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Biomedical subjects

H Van der Pas

Publications and source records attributed to H Van der Pas.

15 recordsLinked to original sources
PubMed1997

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↗
PubMed1996

[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↗
PubMed1995

A randomized comparative study of the TCu380A and Cu-Safe 300 IUDs.

The Cu-Safe 300 is one of the latest additions to the array of available IUDs. It was specifically designed to decrease unwanted side-effects (e.g. bleeding, pain and expulsion) while providing simplicity of insertion, ease of removal and fair contraceptive protection. For comparison, the TCu380A was chosen. Both types were inserted at random in 600 recipients by a group of independent physicians with a long standing experience in intrauterine contraception. Life table analysis was used for comparison over a period of three years. The Cu-Safe 300 produced a slightly but not statistically significant higher pregnancy rate and more expulsions. Removals for bleeding and pain, however, were significantly less frequent. All inserting physicians agreed that insertion and removal of this new device was remarkably easy.

Adolescent↗
PubMed1995

Fertility after hysteroscopic myomectomy.

The available data concerning hysteroscopic myomectomy for submucous myomas has been reviewed with the aim of evaluating the safety and efficacy of this technique in infertile women who wish to preserve or to enhance their fertility potential. A total of 134 infertile patients undergoing hysteroscopic myomectomy by resectoscope or by Nd: YAG laser or by scissors have been collectively recorded. Of these, 79 (58.9%) patients conceived. This clinical outcome is similar to that occurring after laparotomic submucous myomectomy. Moreover, the hysteroscopic approach has several advantages over its abdominal counterpart, such as reduction of length of time of hospitalization, less morbidity and no hysterotomy. The operative risk of hysteroscopic myomectomy is < 3%. Uterine perforation, distension system hazard, infection and haemorrhage are the commonest complications. Hysteroscopic myomectomy is a safe, effective and relatively simple surgical procedure for the restoration of fertility.

Female↗
PubMed1993

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↗
PubMed1989

[The levonorgestrel intrauterine device].

The levonorgestrel IUD offers a valuable improvement for women, who develop menorrhagia with conventional IUDs. However, since the levonorgestrel Nova-T induces amenorrhea and spotting in a substantial proportion of the patients, it is advisable, before insertion, to evaluate the acceptor's reaction to the "new" bleeding pattern induced by the steroid IUD.

Female↗
PubMed1985

The MLCu375 intrauterine contraceptive device.

Reports in the contraceptive literature and our own data concerning the MLCu375 intrauterine device indicate that the high-load ML model is effective, safe, and well tolerated. It is more effective than the MLCu250 without increase in the other cardinal event rates. Consequently, we consider the MLCu375 an improved ML model.

Adult↗
PubMed1985

A decade of experience with the TCu220C.

A decade of experience with the TCu220C has confirmed the prolonged high effectiveness, safety, and acceptability of this device. The present analysis concerns 906 interval insertions performed by three experienced operators using the retraction technique for placement of the TCu220C, and covers a total of 53,875 woman-months of experience. Gross cumulative pertinent event rates at 10 years were: pregnancy 7.5; expulsion 9.1; and removal for bleeding/pain and other medical reasons 21.9 and 9.2, respectively. Both the age and parity of the acceptor influence the long-term performance of the TCu220C.

Adult↗
PubMed1985

IUD insertion during cesarean section.

An IUD (TCu220C) was inserted in 82 women during low-transverse cesarean section. No untoward effect on puerperal morbidity or lactation was observed and no serious complications occurred in this series. At 12 months the rates were zero for pregnancy and 7.7 for expulsion; the latter figure is comparable to that reported after immediate postplacental insertion of the same IUD model. Intracesarean IUD insertion is a procedure that deserves further promotion.

Adult↗
PubMed1985

Immediate post-placental IUD insertion: the expulsion problem.

This paper reports an evaluation of immediate post-placental insertion of a non-copper (Lippes Loop D) and several copper-bearing IUD models (TCu200, TCu220C, MLCu375, MLCu250, Nova T-PP, DimélysR). Based on the analysis of a total of 2,646 insertions and 55,794 woman-months of experience, we conclude that placement of an IUD within ten minutes of delivery of the placenta is a valuable alternative to interval insertion, because this method is safe and effective. Effectiveness was significantly lower for the Lippes Loop D than for the T- and ML-IUD models tested, the latter showing roughly comparable pertinent event rates. Pertinent event rates for copper IUDs were influenced by the skill of the operator; age of the recipient only had a significant effect on effectiveness, whereas parity had no significant effect on pertinent event rates. The single and still unsolved problem associated with immediate postpartum insertion is the greater likelihood of expulsion compared with interval insertion, and this hazard is significantly much greater for the Loop than for the copper-bearing devices assessed. The evolution of the expulsion rates shows a constant time-relationship. This pattern makes it obvious why follow-up of recipients, at least during the first trimester following insertion, is mandatory if immediate post-placental IUD insertion is to be optimally effective.

Adult↗
PubMed1983

Treatment of vaginal candidosis with oral ketoconazole.

Results with ketoconazole were studied in 281 non-pregnant patients with acute and chronic Candida-vaginitis. Several dose regimens were evaluated. The 5-day regimens (200 mg b.i.d. or 400 mg once daily) seem to be the most appropriate schedules in this infection. Side effects were minor. Relapse rates are not different from those, historically known, with topical antifungals.

Administration, Oral↗
PubMedDate not supplied

Is hysteroscopy of value in the investigation of female infertility?

A prospective multicentre study was designed to ascertain the value of hysteroscopy in the evaluation of female infertility. The study comprises 619 CO2 hysteroscopies in women complaining of infertility. Four hundred and ninety nine examinations (80%) were performed without anaesthesia or cervical dilatation. Twenty eight cases of malformation were diagnosed. Adhesions were found in 68 patients (11%), polypi in 56 (9.1%) and submucous fibroids in 51 (8.2%). Endometrial hyperplasia was diagnosed by hysteroscopy in 67 patients, but there was only 42% histological correlation. Examination of the tubal ostia by hysteroscopy revealed 26 patients (4%) with unilateral tubocornual polyps and one with bilateral polyps. The correlation with hysterosalpingography (HSG) in 185 patients was poor. In 20% where the HSG was reported as normal there were hysteroscopically demonstrable lesions whereas there were false positive findings at HSG in 35% of cases. Hysteroscopy is the only technique which provides an accurate clinical evaluation of the uterine cavity although it does not provide significant information about the cervical canal or fallopian tubes.

Adult↗