Clinical performance of the TCu 380A and Lippes Loop IUDs in three developing countries.

The clinical performance of the Copper T 380A (TCu 380A) and the Lippes Loop intrauterine devices (IUDs) were evaluated for 12 months in a group of 710 women who had one of the two IUDs inserted. Results are from a randomized clinical trial conducted at three collaborating research sites located in three developing countries. The gross cumulative life-table pregnancy rate of the TCu 380A IUD was found to be lower than that of the Lippes Loop IUD at 12 months (0.7 and 2.1 per women, respectively). Although this difference was not statistically significant (p = 0.25), it is similar to findings from other studies. The 12-month cumulative removal rate due to personal reasons was significantly different (1.4 and 0.0, respectively, p = 0.05). Statistically significant differences between the two study IUDs were not found with regard to IUD expulsion or IUD removal due to bleeding/pain, medical reasons, planned pregnancy or investigator's choice. A statistically significant difference (p = 0.03) was observed in the number of TCu 380A IUD users experiencing dysmenorrhea (26.1%) during the 12-month study period, compared to Lippes Loop IUD users (18.8%).

PIP: A randomized clinical trial conducted at collaborating research sites in Peru, Nigeria, and Turkey found no significant differences between the performance of the Copper T 380A (TCu 380A) IUD and the Lippes Loop at 12 months post-insertion. The Lippes Loop is one of the few unmedicated IUDs still in use in developing countries, while the TCu 380A is steadily gaining in favor because of its longer effective life-span. Included in the analysis were 356 TCu 380A acceptors and 354 Lippes Loop users. The accidental pregnancy rate was 0.7/100 women-months of exposure for the TCu 380A and 2.1/100 for the Lippes Loop (p = 0.25); the expulsion rates were 3.5% and 6.7%, respectively, and the discontinuation rates were 15.6% and 15.8%, respectively. More women in the TCu 380A group (18.8%) than in the Lippes Loop group (14.3%) reported genitourinary tract infection during the 12-month study period, but this difference was not significant (p = 0.15). In addition, a nonsignificantly greater number of women in the former group (36.9%) than the latter group (31.8%) experienced dysmenorrhea, intermenstrual bleeding, or intermenstrual pelvic pain (p = 0.20). These findings are generally consistent with previous research.

Early chorionic activity in women bearing inert IUD, copper IUD and levonorgestrel-releasing IUD.

Early chorionic activity was assessed in the premenstrual days by means of serum HCG beta-fraction. As control, a group of women with no contraceptive use was studied; early chorionic activity was detected in 31.8% of the cycles. In the group bearing an inert IUD the incidence was 20%, which did not differ from the control; while in the medicated IUD groups (Cu-IUD and LNG-IUD) the incidences were 4.8% and nil, respectively. Both medicated IUD groups showed a significant difference when compared with the control, as well as the inert IUD groups. The meaning of these findings, pointing out differences in the main mechanism of action between inert and medicated IUDs, is discussed.

PIP: Early chorionic activity was compared in 100 IUD users (inert device, copper IUD, and a levonorgestrel-releasing IUD) and 22 controls through measurement of the serum human chorionic gonadotropin (hCG) beta-fraction. In the control group, 7 (32%) of the 22 women had hCG beta-fraction values indicative of chorionic activity (i.e., 5mIU/ml). In the group of women wearing an inert IUD (Lippes Loop), 8 (20%) were positive for early chorionic activity. In contrast, the incidence of premenstrual chorionic activity signs was very low among women with medicated IUDs: 5% among acceptors of the copper IUD and zero among women in the levonorgestrel-releasing IUD group. In general, elevated premenstrual hCG values are indicative of failed implantation. The high incidence of hCG activity recorded among Lippes Loop acceptors in this study is consistent with the anti-implantation effect postulated for inert devices. In contrast, medicated IUDs appear to act by preventing rather than interrupting implantation and therefore should not be regarded as abortifacient contraceptive agents.

Use of echosonography to monitor uterine placement of intrauterine devices after immediate postpartum insertions.

A study designed to monitor uterine placement of IUDs inserted immediately postpartum using echosonography was conducted at the Hospital de Gineco Obstetricia No. 23, "Dr. Ignacio Morones Prieto" in Monterrey, Mexico. TCu220 and Delta T IUDs were randomly assigned to, and inserted in women immediately following a normal vaginal delivery. Ultrasound examinations were to be performed within 60 min postinsertion, at 24 h postinsertion and at 1- and 3-month follow-up visits. There were no differences in the expulsion rates of the two device groups. Data are presented on the readings taken at the ultrasound examinations of the distance between the fundus and the upper part of the stem of the T. These differences differed significantly between the two device groups at the first ultrasound reading only (P less than or equal to 0.01). No relationship was found between the incidence of expulsion and the distance between the IUD and the fundus at any of the readings.

PIP: A study designed to monitor uterine placement of IUDs inserted immediately postpartum using echosonography was conducted at the Hospital de Gineco Obstetricia No. 23, "Dr. Ignacio Morones Prieto" in Monterrey, Mexico. TCu220 and Delta T IUDs were randomly assigned to, and inserted in women immediately following a normal vaginal delivery. Ultrasound examinations were to be performed within 60 minutes post-insertion, at 24 hours postinsertion and at 1- and 3-month follow-up visits. There were no differences in the expulsion rates of the 2 device groups. Data are presented on the readings taken at the ultrasound examinations of the distance between the fundus and the upper part of the stem of the T. These differences differed significantly between the 2 device groups at the 1st ultrasound reading only. No relationship was found between the incidence of expulsion and the distance between the IUD and the fundus at any of the readings.

[Evaluation of the IUD: causes for removal]. / Avaliacao do DIU: causas de retirada.

PIP: Reasons for IUD removal are described in a study carried out in Santa Maria, Brazil. 148 IUD users were studied. The principal reason for removal was excessive bleeding, principally related to the Lippes Loop IUD. 50% of the patients were between 40 and 45 years of age; 30.8% between 15 and 19. 4.7% of the removals were due to pelvic complications and among them, 9.3% were using Lippes Loop, and only 0.8% the Copper T. The following were concluded: IUD is a contraceptive method with an acceptable number of complications; The Lippes Loop IUD provoked excessive bleeding, being the main reason for removal; the acute pelvic inflammation could be treated with the IUD in situ; dysmenorrhea was not a significant reason for removal; the Copper T device proved to be less prone to complications.^ieng

[Endometrial cytology of IUD smears: endometrial reaction study]. / Citologia endometrial de esfregacos de DIU: estudo da reacao endometrial.

PIP: The objective of this research was to ascertain possible abnormal endometrial reactions to the IUD. The Family Planning Clinic of the Gynecology and Obstetrics Department of the Federal University of Minas Gerais, Brazil, used 110 cases from patients with IUDs who used the clinics from July 1981 to December 1982. Pap smears from 102 of these cases were made from material contained on the IUD. Several parameters were used, represented by endometrial cells and associated elements, including the IUD model, the user's age, and the day of the menstrual cycle on which the IUD was removed. The breakdown of endometrial cells was greater in Lippes Loop users than in TCu 200 and Copper 7 users. There was no significant difference in the amount of endometrial cells in the various stages of the menstrual cycle. The large number of cells in 90% of the smears leads to the suggestion that these smears be used for determining exclusion or diagnosis of cancer in the perimenopausal age group when the IUD is removed. A special histiocyte reaction was evident only in Lippes Loop users. A greater frequency of plasmocytes and leukocytes in the pre- and postmenstrual stages should be considered as physiological. A greater frequency of plasmocytes was found in Lippes Loop users, and a smaller frequency of lymphocytes observed from the 8th to 14th days of the menstrual cycle should be considered physiological. The lymphocytes were more frequent in users of the TCu 200 and Copper 7, but not significant enough to suggest the use of medicated IUDs.^ieng

[Postplacental application of 5 different types of intrauterine devices]. / Aplicación postplacenta de cinco tipos diferentes de dispositivos intrauterinos.

PIP: 5 different types of IUDs were used in 1020 women after placental expulsion: T Cu220 in 101 cases; Lippes Loop in 407 cases; T Cu200 in 180; Progestasert in 196; and the Multiload 250 in 136. IUD insertion was accomplished by 3 different techniques: manual, with Forester's forceps, and with an experimental applicator. There were more expulsions and more pregnancies when the applicator was used. Expulsion and pregnancy rates were higher with the Progestasert. The T Cu220C showed the lowest number of expulsions and pregnancies and the highest continuation rate. Removals for medical reasons were similar among all IUD types. (author's modified)^ieng

[Application of intrauterine devices preceded by measurement of the endometrial cavity using a Hollister sound]. / Estudio sobre la aplicación de dispositivos intrauterinos previa medición de la cavidad endometrial con la sonda Hollister.

PIP: The frequency of IUD expulsion, pregnancy, and removal was studied in 694 users. Those IUD types examined were the Lippes Loop D, Copper T-device, the 220C, and the T releasing 65 mcg of progesterone. A comparison was done as to the length of the uterine cavity, measured by a Hollister device which tends to be very accurate. Other authors have described certain length limits in the uterine cavity beyond which the number of pregnancies, expulsions, and removals are greater, but this was not confirmed in the present study. The only statistically significant difference was reduced frequency of such events in those women using the Copper T as compared with the Lippes Loop, independent of uterine cavity length. (author's modified)^ieng

The IUD and anemia: a study of hematocrit.

PIP: Lippes Loop D or Copper T-200 devices were randomly assigned to 400 women in Santiago, Chile, none of whom had been recently pregnant, in the effort to test the relationship between IUD use and anemia and the effect of daily iron supplements on hematocrit levels in conjunction with IUD use. The mean age for the acceptor group was 25.4; the mean parity was 1.9. Daily iron supplements were randomly assigned to 200 women in the group. Daily iron supplements were given to 21 women in the non-iron group who were admitted with hematocrit values of less than 30%. Hematocrit readings were performed at admission and at each subsequent follow-up. Readings were performed on cervical samples at 1, 3, 6 and 12 month follow-up visits. Mean admission hematocrit values were compared to the corresponding values at each follow-up via a paired t-test. There were no significant differences found for users of either IUD in the group taking daily iron supplements. In the non-supplement group, there were significant declines in hematocrit levels at 3 and 6 months after IUD insertion. At 12-months post-insertion, the mean hematocrit values for all groups increased from the 6-month level. Women taking iron supplements had lower rates of expulsion and removal for bleeding and pain, but the results were insignificant.^ieng

[Clinical evaluation of the progesterone T intrauterine device]. / Evaluación clínica del dispositivo intrauterino "T de progesterona".

PIP: This study describes a clinical evaluation of the Progesterone T IUD which releases a daily dose of 65 mcg of progesterone. The device is made of a copolymer of ethylene vinyl and has a transversal arm measuring 3.18 cm and a longitudinal arm 3.61 cm. The longitudinal arm contains 38 mg of natural progesterone, Barium sulfate, and silicone acetate. 146 new users of the Progesterone T were compared with 149 using the Copper 7 Gravigarde. Patients in both groups ranged in age from 17-40 years with an average of 27.2 for Progesterone T and 27.1 for Copper 7 users. Parity ranged from 1-11 with an average of 2.8 for the Progesterone T group and from 1-10 with an average of 2.7 for the Copper 7 group. The average number of spontaneous abortions was .7 for the Progesterone T group and .5 for the Copper 7 group. The groups were also comparable in previous contraceptive usage. In another study, 51 Lippes Loop D users, 52 Progesterone T users, and 50 Copper 7 users were evaluated for menstrual and intermenstrual blood loss in the 3 months prior to and the 1st, 2nd, 4th, 6th, 9th, and 12th months after insertion. At the end of 12 months, the Progesterone T and Copper 7 users respectively had pregnancy rates of 1.4 and 1.5, expulsion rates of 4.2 and 5.8, rates of removal for medical reasons of 2.8 and 3.0, and continuation rates of 87.2 and 84.6. After 1569 women-months of Progesterone T use and 1558 of Copper 7 use there were no statistically significant differences. With the Progesterone T there was 1 removal for pain, 1 for pelvic inflammation, and 2 for menstrual alterations. 4 Copper 7s were removed for bleeding. The average duration of menstrual bleeding was 6.0 days with the Progesterone T and 6.2 with the Copper 7. The number of days of true bleeding were 4.8 on average for the Progesterone T and 5.3 for the Copper 7. Intermenstrual bleeding was twice as common for the Progesterone T. There was no statistically significant difference in incidence of pain reported by the 2 groups at the beginning and end of the study. Both groups had a decline in pain at the end of the study, with the Progesterone T having a slightly more pronounced decline. The average volume of menstrual blood loss increased by 87.8% after insertion of the Lippes Loop D and by 24.3% with the Copper 7 but declined by 44.5% for the Progesterone T.^ieng

[Genital actinomycosis caused by the use of intrauterine devices. Report of 2 cases]. / Actinomicosis genital asociada al uso de dispositivo intrauterino. Informe de dos casos.

PIP: 2 patients aged 31 and 35, multiparous, and wearer of a Dalkon Shield IUD for a period of 3-5 years, were hospitalized for bilateral tubo-ovarian actinomicosis. Both patients were surgically treated, and in both cases there were necrotic materials. An adequate diagnosis of actinomycosis would be incomplete without careful citological examinations of cervico-vaginal exudations. It is also important to stress that any type of IUD should not be worn for longer than 2 years. The article presents a review of the published literature on the subject.^ieng

[Postabortion intrauterine device]. / Dispositivo intrauterino postaborto.

PIP: 433 patients were selected by social workers for postpartum insertion of Lippes Loop. Of these only 261, or 60.27%, were available for followup 10 months after insertion. At that time, 177 patients, or 67.81%, were still wearing the IUD and were satisfied with it. 19, or 7.2%, expelled it, and 40, or 15.32% had it removed for different reasons, such as bleeding or pain. 11 patients asked for definitive contraception, and 14, or 5.36%, became pregnant with the device in situ, a percentage certainly higher than that of 1.9% reported by other authors.^ieng

[Removal from the abdominal cavity of an intrauterine device by culdoscopy]. / Remoción de cavidad abdominal de un dispositivo intrauterino por culdoscopía.

PIP: The article reports on the case of a 21-year old patient whose Lippes Loop D had translocated into the abdominal cavity causing uterine perforation and amenorrhea. The device was easily removed by culdoscopy, and amenorrhea, caused by the partial distruction of the endometrium, treated with hormonal therapy.^ieng

[Perforation of the uterus and the urinary bladder with the Lippes loop]. / Perforación uterina y de vejiga urinaria con asa de Lippes.

PIP: A 25 year old patient, wearer of a Lippes Loop, required removal of the device 10 months after insertion complaining of pain. Endouterine exploration, hysterometry and laparosocpy failed to detect the device. Finally laparotomy was performed and the IUD, which had perforated the uterus and the urinary bladder, was found in the vesical cavity. This occurrence is very rare; it might, however, be avoided by choosing a different IUD type.^ieng

IUD use effectiveness in an urban Guatemalan clinic.

Contraceptive continuation rates-the rates at which people continue to use a particular contraceptive method-can be a great help in determining whether a family planning program is effective or whether new contraceptive methods should be introduced. Until now, very little systematic work has been done to study contraceptive continuation rates in Latin America. The present article reports the results of one of the few existing studies on this subject, which examined the IUD experiences of women admitted to a large family planning clinic in Guatemala City. The study showed that these experiences compared favorably with the IUD experience of groups previously studied in Costa Rica, Taiwan, and the United States.

PIP: Contraceptive continuation rates were determined for 366 women admitted to a large urban family planning clinic in Guatemala city for their 1st IUD insertion between July 1, 1969-June 30, 1970. Data were recorded and analyzed using multiple decrement life table techniques. 75% of the women were between 20-34 years of age; over 90% had had 2 or more pregnancies. 63% of patients wanted no more children, while 37% wanted to space their children. 87.4% received Size D Lippes Loops and 6.8% Size C Lippes Loops. The cumulative continuation rate at the end of the first 12 ordinal months was 72.1/100 1st insertions; after 2 years, an estimated 56% were continuing IUD use. The median length of use was 27 months. 2.2% of women became pregnant during the 1st year, 3.2% within 2 years. 10% expelled the IUD during the 1st year, 13% during the first 2 years of use. 11% of the women had the IUD removed for medical reasons within 1 year and 19% within 2 years. Except for the 1st month, the cumulative continuation rates for women 15-24 years of age were consistently lower than other age groups. The cumulative continuation rates for women with 2 or more living sons were consistently higher than those with fewer sons; the difference of 14.4/100 1st insertions is the most substantial demographic difference. This study showed results which compare favorably with experience in Costa Rica, Taiwan, and the U.S.

[Experience with the intraterine device in the Programa de Planificacion Familiar de la Secretaria de Salubridad y Asistencia 1973-1974]. / La experiencia con el dispositivo intrauterino en el Programa de Planificación Familiar de la Secretaría de Salubridad y Asistencia 1973-1974

PIP: The present study explores the experience obtained with the Lippes Loops C and D in the family planning program of the Secretaria de Salubridad y Asistencia (Ministry of Health) of Mexico. The patterns observed are sufficiently similar to those reported for the majority of other countries for which data are available that it would appear that no special conditions affecting use of this method exist in Mexico. The study is viewed as having utility for practicing physicians as it provides information on relative frequency of temporary and definitive use terminations, relative frequency of method failure, expulsion, withdrawals for various reasons, and the specific groups of women most disposed to each type of event. The variables studied in this representative sample of acceptors are duration of method use, number of pregnancies prior to acceptance, number of children living, age, and educational level. (author's)^ieng

[Family planning in Mexico at the present time. IV. Recent advances and evaluation of contraceptive methods]. / La planificación familiar en México en el monmento actual. IV. Avances recientes y evaluación de los metodos anticonceptivos.

PIP: It has been demonstrated that preparations containing estrogens cause metabolic alterations, while such alterations do not occur or are minimal when progestogens alone are administered. Clinical studies were begun using a new polymer that makes possible the release of a constant predetermined amount of progesterone into the uterus for up to one year. The method of intrauterine release of progesterone proved to be very effective in preliminary studies: one case of pregnancy occurred among 263 women observed over 2068 months (.5 effectiveness index). The effectiveness of the method, with the release of a daily dose of 50 mcg, appears to be higher than that of other intrauterine devices and similar to that of combinations of estrogen and progestogens, that are regarded as the most effective method. A great advantage of the new method is that it does not cause systemic effects.^ieng

The effectiveness of the Copper-T intrauterine device: a collaborative study in five countries.

PIP: Investigators in 5 countries collaborated with the Population Council to study the use-effectiveness of a new intrauterine contraceptive -- a T-shaped inert plastic device modified to bear 200 mm of exposed copper surface. After clinical trials in Santiago, Chile, the TCu-200 was tested on a total of 6257 women in the U.S.A., Colombia, Iran, Korea, Taiwan, and Thailand from May to November 1971. Postacceptance data are available for 95.3%, most of whom were interviewed at home 6 to 13 months after the initial insertion. For women with 1,2, or 3 living children at the time of acceptance, copper-T had higher continuation rates than Lippes Loop acceptors in the same countries. For women with 4 or more living children at the time of acceptance, continuation rates for the T device were only slightly higher, or the same, as those for the Lippes Loop. Pregnancy and expulsion rates for the copper-T were below those for the loop. Because of the uncertainty of the effective life of the copper, it is currently recommended that the device be replaced every 2 years, which would seem to limit it as a preferred device in mass family planning programs. However, recent evidence indicates that the antifertility effect of the copper-T device may last longer than 2 years.^ieng

[Methods of controlling fertility]. / Métodos de regulación de la fecundidad.

PIP: For centuries, mankind has employed various traditional methods of avoiding pregnancy, such as periodic abstinence and coitus interruptus. More recently, devices such as vaginal diaphragms or spermicidal agents have been widely employed. None of these methods, despite technical progress in drugs and devices, has offered a perfect solution to the problems of birth control and family planning. Whatever method is chosen, it should have high acceptability and not require continuous motivation for its use, and it should also take into consideration the different stages of family growth. The 4 main stages are 1) that before marriage, 2) the married state preceding birth of the 1st child, 3) the period between the birth of the 1st child and the last child, and 4) the period after the birth of the last child desired. Such a method must be simple and easy to employ, reversible, not interfere with sexual relations, and otherwise be acceptable, especially in consideration of the psychosocial relations of husband and wife. All the various methods now in use in Mexico are not reviewed, but two are discussed in some detail: oral contraceptives and intrauterine devices and loops. In spite of secondary effects, the oral contraceptive remains among the most effective and simple procedures to assure adequate control of fertility and is far superior to the traditional methods. Devices such as the Lippes loop and 2nd-generation IUDs using Silastic have been improved to eliminate secondary effects, but their chief advantage is in not requiring long-term motivation but only a 1-time decision and 1-time action for use. Their use has been especially beneficial to large-scale family planning efforts. Other methods such as anovulatory pills and male contraceptives are mainly experimental and need further development. An "ideal" method of contraception is still far away and more biomedical research is required for truly effective fertility control.^ieng

IUD insertion immediately after incomplete abortion.

PIP: All women who were admitted to the Felix Bulnes Hospital, Santiaog, Chile, for incomplete abortion between July 1968 and June 1969 were given instruction in family planning and contraceptive services. A total of 584 women chose to have an IUD insertion. Although all the women thought they had received an IUD, 1 group had a Lippes loop D inserted immediately after curettage and the other group had no insertion. The attending doctor had no prior knowledge as to which women were to receive the device nor did the doctor at the follow-up know until after the physical exam had taken place. 30 days after discharge from the hospital, the women returned from check-up and follow-up. At this time the women who had not received an IUD were given an insertion. Differences between the group with insertion and the one without were significant only for the interval between curettage and first menses and for the quantity of flow in relation to previous menstruation. The difference between the 2 groups for duration of menstrual flow was of borderline significance at the .05 significance level. It is concluded from the study that in the absence of psychologi cal bias of the patient to the IUD insertion, and possibly bias in its use by the doctor, there are no serious complications in the first month following immediate postabortal IUD insertion even where the abortion was a septic incomplete one.^ieng