Biomedical subjects

R Dominik

Publications and source records attributed to R Dominik.

11 recordsLinked to original sources

PubMed1999

Contraceptive effectiveness of two spermicides: a randomized trial.

OBJECTIVE: We conducted a multinational randomized trial to determine whether a spermicidal film containing 72 mg of nonoxynol-9 per film was at least as effective in preventing pregnancy as a foaming tablet containing 100 mg of nonoxynol-9 per tablet. METHODS: Between September 1995 and July 1997, 765 women aged 18-35 years who had no evidence of subfecundity were randomly assigned to use one of the two spermicides as their only contraceptive method at every coital act for 28 weeks. Participants were asked to keep coital diaries throughout the study period. Pregnancy tests were performed on a scheduled basis. Each participant was followed for 28 weeks or until she stopped considering the spermicide as her primary method of contraception. RESULTS: The Kaplan-Meier estimate of the 6-month probability of pregnancy during typical use of the spermicide was 28.0% in the tablet group and 24.9% in the film group (P = .78, one-tailed test). The study had nearly 75% power to have detected a difference of seven percentage points between groups. Results were almost identical when the analysis included only months when the participants reported use of the spermicide during every coital act. Reported levels of sexual activity and compliance with use of the spermicide were high in both groups. CONCLUSION: The contraceptive effectiveness of these two spermicidal products appeared similar. Both products were associated with a fairly high risk of pregnancy in this young, highly sexually active population.

Adolescent↗

PubMed1998

Emergency contraception use and the evaluation of barrier contraceptives. New challenges for study design, implementation, and analysis.

The availability of emergency contraception (EC) introduces new complexities to barrier contraceptive evaluation. Researchers must determine whether the primary objective of interest is to measure the effectiveness of the barrier plus EC back-up or the effectiveness of the barrier alone. Barrier contraceptive effectiveness study protocols must specify what study volunteers will be told about EC, under what conditions EC will be dispensed, what information about EC use will be collected, and how EC use will be addressed during data analysis.

Contraception↗

PubMed1996

Lea's Shield: a study of the safety and efficacy of a new vaginal barrier contraceptive used with and without spermicide.

The purpose of this study was to evaluate the safety, efficacy and acceptability of Lea's Shield, a new vaginal contraceptive barrier device, when used with either spermicidal or non-spermicidal lubricant. One-hundred-eighty-five (185) women enrolled at six centers. Half were randomized to use the device with spermicide and half with a non-spermicidal lubricant. To be eligible, volunteers had to be 18-40 years old (inclusive), in good health with regular menses, sexually active in an ongoing relationship and at risk for pregnancy, and willing to use Lea's Shield as their sole means of contraception for six months. Participants were seen at admission, one week, one month, three months and six months. Gross cumulative life table rates were calculated for pregnancy and others reasons for discontinuation. Adverse experiences and responses to an acceptability questionnaire were evaluated. One-hundred-eighty-two (182) volunteers contributed data to the analysis of safety and 146 to that of contraceptive efficacy. The unadjusted six-month life table pregnancy rate was 8.7 per 100 women for spermicide users and 12.9 for non-spermicide users (p = 0.287). After controlling for age, center, and frequent prior use of barrier methods, the adjusted six-month life table pregnancy rate was 5.6 for spermicide users and 9.3 for non-spermicide users (p = 0.086), indicating that use of spermicide lowered pregnancy rates, although not significantly, during typical use. For purposes of comparison, it is important to note that this study differed from the cap/diaphragm and sponge/ diaphragm studies in that a high percentage (84%) of volunteers were parous. For reasons that are unclear, pregnancy rates among parous women using barrier contraceptives tend to be higher than among nulliparous women. Indeed, in this study there were no pregnancies among nulliparous users of Lea's Shield. Standardization of parity of this study population on those of the cap/diaphragm and sponge/diaphragm studies suggests that unadjusted pregnancy rates for this device would have been considerably lower (2.2 and 2.9 per 100 users of spermicide and non-spermicide, respectively) had the study been done using the populations of earlier studies. Since no directly comparative study has been done, these figures provide a tentative estimate of the relative efficacy of Lea's Shield compared with the sponge, cap, and diaphragm. There were no serious adverse experiences attributed to the use of Lea's Shield. Acceptability was very good. Seventy-five percent (75%) of women responded to an end-of-study questionnaire; 87% of these reported that they would recommend Lea's Shield to a friend. Lea's Shield is a new vaginal contraceptive that does not require clinician fitting. Pregnancy rates in this study compare favorably with other studies of barrier contraceptive methods including the cervical cap, diaphragm, and sponge, even though this study was done with greater rigor and with a greater percentage of parous women than previous barrier studies. Lea's Shield appears to be safe and very acceptable to study volunteers.

Adult↗

PubMed1996

Measuring contraceptive effectiveness: a conceptual framework.

We present a conceptual model that outlines the four measures of how well a contraceptive method works: 1) efficacy, 2) effectiveness, 3) perfect-use pregnancy rate, and 4) typical-use pregnancy rate. Moreover, we illustrate how four variables influence these measures: 1) capacity to conceive, 2) frequency and timing of intercourse, 3) degree of compliance, and 4) inherent protection of the method. Because of inter-individual as well as intra-individual variability of the first three variables, generalizing results from a contraceptive clinical trial to other populations is problematic. There is a hierarchy of generalizability of the four outcome measures, with the typical-use pregnancy rate the least generalizable but the easiest to measure, and efficacy the most generalizable but the most difficult to measure. These four variables should be considered in the design and analysis of future contraceptive clinical trials. Finally, this article illustrates why the terms "pregnancy rate" and "failure rate" are not synonymous and why we recommend that the latter term not be used.

Clinical Trials as Topic↗

PubMed1995

The diaphragm with and without spermicide. A randomized, comparative efficacy trial.

OBJECTIVE: To determine the relative contraceptive efficacy of a diaphragm used with spermicide as compared to one used without. STUDY DESIGN: Two hundred sixteen women entered the study between September 1985 and December 1990. Of these, 84 were randomly assigned to the diaphragm-only group and 80 to the diaphragm-with-spermicide group as their primary method of contraception. In addition, a spermicide-only group was planned originally to serve as a control group to assess the contribution to efficacy made by a spermicide alone. Thirty-nine women were randomly assigned to this group, and 13 selected themselves for it. All were followed for a maximum of 12 months. The primary outcome variable was accidental pregnancy. The statistical difference between the two diaphragm groups was analyzed. RESULTS: The 12-month "typical use" failure rates for the diaphragm-only group were 28.6 per 100 women and for the diaphragm-with-spermicide group, 21.2. The 12-month cumulative consistent-use failure rates were 19.3 per 100 women for the diaphragm-only group as compared to 12.3 per 100 women for users of a diaphragm with spermicide. CONCLUSION: Although the consistent use rates were not significantly different, this study had low statistical power and hence gives no support to the hypothesis that adjunctive spermicide use fails to improve the effectiveness of the diaphragm method, especially in view of the magnitude and direction of the difference observed. Unless a study with sufficient power proves that the use of a diaphragm alone is statistically as effective as use of a diaphragm with spermicide, use of a spermicide in conjunction with the diaphragm continues to be the appropriate clinical recommendation.

Adolescent↗

PubMed1992

Management and treatment of diarrhea in Honduran children: factors associated with mothers' health care behaviors.

Data from the 1984 National Maternal-Child Health and Family Planning Survey in Honduras showed that one fifth (n = 711) of the children under five had experienced diarrhea on the day of the interview or the two days preceding the interview. The health care behaviors of the mothers of these children and the factors associated with these behaviors were the focus of this study. Only 22% of the mothers consulted medical personnel concerning the diarrhea episode; 74% treated their children with some type of medication while only 17% of the children received the recommended treatment, oral rehydration therapy. Most children were treated inappropriately, often receiving a combination of antibiotics, antidiarrheals and other drugs. Bivariate and multivariate analyses showed that the variables that most consistently predicted any and all three of the behaviors were the child's age and the severity of symptoms. Mothers of children two years and older were less likely to consult or use ORT than mothers of children 6-23 months of age. Mothers whose children's diarrhea had lasted three or more days or who were vomiting were usually twice as likely to consult, give any type of treatment, or give ORT than mothers whose children had diarrhea for fewer days or who were not vomiting.

Age Factors↗

PubMed1990

Do retroverted uteri adversely affect insertions and performance of IUDs?

A large international multi-center IUD data set (N = 5520) coordinated by Family Health International was analysed to determine if the uterine position of a woman (anteverted, mid-positioned or retroverted) affects the ease of IUD insertion and if knowledge of uterine position would diminish insertion-related problems and improve IUD performance. Findings showed that insertion-related events were rare irrespective of uterine position. Women with retroverted uteri were not associated with higher termination rates for accidental pregnancy, expulsion or removal for bleeding and/or pain after 12 months of IUD use, as compared to the other two uterine position groups. All insertions in this data set were performed by experienced obstetricians/gynecologists, and our findings suggest that women with retroverted uteri should be equally good candidates for IUD contraception.

Adult↗

PubMed1990

A study of infant mortality and causes of death in a rural north-east Brazilian community.

In 1984 a prospective study of 1645 women and 1677 births in a rural community in north-eastern Brazil showed the infant mortality rate to be 65 per 1000 live births. Neonatal, post-neonatal and infant mortality are analysed to determine the most important risk factors for each period. Post-neonatal survival depends largely on factors relating to child care, while neonatal deaths are more likely to be associated with biological factors. The principal cause of death, diarrhoeal disease, was responsible for a third of the deaths.

Brazil↗

PubMed1989

Cervical laceration at IUD insertion--incidence and risk factors.

Incidence and risk factors of cervical laceration at IUD insertion are studied as the one remaining IUD insertion-related rare event using the multi-center IUD database developed by Family Health International. Two-hundred-ten lacerations were reported from 11,646 insertions (1.8 per 100 insertions) performed between 1977 and 1987. The incidence was twice as high in insertions with the copper devices and the multiload devices as in those with the Loop devices. Nulliparous women were found to be at an increased risk compared to multiparous women. Use of a tenaculum at insertion may also be a risk factor for laceration, but this finding needs to be confirmed by future studies. Data were not adequate to examine the effect of insertor's experience on the incidence of cervical lacerations at insertion.

Adult↗

PubMed1989

Iopromide dosage and urographic image quality: is there an optimal dose?

The influence of increasing doses of contrast medium (CM; 0.75, 1.0, 1.5, and 2.0 ml iopromide/kg body weight; 300 mg I/ml) was examined in a randomized, double-blind study. An increase of the dosage resulted in a statistically significant improvement of the quality of the radiographic visualization. This was most pronounced with an increase from 0.75 to 1.0 ml/kg body weight and least pronounced with the increase from 1.5 to 2.0 ml/kg body weight. This improvement was not only visible in the overall quality, but in each part of the urinary tract, the calyces, the pelves, the ureters, and most especially at the parenchyma. Due to economic considerations at the present, a dose of 1.0 ml/kg (300 mg I/ml) is viewed as adequate. Doses below this level should be avoided due to the poorer image quality that results. From a purely medical point of view, the injection of 1.5 ml of nonionic CM/kg body weight is considered optimal.

Adolescent↗

PubMedDate not supplied

Comparative contraceptive efficacy of the female condom and other barrier methods.

Because the research design for the clinical trial establishing the contraceptive efficacy of the female condom--a six-month life-table probability of failure of 15% (12% in the United States vs. 22% in Latin America)--did not include randomization with another method of contraception, no definite conclusion about its comparative efficacy is possible. Comparisons using other female barrier methods as historical controls, however, provide evidence that, among women in the United States, the contraceptive efficacy of the female condom during typical use is not significantly different from that of the diaphragm, the sponge or the cervical cap. The six-month probability of failure during perfect use of the female condom is 2.6% among U.S. women, similar to rates for the diaphragm and the cervical cap but significantly lower than that for the sponge. Meaningful comparisons with the male condom are not possible because of the lack of data from carefully controlled prospective clinical trials. Extrapolations from the results on contraceptive efficacy suggest that perfect use of the female condom may reduce the annual risk of acquiring the human immunodeficiency virus by more than 90% among women who have intercourse twice weekly with an infected male.

Clinical Trials as Topic↗