Non-contraceptive applications of the levonorgestrel intrauterine system

Intrauterine progestins have many important current and potential gynecologic applications. This article describes the evidence for use of intrauterine progestin for common gynecologic conditions beyond its important role in contraception. The pharmacology of and selection criteria for use of the levonorgestrel intrauterine device is discussed, and the evidence for use of intrauterine progestin delivery for menorrhagia, endometriosis management, uterine fibroids, adenomyosis and endometrial hyperplasia is reviewed

“Sometimes they used to whisper in our ears”: health care workers’ perceptions of the effects of abortion legalization in Nepal

BACKGROUND: Unsafe abortion has been a significant cause of maternal morbidity and mortality in Nepal. Since legalization in 2002, more than 1,200 providers have been trained and 487 sites have been certified for the provision of safe abortion services. Little is known about health care workers’ views on abortion legalization, such as their perceptions of women seeking abortion and the implications of legalization for abortion-related health care. METHODS: To complement a quantitative study of the health effects of abortion legalization in Nepal, we conducted 35 in-depth interviews with physicians, nurses, counsellors and hospital administrators involved in abortion care and post-abortion complication treatment services at four major government hospitals. Thematic analysis techniques were used to analyze the data. RESULTS: Overall, participants had positive views of abortion legalization – many believed the severity of abortion complications had declined, contributing to lower maternal mortality and morbidity in the country. A number of participants indicated that the proportion of women obtaining abortion services from approved health facilities was increasing; however, others noted an increase in the number of women using unregulated medicines for abortion, contributing to rising complications. Some providers held negative judgments about abortion patients, including their reasons for abortion. Unmarried women were subject to especially strong negative perceptions. A few of the health workers felt that the law change was encouraging unmarried sexual activity and carelessness around pregnancy prevention and abortion, and that repeat abortion was becoming a problem. Many providers believed that although patients were less fearful than before legalization, they remained hesitant to disclose a history of induced abortion for fear of judgment or mistreatment. CONCLUSIONS: Providers were generally positive about the implications of abortion legalization for the country and for women. A focus on family planning and post-abortion counselling may be welcomed by providers concerned about multiple abortions. Some of the negative judgments of women held by providers could be tempered through values-clarification training, so that women are supported and comfortable sharing their abortion history, improving the quality of post-abortion treatment of complications

The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience

ObjectiveThe objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP).Study designUS health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA.ResultsAmong 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal.ConclusionEvents related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant.ImplicationsThis report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide

Environmental and Molecular Mutagenesis Meeting Report Assessing Human Germ-Cell Mutagenesis in the Post-Genome Era: A Celebration of the Legacy of William Lawson (Bill) Russell

ABSTRACT Although numerous germ-cell mutagens have been identified in animal model systems, to date, no human germ-cell mutagens have been confirmed. Because the genomic integrity of our germ cells is essential for the continuation of the human species, a resolution of this enduring conundrum is needed. To facilitate such a resolution, we organized a workshop at The Jackson Laboratory in Bar Harbor, Maine on September [28][29][30] 2004. This interactive workshop brought together scientists from a wide range of disciplines to assess the applicability of emerging molecular methods for genomic analysis to the field of human germ-cell mutagenesis. Participants recommended that focused, coordinated human germ-cell mutation studies be conducted in relation to important societal exposures. Because cancer survivors represent a unique cohort with well-defined exposures, there was a consensus that studies should be designed to assess the mutational impact on children born to parents who had received certain types of mutagenic cancer chemotherapy prior to conceiving their children. Within this high-risk cohort, parents and children could be evaluated for inherited changes in (a) gene sequences and chromosomal structure, (b) repeat sequences and minisatellite regions, and (c) global gene expression and chromatin. Participants also recommended studies to examine trans-generational effects in humans involving mechanisms such as changes in imprinting and methylation patterns, expansion of nucleotide repeats, or induction of mitochondrial DNA mutations. Workshop participants advocated establishment of a bio-bank of human tissue samples that could be used to conduct a multiple-endpoint, comprehensive, and collaborative effort to detect exposure-induced heritable alterations in the human genome. Appropriate animal models of human germ-cell mutagenesis should be used in parallel with human studies to provide insights into the mechanisms of mammalian germ-cell mutagenesis. Finally, participants recommended that 4 scientific specialty groups be convened to address specific questions regarding the potential germ-cell mutagenicity of environmental, occupational, and lifestyle exposures. Strong support from relevant funding agencies and engagement of scientists outside the fields of genomics and germ-cell mutagenesis will be required to launch a full-scale assault on some of the most pressing and enduring questions in environmental mutagenesis: Do human germ-cell mutagens exist, what risk do they pose to future generations, and are some parents at higher risk than others for acquiring and transmitting germ-cell mutations?

Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use.

OBJECTIVE:The objective was to evaluate amenorrhea patterns and predictors of amenorrhea during the first year after levonorgestrel 52 mg intrauterine system (IUS) placement. STUDY DESIGN:This cohort analysis includes 1714 nulliparous and parous women who received a Liletta® levonorgestrel 52 mg IUS in a multicenter trial to evaluate efficacy and safety for up to 8 years. Participants maintained a daily diary with bleeding information. We assessed bleeding patterns in 90-day intervals; amenorrhea was defined as no bleeding or spotting in the preceding 90 days. We employed multivariable regression to identify predictors of amenorrhea at 12 months. The predictor analysis only included women not using a levonorgestrel IUS in the month prior to study enrollment. RESULTS:In the month before enrollment, 148 and 1566 women, respectively, had used and not used a levonorgestrel IUS. Prior users averaged 50±19 months of use before IUS placement; 38.4% of these women reported amenorrhea at 12 months. Amenorrhea rates for non-prior-users at 3, 6, 9 and 12 months were 0.2%, 9.1%, 17.2% and 16.9%, respectively. During the first 12 months, 29 (1.7%) women discontinued for bleeding irregularities; no women discontinued for amenorrhea. The only significant predictor of amenorrhea at 12 months was self-reported baseline duration of menstrual flow of fewer than 7 days vs. 7 or more days (18.2% vs. 5.2%, adjusted odds ratio 3.70 [1.69, 8.07]). We found no relationships between 12-month amenorrhea rates and age, parity, race, body mass index, baseline flow intensity or hormonal contraception use immediately prior to IUS placement. CONCLUSIONS:Amenorrhea rates during the first year of levonorgestrel 52 mg IUS use are similar at 9 and 12 months. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow. IMPLICATIONS STATEMENT:This information provides more data for clinicians when counseling women about amenorrhea expectations, especially since women seeking a levonorgestrel 52 mg IUS for contraception are different than women desiring treatment for heavy menstrual bleeding. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow

Onsite provision of specialized contraceptive services: does Title X funding enhance access?

BACKGROUND: This article presents the extent to which providers enrolled in California's Family Planning, Access, Care, and Treatment (Family PACT) program offer contraceptive methods onsite, thus eliminating one important access barrier. Family PACT has a diverse provider network, including public-sector providers receiving Title X funding, public-sector providers not receiving Title X funding, and private-sector providers. We explored whether Title X funding enhances providers' ability to offer contraceptive methods that require specialized skills onsite. METHODS: Data were derived from 1,072 survey responses to a 2010 provider-capacity survey matched by unique identifier to administrative claims data. RESULTS: A significantly greater proportion of Title X-funded providers compared to non-Title X public and private providers offered onsite services for the following studied methods: intrauterine contraceptives (90% Title X, 51% public non-Title X, 38% private); contraceptive implants (58% Title X, 19% public non-Title X, 7% private); vasectomy (8% Title X, 4% public non-Title X, 1% private); and fertility-awareness methods (69% Title X, 55% public non-Title X, 49% private) (all p<0.0001). The association between onsite provision and Title X funding remained after stratifying individually by clinic specialty, facility capacity to provide reproductive health services (based on staffing), and rural/urban location. CONCLUSIONS: Extra funding for publicly funded family-planning programs, through mechanisms such as Title X, appears to be associated with increased onsite access to a wide range of contraceptive services, including those that require special skills and training

Amenorrhea rates and predictors during 1 year of levonorgestrel 52 mg intrauterine system use.

OBJECTIVE:The objective was to evaluate amenorrhea patterns and predictors of amenorrhea during the first year after levonorgestrel 52 mg intrauterine system (IUS) placement. STUDY DESIGN:This cohort analysis includes 1714 nulliparous and parous women who received a Liletta® levonorgestrel 52 mg IUS in a multicenter trial to evaluate efficacy and safety for up to 8 years. Participants maintained a daily diary with bleeding information. We assessed bleeding patterns in 90-day intervals; amenorrhea was defined as no bleeding or spotting in the preceding 90 days. We employed multivariable regression to identify predictors of amenorrhea at 12 months. The predictor analysis only included women not using a levonorgestrel IUS in the month prior to study enrollment. RESULTS:In the month before enrollment, 148 and 1566 women, respectively, had used and not used a levonorgestrel IUS. Prior users averaged 50±19 months of use before IUS placement; 38.4% of these women reported amenorrhea at 12 months. Amenorrhea rates for non-prior-users at 3, 6, 9 and 12 months were 0.2%, 9.1%, 17.2% and 16.9%, respectively. During the first 12 months, 29 (1.7%) women discontinued for bleeding irregularities; no women discontinued for amenorrhea. The only significant predictor of amenorrhea at 12 months was self-reported baseline duration of menstrual flow of fewer than 7 days vs. 7 or more days (18.2% vs. 5.2%, adjusted odds ratio 3.70 [1.69, 8.07]). We found no relationships between 12-month amenorrhea rates and age, parity, race, body mass index, baseline flow intensity or hormonal contraception use immediately prior to IUS placement. CONCLUSIONS:Amenorrhea rates during the first year of levonorgestrel 52 mg IUS use are similar at 9 and 12 months. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow. IMPLICATIONS STATEMENT:This information provides more data for clinicians when counseling women about amenorrhea expectations, especially since women seeking a levonorgestrel 52 mg IUS for contraception are different than women desiring treatment for heavy menstrual bleeding. Amenorrhea at 12 months is most common among women with shorter baseline duration of menstrual flow

Cost-savings from the provision of specific contraceptive methods in 2009.

BackgroundPrevious studies have shown that contraceptive provision generates significant public sector cost-savings by preventing health care and social service expenditures on unintended pregnancies. Over the past decade, women's contraceptive options have expanded considerably, calling for the need to better understand the relative cost-benefit of new contraceptive methods.MethodsWe estimated the number of pregnancies averted by each specific contraceptive method by subtracting the total number of pregnancies expected under Family PACT from the total number of pregnancies that would be expected if the program were not available. The cost of providing each method was compared with the savings in reduced public expenditures from averted pregnancies. A resultant cost-benefit ratio was calculated for 11 specific contraceptive methods provided to women under Family PACT.ResultsEvery contraceptive method studied saved more in public expenditures for unintended pregnancy than it costs to provide. Over half (51%) of the pregnancies averted in 2009 were attributable to the most commonly used method, oral contraceptives. Injectable methods accounted for 13% of averted pregnancies, followed by intrauterine contraceptives (12%), and barrier methods (9%). Intrauterine contraception and contraceptive implants had the highest cost-savings with approximately $5.00 of savings for every dollar spent for users of these methods.ConclusionsBecause no single method is recommended clinically for every woman, it is medically and fiscally advisable to offer women all contraceptive methods to enable them to choose methods that best meet their needs, increasing the likelihood of compliance with the method chosen and prevention of unintended pregnancies