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Biomedical subjects

H van Kets

Publications and source records attributed to H van Kets.

14 recordsLinked to original sources

Immediate post-abortal insertion of the frameless GyneFix IUD: initial experience in China.

The promising results obtained with the frameless GyneFix IUD for interval insertion led to the belief that the technology could be useful for immediate post-abortal application to reduce the number of induced and repeat abortions. IUDs have many advantages and the method is acceptable and safe. However, side effects and expulsion of conventional IUDs remain a problem. In an attempt to minimise these problems, the frameless GyneFix IUD was developed. Clinical studies conducted over the past 14 years have shown that the principles on which the device is based are valid. An increasing bulk of clinical evidence shows that the design characteristics of the device (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness, and high tolerance and continuation rates.1 Experience with the frameless IUD in China since 1989 confirms the international experience with the device. The present communication is a second report from China with the GyneFix IUD. In the present study the GyneFix IUD is inserted immediately following termination of pregnancy of less than 10 weeks amenorrhea. It is concluded that immediate post-abortal insertion of the frameless IUD is easy and safe, and appears to be as reliable and as effective as when it is inserted at interval. The GyneFix IUD could, therefore, constitute an important new option in the prevention of abortion.

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↗

Candidiasis in women fitted with an intrauterine contraceptive device.

Vaginal colonization by Candida spp. was compared in 117 women fitted with an intrauterine contraceptive device (IUCD users) and in 100 women not wearing an IUCD (control group). None of the subjects had factors currently assumed to predispose to yeast colonization or infection. Yeasts were present significantly more often in the IUCD users (20%) than in the control group (6%). In two of the 21 women with positive cultures the tail of the IUCD yielded substantially more colonies than the vaginal specimen and in seven, only the tail culture was positive. These findings strongly suggest that the IUCD is a predisposing factor in vaginal colonization by Candida strains. In half the women the presence of yeasts in the vagina was not associated with signs and symptoms of clinical infection. Of the 29 yeast strains isolated 17 were C. albicans, there was no difference in the prevalence of C. albicans between IUCD users and non-users or between symptomatic and asymptomatic women.

Candidiasis, Vulvovaginal↗

A randomized study of two cups for vacuum extraction.

O'Neil designed a set of suction cups which, because of more efficient lateral pull and greater maneuverability, were claimed to be more efficient and perinatally safer than the Malmström model. These claims were checked by comparing the two instruments in a randomized controlled trial comprising 410 attempted elective extractions. The two instrument groups were comparable at entry and the operators had a similar degree of experience, the sole inter-group difference being the 0.5 cm larger diameter of the O'Neil cups. No significant differences were found between the two types of instrument as to failure rate, incidence of correct cup positioning, and capacity of eliciting internal rotation nor was there a significant divergence in neonatal safety. In a few cases the perineum was lacerated by the traction cord affixed to the O'Neil instrument. The results of this study indicate that the relative advantages and disadvantages of the two cup models are unremarkable.

Extraction, Obstetrical↗

Immediate postplacental IUD insertion: a randomized trial of sutured (Lippes Loop and TCu22OC) and non-sutured (TCu22OC) models.

A randomized clinical trial concerning immediate post-placental insertion (IPPI) of the Delta Lippes Loop, Delta TCu22OC, and TCu22OC was undertaken to assess the effect of the addition of catgut strands on IUD performance. A total of 906 devices were inserted and the subjects followed for 20 months, at which time 14,136 woman-months experience had been accumulated. The Delta Loop constantly had inadmissibly high expulsion and pregnancy rates. The two T-IUD models had significantly lower rates of expulsion and pregnancy, and these rates were similar for the sutured and the non-sutured TCu22OC. Immediate postplacental insertion of the three IUD models was totally safe in terms of infection and perforation. Due to the difficulty of insertion and high expellability, the Delta Loop is considered unfit for IPPI. Performance of the TCu22OC was good but the results did not indicate that "suturing" improved the retainability of this IUD model significantly.

Adult↗

The ML Cu250; clinical experience in Belgium and The Netherlands.

The ML Cu250, a copper-wired intrauterine contraceptive device, was inserted in 5736 women, at interval or immediately after delivery of the placenta. Forty-eight months after insertion, the data covering 196 214 woman-months were computerized and then analysed according to the life-table method. Interval insertion was more effective than postplacental insertion. In nulligravidas interval insertion did not increase the removal rates for other medical reasons (including pelvic inflammatory disease), but expulsion rates were higher relative to the entire group (a variety of parities).

Belgium↗

Extra-amniotic prostaglandin E2 gel vs. amniotomy for elective induction of labour.

A randomized study was performed to compare three methods of labour induction in 143 clinically normal women (43 nulliparas) at term: amniotomy with or without intravenous oxytocin, extra-amniotic prostaglandin (PG) E2 gel, and extra-amniotic PGE2 gel plus an indwelling catheter. The three methods appeared to be comparable in effect and all of them were perinatally safe. Thus, if preference is given to keeping the ovular sac intact during the early phase of induced labour, extra-amniotic PGE2 in viscous gel, either with or without an indwelling catheter,. can replace the classical induction technique.

Amnion↗

Extra-amniotic prostaglandin F2alpha in gel for prelabor cervical ripening.

In 22 normal term gravidas with unfavorable cervix, 5 mg PGF2alpha in Tylose gel was instilled into the extra-amniotic space. The treatment improved the cervical state so much that the women could be successfully induced by conventional methods. The procedure was well tolerated by the mother and it appeared to be perinatally safe.

Cervix Uteri↗