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Oral contraceptives: an update.

Despite continual improvement in oral contraceptive formulations, many women still have unwarranted concerns about their safety and remain ignorant of their nonreproductive health benefits. The need for a reliable method of contraception is the greatest among adolescents and women older than 35 years--the two groups in the United States with the highest abortion rates.

Adolescent↗

Factors affecting continuation rates of DMPA.

A prospective study was conducted with 430 new depot medroxyprogesterone acetate (DMPA) acceptors to estimate continuation rates and investigate factors associated with length of use. Data were collected on services received and sociodemographic characteristics of participants. Women were enrolled over the course of 1 year and were followed for up to 13 months. Failure to return to the same clinic within 104 days of the last injection was the outcome of interest. The 3-, 6-, 9-, and 12-month continuation rates were 68%, 67%, 55%, and 51%, respectively. In the bivariate analysis, women who were told to return to the clinic for side effects were more likely to continue using DMPA than those who were not given such advice (p <0.05). Likewise, women who received information on DMPA efficacy, side effects, and amenorrhea were more likely to continue using DMPA compared to those who did not receive such information (p <0.05). A proportional hazards regression model was constructed to estimate the simultaneous effect of various factors on length of use. In results consistent with the bivariate analysis, women who were told to return to the clinic were 2.7 times more likely to continue using DMPA compared to women who did not receive that advice. Likewise, women who were told about the possibility of amenorrhea were 2.5 times more likely to continue using DMPA compared to those who did not receive that information. The regression model also identified new factors such as number of children, attitude toward menstruation, lactating at admission, and spousal input on method choice. The findings suggest that providers play an important role in ensuring the highest possible continuation rates for DMPA.

Adolescent↗

Continuous use of an oral contraceptive for endometriosis-associated recurrent dysmenorrhea that does not respond to a cyclic pill regimen.

OBJECTIVE: To ascertain whether long-term reduction of pain is obtained by continuous administration of an oral contraceptive (OC) in women with endometriosis-associated recurrent dysmenorrhea that does not respond to cyclic OC use. DESIGN: Prospective, therapeutic, self-controlled clinical trial. SETTING: A tertiary care and referral center for patients with endometriosis. PATIENT(S): Fifty women who underwent surgery for endometriosis in the previous year and experienced recurrent dysmenorrhea despite cyclic OC use. INTERVENTION(S): Continuous use of an OC containing ethinyl estradiol (0.02 mg) and desogestrel (0.15 mg) for 2 years. MAIN OUTCOME MEASURE(S): Dysmenorrhea variation during cyclic and continuous OC use, evaluated with a 100-mm visual analog scale and a 0- to 3-point verbal rating scale, and degree of satisfaction with continuous OC treatment. RESULT(S): In the study period, amenorrhea, spotting, and breakthrough bleeding were reported by 19 (38%), 18 (36%), and 13 (26%) women. The mean +/- SD number of >7-day bleeding episodes with consequent 7-day OC suspension was 5.5 +/- 2.1. The mean +/- SD dysmenorrhea visual analog scale and verbal rating scale scores were 75 +/- 13 and 2.4 +/- 0.5 at baseline and 31 +/- 17 and 0.7 +/- 0.6 at 2-year follow-up, respectively. Moderate or severe side effects were reported by 7/50 (14%) women. At final evaluation, 13 (26%) women were very satisfied, 27 (54%) were satisfied, 1 (2%) was uncertain, 8 (16%) were dissatisfied, and 1 (2%) was very dissatisfied. CONCLUSION(S): Long-term continuous OC use can be proposed to women with symptomatic endometriosis and menstruation-related pain symptoms.

Adult↗

Contraception with the cervical cap: effectiveness, safety, continuity of use, and user satisfaction.

With the growing interest in barrier contraceptive methods, the cervical cap has come back into use in North America. We examined the cap's effectiveness, safety, continuity of use, and user satisfaction among 617 women who were fitted at a family planning clinic in Toronto, Canada, between May 1981 and November 1983. Follow-up information was available for 516 of these women. Using a life table analysis with Bayesian adjustment, the probability of becoming pregnant after 12 months of use was 0.166 with a standard error of 0.022. There is evidence that after 1 year of use the caps deteriorate and that this deterioration may increase the risk of pregnancy. Many of the women in this study were very satisfied with the cervical cap; however, such problems as dislodgement, discomfort to user and partner, difficulty with insertion and removal, and unpleasant odour affected acceptability and continuity of use. It is likely that these problems could be alleviated by improving the quality of or changing the materials, modifying the design to improve the fit, and providing a greater range of sizes.

Adolescent↗

Continuous versus cyclic use of combined oral contraceptives for contraception: systematic Cochrane review of randomized controlled trials.

BACKGROUND: With the recent US Food and Drug Administration approval of a combination oral contraceptive that causes a withdrawal bleed every 3 months instead of monthly, avoidance of menstruation through extended or continuous administration (>28 days of active pills) of combined oral contraceptives may become more commonplace for reasons of personal preference rather than limited to treatment of menstrual-associated medical disorders. METHODS: The review aimed to compare contraceptive efficacy, compliance, continuation, satisfaction, bleeding profiles, and menstrual symptoms of combined oral contraceptives with continuous dosing (>28 days of active pills) versus traditional cyclic dosing (21 days of active pills and 7 days of placebo). We searched five computerized databases as well as reference lists of relevant articles for randomized controlled trials (RCT) using continuous or extended combined oral contraceptives for contraception. Two reviewers independently extracted data from eligible articles. RESULTS: Six RCT met inclusion criteria and were of good quality. Contraceptive efficacy and compliance were similar between groups. Discontinuation overall, and for bleeding problems, was not uniformly higher in either group. When studied, participants reported high satisfaction with both dosing regimens. Five out of the six studies found that bleeding patterns were either equivalent or improved with continuous-dosing regimens. The continuous-dosing group had greater improvement of menstrual-associated symptoms (headaches, genital irritation, tiredness, bloating, and menstrual pain). CONCLUSIONS: The variations in pill type and time-interval for continuous dosing make direct comparisons between regimens unfeasible. To allow for comparisons, future studies should choose a previously researched pill and dosing regimen. More attention needs to be directed towards participant satisfaction and menstruation-associated symptoms.

Adult↗

Nurse specialists in family planning: the results of a 3-year study.

In the first three years of a Nurse Specialist Clinic in Family Planning, 1422 new patients were seen. Oral contraception (OCs) was dispensed for 638 patients, 548 intrauterine devices (IUDs) were fitted and 126 patients received an injectable contraceptive. The continuation rate at thirty months was, 73.2 for OCs, and 68.6 for IUDs. The additional training received by the nurse specialists allowed them to practice comprehensive family planning safely and effectively, as shown by the low "problem" rate, 9.1% for OCs and 7.2% for IUDs. Continued use effectiveness, as shown by the second choice of contraception initiated in the clinic for those who stopped using their first method, was also high, 81.5% for OCs and 90.5% for IUD closures.

Contraceptive Agents↗

Study and introduction of family planning methods in developing countries.

Research in developing countries is essential for the evaluation of the safety, efficacy and acceptability of both new and already available contraceptives. Research conducted by scientists in developing countries has also played an essential role in the development of new contraceptives. The continuous delivery of progestin at a low dose, copper IUDs, contraceptive implants, monthly injectables and vaginal rings are examples of new methods developed with the input of research conducted largely in developing countries. When research in developing countries is funded or coordinated by international agencies, local scientists have to be involved not only in its implementation, but in the planning, analysis and dissemination of such research. The World Health Organization, the Population Council and Family Health International have played an important role in supporting collaborative studies for the development, introduction and evaluation of family planning methods in developing countries.

Developing Countries↗

Alternate delivery systems for contraceptive progestogens.

Research continues toward developing an universally acceptable, safe, and effective contraceptive to inhibit the female reproductive process. Progestational systems, either alone or in combination with small amounts of estrogen, approach such an ideal. The pregnane and 19-nortestosterone progestins were examined in this review with regard to contraceptive mechanisms of action and major side effects, such as menstrual abnormalities, metabolic changes, neoplasia, and teratogenicity. These steroids provide highly effective and long-acting contraception, and bypass the oral route of administration, resulting in fewer gastrointestinal and systemic side effects. Data regarding the lack of a deleterious effect of contraceptive progestogens on fetal malformation or cancer of the breast and genital tract reinforce their safety. Further study and refinement are needed, however, to lower the incidence of menstrual abnormalities, hypertension, and detrimental lipid alterations prior to approval for general use.

Abnormalities, Drug-Induced↗

First year clinical experience with six levonorgestrel rods as subdermal contraception.

Previous clinical experience with six levonorgestrel subdermal capsules showed a very good contraceptive effectiveness and continuation rate, but with a high proportion of bleeding disturbances, particularly of increased bleeding. It was hypothesized that bleeding could be reduced by higher plasma levels of the steroid, using subdermal rods instead of capsules, as rods have been shown to have a release rate 3 or 4 times that of the capsules. Fifty volunteers were enrolled in a study of the clinical performance of 6 subdermal levonorgestrel rods. Results were compared with a previous experience with 100 volunteers who wore 6 levonorgestrel capsules for a year in the same clinic. Requirement for volunteers to enter the study were the same for capsules and rods. The proportion of women wearing 6 subdermal rods who had increased bleeding was about one half as for the women using 6 levonorgestrel capsules. On the other hand, women using rods had about twice the incidence of amenhorrea, and about four times more hypomenorrhea (4 days or less of bleeding in a 90-day period). There were no pregnancies among the rod users and the discontinuation rate for medical reasons was not higher than for capsule users in the same clinic.

Adolescent↗

Hormonal contraception and physiology: a research-based theory of discontinuation due to side effects.

Side effects influence the acceptability and continuation of hormonal contraceptives. Counseling the client about the management of side effects is a principal approach advocated for increasing continuation. Evidence of a biological basis for variation in women's tolerance of hormonal contraceptives argues, however, that greater attention should be given to altering the product rather than principally attempting to alter a woman's ability to deal with the product. Discontinuation rates for hormonal contraceptives, largely attributable to side effects and health concerns, are high in nearly all less-developed countries for which Demographic and Health Survey data are available. Oral contraceptives appear to be particularly problematic for Latin American women, most notably in Bolivia. Clinical trials suggest substantial variation in the physiological response to exogenous hormones, and new evidence confirms the hypothesis that the normal hormonal profiles of Bolivian women are significantly lower than those of women in the United States. These findings suggest a need for more population-specific physiological research linked to analyses of the possible association between endogenous hormone differences and contraceptive continuation. Appropriately adjusting the level of the steroid delivered may benefit women's health and improve the acceptability and continuation of hormonal contraceptives.

Contraception Behavior↗

Preliminary analysis of a multicenter clinical trial using Multiload Cu 375SL for emergency contraception.

OBJECTIVE: To evaluate the efficacy, side-effects and acceptability of the Multiload Cu 375SL (MLCu 375SL IUD) used as emergency contraception (EC). METHOD: Women who requested EC had a MLCu 375SL IUD inserted within 5 days after unprotected intercourse. RESULTS: Data from 515 subjects who completed the follow-up visits were analyzed. The majority were parous women (428, 83.1%). Most of the nulliparous women, 70 out of 87 (80.5%), had had a previous abortion. The efficacy rate was 92.40%. Two pregnancies were detected at the follow-up visits. One of them was considered to be a user failure. There were no failures in insertion procedure or no pelvic infections in either group. The common complaints were pain and bleeding. The removal rate in the nulliparous group (14.9%) was significantly higher than in the parous group (3.5%). CONCLUSIONS: Insertion of a MLCu 375SL IUD within 5 days after unprotected intercourse provides an alternative emergency contraceptive method. It is more acceptable to parous women who plan to continue practicing contraception. It is important to provide careful counselling to clients and to emphasize that the insertion of the IUD must be within 5 days after unprotected intercourse in order to reduce the potential risk of pregnancy.

Adult↗

[An introductory clinical trial of three-monthly injectable contraceptive-depot medroxyprogesterone acetate].

OBJECTIVE: To evaluate contraceptive efficacy, continuative rate of use, side effects and acceptability of depot medroxyprogesterone acetate (DMPA) injectable contraception preparation in Chinese women. METHOD: This was an open study. One thousand nine hundred and eighty-five women acquiring contraception received DMPA injection after obtaining informed consent and were followed-up every 3-month up to one year. RESULTS: The total experience accumulated was 1,731.7 women-year with DMPA for 1,985 users. The one year continuation rate was 77.4%. Three subjects became pregnant, the one year accumulative life table failure rate was 0.2%. The accumulative discontinuation rates at one year for other reasons were amenorrhoea (4.8%), bleeding related (13.4%), other medical reasons (2.6%), other personal reasons (2.1%) and lost to follow-up (1.6%). The main complaints were irregular bleeding, amenorrhoea and prolonged bleeding. Lactating women had significantly lower rate of complaint. CONCLUSION: DMPA is a highly effective long-acting contraceptive, it could have good acceptability, especially for lactating women, under the well consultation.

Adolescent↗

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↗

Compliance with depot medroxyprogesterone acetate: a randomized, controlled trial of intensive reminders.

We enrolled women in a prospective, randomized study to determine whether an intensive reminder system would improve compliance in women receiving depot medroxyprogesterone injections. Women selecting this treatment were assigned to a group that received both mail and telephone reminders or to a second group that received only a scheduled appointment at the time of the previous injection. The rate of continuation and the rate of on-time injections did not differ between groups. Women who had prolonged bleeding were more likely to discontinue depot medroxyprogesterone injections.

Adult↗

A multicenter randomized comparative investigation of ML Cu250, TCu-220C and Cu7 IUDs.

The final analysis of 1725 interval insertions of the 3 IUDs is presented. The earlier observations were confirmed at: at 24 months, no significant differences were found between the TCu-220C and ML Cu250 IUDs though the TCu-220C had a lower gross pregnancy rate (2.0 versus 2.9) and the ML Cu250 had a lower expulsion rate (2.3 versus 4.1). Expulsions were more common with the Cu7 when compared to the ML Cu250 (p 0.001) and T-220C (p 0.01); pregnancy rates were also higher with p values of 0.05 and 0.01 respectively. Other use-related terminations were not significantly different among the 3 IUDs and continuation rates at 24 months were: Cu7, 69, TCu-220C, 73, and ML Cu250, 74.

Birth Rate↗