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.

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.

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.

PIP: Physicians inserted the CuFix postpartum (CuFixPP) implant system, an IUD, to a depth of 1.3 cm in the fundal myometrium in 73 healthy women soon after vaginal delivery (10-30 minutes) at either the University Hospital in Gent, Belgium; the University Medical School in Debrecen, Hungary; or Alexandra Hospital of the University of Athens in Greece. Since previous international clinical trials showed unacceptably high rates of expulsion of CuFixPP, researchers conducted this trial to test the IUD after having it modified for immediate postplacental insertion and fixation. None of the physicians had received training in the insertion procedure of this experimental IUD. The cumulative expulsion rate at 12 and 18 months was 3.1. The cumulative pregnancy rate at 12 and 18 months stood at 1.5. The sole reasons for removal at 12 and 18 months were bleeding/pain and planned pregnancy (7.4 at 12 and months and 10.8 at 18 months; 9 at 12 months and 12.2 at 18 months, respectively). Physicians experienced difficulty removing the IUD in 4 cases. The removals did not cause noticeable bleeding. No complications occurred. These findings revealed that, with further modifications, the CuFixPP IUD holds considerable promise as a simple and effective method of postpartum contraception, which can easily be inserted by nurses or midwives, especially in developing countries.

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.

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.

Carbon dioxide hysteroscopy immediately after second trimester abortion.

The use of hysteroscopy has been restricted a.o. by the need for general anesthesia. This applies in particular to the pre- or post-partum period, because the hyperemic atonic uterus is easily over-inflated to a dangerous level. Over-inflation did not occur following 50 aspirotomy D & E procedures in the second trimester, using a para- and intracervical block with lidocaine 1% with adrenaline 1:200,000 only. The uterine cavity was always thoroughly evacuated in these cases in which final check suction had been performed. We recommend that postabortum hysteroscopy should be performed preferably under local anesthesia.

PIP: 50 aspirotomy dilatation and evacuation (D and E) procedures in women whose durations of gestation varied from 14-18 menstrual weeks were followed by hysteroscopy in a test to determine whether the use of local anesthesia with uterotonic drugs could alleviate the problem of low intrauterine pressure caused by anesthesia-related uterine atony. Anesthesia was achieved by paracervical and intracervical block with lidocaine 1% with adrenaline 1:200,000, which provides a vasoconstrictive effect on the vessels of the lower uterine segment. Routine hysteroscopy was performed. The rate of flow of CO2 averaged 50-75 ml/min and never exceeded 75 ml/min. The average amount of CO2 used was 300 ml. Intrauterine pressure varied from 40-60 mmHg and the time required to complete the procedure ranged from 2-5 minutes. The major hysteroscopic observation was that the uterine cavity was almost always thoroughly evacuated. In 6 cases blood obscuring the hysteroscope lens seriously impaired visibility. 4 patients developed a cough shortly after the initiation of CO2 insufflation, probably due to CO2 microembolization. Although no incidence of serious morbidity or side effects occurred, further well documented studies are necessary to assess the safety of CO2 hysteroscopy after 2nd trimester abortion. It is however recommended that postabortion hysteroscopy be performed under local anesthesia to which adrenaline has been added.

Thermoregulated radiofrequency endometrial ablation.

OBJECTIVE: To test the hypothesis that treating dysfunctional uterine bleeding by automated application of electrothermal energy to the uterine cavity, with precise regional control, might yield results equivalent to those reported for hysteroscopically directed laser and electrosurgical endometrial ablations. MATERIALS AND METHODS: Patients with life style compromising menorrhagia, referred to six gynecologic surgical centers for hysterectomy or endometrial ablation, were admitted to the study if they had normal cervical cytology, a benign endometrial biopsy, no defined cause for their bleeding, and consented to participate in the evaluation of a newly developed Vesta DUB Treatment System. The device consists of a silicone-inflatable electrode carrier to be inserted into the uterine cavity and a controller to monitor and distribute current from a matched electrosurgical generator. Treatment involved a 3-minute or shorter warm-up period and a 4-minute treatment phase. RESULTS: Three- to 24-month follow-up data were available for 187 patients, with a mean follow-up of 14.8 months. The amenorrhea rate was 38%. Bleeding was reduced in 95% of patients. Actuarially, 88 +/- 3% of patients should expect to be free of menorrhagia, dissatisfaction, or need for a second procedure out to 24 months. CONCLUSIONS: The unique regional feed-back control offered by this system causes thorough, evenly distributed, thermal destruction 4-5 mm into the myometrium that reduces bleeding with durability equivalent to published reports of hysteroscopic endometrial ablation.

[Contraception with the Lippes Loop D with or without contraceptive foam (author's transl)]. / Zur Verwendung der Lippes-D-Spirale mit und ohne Spermizidum.

Contraception with Lippes Loop D was compared in 1 group of women (N 172) who used a spermicidal preparation with intercourse and a second group (N 190) who used no spermicidal preparation. In the group with a Lippes Loop and a spermicidal preparation, there were 1.2% unplanned pregnancies compared to 6.4% unplanned pregnancies without spermicidal preparation. This combined method approaches the reliability of oral contraception. The third group of women who used a spermicidal preparation erratically is not comparable in the statistical sense to the other two groups. However in this third group there were less unwanted pregnancies than in the group without the use of spermicidal preparation.

Hysteroscopic treatment of early pregnancy conceived despite intrauterine contraception.

PIP: Experience with a hysteroscope for management of pregnancy with and IUD in place in 28 cases is described. Patients had positive pregnancy tests, were 6-11 weeks pregnant, aged 21-37, and 11 were primigravidae. An operating hysteroscope with a 7 mm shaft and wide-angle objective was used with a single handed control, and carbon dioxide insufflation. 2 women had no gestational sac, and were found on laparotomy to have ectopic pregnancies. 5 women had abnormal gestations visible macroscopically, by their green, brown, clotted, folded or atonic gestational sac. 21 patients had apparently normal pregnancies, of which 3 had no IUD in situ and 18 had an IUD. The procedures took 20 minutes maximum, and were not painful for gravid women. Vaginal bleeding lasted about 3 days. Pregnancy outcomes were 13 term infants, 2 spontaneous abortions, 1 premature, and 2 still pregnant. The advantages of hysteroscopy are certain diagnosis with location of the IUD, noninvasive, painless outpatient procedure, and no damage to the fetus.^ieng

Performance of multiload IUD models with different copper loads.

PIP: This study compares the performance in 910 women for up to 2 years of 2 multiload IUD models, the MLCu 250 and the MLCu 375, inserted at interval. The MLCu 375, an experimental model, has a 50% greater copper surface area. Acceptors were women requesting IUDs and having no contraindication for IUD use. Event rates were calculated by life table analysis. Results showed that the pregnancy rates characterizing the MLCu 375 are significantly lower than for the MLCu 250 both at 1 year (p=0.002) and at 2 years of use (p=0.001). Expulsion and removal rates for bleeding and pain at 1 and 2 years were not different for the 2 devices; however, significantly more MLCu 250 than MLCu 375 models have been retrieved at 1 year (p=0.001) and at 2 years (p=0.01) because of other medical reasons including pelvic inflammatory disease. An increase of the copper load from 250 to 375 sq mm did not affect the retainability of the device.^ieng

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.

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.

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.

[The levonorgestrel intrauterine device]. / Das Levonorgestrel-Intrauterinpessar.

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.

Immediate postpartum insertion of a copper-wired intrauterine contraceptive device, the MLCu250.

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.

PIP: In a Belgium study, MLCu250 IUDs were inserted in 600 women immediately after delivery. The women were followed for a total of 9843 women months of use, and the results were analyzed using the life table method. Cumulative continuation rates/100 users were 87.2 at 6 months, 72.7 at 12 months, and 55.8 at 30 months. Expulsion rates/100 users were 3.7 at 6 months, 5.8 at 12 months, and 6.0 at 18, 24, and 30 months. Removal rates for bleeding and pain/100 users were 4.3 at 6 months, 7.1 at 12 months, 9.1 at 18 months, 10.7 at 24 months, and 11.8 at 30 months. Removal rates decreased as the age of the patient increased. Parity did not greatly influence removal rates. 6 pregnancies occurred during the study period, none of which were ectopic. No serious complications were reported but inversion of the devices in the uterine cavity could result in perforation. Efforts to diagnosis inversion should be made, and the device removed if inversion has occurred. The regular MLCu250 inserter was found to be satisfactory while attempts to use a longer inserter proved cumbersome. Tables provide gross cumulative event rates/100 users at 6, 12, 18, 24, and 30 month intervals and at 12 and 24 month intervals by age and by parity. An additional table describes each of the unplanned pregnancies in terms of age, parity, previous IUD use, IUD position, IUD removal time, and interval between insertion and last menstrual cycle.

Four years' experience with the TCu 220C, a long-acting multisleeved copper intrauterine device.

PIP: 4 years of experience with the TCu 220C (901 women; 28,071 woman months of use) - a long-acting multisleeved copper IUD - are analyzed. Event rates were calculated by life-table analysis with a computer program on an IBM 370/148-OS/VS1. Net cumulative rates at 4 years were as follows: pregnancy 3.3, expulsion 5.2, removal for bleeding, pain and other medical reasons 7.7, and 4.3 respectively. The incidence of pregnancy, expulsions, and removal for bleeding/pain decreases with time. Parity influences the performance of the TCu 220C. It seems to affect the pregnancy rate only marginally, but the expulsion and removal rates (for bleeding, pain, or other medical reasons) are higher in the nulliparae, and the same trends appear to be present for women of lower age groups. The IUD insertion technique seems to be important when determining the effectiveness of the method. The expulsion rate is significantly higher when the push-in technique (without sounding) is used, and the same tendency is present for pregnancies and removals for bleeding/pain, albeit to a lesser degree. Refraining from sounding the uterus and pushing-in the TCu 220C introduces the risk of not inserting the IUD high enough into the uterine cavity and therefore increases the risk of expulsion.^ieng

Six years' experience with the T Cu 220C intrauterine contraceptive device.

PIP: A 6-year long evaluation of interval insertion of the T Cu 220C has proven the efficacy, safety, and acceptability of a multisleeved copper-T IUD model. A sample of 947 insertions covers 37,669 woman months of experience. Gross cumulative event rates at 6 years were: pregnancy, 5.6; expulsions, 6.3; removals for bleeding/pain and other medical reasons, 11.4 and 5.2, respectively. Age, parity, and method of insertion influence the performance of the T Cu 220C. The T Cu 220C is an experimental model designed by Tatum to increase the efficacy by delivering copper ions higher up in the uterine cavity and extend the effective life span by using sleeves instead of filamental copper. The device has a T-shaped skeleton of polyethylene into which 20% barium sulfate is incorporated. The total amount of copper is ca. 503 mg and the total surface area ca. 220 mm squared. The IUDs were inserted during or immediately after menstruation, not earlier than 6 weeks after delivery or abortion. Gynecologists performed all insertions using either a push-in or a retraction technique.^ieng