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A 4-cell randomized, blind clinical trial was conducted at three sites in Sri Lanka to evaluate the impact of daily vitamin supplements in preventing oral contraceptive side effects and in improving continuation. No significant effects were found.
The five-year experience of 1,092 laparoscopic tubal sterilizations performed in a free-standing clinic in the U.S. with no anesthesiologist under local anesthesia is reviewed. The current technique of the Hasson "open" method and bipolar cauterization is felt to minimize major mishaps and is acceptably comfortable to the patient.
Three methods of tubal sterilisation, viz. laparoscopy, culdoscopy and minilaparotomy, were evaluated in a trial involving 300 voluntary acceptors at the University Hospital in Medan, Indonesia. Equal numbers of women were randomly assigned to the three surgical groups. The results showed little differences among patients in the three groups for age, number of living children, contraceptive and abortion histories and pre-existing medical conditions. As expected, average surgical time for minilaparotomy was significantly higher than the times reported for the endoscopic techniques. Minilaparotomy also produced the highest incidence of operative complications while culdoscopy accounted for the highest rate of hospitalisation following operation. Four-year follow-up of the patients revealed only one case of pregnancy in the culdoscopy group, three years after tubectomy .
A survey of cap use and efficacy of women who initially purchased a cervical cap at the University of California at Berkeley Student Health Service is described. It reports the follow-up of 65 U.C. women students who purchased either Vimule or Cavity-rim cervical caps from May, 1978 through June, 1981 and raises questions about cervical cap use and efficacy. Participants were divided into two groups: regular and irregular users. Of the 33 regular users, 16 experienced unplanned pregnancy during the study. Survival probabilities were 80% at 6 months, 73% at one year and 52% after 2 years. Life table analysis of the 33 regular users indicated a 20% probability of pregnancy in the first 6 months of use, 27% by 1 year and 48% by the end of 2 years.
Open-ended vasectomy was performed on one-hundred men. Sixty-three of them showed up for follow-up six months later. Spontaneous recanalisation had occurred in two. Sperm granuloma without orchialgia was found in 14 out of 59 men (23.9%). Twenty-one out of the 63 thought their sex life had improved, while 40 thought it was unchanged; only one man mentioned pain during intercourse since vasectomy.
The contraceptive efficacy of progestin-only contraception was studied in epileptic patients using NORPLANT subdermal capsules. The effect of anticonvulsants on levonorgestrel plasma levels was determined. NORPLANT subdermal capsules were inserted into nine epileptic women, and ten control women using no medication. Venous blood samples were taken at 0, 1, 3, 6, 9 and 12 months after insertion and the concentration of levonorgestrel was determined by radioimmunoassay. At 3 to 12 months, the overall mean concentration of plasma levonorgestrel was significantly lower in the six epileptics taking phenytoin alone or in combination with other anticonvulsants (203 +/- 128 pg/ml, mean +/- SD) than in the controls (325 +/- 135 pg/ml, p less than 0.01). After one year, nine of the control patients continued the use of NORPLANT and no pregnancies occurred. Two of the nine epileptics became pregnant during contraception by NORPLANT. They both used phenytoin and their plasma concentrations of levonorgestrel were low near the time of conception. Levonorgestrel released from the capsules had no apparent harmful effects on epilepsy and none of the patients reported an increase in seizure frequency. The results show that contraception by the progestin levonorgestrel is not reliable in epileptic patients using anticonvulsants known to induce metabolizing enzymes of the liver.
This investigation compares the IUD performance of 372 women who had an insertion-related problem (most with moderate or severe pain) and 372 matched women who had no such problem; all women had interval insertion. A woman in the Problem Cohort and her matched counterpart in the Comparison Cohort were inserted with the same IUD type by the same insertor on the same day or on close dates. The six IUD types used by these women were Lippes Loop D, Copper-7, Copper T-200, Copper T-380 Ag, Multiload Copper 250 and Multiload Copper 375. Cumulative gross life-table rates of the pertinent events (accidental pregnancy, expulsion and medical removal for bleeding and pain), adjusted for age and parity, were calculated. Between the Problem Cohort and the Comparison Cohort, no differences were detected in the event rates that were of either statistical or practical significance. Results from this preliminary study suggest that the insertion-related problems usually encountered during interval insertion such as insertion pain, syncope and/or mild cervical laceration are not associated with an increased risk of IUD discontinuation due to pertinent events.
The rate of copper loss from 329 IUDs (Multiload Cu250, TCu-220C and Cu7) which had been terminated for various reasons after 0.5-46 months in-utero were determined. All 3 IUDs showed a wide scatter of release rates with no significant differences between the ML Cu250 and the Cu7. The TCu-220C showed the highest rates and in contrast to the ML Cu250 and Cu7, the decrease with time was not significant. Its rate of copper loss was significantly higher than the ML Cu250 in the 1st year, but comparable after that. The TCu-220C had a similar rate to the Cu7 in the 1st year and significantly higher rates subsequently. The relevance of these findings to observed pregnancy rates and area of copper on the IUDs is discussed.
This paper describes the results from a randomized clinical trial comparing the Collatex vaginal contraceptive sponge (a predecessor of the Today sponge) and Neo Sampoon foaming vaginal contraceptive tablets; the trial was conducted from 1979 to 1983 in four centers located in three countries (two in Yugoslavia and one each in Taiwan and Bangladesh). The sponge was associated with more insertion and retention problems than the tablet, especially in the two Asian centers. More Neo Sampoon users complained of a burning or stinging sensation. This complaint, however, seemed to be well-tolerated and was not a frequent reason for irregular use and/or discontinuation of use of the tablets. Clinically significant medical complications were rarely reported for either method. Sponge users were more likely to report irregular use than tablet users, primarily due to inconvenience of use. Rates of discontinuation at six months of use were also consistently higher among sponge users than Neo Sampoon users in the four centers. Life-table pregnancy rates at 12 months of use ranged from 3.8 to 18.2 per 100 sponge users and 6.2 to 29.9 per 100 Neo Sampoon users, based on data from the two Yugoslavian centers and the Taiwan center (data from the Bangladesh center were excluded from analysis of pregnancy rates). Practical implications of these findings are discussed.
A comparative study of Norinyl 1/35 and Norinyl 1/50 was conducted at the Dom Zdravlja Stari Grad in Belgrade, Yugoslavia. The study sought to evaluate the differences in continuation rates as well as the frequency of selected side effects which might contribute to method discontinuation. The trial included 299 women who were randomly allocated to one of the two oral contraceptives. In the Norinyl 1/35 group, significantly more women (p less than .05) reported a complaint of vaginal discharge as well as an increase in the occurrence of vaginal discharge compared to the Norinyl 1/50 group. There was no significant difference in continuation rates or for particular discontinuation reasons for the Norinyl 1/35 and Norinyl 1/50 groups. No accidental pregnancies were reported during this study. Both oral contraceptives appear to be safe and effective; there appears to be no difference in the acceptability of one oral contraceptive over the other among this group of Yugoslavian women.
IUDs releasing 20 mcg/day of levonorgestrel (LNg20) were in randomized trial together with the Copper T, model TCu 380Ag, in seven centers involving 2244 women. Two-year (25 months) gross cumulative pregnancy rates were 0.2 +/- 0.2 and 0.9 +/- 0.3 for the levonorgestrel and copper releasing devices, respectively (P greater than 0.05). There were no ectopic pregnancies in more than 1600 woman-years of use of each device. Removal rates for bleeding and/or pain or for medical reasons other than menstrual problems did not differ significantly between devices. Oligomenorrhea or amenorrhea prompted 10.7 per hundred (gross rate, 8.4 net rate) women using the LNg 20 IUD to request removal in the two-year period, significantly above the 0.2 per hundred rate among women with the Copper IUD (P less than 0.001). At the end of two years an estimated 59.4 per 100 women were continuing use of the LNg 20 IUD, and 67.5 per 100 (P less than 0.001) with the TCu 380Ag. This difference is almost wholly ascribable to a marked reduction in bleeding episodes and days among women using the LNg 20 device with concomitant removal of device. Hemoglobin rose an average of 0.5 g/dl (P less than 0.001) for this group whereas women using the TCu 380Ag experienced a decline of 0.2 g/dl compared with baseline values (P less than 0.001).
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The efficacy and acceptability of a levonorgestrel-releasing intravaginal ring (IVR) for contraception was assessed in a British cohort studied as part of a multicentre, multinational clinical trial performed under the auspices of the World Health Organisation. One-hundred-and-fifty women took part in the study in two UK centres and completed 1417.5 months of method use. Fifty-nine women discontinued use of the IVR before the end of one year giving an overall discontinuation rate of 39.9 per 100 woman-years. The discontinuation for pregnancy with the ring in situ, was 3.0 per 100 woman-years (life table analysis). Menstrual disturbance, vaginal problems and involuntary expulsion resulted in discontinuation rates of 8.9, 8.4 and 1.6 per 100 woman-years, respectively. This method is an acceptable and effective method of contraception for women.
The levonorgestrel-releasing IUD (LNG-IUD-20), providing a daily dose of 20 ug, has recently been approved for marketing in Finland. The IUD's high efficacy in preventing accidental pregnancy and other numerous positive features make it a promising contraceptive device for worldwide use, just like the currently available T-shaped copper-releasing (TCu) IUDs. This paper reviews published reports comparing the LNG-IUD-20 and the currently used TCu IUDs. The merits and disadvantages of the steroid-releasing IUD are evaluated in terms of its performance and other special features relative to the TCu IUDs. Also, a number of future studies with medical and programmatic importance are proposed. A broader understanding about these two IUD families will facilitate their use in a complementary way for family planning programs.
Termination of early pregnancy was performed in 1572 healthy women with RU486 (mifepristone, 600mg orally once), followed 36-60 hours later by administration of methyl ester of dl-15-methyl-PGF2 alpha (PG05, 1mg vaginal suppository). Complete abortion was accomplished in 91.2% (1433/1571), incomplete abortion in 4.8% (76/1571), and continued pregnancy in 3.9% (62/1571). The time elapsed between RU486 intake and complete expulsion was 2.4 +/- 1.3 days. Expulsion took place on the third day in 935 women (72%), and on the 4th day in 273 women (21.0%). Uterine bleeding occurred on the second or third day after RU486 intake in 1256 women (88.8%), and lasted 11.7 +/- 6.4 (SD) days, range 2-55 days. One subject had blood transfusion due to excessive bleeding. The main side effects were nausea/vomiting (22.3%), abdominal pain (10.2%), headache/dizziness (4.1%) and diarrhea (2.8%). Fatal side effects have not been reported in this study. About 73% of subjects with complete abortion assessed the treatment as good to excellent. Even in the failed cases, 25-42% of subjects considered the treatment as good. Further studies are needed to determine the optimal dose of the RU486 regimen. It should be emphasized that the treatment must be used under close medical supervision in order to monitor the uterine bleeding.
In 1988, a clinical study with a new copper-containing IUD, the FlexiGard, was initiated at the Family Planning Center of the UMSD, Debrecen, Hungary. The aim of this trial was to measure the overall performance of the device with special attention to its frameless design and anchoring system. In one year (from May 1988 through May 1989), 344 FlexiGard devices were inserted in parous women during the first seven days of their menstrual cycle. This report summarizes the one-year results. By the end of the 12 -month follow-up period, 3484 woman-months of use (WMU) were accumulated. The number of women who completed the one-year follow-up period was 264. During this period, 33 cases were terminated for different reasons. The net continuation rate is 89.7 at the end of the first year of use. The device was well retained by the uterus (cumulative expulsion rate 1.5 at 12 months). The cumulative removal rate for bleeding/pain is 4.4 at 12 months and the cumulative pregnancy rate 0.6 at 12 months. The results confirm those of previously conducted multicenter studies with the device. This new generation intrauterine copper contraceptive (ICC) is well tolerated, which is attributed to its design characteristics. Besides, the device is highly effective, and its insertion is easy and safe. Removal of the ICC is equally easily accomplished.
Mifepristone (RU486) should be useful for inducing menstrual bleeding in women with menses delayed up to 10 days. We evaluated this potential use for "menstrual regulation" in a randomized clinical trial with 16 women, half of whom received a single 600 mg dose and half of whom received a placebo. Four of eight women in each treatment group proved to be pregnant. Seven of eight who received mifepristone were not pregnant at two-week follow-up, in contrast to four of eight who received the placebo (p = 0.15). Mifepristone may hold promise for "menstrual regulation" for women who do not have access to medical confirmation of pregnancy or who choose not to have this determination made.
Numerous non-comparative clinical trials of the Dalkon Shield appear to provide ample evidence that the Dalkon Shield was an effective IUD; they seem to yield little evidence that it was a dangerous device, nor markedly different from its contemporaries. Equating the performance of the Dalkon Shield IUD to that of the Lippes Loop or of Copper IUDs is erroneous, however, with respect to rates of pregnancy, expulsion, pelvic infection, septic abortion, death with the device in situ, and tubal infertility. Randomized studies show the Dalkon Shield had approximately double the pregnancy rates of the Lippes Loop D or Copper IUDs (P < .05) and a significantly lower expulsion rate. These differences coupled together with the distinguishing multifilament tail of the Dalkon Shield underlay the higher rates of pregnancy complications, including septic abortions with the device in situ and deaths, associated with the Shield. A five-fold increased risk of hospitalized pelvic infection among Dalkon Shield users found in the Women's Health Study resulted not from ascertainment bias, but was related to the fact that Dalkon Shield users had more severe hospitalized PID than did other hospitalized women with PID and IUD use. Following cessation of distribution and of use of the Dalkon Shield, and following the FDA's recommendation to remove IUDs in case of pregnancy, there have been no deaths reported among pregnant American women with an IUD in situ in a 15-year period. Neither the IUDs of today nor those in use during 1970-1974 are equitable to the Dalkon Shield [corrected].