PubMed Health⌕ Search

Biomedical subjects

I Batar

Publications and source records attributed to I Batar.

15 recordsLinked to original sources

What does society expect from health policy makers in reproductive health?

Family planning, and preventive measures generally, are very important for the health of a society. Despite this, official policy in Hungary has not given them enough support and recognition in recent years. The latest "act for the protection of the fetus," issued some years ago, dealt mainly with abortion; shortly thereafter, the health insurance stopped subsidizing the cost of contraceptives. Nowadays, patients must pay full price not only for condoms, but for pills, IUDs and even sterilization. The cost of preventing unwanted pregnancies became high; for many today, the reliable, modern methods are almost unaffordable. This situation is more than strange in a country with such high numbers and rates of induced abortion. Another problem is that service providers have too few resources. In the wake of the political and fiscal changes that have taken place since the early 1990s, the state does not have enough money to meet the need for this type of preventive work. There are still few non-governmental organizations (NGOs) operating in Hungary: those that there are do not yet have the financial strength to sponsor these initiatives. In light of these circumstances, decision makers concerned to reverse the disturbing demographic trends should concentrate on changing the health policy.

Family Planning Services↗

Preventing abortion and repeat abortion with the Gynefix intrauterine implant system--preliminary results.

The provision of immediate post-abortal contraception is important to reduce the number of unplanned pregnancies and the number of repeat abortions. Immediate post-abortal insertion of an IUD has many advantages and is an acceptable and safe method. However, side-effects and expulsion of conventional IUDs remain a problem. In an attempt to minimize these problems, the frameless intrauterine implant (IUI) was developed. Clinical studies conducted over the past 12 years have shown the validity of the anchoring concept. The design characteristics of the IUI (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness and high tolerance rates. This communication is the first report of clinical experience with the post-abortal version of Gynefix (Gynefix PT) in a limited number of women with pregnancies of less than 10 weeks' duration. This experience suggests that immediate post-abortal insertion of Gynefix PT is easy, safe and the implant appears to be as reliable and effective as interval insertion of the interval version. We conclude that the immediate post-abortal insertion of Gynefix PT is an important novel approach to reducing the incidence of repeat abortions.

Abortion, Induced↗

The frameless GyneFix intrauterine implant: a major improvement in efficacy, expulsion and tolerance.

The CuFix (GyneFix), conceived in 1985, was developed to minimize three major problems frequently associated with discontinuation of IUD use: expulsion, bleeding and pain. Since the initial clinical investigations, over 10,000 woman years of experience and up to 8 years of follow-up in international multicenter, non-comparative and comparative clinical trials, including a large proportion of nulligravid/nulliparous women, have been collected. Based on new clinical information about the GyneFix from a long-term multicenter clinical trial, conducted in young nulligravid/nulliparous and parous women, the importance of this new contraceptive is discussed. The following conclusions were reached: The unique design characteristics of the GyneFix (frameless, flexible and fixed to the fundus of the uterus) have resulted in optimal tolerance and almost complete absence of expulsion. The result is enhanced effectiveness (comparable to OCs and male/female sterilization) and a high rate of continued use. The GyneFix reduces the IUD failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. Framelessness and flexibility explain the absence of side-effects and adverse events caused by dimensional incompatibility between the frame of conventional IUDs and the uterine cavity and may also explain the absence of PID and ectopic pregnancies in any of the clinical studies. The GyneFix is a promising new, highly effective and safe, contraceptive option for parous women and an equally effective and well-accepted method for nulliparous women.

Adolescent↗

IUD expulsion solved with implant technology.

In an attempt to minimize the problem of IUD expulsion, implantation technology has been developed and tested. The trials have extended from 1985 until the present time for interval as well as for immediate postabortal and post-placental insertion and fixation of the CuFix IUD (Gyne-Fix). The present article reports on an ongoing study with GyneFix interval insertion, with an improved inserter, in 820 women, observed up to 3 years, of whom 213 (25.9%) are nulligravid/nulliparous. The cumulative expulsion rate is 0.6 per 100 women-years at 3 years and is not significantly higher in the nulligravid/nulliparous group. The cumulative pregnancy rate is 0.6 and the cumulative removal rate for medical reasons 3.2 at 3 years. The total experience in this multicenter study covers approximately 14,000 woman-months. It is concluded that the design characteristics of the GyneFix (fixed, frameless, and flexible) explain the low expulsion, high efficacy and high acceptability rates. The implantation technology is very effective and the improved inserter allows easy insertion and optimal anchoring.

Adult↗

Immediate postplacental insertion and fixation of the CuFix postpartum implant system.

Since promising results were obtained with the CuFix interval implant system in international clinical trials conducted worldwide, a modification of the device adapting it for immediate postplacental insertion and fixation (IPPIF) seemed a logical approach to solve the expulsion problem of IUDs inserted at that particular time. Seventy-three insertions were performed at three university centers, during 1990 and 1991, both by skilled and unskilled investigators. The results of this multicenter study show the excellent retainability of the modified IUD supporting the validity of the anchoring principle. The insertion procedure is easy, requiring minimal training, and the insertion technique appeared to be safe.

Equipment Design↗

New abortion law in Hungary.

In December 1992, the Hungarian Parliament revised the abortion law. The new law is in some ways more liberal than the former one. A woman can now have an abortion on demand within the first 12 weeks of pregnancy, if she is in a "crisis situation". A compulsory consultation has also been introduced with a nurse who informs the women on issues of contraception, maternity allowance, etc. Under certain circumstances abortion is legal beyond the first trimester. These include for example misdiagnoses of the pregnancy, if the women is under 18 years, or in case of genetical or teratogenic risks. Abortion performed for medical reasons is free of charge. In other cases the fee is HUF 5000, the equivalent of US $60, which can be reduced according to the economical status of the family. In one way the new law can be considered more restrictive; previously, an abortion was free of charge for women who became pregnant with an IUD, whereas now the woman has to pay the abortion fee.

Abortion, Induced↗

One-year clinical experience with FlexiGard.

In 1988, a clinical study with a new copper-containing IUD, the FlexiGard, was initiated at the Family Planning Center of the UMSD, Debrecen, Hungary. The aim of this trial was to measure the overall performance of the device with special attention to its frameless design and anchoring system. In one year (from May 1988 through May 1989), 344 FlexiGard devices were inserted in parous women during the first seven days of their menstrual cycle. This report summarizes the one-year results. By the end of the 12 -month follow-up period, 3484 woman-months of use (WMU) were accumulated. The number of women who completed the one-year follow-up period was 264. During this period, 33 cases were terminated for different reasons. The net continuation rate is 89.7 at the end of the first year of use. The device was well retained by the uterus (cumulative expulsion rate 1.5 at 12 months). The cumulative removal rate for bleeding/pain is 4.4 at 12 months and the cumulative pregnancy rate 0.6 at 12 months. The results confirm those of previously conducted multicenter studies with the device. This new generation intrauterine copper contraceptive (ICC) is well tolerated, which is attributed to its design characteristics. Besides, the device is highly effective, and its insertion is easy and safe. Removal of the ICC is equally easily accomplished.

Adolescent↗

Return to fertility after removal of a levonorgestrel-releasing intrauterine device and Nova-T.

In a European randomized multicenter study, the efficacy and safety of an intrauterine contraceptive device releasing 20 microgram levonorgestrel/24 hours (LNG-IUD) have been evaluated and compared to the Nova-T. Because the LNG-IUD has a strongly suppressive effect on the endometrium and in some women affects ovarian function, the return to fertility after removal of the IUD was studied. Two-hundred-nine women (71 in the Nova-T and 138 in the LNG-IUD group), who had their IUDs removed because of planning pregnancy, were followed at least 24 months or until termination of pregnancy. For the Nova-T, the cumulative conception gross rate was 71.2/100 women after 12 months (79.7 after 24 months) and for the LNG-IUD 79.1 (86.6 after 24 months). The difference between the devices is not statistically significant, and in spite of the endometrial suppression during use of LNG-IUD, there is no delay of return to fertility and in both groups 96% of the pregnancies occurred during the first year after removal of the device. Eighty-four % of the pregnancies in the Nova-T group and eighty-six % in the LNG-IUD group ended in live births. The results suggest that the endometrium recovers quickly, normal ovulations are established and the fertility seems to be unaffected after use of an LNG-IUD.

Female↗

Clinical experiences with intrauterine devices inserted with and without tail.

Nova T and TCu 200 Ag IUDs were inserted with or without a tail in order to study the possible role of the thread on the occurrence of PID. The five-year gross cumulative termination rate for infection was 3.7 in the group with a tail and 1.3 in the group without a tail. The results indicate a lower risk of genital infection if the device is inserted without the tailstrings.

Adolescent↗

Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study.

The use-effectiveness of an intrauterine contraceptive device releasing 20 mcg of levonorgestrel daily (Lng-IUD), and of a Nova T copper-releasing IUD, were studied in a randomized, comparative multicenter trial. The Lng-IUD was inserted in 1821, and the Nova T in 937 women. The 12-month net pregnancy rate with the Lng-IUD (0.1 per hundred women) was significantly lower than that with the Nova T (0.9 per hundred). Removal rates for menstrual problems and/or pain were similar for the two methods (net rates 7.5 and 8.7, respectively). The 12-month continuation rates were 82.2 for the Nova T and 79.7 for the Lng-IUD. The reduction of the bleeding led to oligomenorrhea and amenorrhea in users of the Lng-IUD; the removal rate for these reasons was 1.4. The removal rate for hormonal side effects with the Lng-IUD was 2.4. Blood hemoglobin concentrations increased among users of the Lng-IUD and decreased among users of the Nova T. The results show that the Lng-IUD was a highly effective contraceptive method which reduced menstrual bleeding. It is a promising alternative for women desiring a highly effective method for long-term use.

Adult↗

A comparison between Nova T and Copper T 200 Ag in Hungary.

In a comparative use-effectiveness study, 855 Nova T and 883 TCu 200 Ag devices were inserted in a randomised sequence. By the end of the first year the gross rate of unplanned pregnancy was 1.1 per 100 users of Nova T and 2.1 per 100 users of TCu. After 2 years the pregnancy rates for Nova T and TCu were 3.1 and 4.8 per 100 users, respectively. Although there was no statistically significant difference between the rates for the two devices, they suggest a higher contraceptive efficacy for Nova T.

Clinical Trials as Topic↗