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M Temmerman

Publications and source records attributed to M Temmerman.

At least 55 records · Page 3Linked to original sources

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↗

Declining syphilis prevalence in pregnant women in Nairobi since 1995: another success story in the STD field?

Untreated maternal syphilis during pregnancy will cause adverse pregnancy outcomes in more than 60% of the infected women. In Nairobi, Kenya, the prevalence of syphilis in pregnant women of 2.9% in 1989, showed a rise to 6.5% in 1993, parallel to an increase of HIV-1 prevalence rates. Since the early 1990s, decentralized STD/HIV prevention and control programmes, including a specific syphilis control programme, were developed in the public health facilities of Nairobi. Since 1992 the prevalence of syphilis in pregnant women has been monitored. This paper reports the findings of 81,311 pregnant women between 1994 and 1997. A total of 4244 women (5.3%) tested positive with prevalence rates of 7.2% (95% CI: 6.7-7.7) in 1994, 7.3% (95% CI: 6.9-7.7) in 1995, 4.5% (95% CI: 4.3-4.8) in 1996 and 3.8% (95% CI: 3.6-4.0) in 1997. In conclusion, a marked decline in syphilis seroprevalence in pregnant women in Nairobi was observed since 1995-96 (P<0.0001, Chi-square test for trend) in contrast to upward trends reported between 1990 and 1994-95 in the same population.

Female↗

HIV/STD: the women to blame? Knowledge and attitudes among STD clinic attendees in the second decade of HIV/AIDS.

We aimed to determine the knowledge and attitudes towards HIV/STDs among women attending an STD clinic by interviewing 520 randomly selected women. Nearly all had heard of HIV/AIDS/STDs, with posters, pamphlets and the radio being the main source of their information. The years of schooling was the only predictive factor of knowing a preventive measure of HIV. Two-thirds thought they were at risk of contracting HIV from their regular partner. Knowledge of the sexual habits of their male partners was low with 260 (50%) of the women distrusting their partner. Only 52 (10%) of respondents admitted to sex in exchange for gifts or money. In the event of a positive HIV test result, the perceived partner response would be to blame the woman for introducing the infection into the relationship. After a positive HIV test result, only 3.5% would resort to using condoms while another 3.7% would try to pass on the disease to other people. The quality of their knowledge of the transmission of HIV was low in spite of the fact that most respondents have heard of HIV/AIDS/STDs. Violence against women was expected in relation to a positive test result. There is a need for better educative effort on the modes of transmission and prevention of HIV, also in 'low risk' populations.

Acquired Immunodeficiency Syndrome↗

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 supermarket for women's reproductive health: the burden of genital infections in a family planning clinic in Nairobi, Kenya.

OBJECTIVES: To study the burden of disease of reproductive tract infections (RTIs) and cervical dysplasia in women attending a family planning clinic in Nairobi, Kenya, and to assess the acceptability of integrating reproductive healthcare services into existing family planning facilities. METHODS: In a family planning clinic in Nairobi, Kenya, 520 women were enrolled in a study on RTI and cervical dysplasia. RESULTS: RTI pathogens were detected in over 20% of women, the majority being asymptomatic. HIV-1 testing was positive in 10.2%. The diagnosis of cervical dysplasia was made on 12% of the cytology smears (mild in 5.8%, moderate in 3.5%, severe in 1.2%), and 1.5% had invasive cervical cancer. The intervention of case detection of RTI and Papanicolaou smear taking was well received by clients and considered feasible by the staff. CONCLUSIONS: Early detection and treatment of potentially curable cervical lesions and RTI provide a unique opportunity to improve women's health. In Kenya, where the current contraceptive prevalence rate is 33%, family planning clinics are excellent sites to introduce health interventions.

Adult↗

Systematic analysis of STD control: an operational model.

BACKGROUND: Sexually transmitted diseases (STDs) enhance HIV transmission, and improved management of STD in primary health care decreases HIV incidence. In resource poor countries, those responsible for planning and managing STD control programmes need to be able to analyse the STD situation in their setting and the interventions which are therefore likely to be most cost effective. However, the data required for such decision making are often not available in developing countries. This paper presents an operational model, developed as a practical tool to support planning, monitoring, and evaluation of STD intervention strategies in settings where data are unavailable or inadequate. METHOD: The operational model is based on the approach developed for estimating the effectiveness of control measures in tuberculosis programmes. Using available data, the model takes a step by step approach. It begins with analysis of the total male and female population, the proportion of men and women aged 15-49 years, and the proportion of these who are sexually active. Subsequent steps analyse numbers with STDs, and loss of cases to the health system at each stage between infection and cure. The model was tested in Nairobi, Kenya using available demographic, epidemiological, and public health data; no original data were collected. Data for the total population of Nairobi were not available to illustrate all the steps in the model. For these steps, relevant information was taken where available from a specific study population using a large STD referral centre. RESULTS: Despite the lack of precise data for Nairobi, the model highlighted sex imbalances in population, which has potential implications for STDs. It also showed significant disparities in terms of public health policy--for example, between the number of people infected with STDs and the number who have symptoms, and between the number with symptoms and those who seek treatment from public health facilities. It also showed differences between the numbers who attend a health facility, and those that are correctly diagnosed and treated, and, of these, the proportion that are cured. CONCLUSION: Even where data are incomplete or not available, the model can be a useful tool for analysis. Application of the model, as the Nairobi example illustrates, provides a useful starting point in terms of determining both general and specific determinants of STDs, identifying problems, highlighting significant sex differences, and indicating where it might be appropriate to focus interventions. The model showed that, in Nairobi, only a small proportion of STD cases are removed from the reservoir of infection in the community through curative services, that cases are lost to the health services at every step, and therefore that interventions are required at every step to achieve comprehensive STD control. It highlights the need for strategies to prevent infections, to identify and treat those with and without symptoms, to motivate those who are aware of their infection to seek treatment, and to improve the effectiveness of partner notification and treatment. Finally, the model points to areas where data are inadequate and where STD control programmes need to concentrate information collection efforts.

Adolescent↗

Intrauterine contraception in adolescent women. The GyneFix intrauterine implant.

Pregnancy rates among adolescents have not decreased over the last 10 years, despite numerous efforts. To solve this important health problem, the major strategy recommended is to encourage contraceptive use among sexually active teenagers. An important means of obtaining this is by promoting methods that are not dependent on daily administration in order to avoid noncompliance. One such method (Norplant) has already shown to be much more effective than the combination pill in preventing pregnancy in adolescent women. The frameless intrauterine implant system (fixed, frameless, and completely flexible) has been studied since 1985 in women between 14 and 50 years of age. The results in young nulligravid women confirm its very high effectiveness (cumulative pregnancy rate at 36 months: 1.4%), its low expulsion rate (cumulative rate at 36 months: 0.9%) and its optimal tolerance (cumulative removal rate for medical reasons at 36 months: 2.4%), resulting in a high acceptance of the implant and a high continued use. The system (GyneFix) offers long-term protection (5 years), and its insertion, with or without anesthetic, is easily accomplished in the office. The GyneFix should therefore be recommended as an excellent alternative for birth control pills for young women with low risk for STDs, especially when compliance is a problem, without an increased risk for complications and without systemic side effects. Removal of the device is accomplished by traction on the tail. It can also be used for emergency contraception and for insertion immediately after termination of pregnancy.

Adolescent↗

Antimicrobial prophylaxis in pregnancy: a randomized, placebo-controlled trial with cefetamet-pivoxil in pregnant women with a poor obstetric history.

OBJECTIVE: This study was undertaken to measure the impact of a single oral dose of cefetamet-pivoxil on pregnancy outcome in a population with substantial rates of low birth weight and high prevalence rates of maternal infections. STUDY DESIGN: A total of 320 pregnant women with a poor obstetric history, defined as a history of low birth weight or stillbirth, were randomized to receive a single oral dose of 2 gm of cefetamet-pivoxil or a placebo at a gestational age between 28 and 32 weeks. Patients were assessed at delivery and 1 week post partum for pregnancy outcome, postpartum endometritis, human immunodeficiency virus-1 and gonococcal infections. RESULTS: A total of 253 (79%) women gave birth at the maternity hospital, of whom 210 (83%) attended the follow-up clinic. Overall, 18.1% of these pregnant women were human immunodeficiency virus-1 seropositive, whereas 9.5% had antibodies against Treponema pallidum. There was a significant difference between cefetamet-pivoxil- and placebo-treated women in infant birth weight (2927 gm vs 2772 gm, p = 0.03) and low birth weight (< 2500 gm) rates (18.7% vs 32.8%, p = 0.01, odds ratio 2.1, 95% confidence interval 1.2 to 3.8). The stillbirth rate was 2.2% in the cefetamet-pivoxil group and 4.2% in the placebo group (not significant). Postpartum endometritis was found in 17.3% in the intervention arm versus 31.6% in the placebo group (p = 0.03, odds ratio 2.2, 95% confidence interval 1.1 to 7.6). Neisseria gonorrhoeae was isolated from the cervix in 5 of 103 (4.9%) women in the intervention and in 14 of 101 (13.9%) in the placebo group (p = 0.04, odds ratio 3.2, 95% confidence interval 1.1 to 10.5). CONCLUSION: A single oral dose of cefetamet-pivoxil administered to pregnant women with a poor obstetric history seemed to improve pregnancy outcome in this population with high rates of maternal infections. Larger studies should be carried out to examine the public health impact, the feasibility, and the overall cost/benefit ratio of this intervention.

Acquired Immunodeficiency Syndrome↗

The GyneFix implant systems for interval, postabortal and postpartum contraception: a significant advance in long-term reversible contraception. International Study Group on Intrauterine Drug Delivery.

Intrauterine contraception has a number of important advantages over other forms of contraception and remains, therefore, an important method of birth control. However, side-effects and other drawbacks have reduced its overall acceptance. Also misconceptions and lack of updated scientific knowledge among the potential users and providers are major obstacles to the widespread use of intrauterine contraception. Ideally, an intrauterine device (IUD) should prevent pregnancy effectively, be well tolerated, not become displaced or expelled over time, cause a minimum of side-effects, be long-lasting, have a strictly local effect, and be easy to insert and remove. A group at the University of Ghent, Belgium, the International Study Group on Intrauterine Drug Delivery, has developed, since 1985, a totally new concept in order to improve current intrauterine contraceptive efficacy and enhance tolerance, by creating a harmonious relationship between the uterine cavity and the contraceptive 'foreign body'. The new concept (GyneFix) consists of a non-biodegradable suture thread made of surgical 00 monofilament polypropylene on which six copper tubes are threaded, providing a total surface area of 330 mm2. The upper and lower tubes are crimped onto the thread to keep the tubes in place. The upper extremity of the thread is provided with a knot which serves as an anchor. The knot is implanted in the myometrium of the uterine fundus with a specially designed insertion instrument, thereby permanently securing the device in the uterine cavity. Since the initial clinical investigations, over 10,000 woman years of experience and up to 10 years' follow-up in international multicenter, non-comparative and comparative clinical trials have been collected. The clinical material also included a large number of nulligravid and nulliparous women. Due to the design characteristics of the GyneFix and its anchoring in the uterine fundus, an optimal tolerance and almost complete absence of expulsion were obtained. The constant release of copper ions in the upper part of the uterine cavity results in the high effectiveness of the anchored device. The effectiveness is higher than in the high-load conventional copper IUDs which have a risk of becoming displaced, partially or totally expelled in 10% or more (nulliparous women), resulting in a significant number of accidental pregnancies. The absence of frame and, as a consequence, its flexibility, explain the low incidence of side-effects and the very low incidence of complications, such as pelvic inflammatory disease and ectopic pregnancies. This new concept could be a major step forward in the acceptance of intrauterine contraception worldwide and increase its popularity. This article reviews the experience with the new concept for interval, postabortal and postpartum contraception.

Abortion, Induced↗

[Intrauterine copper contraceptive implants].

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 women 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. The following conclusions were reached: 1. The unique design characteristics of 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. GyneFix reduces the IUD-failure rate to a minimum and is, therefore, a welcome reversible alternative to OCs and female surgical contraception. 2. Frameless 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. 3. Insertion of GyneFix, with or without local anaesthesia, is easily accomplished in the office of a few minutes. Removal is easy, quick and painless. 4. GyneFix is an equally effective and well accepted method fro nulliparous women.

Equipment Design↗

The right not to know HIV-test results.

Large numbers of pregnant women in Africa have been invited to participate in studies on HIV infection. Study protocols adhere to guidelines on voluntary participation after pre-test and post-test counselling and informed consent; nevertheless, women may consent because they have been asked to do so without fully understanding the implications of being tested for HIV. Our studies in Nairobi, Kenya, show that most women tested after giving informed consent did not actively request their results, less than one third informed their partner, and violence against women because of a positive HIV-antibody test was common. It is important to have carefully designed protocols weighing the benefits against the potential harms for women participating in a study. Even after having consented to HIV testing, women should have the right not to be told their result.

Counseling↗

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↗

Risk factors for mother-to-child transmission of human immunodeficiency virus-1 infection.

OBJECTIVE: Our aim was to examine maternal, obstetric, and infant characteristics of mother-to-child transmission of human immunodeficiency virus-1 in Nairobi, Kenya. STUDY DESIGN: Proviral human immunodeficiency virus-1 was detected by polymerase chain reaction in peripheral blood samples taken between 6 weeks and 3 months of age from 107 children born to human immunodeficiency virus-1 seropositive women. The association of maternal, infant, and obstetric variables with human immunodeficiency virus-1 transmission was examined. RESULTS: The mother-to-child transmission rate was 31% (95% confidence interval 21.6 to 40.2) as defined by the presence of proviral human immunodeficiency virus-1 in the infant. Variables associated with transmission in a univariate analysis included placental inflammation (7/12 in the transmitting group as compared with 2/22 in nontransmitters, p = 0.006), low maternal CD4 and high CD8 percentages (21% and 52%, respectively, in transmitting mothers and 32% and 40% in nontransmitting mothers; p = 0.001), and the gender of the neonate (20/29 infected neonates were female as compared with 26/65 noninfected children, p = 0.02). Sexually transmitted diseases were found more often in transmitting mothers but the differences were not significant. Birth weight and gestational age were not related to vertical transmission of human immunodeficiency virus-1. CONCLUSION: Risk factors for mother-to-child transmission of human immunodeficiency virus-1 included chorioamnionitis, an impaired maternal immune status, and female gender.

Adult↗

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↗

Syphilis control in pregnancy: decentralization of screening facilities to primary care level, a demonstration project in Nairobi, Kenya.

A decentralized syphilis control program in pregnant women was implemented in nine Nairobi City Council antenatal clinics between July 1992 and August 1993, whereby pregnant women were screened for syphilis, treated before leaving the clinic if RPR seroreactive, and counselled on the importance of partner treatment and sexual abstinence during treatment in order to protect their unborn babies from getting congenital syphilis. A total of 13,131 pregnant women were screened for syphilis (RPR test), 87.3% of seroreactive women were treated on site and 50% of partners returned to the clinic and were treated. The prevalence of RPR reactivity was 6.5%. Based on other data the program could theoretically have prevented 413 cases of congenital syphilis at a cost of approximately 50 USD per prevented case. This demonstration project shows that decentralized prevention of congenital syphilis in antenatal clinics by nurses is feasible and inexpensive and should receive priority in resource allocation in reproductive health and child survival programs.

Female↗