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Pregnancy rates (method and user) were evaluated for 2245 women who participated in the phase III clinical trials of the Today contraceptive sponge. User and method pregnancy rates were similar for women of different ages and parities. The 1-year method and user pregnancy rates (life table per 100 women) were 8.2 and 5.6, respectively.
OBJECTIVE: Our goal was to evaluate both the continuation and pregnancy rates and the side effects experienced during the first year of use by adolescents who selected Norplant implants as compared with those who chose oral contraceptives for contraception. Furthermore, side effects experienced at 6 versus 12 months among Norplant implant users were compared to determine whether they diminished with continued use of this method. STUDY DESIGN: We conducted a case-control study of 56 adolescents < or = 18 years old who selected implants as compared with 56 age-matched controls who chose oral contraceptive pills during the same time period. RESULTS: Only 34% of patients prescribed oral contraceptives as compared with 91% of Norplant implant patients were still using their chosen method 1 year later. As a result 25% of oral contraceptive users became pregnant within 12 months as compared with none who selected Norplant implants. Side effects were reported by > 80% of patients in both groups, with menstrual irregularities reported more often by Norplant implant users than by oral contraceptive users (73% vs 5%, p = 0.01). Furthermore, Norplant implant users gained more weight than oral contraceptive users (8.7 vs 4.2 pounds) and were twice as likely to have an abnormal Papanicolaou smear. Finally, little diminution in side effects was observed during the second 6 months of Norplant implant use. CONCLUSIONS: These data confirm that Norplant implants provide better protection against unintended pregnancy in an adolescent population but may be associated with more side effects. Clinicians should be aware of these findings so they can adequately counsel young patients about these two methods of contraception.
This study was conducted to evaluate a new and improved inserter (GyneFix) for the anchoring of the Frameless IUD in the uterine cavity. Previous studies conducted with a prototype inserter (Flexigard) did not show fully the advantages of the new anchoring concept because of the shortcomings of the Flexigard inserter and the complexity of the insertion technique. The GyneFix IUD was compared with the TCu380A IUD in six centers in China in approximately 300 women in each group. Only parous women were included in the study. The data from this 3-year, ongoing study demonstrate that the shortcomings of the inserter have been corrected, resulting in better performance and a much reduced rate of failed insertion/expulsion of the frameless and anchored device. The cumulative expulsion rate with the GyneFix IUD was 3.0 at 3 years (annual rates 2.67, 0.33, and 0.0, respectively) compared with a cumulative expulsion rate of 7.38 at 3 years with TCu380A (annual rates 4.63, 1.76, and 1.04, respectively). This difference is statistically significant. The majority of the expulsions with the anchored IUD occurred early in the study, indicating improper anchoring technique. The study also shows that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0 at 3 years) versus one pregnancy with TCu380A (cumulative pregnancy rate 0.34 at 3 years). The total use-related discontinuation rate at 3 years was significantly lower with the GyneFix IUD (8.34) than with the TCu380A IUD (14.13) and results in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (90.73 vs 85.25). Neither perforations nor pelvic inflammatory disease cases were encountered with either device in this study, demonstrating the safety of the anchoring system.
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This is a study of 296 nulliparous women who used Copper IUD's as their method of contraception. At the time of first insertion the women had an average age of 21.6 years. The gross cumulative pregnancy rate rose to 11.8 over 5 years. The gross cumulative expulsion rate rose to 13.6 over 5 years and the removal rate for bleeding and pain to 20.4. The net rates were lower over 5 years (pregnancy 8.6, expulsion 11.2 and bleeding and pain 17.3). 29 women expelled their IUD's, of whom 20 underwent reinsertion. 43 women requested removal of their IUD's because of bleeding and pain, of whom 6 requested a reinsertion at a later date. Taking reinsertions into account, the continuation rate over 5 years was 55.2. Inability to insert the IUD was encountered in 28 women (8.6%). In 20 of the women cervical stenosis precluded the insertion of the IUD without local anesthetic, and in the other 8, the pain and/or syncope encountered during sounding the uterus precluded the continuation of the procedure. Insertion problems were encountered in 31 women (10.5%). Syncope occurred in 4 women and one of the women developed a 'grand mal' seizure. Clinically significant pelvic infection occurred within 30 days of insertion in 5 women (approximately 1% of insertions), and one woman developed pelvic infection from gonorrhoea.
A randomized comparative clinical study of the Steel Ring, VCu200 and TCu220c IUDs was carried out in Beijing. Six-hundred subjects were recruited and each group of 200 was inserted with one of the three devices. The TCu220c and the VCu200 had statistically significantly lower pregnancy and expulsion rates at one and two years of use than the Steel Ring. However, the Steel Ring consistently had the lowest rate of removal for pain and/or bleeding. At two years, the early differences of use-related discontinuation and continuation between the higher rates of the Steel Ring and the lower rates of the VCu200 and TCu220c were significantly reduced. There were no statistically significant differences of net event rates between VCu200 and TCu220c.
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A two-year controlled clinical study of the effectiveness of postcoital IUD as a continuing contraceptive method in 98 women requesting a postcoital contraception is presented. The control group was selected from women requesting an IUD as contraceptive choice. The rates of accidental pregnancy, expulsion and removal for medical reasons did not differ between the two groups. Removal for personal reasons was the only termination event that showed a significant difference at one year. Moreover, the removal for personal reasons of interceptive IUD users mainly occurred in the early months after insertion. Postcoital IUD has proved to be an effective continuing contraceptive method. Special attention and sympathetic counseling should be given to postcoital IUD users before insertion and during the three months following insertion.
This report describes the five-year experience of the first 250 acceptors of NORPLANT implants in Assiut, Egypt. The five-year net continuation rate was 58.6 per 100 women. The five-year net cumulative pregnancy rate was 1.6 per 100 women. About three-fourths of those who continued use of this contraceptive through the fifth year reported having regular cycles. There was definite improvement in the bleeding pattern with time. The five-year net termination rate because of bleeding problems was 17.7 per 100 women. After 5 years of NORPLANT use there was a slight, statistically insignificant increase in weight, systolic and diastolic blood pressures. Of those who used contraceptives after the end of the five-year term of NORPLANT, about one-third opted to have reinsertion of the implants for a second term. About 96% of those who used NORPLANT through the fifth year reported that their experience with the contraceptive had been satisfactory.
Out-patient sterilization services were introduced by the Family Planning Clinic of the Department of Obstetrics and Gynaecology, College of Medicine, Lagos, in September, 1981. This paper reviews the results of the first five years of its availability. There were 96 out-patient interval sterilizations, 47 were by the laparoscopic and 49 by the minilaparotomy procedures, representing 0.7% of maternities. Both local and general anaesthesia was used for the procedures. The patients' ages ranged from 28-52 years, all but three being above 31 years. Their parity ranged from 2-15 with between 2-10 living children. Only five patients had less than four children. 37.5% had used no contraception before. Termination of pregnancy was performed at the same time as tubal ligation in 12.5%, and 75% of these were secondary to contraceptive failure. Three patients had emergency laparotomy although in only one was it related to the sterilization procedure. Three patients were observed for 24 hours with no complications. Two patients were re-admitted after one week with pelvic peritonitis. The major complication rate was 3.1%. The failure rate was one per cent. There have been no requests for reversal. The results are compared with those of patients having puerperal sterilization during the same period, who totalled 2% of the maternities.
One-hundred-and-ninety-eight women used a levonorgestrel-releasing intracervical contraceptive device (LNG-ICD) designed to release 20 micrograms levonorgestrel/day. Clinical performance during the first two years of LNG-ICD use was evaluated. A total of seven pregnancies occurred during the study period, all of them during the first year. Six pregnancies were after unnoticed expulsion of the device. One pregnancy occurred in an epileptic women using carbamazepine, with the LNG-ICD remaining in situ. Eighteen spontaneous expulsions occurred, 16 during the first year and 2 during the second year. Three pelvic infections were observed, all of them during the first year. Bleeding problems, hormonal side effects and other medical reasons were the most common side effects resulting in removal of the device. The continuation rate was 72.6 per cent after one year and 57.1 per cent after two years.
The effectiveness of Norplant implants over a seven year period of continuous use was studied in a multicenter trial. Pregnancy rates were 0.4 per 100 in both year six and year seven. More than 3,600 women completed 6 years and more than 2,400 women completed 7 years. Pregnancy rates increased with weight (p < .05) and decreased with age, but in years 6 and 7 combined, the pregnancy rate neither reached nor exceeded 1 per 100 woman years in any 5 year age group or in any 10 kg weight group.
A total of 265 women who had the Norplant system inserted were followed for 5 years. The present study is based on 11,435 women-months of use, describing the continuation rates and efficacy of Norplant among these women. The 5-year cumulative continuation rate was 45.7 per 100 continuing users. The continuation rates were age-dependent. The women > or = 35 years of age consistently maintained higher continuation rates at all time intervals as compared with those of younger women. During 5 years of follow-up, five women became pregnant. Three pregnancies occurred in year 2, one in year 3, and one in year 5. The 5-year cumulative pregnancy rate was 2.5 per 100 continuing users. The weight of the user did not influence the pregnancy rate. The continuation rates, as well as the pregnancy rates, are comparable to those reported from other countries in the region.
Experience with the LEM intrauterine device in an immediate postpartum program at the Jose Fabella Memorial Hospital, Manila, Philippines, is reported. During a 6-month period, the LEM was inserted in 1359 women immediately after normal term deliveries. The early expulsion rate was high, but removals for bleeding or pain were minimal. Pregnancy rates during the second 6 months of use were higher than those reported previously for postpartum insertions of the LEM device.
Within a 1-year period, three patients presenting to the University of Chicago, Chicago Lying-In Hospital with a complaint of lower abdominal pain were diagnosed at laparotomy to have ovarian pregnancies according to the criteria of Spiegelberg. All of the patients were at the time using the Copper-7 intrauterine device for contraception. There are now 50 known cases of ovarian pregnancies in patients using the intrauterine device (IUD). The characteristics of these patients do not differ markedly from those previously reported in studies on tubal pregnancies, with and without the IUD, but the presentation of patients tends to be more variable than in tubal pregnancies. The increasing incidence noted here, in a population already known to be particularly prone to pelvic inflammatory disease and therefore ectopic pregnancies in general, lends further credence to a questioning of the desirability of the IUD in such a population.
The presence of a sperm granuloma at the vasectomy site prevents epididymal pressure build-up, perforation, and the formation of an epididymal sperm granuloma. It thus enhances reversibility of the vasectomy and lessens the likelihood of epididymal discomfort. In two prospective vasectomy series, a sperm granuloma was intentionally allowed to form by not sealing the testicular end of the vas. The sperm granuloma resulted in no instance of orchialgia, but created a greater risk of spontaneous recanalization. This latter problem could only be solved by more careful sealing of the upper end of the vas. In a separate series of nine patients vasectomized elsewhere and specifically referred to us for chronic and persistent postvasectomy orchialgia, seven had no sperm granuloma at the vasectomy site. Pain in these cases was localized in the epididymis and was relieved by vasovasotomy. Any technique of vasectomy carries a very small risk of orchialgia, whether due to the presence of a sperm granuloma at the vasectomy site or to increased epididymal pressure.