Immediate postplacental insertion of GYNE-T 380 and GYNE-T 380 postpartum intrauterine contraceptive devices: randomized study.

OBJECTIVE: The purpose of the investigation was to compare the 1-year expulsion and efficacy rates of the GYNE-T 380 and the GYNE-T 380 Postpartum intrauterine contraceptive devices when inserted within 10 minutes after expulsion of the placenta in a term pregnancy. The two intrauterine contraceptive devices were identical, except that one was inserted by means of a temporary fundal suspension system and the other was placed directly into the uterine cavity. STUDY DESIGN: The study was a multicenter, randomized trial of intrauterine contraceptive devices in which 300 subjects accepted the GYNE-T 380 IUD and 292 subjects the GYNE-T 380 Postpartum IUD in clinics with adequate follow-up. RESULTS: At 1 year the gross cumulative expulsion rate was 13.2 per 100 cases (39 expulsions) with the GYNE-T 380 intrauterine contraceptive device and 16.2 per 100 cases (46 expulsions) with the GYNE-T 380 Postpartum device. There was no significant difference in the rate of expulsion between the two devices at any time during the year. There was one first-year intrauterine pregnancy, which occurred in a subject using the GYNE-T 380 device. The continuation rate for each device was above 80 per 100. CONCLUSION: The results indicate that both the GYNE-T 380 Postpartum and the standard GYNE-T 380 intrauterine contraceptive devices are safe and effective when inserted immediately after delivery of the placenta.

PIP: In clinics in Belgium, Chile, and the Philippines, data on 300 healthy, sexually active acceptors of the GYNE- T 380 IUD were compared with data on 292 healthy, sexually active acceptors of the GYNE-T 380 Postpartum IUD in order to compare the 10-year expulsion and efficacy rates of these 2 IUDs when inserted within 10 minutes of delivery of the placenta in a term pregnancy. The IUDs were identical, except that the GYNE-T 380 Postpartum IUD was inserted by a temporary fundal suspension system, while the GYNE-T 380 IUD was inserted directly into the uterus. No perforations occurred. The minimal complications that did occur were the same as those associated with interval IUD insertion: irregular spotting, menorrhagia, and uterine cramping. The rates for IUD discontinuation due to bleeding or pain and for other medical reasons were the same for both copper- releasing IUDs (3%). The removal rate for other medical reasons was less than 1% for each IUD. The only intrauterine pregnancy occurred in a woman using the nonsuspended, standard GYNE-T 380 IUD. The IUD continuation rate was greater than 80% for each IUD. Within each clinic, no statistically significant difference in the IUD expulsion rate existed at any time during the 12-month study period. Overall, the expulsion rates for the 2 IUDs were similar (e.g., at 12 months, 16.2% for GYNE-T 380 Postpartum IUD and 13.2% for GYNE-T 380 IUD). The Philippine clinic had significantly higher 1-year IUD expulsion rates regardless of IUD type than the Chilean clinic (24-32% vs. 5-6%). The Belgian clinic had moderately high 1-year IUD expulsion rates regardless of IUD type (8-16%). The different expulsion rates between clinics suggest differences in techniques used during insertion. These findings show that both IUD types inserted immediately after placental delivery are safe and acceptable. If the techniques associated with the low expulsion rates in Chile can be taught, these IUDs can be a practical, safe, convenient, and acceptable contraceptive method.

Clinical experience with the GYNE-T 380 postpartum intrauterine device.

OBJECTIVE: The insertion of conventional intrauterine devices (IUDs) during the 1st 10 days after delivery is associated with a high rate of expulsions. DESIGN: The GYNE-T 380 (Ortho Pharmaceutical [Canada] Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no. 2 catgut to the top of the IUD (GYNE-T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the uterine fundus. PATIENTS, PARTICIPANTS: This modified IUD was evaluated in a phase II trial involving 190 women at four clinical sites. MAIN OUTCOME MEASURES: There were no pregnancies during the 1st year of the study. The continuation rate was 74 per 100 women and a life table expulsion rate of 9.6 and 13.3 per 100 women was observed at 6 and 12 months, respectively. RESULTS: Complications associated with the insertion and the use of this IUD were minimal. Large scale trials evaluating this IUD are in progress.

PIP: The insertion of conventional IUDs during the 1st 10 days after delivery is associated with a high rate of expulsions. The Gyne T 380 (Ortho Pharmaceutical, Canada Ltd., Toronto, Ontario, Canada) IUD was modified by the addition of a loose loop of knotted biodegradable no.2 catgut to the top of the IUD (Gyne T 380 postpartum IUD). After delivery, a special inserter was used to imbed the knotted portion of the loop into the myometrium of the of the uterine fundus. This modified IUD was evaluated in a phase II trial involving 190 women at 4 clinical sites; continuation rate was 74/100 women, the life table expulsion rate as 9.6 and 13.3/100 women observed at 6 and 12 months, respectively. There were no pregnancies during the 1st year of study. Complications associated with the insertion and use of this IUD were minimal and largescale trials evaluating this IUD are now in progress.

Milestones in intrauterine device development.

PIP: The IUD has undergone numerous modifications and innovations since the Graefenberg ring of the early 1900s. This and the other small rings were initially designed so as to introduce a foreign body of minimal size into the uterine cavity. Larger plastic devices, introduced in the 1960s (e.g., Lippes Loop, Birnberg bow, Margulies Spiral), were purported to have lower pregnancy and expulsion rates. Monofilament tails were also added because the ease of detection and extraction of the IUD allowed by the tail was felt to be more important than the risk of potential infection. With the development of the Dalkon Shield in the late 1960s came a new era in IUD development. The A.H. Robins Company, developers of the Shield, elected to add a sheathed multifilament tail which, over the next 4 years, resulted in 242 spontaneous midtrimester septic abortions in women wearing the Shield; only 37 women not wearing a Dalkon Shield experienced this event. 10 maternal deaths resulted. Salpingitis and pelvic inflammatory disease (PID) were other serious results of IUD wear. Consequently, IUD use in the US and worldwide dropped. Of major import was the finding that, when compared to noncontraceptors, the relative risk of PID was 15.6 for longterm Dalkon Shield users and only 1.5 for longterm users of other types of IUDs. When Dalkon Shield data are extracted, there remains a very low rate of serious complications resulting from IUD wear. The problem with the Dalkon Shield has encouraged more research in the direction of the tailless IUD. The development of the small T-shaped IUD came as an attempt to have a device which was adapted to the size and shape of the uterine cavity rather than the other way around. To this was added copper to enhance the contraceptive effect. Copper-medicated IUDs, among them the Copper 7, Nova-T, and the Multiload, were added to the list of available IUDs. Progestogens have been now incorporated with the plain T. This has resulted in the Progestasert and the Levonorgestrel T, both of which effect a reduction in menstrual blood loss. While major advances have been made in the field of intrauterine contraception, more innovations and improvements can be expected in the future.^ieng

Copper loss from the copper T model TCu22OC.

The effect of mineral deposits on the copper dissolution rate of the Copper T Model TCu22OC was examined. 118 Copper T22OC devices removed from subjects for various medical and personal reasons after 12 to 72 months in utero were examined and graded based on the proportion of the total copper area covered with mineral deposits. The deposits increased in average size during the first three years of IUD use and then remained relatively constant. Seventeen percent of the devices were in situ for four or more years. Copper analysis was performed on 30 Copper T 22OC devices from selected periods of use : 12-14, 22-26, 36-39 and 48-72 months of use. The mean daily copper loss was 29.4 micrograms and the range, 7.3 to 62.1 micrograms. An inverse correlation between the amount of mineral deposit on the copper surface and the rate of copper loss was observed.

Four years of experience with the TCu 380A intrauterine contraceptive device.

A study of the United States acceptors of the Copper T, model TCu 380A, initiated in 1972, was carried to the completion of 4 years of observation. The 1051 receptors, whose median age was 22.3 years, accumulated a total of 1927 years of use. At the end of 4 years, the cumulative net pregnancy rate was 1.9 per 100 women, and the gross rate was 2.8 per 100. The annual continuation rate over the 4-year interval averaged 77 per 100. The TCu 380A intrauterine device (IUD) has provided extremely effective and undiminishing protection against pregnancy through 4 years of use in a group of young women. This degree of protection has not as yet been equaled when randomized comparative trials have been carried out with other copper-bearing IUDs.

Barrier contraception: a comprehensive overview.

The barrier class of contraceptives used either alone or with supplementary spermicidal agents includes the most ancient of methods for the control of human fertility. Modern innovations have effected marked improvement in their efficacy and acceptability, so that they have become key means of controlling fertility in the world today. The traditional diaphragms and condoms decreased in popularity to some extent when methods such as the OCs and IUDs became available for general use. However, the plain or medicated barriers are regaining their rightful position in our contraceptive armamentarium as more and more questions are being raised about the real or potential adverse side effects of systemic and intrauterine contraceptives. There is evidence throughout the world of the growing popularity and use of locally acting mechanical and/or spermicidal contraceptive methods. Their impact upon the increasing world population can be expected to become even greater when the true need for the control of fertility becomes more generally recognized and appreciated.

Contraceptive and sterilization practices and extrauterine pregnancy: a realistic perspective.

Comparative data on the incidence of ectopic pregnancy among accidental pregnancies associated with failure of a contraceptive or sterilization procedure are shown in Table 16. The practical clinical significance of the data in this review is predicated upon a number of related factors. One of the most important of these is the realistic failure rate (or success rate) of each contraceptive or sterilization method. The reported efficacy of various contraceptive methods has such a wide range that we have not attempted to calculate the likelihood that a woman may experience an ectopic pregnancy within a particular time period while using a specific method. The success or failure rate of each method is influenced by such variables as (1) the conscientiousness and ability of the patient to follow instructions, (2) the true failure rate of the method itself, (3) the experience of the clinician prescribing a method or performing a surgical procedure, and (4) other factors less clearly defined. Because of these many variables, the data shown in Table 16 were calculated on the basis of the number of reported accidental pregnancies which occurred coincidentally with, or subsequent to, a specific contraceptive or sterilization modality. (formula: see text). These data do not reflect the actual rate of occurrence of ectopic pregnancy with respect to woman-months of experience. We recognize the significant influence that age, race, gravidity, and socioeconomic factors have upon the incidence of ectopic pregnancy, but were unable to control for these factors in the data presented in this review. These data reprresent only what has occurred under specific circumstances and cannot logically be extrapolated to any specific future case or study series. It is important to emphasize the necessity of constant awareness by the medical and paraprofessional personnel of the potentially increased risk to the patient of an extrauterine pregnancy should one or another of these contraceptive or sterilization procedures fail. Complacency or a false sense of security on the part of responsible medical personnel concerning women who are "protected against conception" can quickly lead to a life-threatening situation in case of an ectopic pregnancy. Prompt diagnosis and definitive treatment of the extrauterine pregnancy is vital for the successful management of this serious complication of conception.

Management and outcome of pregnancies associated with the Copper T intrauterine contraceptive device.

The clinical outcome of 918 pregnancies in women who conceived while using one or another of four models of the Copper T intrauterine contraceptive device (IUD) is presented. Elective abortion was chosen by 58 per cent of the women. The clinical management and course of 275 women who elected to allow their unplanned pregnancy to continue are described. The Copper T was either expelled or extracted during the pregnancy in 118 of the women, while the IUD remained in situ for the duration of the pregnancy in the remaining 157 patients. The incidence of spontaneous abortion more than doubled when the IUD remained in utero. The chance of a live birth being premature was four times greater when the IUD remained in situ than when it was removed. There were 27 ectopic pregnancies in this entire series, giving an incidence of 3.4 per cent. In addition, the data suggest, but do not prove, that there is an increased risk of having an ectopic pregnancy if the woman has worn the Copper T for more than two years. A benign fibroma of the vocal cord was the only congenital anomaly detected. These observations suggest that the incidence of developmental defects is not adversely affected by the presence of intrauterine copper.

The Dalkon Shield controversy. Structural and bacteriological studies of IUD tails.

The recent report of 209 cases of septic spontaneous abortion and 11 maternal deaths in the United States in women using the Dalkon Shield intrauterine device (IUD) raised the question about a possible causal relationship between the IUD and pelvic sepsis. It is essential to determine whether or not this sipsis is unique to the Dalkon Shield or generic to all types of IUDs. Our studies permit the conclusion that the tail of the Dalkon Shield is structurally and functionally different from the tails of the four other IUDs tested. The unique characteristics of the Dalkon tail theoretically could provide a mechanism whereby pathogenic bacteria from the vagina enter the uterine cavity and cause sepsis.

Copper levels in maternal and fetal tissues of rabbits bearing intrauterine copper wires.

PIP: A study was undertaken to determine if copper wire, placed within the uterine lumen after implantation and kept in situ throughout pregnancy, results in an excessive accumulation of the metal in maternal and/or fetal tissues; and if so, what effect if any, such an accumulation may have on both mother and offspring. Copper wires were inserted into the uterine cavities, near the utero-tubal junction, of rabbits on Day 7 of pregnancy and were allowed to remain in situ until Day 28, at which time the animals were sacrificed. Tissues from mother and offspring were subjected to routine histological examinations and their copper content was determined. A parallel series of sham-operated animals served as the control. Copper was released from the intrauterine copper wires at an average daily rate of 38.81 plus or minus 7.26 mcg. Histological examination of maternal adrenal, brain, heart, kidney, liver, lung, ovary, spleen, and uterus revealed no anatomical abnormalities. There was no increase in copper in any of the tissues except the uteri and placentae of animals bearing intrauterine copper wires. There were no anatomical abnormalities in either fetal brain, heart, kidney, liver, or lung. There was an increase in the amount of copper found in the liver of fetuses obtained from animals bearing intrauterine copper wires. As there were no histological differences between livers of the control and experimental groups, and no evidence of teratological effects due to copper, it is assumed that this small but significant increase in fetal liver copper is insufficient to produce any toxic effects on the offspring.^ieng