Biomedical subjects
Publications and source records attributed to H Van Kets.
The initial results of a pilot trial (314 insertions and 3784 woman-months of experience at 18 months) suggest the low expulsion rate (0.0) and high clinical effectiveness (pregnancy rate 0.0) of the Ombrelle-380, a new high-load copper-releasing IUD of French origin.
The Dimélys is a new lily-shaped copper-bearing IUD of French origin of which the first clinical results are reported here. This device was inserted at interval in 348 women and 8975 woman-months of experience were accumulated at 3 years. Though only moderately effective (pregnancy rates 2.8 and 5.7 at 1 and 3 years, respectively) the Dimélys is well retained by the uterus (expulsion rates 1.5 and 2.5 at 1 and 3 years, respectively). Clinical efficacy was found to be influenced by the recipient's age, and expulsion rates were significantly higher when inserted by unskilled operators.
Clinical evaluation of the Postpartum Nova-T or Nova-T-PP (a Nova-T IUD adapted for postpartum insertion) was based on 412 insertions and showed that this model--besides being effective and safe--had a low expulsion rate (7.2% at 1 year). To prove that the Nova-T-PP's low expulsion rate is indeed the result of its special design, a randomized trial was conducted to compare the Nova-T-PP with the parent model (Nova-T) when inserted within 10 minutes of delivery of the placenta. The result of this study (408 insertions, 203 of them Nova-T) indicate that there is no significant difference in expulsion rate between the two IUD models, suggesting that the addition of two extra arms to the original Nova-T model does not improve the retention of the adapted IUD model.
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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.
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.
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.
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.
A single, endocervical application of a new commercial preparation of prostaglandin E2 (PGE2) gel, 0.5 mg of PGE2 in 2.5 ml (3 g), was evaluated for preinduction cervical softening. Safety and efficacy were assessed in a comparison with a 2.0 mg PGE2 vaginal tablet and placebo in normal nulliparous women at term, with low Bishop scores. Treatment was administered in randomized, double blind fashion. Overall success, defined as a progression in Bishop score of at least 3 points within 12 hours, was achieved in 22/40 (55%) of the gel group, 15/41 (37%) in the tablet treated women, and 8/40 (20%) in those receiving placebo. Of interest was the observation that of women with very unfavorable induction features (Bishop score 0-2), the cervical gel treatment resulted in a 6/8 (75%) success rate compared with 2/13 (15%) success for the vaginal tablet and 0/17 (0%) for placebo. In as much as a very low incidence of side effects accompanied this treatment scheme, expanded multi-center testing is recommended.
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Indomethacin was administered from the 20th to the 34th week of gestation to 51 women (59 fetuses) in whom bed rest and a beta-mimetic compound (ritodrine) had failed to stop preterm labor. No serious maternal side effects were observed. Of the 8 perinatal deaths, 5 were not and 3 were possibly related to the prostaglandin synthesis inhibitor. The sole case of serious neonatal morbidity is not considered to have had a causal relationship with the indomethacin treatment.
The MLCu250, a copper-wired intrauterine contraceptive device, was inserted in 600 women immediately after delivery of the placenta. Thirty months after insertion, 9843 woman months of experience were computerized and the data analysed according to the life-table method. The gross cumulative pregnancy and expulsion rates were 1.3 and 6.0 respectively. No serious complications were observed and the puerperium was uncomplicated.
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A randomized study to evaluate the effect of natural estrogens on the unripe uterine term cervix was conducted. One hundred and five term gravidas were studied, of whom 70 were treated with 180 mg 17 beta-estradiol or 250 mg estriol (treated women) and 35 were treated with gel only (control group). In all subjects the distented Foley catheter used for the instillation was left in situ. Twelve hours after the instillation there was no apparent difference in mean cervical progress between treated women and controls and the rather unexpected degree of cervical ripening is atributed to the intra-uterine balloon catheter. The procedure could not be shown to have any untoward effect on the mother or the fetus.
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