Clinical performance of copper-T-200, multiload-250 and Nova-T: A comparative multicentre study.

A randomized multicentre study of Copper-T-200 (CuT), Multiload-250 (ML) and Nova-T (NoT) was conducted to evaluate the clinical performance of these three IUDs in the hands of general practitioners with varying experience in the different insertion techniques. After 36 months of use a total of 19,821 treatment cycles was accumulated. The continuation rate was 69.7% for CuT, 60.9% for ML and 61.8% for NoT. The cumulative expulsion rate after 36 months was 5.0% and equally distributed among centres and types of IUD. Removal for medical reasons was 11.4% and also equally distributed among the centres and the types of IUD. The pregnancy rate was insignificantly higher for the NoT compared with the two other types.

PIP: A randomized multicenter study of Copper-T-200 (CuT), Multiload-250 (ML) and Nova-T (NoT) was conducted to evaluate the clinical performance of these 3 IUDs in the hands of general practitioners with varying experience in the different insertion technics. After 36 months of use a total of 19,821 treatment cycles was accumulated. The continuation rate was 69.7% for CuT, 60.9% for ML, and 61.8% for NoT. The cumulative expulsion rate after 36 months was 5.0%, equally distributed among centers and types of IUD. Removal for medical reasons was 11.4%, also equally distributed among centers and IUD types. The pregnancy rate was insignificantly higher for the NoT compared with the other 2 types.

Clinical experience with a triphasic oral contraceptive.

A triphasic combined oral contraceptive containing fluctuating amounts of ethinylestradiol and levonorgestrel was tested clinically in a multicenter trial at six hospitals in Norway. 367 women were included in the study, 3 588 cycles were studied, and the follow up period was 12 months. The one year continuation rate was 67%. Five pregnancies occurred during the study period. All of them had to be considered as patient failures. The causes for stopping medication were side effects in about 50% and the rest for personal reasons. The cycle control taking into account duration of bleeding, amount of flow, and intermenstrual bleeding was good and comparable to the low-dose monophasic combined pills. The incidence of side effects was low. One woman had an increase in systolic blood pressure to more than 140 mmHg. Thrombophlebitis was not registered. In conclusion the triphasic oral contraceptive was effective and had a good cycle control and low incidence of side effects.

PIP: A triphasic combined oral contraceptive (OC) containing fluctuating amounts of ethinyl estradiol and levonorgestrel was tested clinically in a multicenter trail at 6 hospitals in Norway. 367 women were included in the study, 3588 cycles were studied, and the follow-up period was 12 months. The 1 year continuation rate was 67% 5 pregnancies occurred during the study period. All were considered patient failures. The causes for stopping medication were side effects in about 50% and the rest for personal reasons. The cycle control taking into account duration of bleeding, amount of flow, and intermenstrual bleeding was good and comparable to the low-dose monophasic combined pills. The incidence of side effects was low. 1 woman had an increase in systolic blood pressure to more than 140 mmhg. Thrombophlebitis was not registered. In conclusion, the triphasic OC was effective and had good cycle control and low incidence of side effects.

Pelvic inflammatory disease associated with Chlamydia trachomatis infection after therapeutic abortion. A prospective study.

Chlamydia trachomatis was cultured from the cervix of 70 of 557 (12.6%) patients admitted for therapeutic abortion. Postoperatively, 22 (3.9%) developed acute pelvic inflammatory disease (PID); of these women, 14 (63.6%) had harboured C trachomatis in the cervix before the abortion. Thus of 70 patients with chlamydial infection, 14 (20%) developed PID postoperatively. Of the chlamydia-positive patients, six of the 15 (40%) aged less than 20 years and eight of the 53 (15%) patients aged 20-30 years developed PID. Twelve of the 70 women with chlamydial infections showed a significant increase in serum chlamydial IgG antibody titres over a four week period; four of these women developed PID. Neisseria gonorrhoeae was recovered from only four patients, one of whom developed PID after the abortion. Treatment with a single dose of intravenous doxycycline (200 mg) was given before and during surgery to about half of the patients. In our study, this regimen had no protective effect against the development of PID associated with C trachomatis.

PIP: Chlamydia trachomatis was cultured from the cervix of 70 of 557 (12.6%) patients admitted for therapeutic abortion. Postoperatively, 22 (3.9%) developed acute pelvic inflammatory disease (PID); of these women, 14 (63.6%) had harbored C. trachomatis in the cervix prior to the abortion. Thus, of 70 patients with chlamydia infection, 14 (20%) developed PID postoperatively. Of the chlamydia-positive patients, 6 of 15 (40%) aged 20 years and 8 of 53 (15%) patients aged 20-30 developed PID. 12 of 70 women with chlamydial infections showed a significant increase in serum chlamydial IgG antibody titers over a 4-week period; 4 of these women developed PID. Neisseria gonorrheae was recovered from only 4 patients, 1 of whom developed PID after the abortion. Treatment with a single dose of intravenous doxycycline (200 mg) was given prior to and during surgery to about 1/2 of the patients. In this study, such a regimen had no protective effect against the development of PID associated with C. trachomatis.

Experience with prostaglandins for therapeutic abortion in Norway. Their need and their benefits.

Since 1977 the number of therapeutic abortions has been decreasing in Norway, a trend which is probably due to improved contraceptive practice. The results with PGs used for cervical dilatation in late first trimester and induction of abortion in the second trimester are reported. Pretreatment overnight or for 3-4 hours simplified the surgical procedure and Sulprostone (Schering AG) caused fewer side effects than 15(S) 15 Me F2 alpha. In the second trimester 15(S) 15 Me F2 alpha was administered by different routes and in different doses. 16,16 diMe trans delta 2E2 was given only as vaginal suppositories. Side effects were fewer by the intraamniotic route than by the other routes. The need for and benefits of PGs for therapeutic abortions are discussed.

Sulprostone for preoperative cervical dilatation in primigravidae scheduled for late first trimester termination of pregnancy.

The cervix was primed with intracervical (intramural), i.m. or s.c. injections of Sulprostone in varying doses at various times before termination of late first trimester pregnancy in 170 primigravidae. Intracervical administration of Sulprostone (25-100 micrograms) 14-16 h before surgery required the lowest dosage and had no side effects. However, the highest dose of Sulprostone (100 micrograms) achieved a cervical dilatation to Hegar 7 or more in only 40% of patients. A cervical dilatation of Hegar 7 or more was achieved in 90% of the cases when 350 micrograms of Sulprostone was given i.m. 3-4 h preoperatively.

PIP: The cervix was primed with intracervical (intramural), intramuscular, or subcutaneous injections of Sulprostone in varying doses at various times before termination of late 1st trimester pregnancy in 170 primigravidae. Intracervical administration of Sulprostone (25-100 mcg) 14-16 hours prior to surgery required the lowest dosage and had no side effects. However, the highest dose of Sulprostone (100 mcg) achieved a cervical dilatation to Hegar 7 or more in only 40% of the patients. A cervical dilatation of Hegar 7 or more was achieved in 90% of the cases when 350 mcg of Sulprostone was given intramuscularly 3-4 hours preoperatively.

Experience with 16-phenoxy-omega-tetranor-PGE2-methylsulfonamide (sulprostone) for termination of second trimester pregnancy.

A new PGE2-analogue (Sulprostone) was administered extraamniotically or intramuscularly for termination of 70 second trimester pregnancies (13-20 weeks gestation). When the extraamniotic route was used, the 24-hr success rate rose from 27.3 to 67.7 percent by increasing the dose from 25 to 100 micrograms. Gastrointestinal side effects were not recorded with doses up to 50 micrograms. At 100 micrograms, the average number of episodes of nausea or vomiting were 0.29 and 0.26, respectively. Repeated intramuscular injections of 500 micrograms (3 or 4 times) at 3-hourly intervals did not improve the success rate compared with a 100 micrograms extraamniotic dose, but the average number of episodes of nausea or vomiting increased to 0.9 and 1.0, respectively. The success rate was too low with the doses and administration routes used.

Two oral contraceptives, efficacy, serum proteins, and lipid metabolism. A comparative multicentre study on a triphasic and a fixed dose combination.

A triphasic, combined oral contraceptive containing 30 - 40 - 30 micrograms ethinyloestradiol (EE), and 50 - 75 - 125 micrograms levonorgestrel was compared with a fixed dose combination containing 30 micrograms EE and 150 micrograms desogestrel in a randomized multicentre trial in 193/199 women and 1 063/1 073 cycles, respectively. The duration of the trial was six months. Eleven centres in Denmark, Sweden, and Norway participated. Contraceptive reliability, bleeding control and side effects were evaluated. Influence on serum sex hormone binding globulin (SHBG) and transcortin was assayed as well as lipid metabolism. Three pregnancies occurred in the group using the triphasic regimen but none in the fixed dose regimen. Two of the three pregnancies were considered drug failures and the third a possible interaction. Possible reasons for the triphasic contraceptive failure are discussed with special reference to a British report on eight pregnancies. Bleeding control appeared to be equally good for the two preparations. However, the number of cycles with spotting, breakthrough bleeding and missed withdrawal bleeding were above the levels reported earlier on the triphasic regimen. About 80 per cent of the women completed the planned six months on either combination. Side effects were generally mild and in accordance with earlier reports on low dose oral contraceptives. Metabolically the triphasic levonorgestrel combination increased SHBG 100 per cent versus 200 per cent for the fixed desogestrel combination. Transcortin rose about 98 and 110 per cent, respectively. Both preparations induced similar changes in the levels of lipids and lipoproteins with the exception of a significant increase in the arachidonic content of cholesterol during treatment with the desogestrel-containing preparation.

Termination of early first trimester pregnancy with 16,16-dimethyl trans delta 2 prostaglandin E1 methyl ester.

Thirty healthy women with early first trimester pregnancy applying for legal abortion were given five vagitories containing 1 mg 16,16-dimethyl-trans delta 2 prostaglandin E1 (16,16-dimethyl PGE1). They were instructed to take one vagitory every third hour. The treatment was evaluated at follow-up visits after one, two and four weeks. Complete abortion was recorded in 27 cases. The pregnancy test was still positive after two weeks in three women, who underwent surgical termination, and were recorded as failures. The most common side-effects were bleeding, pain and gastrointestinal symptoms. No serious side-effects were recorded. Repeated administration of vagitories containing 1 mg 16,16-dimethyl PGE1 seems to be a safe and effective method of "menstrual extraction". The efficacy should be increased and the rate and intensity of side effects decreased if "menstrual extraction" is to compete with conventional dilatation and curettage.

Contraceptive practice before and after therapeutic abortion. II. Use-effectiveness of oral contraceptives and intrauterine devices.

Of 180 women who underwent therapeutic abortion in a certain period in 1977, 71.7% were unmarried and 63.9% were unmarried primigravidas. At the first follow-up visit 3 to 6 weeks postabortion 55.0% of the unmarried primigravidas chose oral contraceptives and 43.2% chose intrauterine devices (IUDs). Of the unmarried women, 25.7% chose oral contraceptives and 65.7% chose IUDs. For unmarried primigravidas the 1-year continuation rates for oral contraceptives and IUDs were 83.6% and 93.8%, respectively. For married women the figures were 55.6% for oral contraceptives and 91.3% for IUDs. The differences between use of oral contraceptives and use of IUDs in the two groups of women was not statistically significant. We recorded no contraceptive failure, but three episodes of pelvic inflammatory disease occurred among unmarried primigravidas. The results indicate a high motivation for reliable methods and a high continuation rate following therapeutic abortion. The results may also indicate that oral contraceptives and IUDs represent equivalent methods for both parous and nulliparous women.

PIP: 195 women undergoing therapeutic abortion in a clinic were included in this study of the efficacy of various forms of contraception postabortion. 180 women were followed for the complete study; of these, 71.7% were unmarried and 63.9% were unmarried primigravidas. 3-6 weeks postabortion, the patients were offered a choice of contraception; 55% of the unmarried primas chose oral contraceptives, whereas 43.2% chose IUDs. Among the married population, 25.7% chose oral contraceptives, and 65.7% requested IUDs. Continuation rates for 1 year were calculated. Unmarried primas had continuation rates of 83.6% for oral contraceptives and 93.8% for IUDs. Married women had continuation rates of 55.6% and 91.3%, respectively, for oral contraceptives and IUDs. None of these rates showed statistical significance. Motivation for reliable contraception postabortion is very high, as judged by these continuation rates. There were no contraceptive failures; however, 3 cases of acute pelvic inflammatory disease were reported among the unmarried primas. The results indicate that either method is efficacious for both parous and ulliparous clients.

Experience with two different medicated intrauterine devices: a comparative study of the Progestasert and Nova-T.

A comparative study of the Progestasert (UPS) and the Nova-T in 326 randomly selected women was carried out. The observation period was 1 year. The over-all continuation rates for the two types of intrauterine devices (IUDs) were similar. The expulsion rate for the Nova-T (9.2%) was considerably higher (P = 0.001) than that for the UPS (1.2%). Medical removals for bleeding/pain were more frequent (P = 0.028) for the UPS (15.4%) as compared with the Nova-T (6.1%). The pregnancy rate for the UPS (Pearl index = 4.8) was insignificantly higher than that for the Nova-T (Pearl index = 2.8). Two of the pregnancies in the UPS group were ectopic. No significant changes in the reactive immunoglobulins (IgA, IgG, or IgM) were observed in either of the groups. Our results indicate that neither of these two IUDs is preferable to the already existing medicated IUDs, such as the Copper T or the Copper 7.

PIP: This study 1) compared the efficacy and continuation rates for the Progestasert (UPS) and Nova-T (Y-shaped, copper-medicated, 200 sq. mm., with flexible arms) and 2) determined the serum immunoglobulin response to women wearing 1 of these 2 differently medicated IUDs. Overall continuation rates for the 2 types of IUDs over a 1-year observation period (UPS must be changed yearly) were similar. Expulsion rate for Nova-T (9.2%), however, was considerably higher (P=.001) than for the UPS (1.2%). Pregnancy rate for the UPS by the Pearl index was 4.8 and was insignificantly higher than that for Nova-T (Pearl index=2.8). 2 UPS pregnancies were ectopic. Removals for bleeding/pain (i.e., medical removals) were more frequent (P=.082) for UPS (15.4%) than for Nova-T (6.1%). No significant changes in reactive immunoglobins (Igs), i.e., IgA, IgG, or IgM, were observed in either IUD group. Results suggested that neither IUD was preferable to already existing medicated IUDs.

Rupture of the uterus following treatment with 16-16-dimethyl E 2 prostaglandin vagitories.

Rupture of the uterine body was found after induction of therapeutic abortion with vaginal suppositories containing 16, 16-dimethyl prostaglandin E 2 in a 20-year-old primigravida. A short discussion is given on the cervical complications that can occur after prostaglandin induction of abortion, stating that rupture of the uterine body also can be seen. So far, no prostaglandin compound seems to avoid such complications.

Therapeutic abortion in late first trimester. Prostaglandin pretreatment compared with primary surgery.

One hundred randomly selected nulliparous women, 10-11 weeks pregnant, were submitted to either primary surgery (50 cases) or pretreatment overnight with vaginal suppositories of 15(S)15 methyl prostaglandin F2 alpha methyl ester (50 cases) followed by vacuum aspiration. No peroperative complications were recorded in either of the two groups. Thirtyfive of the 50 pretreated women aborted during the pretreatment period and a variable cervical dilatation was observed in the remaining 15 women of this group. The incidence of early postoperative pelvic infection tended to be less in the pretreated group as compared with the other group.

Therapeutic abortion. The 1975 report from Ullevål Hospital.

The results from a prospective study of 1228 therapeutic abortions (the 1975 material) are reported. First trimester pregnancies (1028 cases) were terminated by suction and curettage and second trimester pregnancies by prostaglandins (200 cases). The overall follow-up (4-6 weeks after termination) was 94.3%. The incidence of perforation was 0.5% of the surgical terminations, none of which, however, resulted in any other complications. The mean incidence of re-admission was 3.9%, the main causes being retained products or pelvic infection. The mean incidence of pelvic infection (salpingitis/parametritis) was 1.6%. The highest incidence of pelvic infection was found in early pregnancies (less than 8 weeks) or nulliparous women (2.7%) and the lowest (1.5%) in the induction group.

15(S)15-methyl prostaglandin F2alpha for termination of very early human pregnancy. A comparative study of a single intramuscular injection and vaginal suppositories.

The results of a comparative study of the efficacy and acceptability of 15(S)15-methyl prostaglandin F2alpha (15-Me-PGF2alpha) administered as a single i.m. injection or vaginal suppositories (15-Me-PGF2alpha methyl ester) every 3rd hr for termination of very early human pregnancy is reported. The amenorrhoic period varied from 37 to 60 days. Group I (30 cases) received 0.6 mg as a single i.m. injection without any pretreatment. Retrospectively 24 of the 30 women were in fact pregnant and 22 of them aborted. Group II received suppositories (1.0 or 1.5 mg per suppository). In this group all women were pregnant and they all aborted. Symptoms such as pain, bleeding, vomiting and diarrhea started in general earlier in the i.m. group and they were more marked. In the present series the efficacy and acceptability were highest for the vaginal route of administration.