Randomized clinical study of the TCu-380 A and the TCu-200 B. IUDs.

PIP: Researchers followed 100 multiparous women who requested an IUD at the family planning clinic at El-Hussin University Hospital in Egypt 1, 3, 6, and 12 months after insertion of either the TCu-380 A or the TCu-200 B. They enrolled these women between September 1986-September 1987. The TCu-380 A had a higher continuation rate (89.7%) than the TCu-200 B (81.9%), but the difference was not significant (p=0.1). The continuation rate for TCu-380 A was higher than that of other studies (range 51.7-69.7%). The high continuation rate for TCu-380 A may have been due to careful selection of IUD candidates. For example, only multiparous women who had not had a pelvic infection after the last pregnancy and whose gynecological exam found no abnormalities were included. No one requested removal of the TCu-380 A because of bleeding and/or pain, but 8.7% of the TCu-200 B users did. Yet expulsion or displacement accounted for the leading reasons for removal of the TCu-380 A. Nevertheless the differences in reasons for removal between the 2 copper releasing IUDs were not statistically significant. No one with a TCu-380 A experienced a pregnancy, but the pregnancy rate for those with a TCu-200 B stood at 4 per 100 women-year. 46% of TCu-380 A users were 30 years old. Since higher pregnancy rates have occurred in women 30 years old at insertion than those 30 years old at insertion made the effectiveness rate of TCu-380 A all the more significant. In conclusion, if health workers properly screen women who wish to have an IUD, the TCu-380 A can be as effective in developing countries as it is in developed countries.^ieng

Menstrual blood loss of TCu-380 A and TCu-200 B IUDs.

PIP: Menstrual blood loss (MBL) increases after IUD insertion, but this could be decreased if copper (Cu) is added to the IUD. The degree of MBL decrease is directly proportional to the surface area of Cu added. The present study was conducted on 50 women (25 fitted with the TCu-200 B and 25 with the TCu-380A). MBL was estimated in both groups during the preinsertion (control) cycle and on the 1st, 3rd, 6th, and 12th postinsertion cycles using the atomic absorption spectrophotometer technique. MBL was significantly higher in the postinsertion cycles as compared to the preinsertion cycle in both groups (p0.05). Although there was an increase in MBL during the postinsertion cycles among the groups examined, this increase was significantly lower in women fitted with the TCu-380A as compared to those fitted with the other model. Removal rates for bleeding were 0 and 8.7/100 women-years respectively for the TCu-380A and TCu-200 B IUD users.^ieng

Hysterographic orientation of IUDs in relation to menstrual blood loss.

PIP: To correlate the position and orientation of different models of MLCu IUDs in utero with incidence of side effects, 35 married, nonlactating, and sexually active women, 18-24 years of age and with regular menstrual periods were studied. All had been pregnant at least once and had had at least 3 menstrual periods after the last delivery or 2 periods after the last abortion. A physical and gynecological examination was performed. The women were divided into 4 groups: 30 women (3 groups of 10 patients) were fitted with standard MLCu 250, short MLCu 250, and MLCu 375 IUDs. The 4th group consisted of 5 women in whom MLCu 250 mini was inserted. Menstrual blood loss collected in cotton pads of constant weight provided by the investigator. The women were carefully instructed on how to collect their menstrual blood, and polyethylene bags were supplied to them. Menstrual blood loss was calculated. Follow-up visits were planned at monthly intervals, and questions about side effects were asked. In 30 women hysterography was done twice. Initially, it was performed following the 1st postinsertion menstruation. A 2nd hysterogram was performed following the 3rd postinsertion menstruation. The IUD was properly oriented in utero in 20 cases (67%). These were fitted with short MLCu 250 (8 cases), MLCu 375 (6 cases), Standard MLCu 250 (4 cases), and mini MLCu 250 (2 cases). The other 2 patients had small uterine cavities fitted with mini devices. Device displacement was noted in 10 cases among those fitted with MLCu 250, Standard (2 cases), MLCu 250 mini (3 cases), MLCu 375 (2 cases). Subjective increased menstrual blood loss was reported in 11 cases. There was no significant difference between pre- and postinsertion menstrual blood loss. Intermenstrual bleeding was reported in 3 cases, 1 fitted with a short MLCu 250 and 2 cases fitted with MLCu 375. Hysterographically the device was properly oriented in 2 cases with a large uterus. 5 cases had a moderate degree of dysmenorrhea, 1 case fitted with short MLCu 250, 3 cases with standard MLCu 250, and 1 case with MLCu 375. Hysterographically the device was displaced in utero in 2 cases, and most of the cases had a large size uterus. All these patients experienced no dysmenorrhea prior to IUD insertion. Moderate deep seated pelvic pain and low abdominal cramps were experienced in 3 cases, a case in each group of those fitted with different models of MLCu 250. Pain was not reported in patients fitted with MLCu 375.^ieng

Menstrual pattern and blood loss with U-coil inert progesterone-releasing IUDs.

Menstrual blood loss (MBL) was estimated before and after insertion of the U-coil progesterone-releasing device in 37 patients. The same procedure was carried out in 39 cases fitted with an inert U-coil IUD of the same size and shape. Blood loss was estimated by the atomic abosorption technique during the preinsertion cycle and at the 1st, 3rd, 6th, 9th, and 12th postinsertion cycles. MBL was significantly reduced in patients fitted with a progesterone-releasing U-coil compared to those fitted with an inert U-coil who showed a significant increase in MBL. The cycle length was prolonged with the progesterone U-coil, and was reduced with inert U-coil devices. The duration of flow was significantly reduced with the progesterone U-coil and significantly prolonged with the inert device. The incidence of intermenstrual spotting was higher with the progesterone U-coil than with the inert U-coil. The hemoglobin level was significantly increased with the progesterone U-coil while it was significantly reduced with inert U-coil devices.

Clinical evaluation of U-coil progesterone releasing device versus inert U-coil IUD.

PIP: 76 patients were randomly selected to be fitted with U-Coil intrauterine device. The inert U-Coil device was inserted in 39 patients and the progesterone releasing U-coil device was inserted in 37 patients. Patients fitted with both types of device were followed up for 12 postinserton months. The main side effects of the device were expulsion, removal for pelvic pain and bleeding and dysmenorrhea. No expulsion in those women fitted with inert U-coil device was reported. Expulsion of the progesterone U-coil device occurred in 3 patients (8.1%). Removal for bleeding and pain in women fitted with inert U-coil was necessary in 2 patients (5.1%). In patients fitter with progesterone U-coil, removal for bleeding and pain was necessary in 1 patient (2.2%). Pelvic pain was reported in 10 patients (25.6%) fitted with inert U-coil device, while it was reported in 1o patients (35.1%) fitted with progesterone U-coil device. Dysmenorrhea occurred in 29 patients (74.4%) fitted with inert U-coil device compared to 19 patients (59.5%) fitted with progesterone U-coil device. All removals of inert U-coil device th removal for bleeding and pain was only 1 case with uterus in anteverted position and in 1 expulsion the uterus was in midosition.^ieng

Thyroid function tests under the effect of steroidal contraceptives compared to normal pregnancy.

PIP: The effects of the oral contraceptive pill on th blood and urinary levels of various hormones was studies using 5 groups of women. Group 1 consisted of 59 women using combined contraceptive pills for 1 to 12 years under the commercial names of primovlar (25 cases) Anovlar (19 cases) and Ovral (15) cases; group 2 consisted of 50 pregnant women during the 1st trimester; group 3 consisted of 50 pregnant women during th 2nd trimester; group 4 consisted of 50 pregnant women during the 3rd trimester and group 5 was the control group consisting of 10 fertile nonpregnant women. Triiodothynine (T3) and throxine (T4) were determined in the sera of 59 women using combined contraceptive pills (estrogen 0.05 mg and progestogen 0.5 mg/pill), 150 pregnant women during the 1st, 2nd and 3rd trimesters and 10 normal fertile women used as controls. There were marked differences in the value of thyroid function tests in the euthyroid nonpregnant and euthyroid pregnant women. The effect of contraceptive pills coincided with the effect of pregnancy during the 3rd trimester. The protein bound iodine (PBI) shows insignificant increase during the 1st and 2nd trimester, while significant increase has been found during the 3rd trimester and in contraceptive pill users, p0.05. Total serum thyroxine shows insignificant increase occurred during the 3rd trimester and in contraceptive pill users. Thyro-binding Index showed no change than normal control during the first, second and third trimesters, while a nonsignificant increase has been found in contraceptive pill users, p0.05% uptake of T3 is not changed during the 1st and 2nd trimesters, while a decrease has been noticed in contraceptive pill users (21.8%) and a slight decrease occurred during 3rd trimester(27.9%) compared to the normal nonpregnant group^ieng

Hysterographic study of some side effects of the copper T 200 device.

PIP: A hysterographic study using the diluted dye technique (Urographin diluted to 15%) was carried out on 80 women to study the side effects that might result during the use of the T Cu 200 device in te 1st year of insertion. The hysterographic pictures showed the position and orientation of the device inside the uterine cavity and the side effects were related to the position of the device and size of the uterus in some cases. The women were divided into 4 groups according to their subjective symptoms; a control group with no complaints (37 cases), a group complaining of bleeding (27 cases), a group complaining of pain (11 cases) and a group who expelled the device (5 cases). The group complaining of bleeding were found to have a large sized uterine cavity. This was found to be statistically significant when compared to the control group. The other X-ray findings of orientation, anchorage or displacement of the device inside the uterine cavity were statistically insignificant when compared to the findings of the control group. The hysterographic findings in the group complaining of pain were statistically insignificant when compared to those in the control group. Cases of expulsion of the devices were found to have a large sized uterine cavity, a wide fundus and a diluted uterine isthmus. These findings were statistically significant when compared to thagt in the control group. Tables, charts and photographs illustrate the results of this study.^ieng

Selection of best parameters for ovulation detection in induction of ovulation with organic non-steroidal synthetic compounds.

PIP: Clomiphene, Tamoxifen and Epimesterol were used to determine the proper selection of the best parameter of ovulation detection in the absence of pregnancy. The trial consisted of 65 anovular infertile Egyptian women, ranging from 18-35 years of age, with at least 1 year of infertility, with different menstrual patterns varying from amenorrhea, oligohypomenorrhea to anovular menstruation. 6 parameters of ovulation detection were used: 1) basal body temperatures; 2) endometrial biopsy; 3) serial vaginal smears; 4) cervical mucus changes; 5) LH assay in morning urine; and 6) plasma progesterone by C.P.B. Clomiphene was tried on 25 patients as was Tamoxifen. Epimesterol was tried on 15 patients. The patients received the drugs for 174 courses. 41 had ovulation in 77 courses; 14 patients got pregnant; 4 of them aborted. It was occasionally difficult to decide on the basis of 1 test alone, whether a patient ovulated in a particular cycle because of the anti-estrogenic effect observed particularly with Tamoxifen and Clomiphene, but not with Epimesterol. The best parameter of ovulation detection in non-pregnant cases was hormonal assay. Due to the requirement of special equipment for such assay, endometrial biopsy at the onset of menstruation done parallel with BBT to avoid induction of abortion in early undiagnosed threatened abortion could be considered a fairly good parameter of ovulation detection.^ieng

Hysterography and menstrual blood loss in women using the T Cu 200 device.

PIP: A study was conducted using 32 women who had Copper T 200 IUDs inserted at the family planning clinic at Al-Ashar University Hospital in Cairo, Egypt. The study was conducted to determine the association between menstrual blood loss following IUD insertion, the shape and size of the uterine cavity, and the position and orientation of the IUD within the uterus. A preinsertion measurement of blood loss was used as a control. Hysterographic measurement was then done for the 1st 3 cycles postinsertion and at the 6th, 9th, and 12th cycles. Additionally, X-ray measurement was done after the 12th cycle. All findings are tabulated, graphed, diagrammed, and/or pictured. 1 group of women was found to have had no increase in menstrual loss; the other had an increase. Almost 95% of the women with increased blood loss had a large uterine cavity as compared to only 61.5% of the group with no increase. This difference, however, was not statistically significant. The group having conical uterine cavities with medium fundus had a statistically significant greater blood loss than women with conical narrow fundus. Increased bleeding had no relation to the orientation or displacement of the IUD within the uterine cavity or to the presence or absence of anchorage.^ieng

Fibrinolytic activity of menstrual blood in normal and menorrhagic women and in women wearing the Lippes Loop and the Cu-T (200).

Assessment was made of the fibrinolytic activity in menstrual and peripheral blood of 30 normally menstruating and 30 menorrhagic patients and of 30 women wearing Lippes Loops and 15 wearing CU-T (200)s. Assessment was performed by measuring the area of lysis on heated and unheated fibrin plates. Also, histochemical identification of fibrin fibrils in the menstrual endometrium was performed by Mallory's phosphotungstic acid hematoxylin method. Results in the normally menstruating group were compared to those of the menorrhagic women, and together these were compared with results in the groups of women wearing intrauterine devices. The fibrinolytic activity in menstrual blood was significantly increased in menorrhagic patients compared to that in normally menstruating patients, but no significant difference was detected in the plasma of either group. The histochemical study of the normally menstruating endometrium revealed dense intravascular and extravascular deposits of fibrin. Less dense intravascular fibrin deposits, but no extravascular ones, were present in the menorrhagic patients. The increase in the fibrinolytic activity of menstrual blood and the decrease in the density of fibrin deposits in the menstrual endometrium of the menorrhagic women were thus associated and were probably involved in the excessive menstrual loss. The fibrinolytic activity of menstrual blood in women wearing Lippes Loops was higher than that in women with Cu-T (200)s and was associated with decreased density of fibrin fibrils in the menstruating endometrium. This may explain the increased blood loss associated with the use of the Lippes Loop.