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

Evaluation of the London Measure of Unplanned Pregnancy in a United States population of women

Copyright @ 2012 Morof et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Objective: To evaluate the reliability and validity of the London Measure of Unplanned Pregnancy (a U.K.-developed measure of pregnancy intention), in English and Spanish translation, in a U.S. population of women. Methods: A psychometric evaluation study of the London Measure of Unplanned Pregnancy (LMUP), a six-item, self-completion paper measure was conducted with 346 women aged 15–45 who presented to San Francisco General Hospital for termination of pregnancy or antenatal care. Analyses of the two language versions were carried out separately. Reliability (internal consistency) was assessed using Cronbach’s alpha and item-total correlations. Test-retest reliability (stability) was assessed using weighted Kappa. Construct validity was assessed using principal components analysis and hypothesis testing. Results: Psychometric testing demonstrated that the LMUP was reliable and valid in both U.S. English (alpha = 0.78, all item-total correlations .0.20, weighted Kappa = 0.72, unidimensionality confirmed, hypotheses met) and Spanish translation (alpha = 0.84, all item-total correlations .0.20, weighted Kappa = 0.77, unidimensionality confirmed, hypotheses met). Conclusion: The LMUP was reliable and valid in U.S. English and Spanish translation and therefore may now be used with U.S. women.The study was funded by an anonymous donation

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

Efficacy of the 1-year (13-cycle) segesterone acetate and ethinylestradiol contraceptive vaginal system : results of two multicentre, open-label, single-arm, phase 3 trials

A ring-shaped, contraceptive vaginal system designed to last 1 year (13 cycles) delivers an average of 0.15 mg segesterone acetate and 0.013 mg ethinylestradiol per day. We evaluated the efficacy of this contraceptive vaginal system and return to menses or pregnancy after use. In two identically designed, multicentre, open-label, single-arm, phase 3 trials (one at 15 US academic and community sites and one at 12 US and international academic and community sites), participants followed a 21-days-in, 7-days-out segesterone acetate and ethinylestradiol contraceptive vaginal system schedule for up to 13 cycles. Participants were healthy, sexually active, non-pregnant, non-sterilised women aged 18-40 years. Women were cautioned that any removals during the 21 days of cyclic use should not exceed 2 h, and used daily paper diaries to record vaginal system use. Consistent with regulatory requirements for contraceptives, we calculated the Pearl Index for women aged 35 years and younger, excluding adjunctive contraception cycles, as the primary efficacy outcome measure. We also did intention-to-treat Kaplan-Meier life table analyses and followed up women who did not use hormonal contraceptives or desired pregnancy after study completion for 6 months for return to menses or pregnancy. The trials are registered with ClinicalTrials.gov, numbers NCT00455156 and NCT00263341. Between Dec 19, 2006, and Oct 9, 2009, at the 15 US sites, and between Nov 1, 2006, and July 2, 2009, at the 12 US and international sites we enrolled 2278 women. Our overall efficacy analysis included 2265 participants (1130 in the US study and 1135 in the international study) and 1303 (57.5%) participants completed up to 13 cycles. The Pearl Index for the primary efficacy group was 2.98 (95% CI 2.13-4.06) per 100 woman-years, and was well within the range indicative of efficacy for a contraceptive under a woman's control. The Kaplan-Meier analysis revealed the contraceptive vaginal system was 97.5% effective, which provided further evidence of efficacy. Pregnancy occurrence was similar across cycles. All 290 follow-up participants reported return to menses or became pregnant (24 [63%] of 38 women who desired pregnancy) within 6 months. Interpretation The segesterone acetate and ethinylestradiol contraceptive vaginal system is an effective contraceptive for 13 consecutive cycles of use. This new product adds to the contraceptive method mix and the 1-year duration of use means that women do not need to return to the clinic or pharmacy for refills every few months78e1054e1064We thank The Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health (NICHD), the US Agency for International Development (USAID), and WHO for funding the phase 3 studies. We also acknowledge all participating study investigators (appendix p 1) and coordinators at the 27 clinical sites for conduct of the two phase 3 clinical trials and the over 2200 women participants from eight countries. We further acknowledge the medical writing assistance of Kathleen Ohleth (Precise Publications; Bedminster. NJ, USA) supported by TherapeuticsMD (Boca Raton, FL, USA). The NICHD (contract no HHSN27500403372) funded and conducted the US study and USAID (grant no GPO-A-00-04-00019-00) funded the international study, which was conducted by the Population Council. WHO Department of Reproductive Health and Research funded two international study sites. Medical writing support for manuscript submission and resubmission was supported by TherapeuticsMD. The authors acknowledge the major contribution of Daniel R Mishell Jr (deceased), from the Department of Obstetrics and Gynecology, University of Southern California, Keck School of Medicine (Los Angeles, CA, USA) who invented the concept of the vaginal system to deliver contraceptive steroids, did many of the clinical studies for the segesterone acetate and ethinylestradiol contraceptive vaginal system, and was a principle investigator for the 300 B phase 3 study analysed in this Article while a member of the International Committee for Contraceptive Research (ICCR) of the Population Council. The authors also gratefully acknowledge the contribution of Horacio B Croxatto, from the University of Chile (Santiago, Chile), who established the clinical centre in Chile, participated in all pivotal clinical studies for this ring, and provided guidance for the full development of this new contraceptive while a member of the ICC

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?

Pedoman klinis kontrasepsi

Buku ini dipersembahkan bagi seluruh profesional perawatan kesehatan yang mengemban tanggung jawab sosial dalam membantu para pasangan menggunakan kontrasepsi secara aman dan efektif.viii, 412 hlm.: ilus.; 24 c

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. L

Documentation of Contraception and Pregnancy Intention In Medicaid Managed Care

Context: Clinical guidelines recommend the documentation of pregnancy intention and family planning needs during primary care visits. Prior to the 2014 Medicaid expansion and release of these guidelines, the documentation practices of Medicaid managed care providers are unknown. Methods: We performed a chart review of 1054 Medicaid managed care visits of women aged 13 to 49 to explore client, provider, and visit characteristics associated with documentation of immediate or future plans for having children and contraceptive method use. Five managed care plans used Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes to identify providers with at least 15 women who had received family planning or well-woman care in 2013. We conducted multilevel logistic regression analyses with documentation of contraceptive method and pregnancy intention as outcome variables and clinic site as the level 2 random effect. Results: Only 12% of charts had documentation of pregnancy intention and 59% documented contraceptive use. Compared to women with a family planning visit reason, women with an annual, reproductive health, or primary care reason for their visit were significantly less likely to have contraception documented (odds ratio [OR] = 11.0; 95% confidence interval [CI] = 6.8-17.7). Age was also a significant predictor with women aged 30 to 49 (OR = 0.6; 95% CI = 0.4-0.9), and women aged 13 to 19 (OR = 0.2; 95% CI = 0.1-0.6) being less likely to have a note about pregnancy intention in their chart. Pregnancy intention was more likely to be documented in multispecialty clinics (OR = 15.5; 95% CI = 2.7-89.2). Conclusions: Interventions to improve routine medical record documentation of contraception and pregnancy intention regardless of patient age and visit characteristics are needed to facilitate the provision of family planning in managed care visits and, ultimately, achieving better maternal infant health outcomes and reduced costs

Documentation of Contraception and Pregnancy Intention In Medicaid Managed Care

Context: Clinical guidelines recommend the documentation of pregnancy intention and family planning needs during primary care visits. Prior to the 2014 Medicaid expansion and release of these guidelines, the documentation practices of Medicaid managed care providers are unknown. Methods: We performed a chart review of 1054 Medicaid managed care visits of women aged 13 to 49 to explore client, provider, and visit characteristics associated with documentation of immediate or future plans for having children and contraceptive method use. Five managed care plans used Current Procedural Terminology and International Classification of Diseases, Ninth Revision codes to identify providers with at least 15 women who had received family planning or well-woman care in 2013. We conducted multilevel logistic regression analyses with documentation of contraceptive method and pregnancy intention as outcome variables and clinic site as the level 2 random effect. Results: Only 12% of charts had documentation of pregnancy intention and 59% documented contraceptive use. Compared to women with a family planning visit reason, women with an annual, reproductive health, or primary care reason for their visit were significantly less likely to have contraception documented (odds ratio [OR] = 11.0; 95% confidence interval [CI] = 6.8-17.7). Age was also a significant predictor with women aged 30 to 49 (OR = 0.6; 95% CI = 0.4-0.9), and women aged 13 to 19 (OR = 0.2; 95% CI = 0.1-0.6) being less likely to have a note about pregnancy intention in their chart. Pregnancy intention was more likely to be documented in multispecialty clinics (OR = 15.5; 95% CI = 2.7-89.2). Conclusions: Interventions to improve routine medical record documentation of contraception and pregnancy intention regardless of patient age and visit characteristics are needed to facilitate the provision of family planning in managed care visits and, ultimately, achieving better maternal infant health outcomes and reduced costs