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At least 19 recordsLinked to original sources
PubMed1984

A comparative trial of the Today contraceptive sponge and diaphragm.

A comparative trial was conducted in the United States to compare the Today contraceptive sponge and the diaphragm used with spermicide. Subjects were randomly assigned to contraceptive methods and were followed up for 1 year. None of the subjects were previous sponge users, but about 30% were previous diaphragm users. The overall cumulative 1-year life-table pregnancy rate was higher for sponge users compared to diaphragm users. No serious side effects occurred with either product. The discontinuation rates for allergic-type reactions and discomfort were higher for sponge users. Similar rates of method-related complaints and discontinuation rates for personal and product-related reasons suggest there were no differences in the acceptability of the two products. In this trial, the allowable use time for the sponge was 2 days. The sponge is now recommended for 1-day use. The overall results of the study indicate the sponge to be a safe and acceptable method of contraception with an effectiveness rate in the range of that for other vaginal contraceptives.

Adolescent↗
PubMed1988

A comparative clinical trial of Norinyl 1/35 versus Brevicon in Rio Clara, Brazil.

A comparative clinical trial of two combined oral contraceptives (OCs) with equivalent estrogen content, but different amounts of progestogens, was conducted at the Centro Medico Especializado em Planejamento Familiar in Rio Clara, Brazil. The study was designed to determine the differences in discontinuation rates between Norinyl 1/35 (Syntex) and Brevicon (Syntex) as well as the frequency of selected side effects which might contribute to method discontinuation. Both OCs contain 0.035 mg of ethinyl estradiol; Brevicon contains 0.5 mg and Norinyl 1/35 contains 1 mg norethindrone. Three-hundred women enrolled in the study were randomly assigned to either the Norinyl 1/35 or Brevicon OCs and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Intermenstrual bleeding was reported by significantly more women in the Brevicon group than in the Norinyl group (p less than 0.05), and significantly more Brevicon users reported an increase in intermenstrual bleeding. At the end of the study period, no differences were found between the two OC groups in terms of discontinuation rates, but a large number of women in each group discontinued for menstrual problems. The total discontinuation rates at 11 months for both groups were extremely high: 68.2 for the Norinyl 1/35 group and 75.2 for the Brevicon users. The largest group of discontinuations were comprised of those discontinuing for menstrual problems, other personal reasons, planned pregnancy and side effects.

Adult↗
PubMed1990

Long-term contraception with the levonorgestrel 20 mcg/day (LNg 20) and the copper T 380Ag intrauterine devices: a five-year randomized study.

An intrauterine device, releasing approximately 20 micrograms/day of levonorgestrel (LNg 20), used by 1124 women, was studied in a randomized trial of five years duration in comparison with the Copper T, model TCu 380Agm in 1121 women. At five years, the gross cumulative pregnancy rate of 1.1 +/- 0.5 per 100 among users of the LNg 20 devices was not significantly different from the rate of 1.4 +/- 0.4 per 100 experienced by users of the Copper T 380Ag. The steroid-releasing IUD had significantly higher termination rates for expulsion and amenorrhea, a significantly lower termination rate for other menstrual problems and pain, and a lower continuation rate. The five-year continuation rate among women using the TCu 380Ag was 40.6 per 100 as compared with that of 33.0 per 100 among women randomized to the LNg 20 device (P less than .001). Terminations attributed to amenorrhea with the LNg device primarily account for differences in continuation. These two intrauterine devices are the most effective long-term, reversible IUDs yet reported in the literature. No other contraceptive methods have exhibited such low long-term pregnancy rates in randomized comparative trials.

Adolescent↗
PubMed1990

A randomized trial of the Gyne T 380 and Gyne T 380 Slimline Intrauterine Copper devices.

To facilitate manufacture and insertion of the Gyne T 380 IUD, design changes were instituted. Copper collars were seated flush at the ends of the horizontal crossbar of the device. A randomized study of the Gyne T 380 Slimline, the new design, was undertaken in comparison with the standard Gyne T 380. A total of 996 women were enrolled, with 698 Slimline insertions and 298 of the standard Gyne T. No statistically significant difference in ease of insertion or in performance was detected between the models. At one year, the pregnancy rate of each model was below 0.5 per 100 and the continuation rate was 79-80 per 100. Pelvic inflammatory disease or endometritis was found in one percent of subjects in the first year. This is the seventh multicenter randomized study of a collared T IUD with 380 mm2 of copper surface. In all seven, the one-year gross pregnancy rate has been 1.2 per 100 or lower.

Adult↗
PubMed1990

Is the copper T 380A device associated with an increased risk of removal due to bleeding and/or pain? An analysis.

Previous studies have consistently shown that the family of the Copper T 380 devices is more effective in preventing accidental pregnancies than the inert, as well as most other, if not all, copper devices. However, a number of these studies also reported a higher removal rate due to bleeding and/or pain for the TCu 380A than for other devices. The programmatical importance of these findings prompted us to analyze the international multi-center randomized clinical trial datasets to examine this question on the new TCu 380A (ParaGard) recently marketed in the U.S. Our results, while confirming the inherent superior efficacy of the TCu 380A, did not reveal a significantly higher removal rate because of bleeding and/or pain among TCu 380A users than among users of the comparative devices, which included the Lippes Loop D, the TCu 200, the TCu 220 and the Multiload Cu 250 devices.

Adolescent↗
PubMed1991

A longitudinal study of contraception and pregnancy outcome in a representative sample of young Swedish women.

The prevalence of contraception and pregnancy history in the same women, aged 19 and 24 years, was assessed in a longitudinal cohort study by means of a postal questionnaire. A one-in-four random sample of all the women born 1962, resident in the city of Göteborg in 1981, was obtained from the population register (n = 656). The response rate was 91%. Respondents from 1981 were re-assessed in 1986 (response rate: 83%). The respondents from 1986 (n = 488) represent 74% of the original sample from 1981. Contraceptive usage in the same women aged 19 and 24 years (in brackets) was as follows: Oral contraception (OC) 47% (51%); intrauterine device 3% (11%), p less than 0.01; barrier methods 11% (11%); depot gestagen 0 (0.2%); no contraception 39% (26%), p less than 0.05. OCs were being taken or had been taken by 89%. Reasons given for cessation of OC were as follows: Contraception not required 10% (15%); fear of OC 26% (29%); menstrual disorder 17% (14%); weight increase 18% (10%), p less than 0.05; mental side effects 15% (9%); desire to become pregnant 7% (17%), p less than 0.01. Pregnancies (n = 362) were reported by 194 (43%) of the women. 44% of the pregnancies terminated in legal abortion. The medical complication rate following legal abortion was 15%. Thus, despite the availability of effective contraception, the ratio of legal abortions to live births was high. Fear of side effects was the commonest reason for discontinuing OC.

Adult↗
PubMed1991

The efficacy and acceptability of a low-dose levonorgestrel intravaginal ring for contraception in a UK cohort.

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.

Adolescent↗
PubMed1991

An evaluation of the Bioself 110 electronic fertility indicator as a contraceptive aid.

The Bioself 110 is a hand-held electronic device that combines the BBT and calendar methods of fertility regulation for planning or preventing pregnancy. A pilot study was undertaken in three centers in the United Kingdom to evaluate the Bioself 110 as a contraceptive aid. This paper deals with 1238 cycles from 131 women. Only one unplanned pregnancy occurred where a volunteer correctly used the Bioself 110 and had intercourse on a supposedly "safe" day. A second pregnancy was experienced by a volunteer who incorrectly used the device and had intercourse on what she though was a "safe" day. Another 11 unplanned pregnancies occurred due to barrier method failures, as well as 11 pregnancies where the volunteers knowingly had unprotected intercourse during the fertile phase. There were five planned pregnancies. The Bioself 110 was correctly used in 71% of the cycles studied. Eighty-four percent of the volunteers indicated that they were satisfied with the Bioself 110 after six to twelve cycles of use. It was concluded that the Bioself 110 can serve as an effective family planning aid and should be added to the menu of contraceptive methods available to women today.

Adolescent↗
PubMed1991

A comparative clinical trial of the TCu 380A, Lippes Loop D and Multiload Cu 375 IUDs in Indonesia.

The Copper T 380A (TCu 380A), Lippes Loop D (LLD) and the Multiload Cu 375 (MLCu 375) IUDs were evaluated for safety and efficacy in a multicenter randomized clinical trial in Indonesia. A total of 2992 women were enrolled into the study and data for 2845 women were analyzed (147 cases did not meet protocol criteria). Although study IUDs were randomly assigned, LLD users in this study were older and of higher parity than TCu 380A and MLCu 375 users. The 24-month gross cumulative life-table pregnancy rates for TCu 380A, LLD and MLCu 375 users were 1.2, 2.2 and 2.7, respectively. The 24-month expulsion rates for TCu 380A, LLD and MLCu 375 users were 6.7, 7.5 and 5.3, respectively. Overall, 24-month continuation rates were 85.5%, 85.0% and 85.4% for the respective device groups. Differences in both gross and age- and parity-adjusted life-tables rates for the major outcome variables were not statistically significant at 24 months postinsertion. The study suggests that the TCu 380A, LLD and MLCu 375 IUDs seem to be safe and effective contraceptive options for Indonesian women.

Adolescent↗
PubMed1991

Clinical experience with triphasic oral contraceptive (Triquilar) in 527 women in China.

From October 1987 to May 1989, a total number of 527 women completed a total of 6,291 treatment cycles in 6 centers in China for the study of a triphasic oral contraceptive - Triquilar. The mean age of subjects was 30.21 +/- 2.84 years. There were 7 pregnancies during the study period. Among them, five were patient failures because of missed pill or incorrect intake; one had taken barbiturates along with Triquilar. Only one woman became pregnant in the 11th treatment cycle without any reason being found. In most cases, menstrual flow decreased and dysmenorrhea improved as treatment continued. Of the total treatment cycles, the incidence of missed withdrawal bleeding was 0.25%, spotting 0.97%, and breakthrough bleeding 0.48%. Nausea and vomiting was the most common side effect and accounted for 6.4% of the total treatment cycles. This was followed by breast tenderness (3.7%), dizziness (2.4%) and headache (1.6%). Most of the side effects occurred during the first few cycles and were alleviated later. By the end of one year, the total dropout was 64 cases. The reasons for discontinuing treatment were: pregnancy 1.33 (per hundred women), menstrual disturbances 0.76, side effects 3.80, other medical reasons 2.09, and personal reasons 4.18. The results confirm that Triquilar is an effective oral contraceptive with good cycle control and low incidence of side effects. No serious reaction has been reported. It has been well accepted by the Chinese women. However, due to the low dosage of steroids, it is of utmost importance to avoid errors in its use.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1991

A comparative study of 35 mcg and 50 mcg combined oral contraceptives: results from a multicenter clinical trial.

A comparative multicenter clinical trial of two combined oral contraceptives (OCs) differing only in the estrogen content (35 mcg ethinyl estradiol versus 50 mcg mestranol) was conducted at five clinics located in Yugoslavia, Egypt, Sri Lanka, Costa Rica and Mexico. The trial was designed to determine the differences between Norinyl 1+35 (Syntex) and Norinyl 1+50 (Syntex) in rates and reasons of discontinuation, and frequency of selected side effects which might contribute to method discontinuation. This report includes analysis of 1698 women, all of whom were interval patients (at least 42 days but within 26 weeks postpartum), randomly allocated to one of the above OCs between October 1982 and January 1984. Follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Significantly more women in the Norinyl 1+35 group (p less than .001) reported intermenstrual bleeding (primarily staining and spotting), as well as an increase in the occurrence of intermenstrual bleeding compared to women in the Norinyl 1+50 group. There were no significant differences between the groups for side effects with the exception of more women in the Norinyl 1+50 group (p less than .05) reporting breast discomfort. The lost to follow-up rate at 12 months was 19.3% for both the Norinyl 1+35 and the Norinyl 1+50 groups. The total discontinuation rate (including women lost to follow-up) at 12 months was 43.5% for the Norinyl 1+35 group and 41.0% for the Norinyl 1+50 group. There were no significant differences between the two groups for gross cumulative life table discontinuation rates (p greater than .05). There were six accidental pregnancies attributed to user failure reported during the study period; four in the Norinyl 1+35 group and two in the Norinyl 1+50 group.

Adult↗
PubMed1985

A crossover pill study among Sudanese women.

A crossover study from a standard-dose to a low-dose oral contraceptive was conducted in the Sudan. Reported side effects were very few, with a headache the most frequently reported. Switching to the other pill did not affect the rate of any side effects.

Adolescent↗
PubMed1990

Duration of use of copper releasing IUDs and the incidence of copper wire breakage.

The incidence of copper wire breakage for IUDs (Multiloads) using 0.3 and 0.4 mm diameter copper wire was evaluated by examining 969 devices that had been removed for various reasons. The IUDs were examined by light microscopy to determine the integrity of the copper wire. As expected, the incidence of breakage increased with increasing duration of IUD use. The cumulative breakage rate (life table) was significantly lower (p less than 0.05) for the Multiload 375 that used 0.4 mm diameter wire, compared to the Multiload 250 that used 0.3 mm diameter wire. The cumulative rates were 5.4 per 100 IUDs after 3 years for the Multiload 250, and 3.8 per 100 IUDs after 5 years for the Multiload 375. In only 1 (0.1%) of the 969 Multiloads examined, the breakage of the copper wire was sufficiently extensive to adversely affect the user's risk of pregnancy.

Equipment Failure↗
PubMed1990

Oral contraceptive therapy and the surgical management of ENT patients: a review of current clinical practice.

The current policy of British Otolaryngologists with regard to the preoperative cessation of the oral contraceptive pill is reported. This is based on a confidential questionnaire sent to all members of the British Association of Otolaryngologists. The overall response rate was 66%, 91% of which were from practising otolaryngologists and forms the basis of this report, the remaining 9% being from respondents not engaged in active surgery. Although there is evidence to show an increased risk of developing thromboembolic complications after major abdominal, gynaecological and hip surgery in those patients taking the oestrogen-containing contraceptive pill, the risk following minor and intermediate surgery (which forms the bulk of the otolaryngologist's workload) is not known. Not surprisingly therefore the results of the survey show a varied policy across the country with 36.5% of respondents choosing to continue the pill and 25% always stopping the pill preoperatively. The remainder elect to stop the pill only in certain circumstances.

Contraceptives, Oral↗
PubMed1989

Laparoscopic removal of translocated intrauterine contraceptive devices.

Data is presented regarding 20 translocated intrauterine contraceptive devices (IUCD). Successful laparoscopic removal was made in 13 (65%) cases though all these devices were Copper 'T' 200 model which tend to produce dense adhesions. Only when the IUCD was suspected to be partially or fully in the gut lumen or thick adhesions were present, or the device was not visualised, was laparotomy performed. Hence it is advocated that laparoscopy should be performed as a routine in patients with suspected translocated IUCD, as it obviates the need for laparotomy and thus decreases the duration of the hospital stay as well as preventing morbidity associated with laparotomy.

Adult↗
PubMed1988

A randomized trial of three copper IUDs (MLCu250, MLCu375 and Nova-T).

A randomized prospective trial of three copper IUDs, Nova-T, MLCu375 and MLCu250, including 200 of each, is presented. Insertion was done at the hospital outpatient clinic on normally menstruating women and on women in puerperio. Follow-up was scheduled after 12, 24 and 36 months. Pregnancy rates were low for all 3 models. Pearl indices after 3 years were 0.5, 0.9 and 0.8 for Nova-T, MLCu375 and MLCu250 respectively (NS). Abnormal bleeding and/or pain was the most frequent termination cause. Minor differences in the termination rates because of abnormal bleeding and/or pain were found and are discussed. The continuation rates based on all medically relevant IUD removals were 74%, 73% and 81% after 3 years for Nova-T, MLCu375 and MLCu250 respectively. No important difference in clinical performance between the three copper IUDs could be demonstrated.

Clinical Trials as Topic↗
PubMedDate not supplied

The quality of family planning services in rural China.

This article provides a preliminary analysis of three aspects of service quality in four rural counties in China--the availability of contraceptive methods, information given to users, and provider knowledge about methods. Contraceptive choice and characteristics of contraceptive use by women in the study areas are also examined. The data are derived from a survey carried out by the authors during 1987, under the auspices of China's State Family Planning Commission. The survey was conducted in four rural counties located in Fujian and Heilongjiang provinces. A total of 318 married women of reproductive age were randomly selected and interviewed. All family planning service sites serving the women were visited and a sample of service providers was interviewed. No shortage of contraceptives existed in any of the counties, but variations in community wealth and local procurement practices have resulted in the acquisition of an IUD with high failure rates. Although providers believe they inform women about method choices and side effects, women were poorly informed about the methods they selected. Not all providers who insert IUDs and distribute pills were knowledgeable about contraindications and side effects of the methods. Ever-use of contraception was nearly 100 percent, but most women, especially in Heilongjiang, have only used one method: the IUD or sterilization. Improvements in quality, especially in method mix, providers' level of knowledge, and the quality and quantity of information provided to users will likely improve contraceptive continuation, client satisfaction, and women's health.

China↗