

In 1992, an open single-group phase III clinical trial was started at three centers to investigate the clinical performance of the high copper surface area Nova-T 380, a modification of Nova-T. This report presents the interim results of the first two years of use. A total of 400 women volunteers were enrolled in the study. The mean age was 31.4 years (SD 5.5) with a minimum of 18 and a maximum of 44 years. At the cut-off date, 259 women had passed the 24-month visit. Gross cumulative life-table rates at the end of the first and second years, respectively, calculated by the Kaplan-Meier method, were as follows: pregnancy 0.5 and 1.6, expulsion 1.6 and 2.8, bleeding 4.7 and 8.7, pain 1.3 and 2.3, removal for other medical reasons 1.7 and 3.9, planning pregnancy 1.1 and 6.0, removal for other personal reasons 0.5 and 1.5, per 100 users. No ectopic pregnancies or PIDs occurred. The continuation rates were 89.0 and 75.5 at 12 and 24 months, respectively. The first two-year performance of the Nova-T 380 was good. Bleeding problems were in the same range as with devices with smaller copper surface areas. No unexpected serious adverse events were encountered.

Abdominal Pain↗
PubMed1999

A decade of experience with TCu200.

This paper summarizes ten years of experience with 2766 interval insertions of the TCu200 device. One hundred and twenty months of use were completed by 572 patients and the cumulative woman-months of use were 159,664. For evaluating the overall performance, gross cumulative and yearly specific life-table termination and continuation rates were calculated as suggested by Tietze [2]. The cumulative pertinent rates at the end of the ten-year follow-up period were as follows: pregnancy 10.2; expulsion 6.3; bleeding/pain 32.3; and removal for other medical reasons 19.4. The gross annual rates for the same conditions at the end of the first year of use were: 1.8, 2.4, 4.2, and 2.0, while in the tenth year they were: 0.6, 0.1, 4.4, and 2.8, respectively. The continuation rate was 89.1 at the end of the 12th month and 33.2 at the end of the 10th year. Based on this evaluation, the TCu200 IUD has a good overall performance and a longer lifespan than was previously expected.

Female↗
PubMed1999

GyneFIX. The frameless intrauterine contraceptive implant--an update for interval, emergency and postabortal contraception.

This article reviews the clinical experience with the GyneFix intrauterine implant system for interval, emergency and post-abortal contraception. The relatively high rate of unintended pregnancies and abortions in the world signifies that greater access to contraception is necessary. Unwanted pregnancies and abortions could be avoided by widening the range of effective and acceptable contraceptive methods for use in situations where current methods are far from optimal. High effectiveness, protection against sexual transmitted infections, long duration of action, reversibility and safety are some of the most important attributes of contraceptives valued by women. The development of the frameless intrauterine device is a response to the need to develop contraceptives with high user continuation rate. GyneFix has the lowest failure rate of all copper IUDs currently available. Its performance is further optimised by the atraumatic frameless design which minimises the side effects and discomfort experienced with conventional IUDs. GyneFix could, therefore, be a useful new contraceptive option in looking at ways to reduce the number of unwanted pregnacies and induced abortions.

Abortion, Induced↗
PubMed1997

Interval and postabortal contraception with the frameless GyneFix.

Intrauterine contraceptive devices (IUDs) have not suffered from the same negative influences in the developing world as in the first world. The method has too many basic advantages to be gainsaid including, most importantly, that it has the lowest lifetime cost of any effective method of contraception, and that user compliance is not an issue once the device is in place. However, the global community is not immune from trends that are seen in selected industrialized countries. Today, better methods of contraception are requested and the discomforts associated with earlier models of IUD, which were once acceptable, are less so today. Faced with the side-effects of oral contraception and the high cost in developing countries, many women who have completed their families undergo surgical sterilization as the only long-term method available to them, notwithstanding severe cultural and economic reservations about doing so. The development of the frameless device is a response to the growing need to develop high-performing, long-acting, reversible and acceptable contraceptives with a high continuation of use and to respond to the urgent need to reverse the legacy of neglect of immediate postabortal family planning.

Abortion, Induced↗
PubMed1992

Clinical experiences with MLCu250 and MLCu375 IUD.

The paper summarizes the author's ten-year experience with 1446 interval insertions of the MLCu250 standard-type device, and makes comparison between the first two-year results of this and the MLCu375 IUD. The 120th month was completed by 106 MLCu250 users, and the cumulative woman-months of use (wmu) were 78,078. At the end of the second year, 976 patients were at risk in this group, representing a total of 28,097 wmu. From the initial 224 MLCu375 IUD cases, 160 (2,151 wmu) and 93 (3634 wmu) were eligible for life-table calculation at the end of the first and the second year, respectively. The overall performance was evaluated by net and gross cumulative and yearly specific rates as suggested by Tietze. These figures are detailed by the article. Based on this evaluation, two statements are made: (1) the MLCu250 standard-type device has a good overall performance and a longer life span than was previously expected; (2) the first two-year results with the MLCu375 are more favorable (lower termination rates, higher continuation) than the MLCu250.

Adult↗
PubMed1991

Analysis of transforming gene regions of human papillomavirus type 16 in normal cervical smears.

Exfoliated cells from the uterine cervix of 102 Hungarian women with no cytological abnormality were screened using the polymerase chain reaction (PCR) for human papillomavirus (HPV) type 16 infection. Twenty-nine patients with histologically confirmed cervical intraepithelial neoplasia (CIN) served as reference cases. PCR was performed with 2 different HPV 16 specific oligonucleotide primer pairs flanking a 300 and a 200 base-pair fragment from the early 6 (E6) and early 7 (E7) genes, position 215-514 and 605-805. The specimens exhibited the same proportions of type 16 sequences specific for the tested regions. 8.8% (9/102) of normal samples showed amplification for HPV type 16 E6 and E7 regions, while 48.3% (14/29) of CIN biopsies were positive for the same gene sequences.

Cervix Uteri↗
PubMed1990

[The Szontágh IUD and cervix carcinoma (results of a 10-year follow up study)].

Based on a ten-year follow-up of 8334 Szontágh IUD (a non-medicated, Hungarian-made device) cases, the author evaluates the connection between the IUD and the cervical cancer. At the end of the tenth year, the number of those at risk is 1159, and the cumulative woman-month of use is 397 817. During the observation period, 35 devices were removed for suspect colposcopic and/or cytologic findings. Using life table rates the author analyses the occurrence of the invasive and the in situ carcinoma, the dysplasia and those cases where the histopathology performed after the IUD removal resulted in "negative" finding. The 35 removals represent a 5.2 net cumulative termination rate at the end of the 120th month (calculated for 1000 women). The same figure for the 2 in situ and the 3 invasive carcinoma is 0.3 and 0.4, respectively. Evaluating the gross specific (annual) rates, it is stated that there is not any correlation between the duration of the IUD use and the occurrence of cervical malignancy; consequently, the intrauterine contraceptive device does not cause carcinoma. These rates were compared to the overall country figures, and the IUD users showed lower frequency. Of course, it does not mean that the device gives protection against malignancy, but it proves that the regular follow-up helps to discover the suspect cases in time.

Female↗
PubMed1989

Human papillomavirus in cervical smears taken from women wearing an intrauterine contraceptive device.

Cervical cells were screened for human papillomavirus (HPV) infections by in situ filter hybridization in 108 patients wearing intrauterine contraceptive devices. The cells were tested for the presence of HPV 6, 11, 16, 18 DNA. In 86 cases (79.6%) no reactions were obtained with 32P-labeled HPV DNA probes. 22 smears (20.3%) were positive for HPV: type 6 and 11 sequences were demonstrated in 17 cases (3 of them carried both). 4 smears hybridized with the probe for oncogenic HPV 16 and one with that for oncogenic type 18. All these five patients had normal smears and no abnormality on colposcopy.

Female↗
PubMed1988

MLCu250 IUD: a decade of experience.

The paper summarizes the author's ten-year experience with 1446 interval insertions of the MLCu250 Standard type device. The 120th month was completed by 106 patients and the cumulative woman-months of use were 78,078. For evaluating the overall performance, gross cumulative and yearly specific life table termination and continuation rates were calculated as suggested by Tietze. The cumulative pertinent rates at the end of the ten-year follow-up period were as follows: pregnancy, 9.9; expulsion, 8.8; bleeding/pain removal, 33.4; and removal for other medical reasons, 24.5. The gross annual rates for the same conditions at the end of the first year of use were: 2.4, 4.4, 5.1 and 1.2, while at the 120th month they were: 0.8, 0.0, 6.1 and 5.5, respectively. The continuation rate was 83.7 at the 12th month, and 26.7 at the end of the 10th year. Based on this evaluation, the MLCu250 Standard IUD has a good overall performance and a longer life span than was previously expected.

Adult↗
PubMed1988

One-year results with the Fincoid IUD--a Hungarian experience with the short model.

This study presents the one-year experience with a new copper-releasing intrauterine contraceptive device, the Fincoid IUD. Between November 1984 and August 1985, 650 Fincoid devices were inserted in parous women to test the efficacy and clinical performance of the devices. After one year, 16 pregnancies had occurred (2.8 net cumulative rate); 26 devices had been partially or totally expelled (4.4); 27 devices had been removed for bleeding and/or pain (4.7); and 16 devices had been removed for other medical reasons (2.8). The continuation rate at the end of the first year was 84.3, indicating a good clinical performance.

Female↗
PubMed1988

Clinical experiences with the Spring Coil intrauterine device: a ten-year follow-up study.

In a ten-year follow-up study analysing 1080 cases and 29,138 cumulative woman-months of use, the clinical experiences of the Spring Coil IUD are evaluated using the life table technique, the net cumulative pertinent termination rates calculated for 100 women at the end of the 10th year, were as follows: pregnancy 1.2; expulsion 32.5; bleeding/pain removal 31.6; removal for other medical reasons 6.2. The results support the concept that in problem- and symptom-free cases, routine IUD removal is not necessary.

Adult↗
PubMed1988

Clinical experience with intrauterine contraceptive devices (IUDs) inserted with and without tail.

Between 1982 and 1984, two comparative clinical trial for testing new types of IUDs, were initiated at the Family Planning Center (Debrecen, Hungary) in collaboration with the Leiras Research Laboratories (Turku, Finland). 685 Nova T and 500 TCu 200Ag IUDs with and without tail were inserted in a randomized manner in order to study the possible role of the thread of the device in generating pelvic inflammatory disease (PID). Because there were no statistically significant differences between the corresponding rates of the devices, the data regardless of the type of the IUD, were pooled, then separated into two new groups: the study group (IUD without tail) consisted of 581 cases, while the control population (IUD with tail) included 602 insertions. The age and parity distribution was the same in both groups (mean age 29.4, mean parity 1.9). In the study group 300 patients completed the two-year follow-up, and 9675 womanmonths of use were evaluated. The corresponding figures for the control population were 304 and 9935, respectively. The two-year gross cumulative termination rates for the study and the control group were as follows: pregnancy 4.4 and 4.6; expulsion 1.9 and 2.9; bleeding/pain removals 6.3 and 6.0, removal for infection 0.2 and 2.7; removal for other medical reason 2.1 and 1.9; removal for planning pregnancy 4.6 and 6.6; removal for other personal reason 1.6 and 0.6. The pregnancy, expulsion and removal rates, except infection, were almost the same in both groups. There was a statistically significant difference only between the rates of removals for PID (p less than 0.05): during the two-year period of use 12 devices were removed for infection and out of these only 1 was inserted without tail! Although these findings are promising, to draw a final conclusion more cases and a longer follow-up are needed.

Adult↗
PubMed1986

How does the IUD influence subsequent fertility?

Analyzing the data of 649 women, 587 pregnancies and 502 deliveries after discontinuation of IUD use, the return of fertility was investigated in a retrospective study. The non-medicated, Szontágh-type device was removed for planned pregnancy in every case and after removal, the women did not use any kind of contraception until the first conception. Using the life table technique for calculation, the cumulative conception rate was 90.5 at the end of the first year after discontinuation of IUD use. The duration of IUD use did not influence the length of time that had elapsed until the first conception after removal, and the outcome of pregnancies was the same in the study and the local control group. The period of time between discontinuation and first conception did not influence the length of gestation and there were statistically no significant differences in the frequencies of abortion, immature or premature, and mature delivery among the pregnancies conceived in the first, second, third and fourth quarter of the year after removal. The frequency of malformations and the sex ratio of the newborns also were found to be the same in the study and the control group. The birthweight corresponded to that of the local standard values. It is stated that, as for the return of fertility, the Szontágh IUD fulfils the requirement established for all temporary contraceptive methods. After removing the device fertility was restored and no negative effects on conception, course and outcome of pregnancy were observed. In our opinion, the conclusions drawn from these results may apply to other inert IUDs, however, further investigation of the question with more cases and different types of IUD should be made.

Abortion, Spontaneous↗
PubMed1985

Clinical experience with the MLCu250 IUD (eight-year results).

Between 1977 and 1981, 1561 MLCu250 standard model IUDs were inserted at the Family Planning Center, Department of Obstetrics and Gynecology, University Medical School of Debrecen, Hungary. The majority were in the first (61.3%) and second (32.2%) segment and only a few were in the third (5.4%), fourth (1.0%) or fifth (0.1%) segment. Insertions were performed in the postmenstrual, postabortal, postpartal and postpuerperal periods. This report evaluates the data for interval insertions only, representing a total of 1457 cases and 65762 woman-months of use during an 8-year follow-up period. Using Tietze's life table technique, cumulative and yearly specific termination rates have been calculated. Fifty per cent of the devices were in place after 5 years of use, and 27.8% of the patients wore the IUD even at the end of the eighth year after insertion. The pertinent termination rate (pregnancy, expulsion, removal for bleeding/pain and for other medical reasons together) was 56.8 in the 96th ordinal month. These findings prove the good over-all performance of the MLCu250 IUD and demonstrate a longer life span for the device than was previously expected.

Female↗