Ayşe Akın

Extended use up to 5 years of the etonogestrel-releasing subdermal contraceptive implant: comparison to levonorgestrel-releasing subdermal implant

STUDY QUESTION Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? SUMMARY ANSWER The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. WHAT IS KNOWN ALREADY The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy. The ENG-implant has both well established safety and efficacy for up to 3 years. Pharmacokinetic data on ENG show high levels at 3 years and some previous clinical research confirms efficacy beyond the current approved duration of 3 years. Today, many women, because the labeled duration has been reached, have the ENG implant removed at 3 years, increasing costs, inconvenience and risks. STUDY DESIGN SIZE, DURATION For the first 3 years, this study was an open-label, multi-centre randomized trial comparing the 3-year ENG implant to the 5-year levonorgestrel (LNG)-releasing implant. After 3 years, a subset of 390 ENG participants, consented to extended use. We compared efficacy, side effects and removal procedures of both implants. We used Kaplan–Meier (K–M) analysis. We included an observational cohort of copper intrauterine device (IUD) users as non-users of hormonal contraceptive method for comparative purposes. PARTICIPANTS/MATERIALS, SETTING, METHODS The study took place in family planning clinics in seven countries worldwide. Women were enlisted after an eligibility check and informed consent, and 1328 women were enrolled: 390, 522 and 416 in the ENG-implant, LNG-implant and IUD groups, respectively. MAIN RESULTS AND THE ROLE OF CHANCE Over 200 women used the ENG implant for at least 5 years. No pregnancies occurred during the additional 2 years of follow up in the ENG or LNG implant group. The overall 5-year K–M cumulative pregnancy rates for ENG- and LNG- implants were 0.6 per 100 women-years (W-Y) [95% confidence interval (CI): 0.2–1.8] and 0.8 per 100 W-Y [95% CI: 0.2–2.3], respectively. Complaints of bleeding changes were similar; however, ENG-users were more likely than LNG-users to experience heavy bleeding (p < 0.05). The median duration of the implant removal procedure was 64 seconds shorter for the one-rod ENG-implant (inter-quartile range (IQR) = 30.5, 117.5) compared to the two-rod LNG product (IQR = 77.0, 180.0). The 2-year rate for pregnancy in the IUD group compared with the two implant groups combined was 4.1 per 100 W-Y [95% CI: 2.5–6.5]. LIMITATIONS, REASONS FOR CAUTION Few women were ≤19 years old or nulligravida. Although there was no weight limit for enrolment in the study, the number of women ≥70 kg were few. WIDER IMPLICATIONS OF THE FINDINGS The results from this study corroborate previous evidence showing high contraceptive efficacy through 4 years for the ENG-implant. Data through 5 years are a novel contribution and further proof of the products capability to provide safe and effective contraception that rivals the current 5-year LNG-subdermal implant. The findings provide valuable information for policy makers, family planning programmers and clinicians that the ENG-releasing subdermal implant is still highly effective up to 5 years after insertion. Compared to previous efforts, our study population was geographically diverse and our study had the highest number of participants completing at least 5 years of use. TRIAL REGISTRATION The trial was registered as ISRCTN33378571. STUDY FUNDING/COMPETING INTEREST(S) The contraceptive devices and funds for conduct of the study were provided by the United Nations Development Programme/United Nations Population Fund/World Health Organization (WHO)/UNICEF/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), WHO. This report contains the collective views of an international group of experts, and does not necessarily represent the decisions or the stated policy of the WHO. All stated authors have no conflict of interest, except Dr Hubacher who reported grants from United States Agency for International Development, during the conduct of the study; other from Advisory Boards (Teva, Bayer, OCON), outside the submitted work.

The unmet need for safe abortion in Turkey: a role for medical abortion and training of medical students

Abstract Abortion has been legal and safe in Turkey since 1983, but the unmet need for safe abortion services remains high. Many medical practitioners believe that the introduction of medical abortion would address this. However, since 2012 there has been political opposition to the provision of abortion services. The government has been threatening to restrict the law, and following an administrative change in booking of appointments, some hospital clinics that provided family planning and abortion services had to stop providing abortions. Thus, the availability of safe abortion depends not only on permissive legislation but also political support and the ability of health professionals to provide it. We conducted a study among university medical school students in three provinces on their knowledge of abortion and abortion methods, to try to understand their future practice intentions. Pre-tested, structured, self-administered questionnaires were answered by 209 final-year medical students. The students’ level of knowledge of abortion and abortion methods was very low. More than three-quarters had heard of surgical abortion, but only 56% mentioned medical abortion. Although nearly 90% supported making abortion services available in Turkey, their willingness to provide surgical abortion (16%) or medical abortion (15%) was low, due to lack of knowledge. Abortion care, including medical abortion, needs to be included in the medical school curriculum in order to safeguard this women’s health service. Résumé L’avortement est légal et sûr en Turquie depuis 1983, mais les besoins non satisfaits en services d’avortement sûr demeurent élevés. Beaucoup de praticiens pensent que l’introduction de l’avortement médicamenteux pourrait y répondre. Néanmoins, depuis 2012, les services d’avortement suscitent une opposition politique. Le Gouvernement a menacé de restreindre la législation et, après un changement administratif dans la prise des rendez-vous, certains centres hospitaliers assurant des services de planification familiale et d’avortement ont dû cesser de pratiquer des avortements. La disponibilité d’avortements sûrs dépend donc non seulement d’une législation permissive, mais aussi du soutien politique et de la capacité des professionnels de santé à les pratiquer. Nous avons étudié les connaissances sur l’avortement et les méthodes d’avortement d’étudiants en médecine dans trois provinces, pour tenter de comprendre leurs intentions quant à leur future pratique. 209 étudiants en médecine de dernière année ont répondu à des questionnaires structurés testés au préalable et autoadministrés. Les étudiants connaissaient très mal l’avortement et les méthodes d’avortement. Plus des trois quarts avaient entendu parler de l’avortement chirurgical, mais 56% seulement ont mentionné l’avortement médicamenteux. Même si près de 90% soutenaient la disponibilité des services d’avortement en Turquie, ils étaient peu disposés à pratiquer l’avortement chirurgical (16%) ou médicamenteux (15%), en raison d’un manque de connaissances. L’avortement, notamment médicamenteux, doit être inclus dans le programme des études de médecine afin de garantir ce service de santé des femmes. Resumen En Turquía, el aborto es legal y seguro desde 1983, pero aún hay una gran necesidad insatisfecha de servicios de aborto seguro. Muchos profesionales médicos creen que la introducción de servicios de aborto con medicamentos resolvería esta situación. Sin embargo, desde 2012 ha habido oposición política a la prestación de servicios de aborto. El gobierno ha estado amenazando con restringir la ley y, tras un cambio administrativo en la programación de citas, algunas clínicas hospitalarias que ofrecían servicios de planificación familiar y aborto tuvieron que dejar de realizar abortos. Por tanto, la disponibilidad de servicios de aborto seguro depende no solo de una legislación permisiva sino también del apoyo político y de la capacidad de los profesionales de la salud para proporcionarlos. Realizamos un estudio entre estudiantes de facultades de medicina en tres provincias, acerca de su conocimiento del aborto y los métodos de aborto, con el fin de entender sus intenciones de ejercer su futura profesión. Cuestionarios estructurados, autoadministrados y pre-piloteados fueron contestados por 209 estudiantes de medicina en su último año. Su nivel de conocimiento del aborto y los métodos de aborto era muy bajo. Más de tres cuartas partes habían oído hablar del aborto quirúrgico, pero solo el 56% mencionó el aborto con medicamentos. Aunque casi un 90% apoyó hacer los servicios de aborto disponibles en Turquía, pocos estaban dispuestos a proporcionar servicios de aborto quirúrgico (16%) o aborto con medicamentos (15%), debido a la falta de conocimiento. Los servicios de aborto, que incluyen el aborto con medicamentos, deben integrarse en el currículo de las facultades de medicina a fin de salvaguardar este servicio de salud de las mujeres.

Introducing medical abortion in Turkey: Perspectives of physicians

To better understand the knowledge, attitudes, and perspectives on medical abortion (MA) held by physicians in Turkey.