OBJECTIVES:To update a 2016 review and answer three questions: (1) Among women using an intrauterine device (IUD), does breastfeeding increase the risk of adverse events? (2) Among breastfeeding women, does IUD use increase the risk of adverse events? (3) Among breastfeeding women, does copper (Cu)-IUD use increase risk of adverse breastfeeding or infant outcomes? METHODS:We searched multiple databases from inception to August 2023. We extracted prespecified data and assessed risk of bias (RoB) for each article and certainty of evidence for each outcome. RESULTS:Thirty-eight articles met the inclusion criteria; 16 were newly identified since the previous review, most with high RoB. Evidence suggested no effect of breastfeeding on IUD-related adverse events (ie, expulsion, bleeding, pain and infection) compared with not breastfeeding; however, an increased relative risk of perforation was observed with breastfeeding at the time of IUD insertion compared with not breastfeeding. For perforation, relative measures of association ranged from 1.4 to 10.1, and absolute rates varied (eg, 0.6-7% or 6.8 per 1000). Evidence suggested no effect of IUD use on risk of adverse events (ie, bleeding, pain and infection) among breastfeeding women compared with no IUD use. Evidence suggested no effect of Cu-IUD use on breastfeeding or infant outcomes among breastfeeding women compared with no Cu-IUD use. CONCLUSIONS:We continued to find an increased relative risk of IUD perforation among breastfeeding women compared with no breastfeeding; however, the absolute risk is low. No other adverse effects with IUD use and breastfeeding were observed. The certainty of evidence for all outcomes was very low.

OBJECTIVES:To systematically review literature on management of bleeding irregularities during contraceptive implant use. STUDY DESIGN:We searched multiple databases through November 2022 for randomized clinical trials assessing treatment of bleeding irregularities during implant use. Primary outcomes were changes in bleeding irregularities during and after treatment and patient satisfaction. We extracted data and assessed risk of bias for each included study, narratively summarized results, and determined certainty of evidence for primary outcomes. RESULTS:Twenty-one articles met inclusion criteria. Risk of bias ranged from high to low. Trials examining some non-steroidal anti-inflammatory drugs (celecoxib and mefenamic acid), tamoxifen, and ulipristal acetate (UPA) generally showed improved bleeding patterns during and after treatment compared with placebo, while ibuprofen trials showed no improvements during treatment and inconsistent results after treatment. Trials of tranexamic acid, some hormonal treatments [oral ethinyl estradiol (EE; 50 mcg), combined oral contraceptives], and mifepristone with EE or doxycycline showed improved bleeding patterns only during treatment. Mifepristone alone, doxycycline alone or with EE, oral EE (20 mcg), transdermal estradiol patch, oral levonorgestrel, aspirin, and vitamin E were not consistently effective during or after treatment. Six trials measured patient satisfaction and found improved satisfaction with bleeding patterns for tamoxifen and UPA, and improved satisfaction with treatment for celecoxib, tamoxifen, and mifepristone. CONCLUSIONS:Across the different interventions assessed, certainty of evidence ranged from high to very low. The evidence summarized in this systematic review can help providers counsel patients about interventions to improve bleeding irregularities with contraceptive implant use, depending on patient preferences and goals. IMPLICATIONS:Patients experiencing bothersome bleeding irregularities during contraceptive implant use may be offered different options to manage bleeding and improve their satisfaction. More data are needed on the effectiveness of specific interventions (drugs, regimens, and repeat dosing) and patient satisfaction outcomes.

OBJECTIVE:To identify and synthesize original research on contraceptive user values, preferences, views, and concerns about specific family planning methods, as well as perspectives from health workers. STUDY DESIGN:We conducted a systematic review of global contraceptive user values and preferences. We searched 10 electronic databases for qualitative and quantitative studies published from 2005 to 2020 and extracted data in duplicate using standard forms. RESULTS:Overall, 423 original research articles from 93 countries among various groups of end-users and health workers in all 6 World Health Organization regions and all 4 World Bank income classification categories met inclusion criteria. Of these, 250 (59%) articles were from high-income countries, mostly from the United States of America (n = 139), the United Kingdom (n = 29), and Australia (n = 23). Quantitative methods were used in 269 articles, most often cross-sectional surveys (n = 190). Qualitative interviews were used in 116 articles and focus group discussions in 69 articles. The most commonly reported themes included side effects, effectiveness, and ease/frequency/duration of use. Interference in sex and partner relations, menstrual effects, reversibility, counseling/interactions with health workers, cost/availability, autonomy, and discreet use were also important. Users generally reported satisfaction with (and more accurate knowledge about) the methods they were using. CONCLUSIONS:Contraceptive users have diverse values and preferences, although there is consistency in core themes across settings. Despite the large body of literature identified and relevance to person-centered care, varied reporting of findings limited robust synthesis and quantification of the review results.

Introduction: The transition from paper to digital systems requires quality assurance of the underlying content and application of data standards for interoperability. The World Health Organization (WHO) developed digital adaptation kits (DAKs) as an operational and software-neutral mechanism to translate WHO guidelines into a standardized format that can be more easily incorporated into digital systems. Methods: WHO convened health program area and digital leads, reviewed existing approaches for requirements gathering, mapped to established standards, and incorporated research findings to define DAK components. Results: For each health domain area, the DAKs distill WHO guidelines to specify the health interventions, personas, user scenarios, business process workflows, core data elements mapped to terminology codes, decision-support logic, program indicators, and functional and nonfunctional requirements. Discussion: DAKs aim to catalyze quality of care and facilitate data use and interoperability as part of WHO's vision of SMART (Standards-based, Machine-readable, Adaptive, Requirementsbased, and Testable) guidelines. Efforts will be needed to strengthen a collaborative approach for the uptake of DAKs within the local digital ecosystem and national health policies.

OBJECTIVE:We sought to systematically review the literature on health workers' values and preferences related to contraceptive methods.STUDY DESIGN:As part of a larger review, we searched ten electronic databases for published articles from January 1, 2005 through July 27, 2020. We included studies that reported qualitative or quantitative data from the perspective of health workers providing family planning services globally.RESULTS:Forty-one studies met our inclusion criteria. These studies included 12,643 health workers and were conducted in 27 countries. Health worker values and preferences for contraceptive methods were affected by factors related to contraceptive method characteristics (e.g., bleeding pattern and convenience), the contraceptive user (e.g., medical history, parity), and the health worker themselves (e.g., training, environment). Differences were also noted between various professions/specialties (e.g., comfort level with contraceptive methods, depth of experience). While contraceptive counseling and provision were influenced by health worker values and preferences, they were also affected by health worker misconceptions and biases.CONCLUSION:Health worker values and preferences for contraception are affected by the client's history, medical eligibility, and the health worker context. Provision of contraception that is affected by harmful bias towards certain populations or about certain methods can negatively affect patient-centered care. Future work should address knowledge gaps and health worker biases by improving and standardizing education and training globally, to ensure high-quality, rights-based, and patient-centered contraceptive services.

There is limited information on contraceptive values and preferences of sex workers. We conducted a mixed-method study to explore contraceptive values and preferences among sex workers. We conducted an online survey with individuals from 38 countries (n = 239), 6 focus group discussions (FGD, n = 68) in Zimbabwe, and 12 in-depth phone interviews (IDI) across 4 world regions, in June and July of 2019. Participants were asked about awareness of contraceptives, methods they had used in the past, and the determinants of their choices. Differences between respondents from high-, low- and middle- income countries were examined. Qualitative data were analysed thematically. Survey participants reported an awareness of modern contraceptive methods. FGDs found that younger women had lower awareness. Reports of condomless sex were common and modern contraceptive use was inconsistent. Determinants of contraceptive choices differed by setting according to results of the survey, FGD, and IDI. Regardless of country income level, determinants of contraceptive choices included ease of use, ease of access to a contraceptive method, and fewer side effects. Healthcare provider attitudes, availability of methods, and clinic schedules were important considerations. Most sex workers are aware of contraceptives, but barriers include male partners/clients, side effects, and health system factors such as access and clinic attitudes towards sex workers.

To assess the feasibility, functionality and acceptability of a mobile application (app), the World Health Organization (WHO) Postpartum Family Planning (PPFP) Compendium, in clinical care.

Among the 1.9 billion women of reproductive age worldwide in 2019, 1.1 billion need family planning and 270 million have an unmet need for contraception. For women and adolescent girls living with human immunodeficiency virus (HIV), using effective contraception reduces the mother-to-child transmission of HIV by preventing unintended pregnancies and enabling the planning and safer conception of desired pregnancies with optimal maternal and child health outcomes. The World Health Organization (WHO) recommends that sexual and reproductive health services, including contraception, may be integrated within HIV services. Integration is associated with increased offers and uptake of sexual and reproductive health services, including contraception, which is likely to result in improved downstream clinical outcomes. Integrating HIV and sexual and reproductive health services has been found to improve access, the quality of antenatal care and nurse productivity while reducing stigma and without compromising uptake of care. Research is encouraged to identify approaches to integration that lead to better uptake of sexual and reproductive health services, including contraception. Implementation research is encouraged to evaluate different strategies of integration in different health systems and social contexts; such research should include providing contraception, including long-acting contraception, in the context of less frequent clinical and ART refill visits.

Universal access to sexual and reproductive health services and information, including access to the full range of safe and effective contraceptive methods, is fundamental to the rights and well-being of adolescents and adults of all genders [1World Health Organization. Ensuring human rights in the provision of contraceptive information and services: Guidance and recommendations. Geneva, Switzerland: World Health Organization; 2014. Accessed May 9, 2018. Available at: http://www.who.int/reproductivehealth/publications/family_planning/human-rights-contraception/en/.Google Scholar, 2World Health Organization. Framework for ensuring human rights in the provision of contraceptive information and services. Geneva, Switzerland: World Health Organization; 2014. Accessed May 9, 2018. Available at: http://who.int/reproductivehealth/publications/family_planning/framework-hr-contraceptive-info/en/.Google Scholar]. The benefits to society and life-saving consequences when quality contraceptive services and information are available, accessible, and acceptable cannot be understated. In developing regions alone, use of modern contraception prevents an estimated 308 million unintended pregnancies each year, and estimates indicate that satisfying the unmet need for modern contraception would result in 76,000 fewer maternal deaths worldwide each year [[3]Darroch J. Adding It Up: Investing in Contraception and Maternal and Newborn Health, 2017- Estimation Methodology. New York, New York: Guttmacher Institute; 2018. Accessed May 9, 2018. Available at: https://www.guttmacher.org/fact-sheet/adding-it-up-contraception-mnh-2017.Google Scholar]. Recently, a landmark analysis of the impact of family planning noted that achieving the Sustainable Development Goal (SDG) themes (people, planet, prosperity, peace, and partnership) will require investments directed towards family planning [[4]Starbird E. Norton M. Marcus R. Investing in family planning: key to achieving the sustainable development goals.Glob Health Sci Pract. 2016; 4: 191-210Crossref PubMed Scopus (146) Google Scholar]. Specifically, use of modern contraceptives and met demand for family planning represent key indicators within SDG target 3.7 [[5]Sustainable Development Solutions Network: A Global Initiative of the United Nations. Target 3.7. Indicators and a Monitoring Framework: Launching a data revolution for the Sustainable Development Goals. Paris, France: UN SDSN; 2017. Accessed May 16, 2018. Available at: http://indicators.report/targets/3-7/.Google Scholar] which also measure progress on other global health initiatives and frameworks, such as the United Nation’s Every Woman, Every Child initiative [[6]United Nations. Every Woman Every Child. Global Strategy for Women's, Children’s, and Adolescents’ Health. Geneva, Switzerland: United Nations Secretary-General; 2016. Accessed May 16, 2018. Available at: https://www.everywomaneverychild.org/.Google Scholar] and Family Planning 2020 [[7]FP2020. Family Planning 2020. Washington, DC: United Nations Foundation; 2018. Accessed May 16, 2018. Available at: http://www.familyplanning2020.org/.Google Scholar]. Despite advances and global momentum to improve contraceptive access, there has been limited recognition on the part of policy makers that delivery of contraceptive services cannot solely rely on a health care provider recommending a course of action and/or treatment that they consider to be in the best interest of the patient. Such an approach is not justified as contraception uniquely straddles a space where decisions about two socially sensitive topics – fertility and reproduction – take place. For contraception, the provider counsels the client on their contraceptive options but generally does not recommend one particular method over another method: contraceptives are within the purview of the individual instead of the provider [[8]Altshuler A.L. Gaffield M.E. Kiarie J.N. The WHO's medical eligibility criteria for contraceptive use: 20 years of global guidance.Curr Opin Obstet Gynecol. 2015; 27: 451-459Crossref PubMed Scopus (22) Google Scholar]. There is growing acknowledgement that clinicians and other experts are not always the best judges of what matters to patients or other service users. Fundamentally, it is the right of contraceptive users to exercise their own reproductive rights. To this end, World Health Organization (WHO)’s contraceptive guidance does not recommend specific methods for different types of individuals, rather, WHO recommendations respond to whether certain methods are deemed safe and effective according to an individual’s characteristics. Ultimately, contraceptive choice for the individual based upon his or her own values and preferences lies at the very heart of this discussion. Additionally, social pressures, sanctions, and approval from community and family members have long been recognised as playing a significant role in shaping fertility preferences [[9]Costenbader E. Lenzi R. Hershow R.B. Ashburn K. McCarraher D.R. Measurement of social norms affecting modern contraceptive use: a literature review.Stud Fam Plann. 2017; 48: 377-389Crossref PubMed Scopus (21) Google Scholar]. When considering the views and preferences of individuals, there are additional important aspects that distinguish contraception from other health services or interventions. First, reproductive age can span 30–40 years, beginning from early adolescence and extending to menopause in the case of a woman (approximately age 15–49). It is entirely understandable that the contraceptive needs and preferences of an adolescent will be different from an adult. Second, the importance of pregnancy prevention is influenced by life circumstances and situations, which can change significantly throughout the life course. Additionally, preferences around contraception may vary depending upon a particular method’s characteristics and features: e.g., hormonal vs. non-hormonal, long-acting versus short-acting, delivery system, effectiveness and whether there are side effects or other concerns. Again, the relative importance of these aspects of contraception may vary both between individuals and across an individual’s lifespan. With more than 15 different forms of safe and effective forms of contraception available, one cannot assume a ‘one size fits all’ approach. Within its mandate as a global normative body, WHO produces evidence-based guidance on family planning/contraception. Building upon the 1994 International Conference on Population and Development, WHO’s Department of Reproductive Health, in collaboration with a network of international partners, issues evidence-based guidance on: (a) the safety of various contraceptive methods in the context of specific health conditions and characteristics (the Medical eligibility criteria for contraceptive use or MEC) [[10]World Health Organization. Medical eligibility criteria for contraceptive use: A WHO family planning cornerstone – fifth edition. Geneva, Switzerland: World Health Organization; 2015. Accessed May 9, 2018. Available.Google Scholar] and (b) how to use contraceptive methods safely and effectively once they are deemed to be medically appropriate (the Selected practice recommendations for contraceptive use or SPR) [[11]World Health Organization. Selected practice recommendations for contraceptive use - third edition. Geneva, Switzerland: World Health Organization; 2016. Accessed May 9, 2018. Available at: http://www.who.int/reproductivehealth/publications/family_planning/SPR-3/en/.Google Scholar]. Periodically, WHO reviews the recommendations published in these guidelines, providing policy makers and programme managers access to the most updated information available when they develop their national policies and programmes. Development of the latest MEC and SPR documents entailed several adjustments to align more closely with requirements set forth in the WHO Handbook for Guideline Development [[12]World Health Organization Guidelines Review Committee Secretariat. WHO Handbook for Guideline Development. Geneva, Switzerland: World Health Organization; 2012. Accessed May 9, 2018. Available at: http://apps.who.int/iris/bitstream/handle/10665/75146/9789241548441_eng.pdf;jsessionid=0AA3FA02F1C08E7AB373A94BF5FC16D1?sequence=1.Google Scholar], authored by the Guidelines Review Committee Secretariat1The first edition was published in 2012, the second edition in 2014. 1The first edition was published in 2012, the second edition in 2014.. Explicit consideration of the values and preferences of end-users of the MEC and SPR recommendations – women, girls, men, and boys – as part of applying the Grading Recommendations, Assessment, Development and Evaluation (GRADE)2For further information on GRADE, see: www.gradeworkinggroup.org/index.htm. 2For further information on GRADE, see: www.gradeworkinggroup.org/index.htm. approach to evidence review and recommendation formulation, was a pivotal change. Thus, the relative importance that people assign to the benefits and harms of contraception were incorporated into the development of the new MEC and SPR recommendations. WHO remains wholeheartedly committed to assuring that values and preferences of end-users are a central aspect of all future revisions of these guidelines. A recent review of the evidence of the risk of HIV acquisition with the use of hormonal contraception highlights the crucial role that values and preferences must play in informing recommendations [[13]World Health Organization. Hormonal contraceptive eligibility for women at high risk of HIV: Guidance statement. Geneva, Switzerland: World Health Organization; 2017. Accessed May 9, 2018. Available at: http://www.who.int/reproductivehealth/publications/family_planning/HC-and-HIV-2017/en/.Google Scholar]. As noted in the executive summary:In formulating these recommendations, the individuals most affected by the guidance were kept at the centre of the GDG’s deliberations – those women wanting to prevent pregnancy who are at high risk of HIV acquisition. At the core of the group’s decision-making were the sexual and reproductive health and rights of women and girls, and, in particular, the human rights principles of ensuring informed decision-making and a choice of contraceptive methods. Women have their own individual preferences and values concerning contraception, and their perceptions of the risks and consequences of unintended pregnancy and HIV acquisition may vary. All women have the right to evidence-based information on contraceptives, to quality services and to the assurance of opportunities to make an informed choice without discrimination. (pages 1-2) The Guideline Development Group noted that “WHO encourages [the global health community to undertake] research that clearly elucidates women’s preferences and values in contraceptive decision-making” (page 10). In this issue of Contraception, WHO and collaborating colleagues are pleased to publish a series of systematic reviews which present a qualitative synthesis of evidence addressing contraception values and preferences among a diverse range of populations. These reviews were prepared to inform and guide the development of WHO’s latest recommendations regarding contraceptive eligibility and provision, and will continue to serve as background information for future revisions of these recommendations. We wholeheartedly acknowledge that contraceptive values and preferences will continue to evolve and vary over time, depending upon socio-cultural and socioeconomic factors as well as changing norms related to gender, sexuality, reproduction, and fertility. The series starts with a paper detailing the protocol and methods used to conduct the systematic reviews. These subsequent reviews provide an overview of the results gleaned from more than 300 articles identified from a comprehensive search of the literature, as well as focused analyses among the following groups: sexually active women; women with specific medical conditions; men; young people and adolescents; women living with HIV; health care providers; and people living in humanitarian contexts or special social conditions. We encourage readers to consider the findings presented in this series of reviews as informative to health policy and the development of new contraceptive methods to expand method choice, as well as having the potential to stimulate ongoing and new research. Improving our understanding of the values and preferences of individuals and populations that influence contraceptive decision-making has far-reaching benefits for all of us, and will be a giant leap towards meeting globally agreed-upon development goals.

Background: Immediate contraceptive initiation, including start of a method before abortion completion, is a convenient option for women seeking abortion care. Objectives: To evaluate the effect of systemic hormonal contraception initiation on medical abortion effectiveness and the safety of hormonal contraceptive methods following abortion. Data sources: PubMed, Popline, Cochrane Library, and Clinicaltrials.gov. Study eligibility criteria: Studies that assessed medical abortion effectiveness after systemic hormonal contraception initiation and the safety of hormonal contraception initiation after abortion. Participants: Pregnant persons undergoing or who had recently undergone an abortion. Interventions: Initiation of systemic hormonal contraception post abortion or on the day of the first pill of the medical abortion. Study appraisal and synthesis methods: We assessed study quality using the US Preventive Services Task Force evidence grading system. We created narrative summaries and calculated pooled relative risks when appropriate. Results: We identified 16 studies for inclusion, 7 randomized controlled trials, and 9 cohorts. Nine studies assessed medical abortion effectiveness with hormonal contraception initiation and generally found no decreased risk of abortion success or increased risk of additional treatment. One fair-quality study reported a small increase in ongoing pregnancy rate with immediate depot medroxyprogesterone (DMPA) compared with delayed DMPA initiation (3.6% vs 0.9%, risk difference 2.7%, 90% confidence interval 0.4-5.6). We identified no bleeding-related safety concerns following hormonal contraception initiation after medical or surgical abortion. Pooled results were too imprecise to draw firm conclusions. Limitations: Included studies were poor or fair quality and primarily in high-income or upper-middleincome settings. Conclusions: Abortion effectiveness did not differ between immediate vs delayed initiation of most systemic hormonal contraceptive methods after a first trimester medical abortion. However, immediate DMPA initiation did show increased ongoing pregnancy. Bleeding effects with hormonal contraception initiation postabortion appeared minimal. (C) 2021 Published by Elsevier Inc.

Introduction: Offering HIV testing services (HTS) within sexual and reproductive health (SRH) services is a priority, especially for women who have a substantial risk. To reach women with HIV who do not know their status and prevent mother-to-child HIV transmission, the World Health Organization (WHO) recommends routinely offering HTS as part of family planning (FP) service delivery in high HIV burden settings. We conducted a landscape analysis to assess HTS uptake and HIV positivity in the context of FP/SRH services. Assessment of Research and Programs: We searched records from PubMed, four gray literature databases, and 13 organization websites, and emailed 24 organizations for data on HTS in FP/SRH services. We also obtained data from International Planned Parenthood Federation (IPPF) affiliates in Eswatini, Kenya, Lesotho, Malawi, Namibia, Uganda, Zambia, and Zimbabwe. Unique programs/studies from records were included if they provided data on, or barriers/facilitators to, offering HTS in FP/SRH. Overall, 2,197 records were screened and 12 unique programs/studies were eligible, including 10 from sub-Saharan Africa. Four reported on co-delivery of SRH services (including FP), with reported HTS uptake between 17 and 94%. Six reported data on HTS in FP services: four among general FP clients; one among couples; and one among female sex workers, adolescent girls, and young women. Two of the six reported HTS uptake >50% (51%, 419/814 Kenya; 63%, 5,930/9,439 Uganda), with positivity rates of 2% and 4.1%, respectively. Uptake was low (8%, 74/969 Kenya) in the one FP program offering pre-exposure prophylaxis. In the IPPF program, seven countries reported HTS uptake in FP services and ranged from 4% in Eswatini to 90% in Lesotho; between 0.6% (Uganda) and 8% (Eswatini) of those tested were HIV positive. Implications: Data on providing HTS in FP/SRH service delivery were sparse and HTS uptake varied widely across programs. Actionable Recommendations: As countries expand HTS in FP/SRH appropriate to epidemiology, they should ensure data are reported and monitored for progress and impact.

OBJECTIVE: To systematically review the literature to determine if extended use of in- trauterine devices, including the copper or levonorgestrel intrauterine device, beyond approved durations is effective and safe for preventing pregnancy. STUDY DESIGN: We searched PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Global Index Medicus from inception through June 2019. We considered primary studies of women using the T380A copper or currently available levonorgestrel intrauterine devices past their approved duration (extended use). The primary outcome was pregnancy. Safety outcomes included adverse events and side effects that led to discontinuation. We abstracted study data into evidence tables and assessed study quality as related to the risk of bias, precision, and external validity. For each intrauterine device type, we calculated a pooled pregnancy rate during the first 2 years of extended use using the Poisson inverse variance method. RESULTS: Of 4068 studies identified by our search, 4 good -to -poor -quality studies of the 52 mg levonorgestrel intrauterine device (approved for 5 years), with a total of 2098 women starting extended use, and 2 good -to -fair -quality studies of the T380A copper intrauterine device (approved for 10 years), with 245 women starting extended use, met inclusion criteria. For the levonorgestrel intrauterine device, the pooled pregnancy rate was 0.02 per 100 person -years (95% confidence interval, 0.00-0.45) in year 6, 0.03 per 100 person -years (95% confidence interval, 0.00-0.71) in year 7, and 0.02 per 100 person -years (95% confidence interval, 0.00-0.29) in years 6 and 7 combined. During this same time, annual rates of adverse events or discontinuation owing to side effects ranged from 0 to 3.7 per 100 participants. For the copper intrauterine device, the pooled pregnancy rate for years 11 and 12 was 0.0 per 100 person -years (95% confidence interval, 0.0-0.8), and annual rates of adverse events and discontinuation owing to side effects during extended use ranged from 0 to 4.6 per 100 participants. CONCLUSION: The available evidence suggests that rates of pregnancy, adverse events, and discontinuation owing to side effects during the first 2 years of extended use of the 52 mg levonorgestrel intrauterine device and the T380A copper intrauterine device are low and comparable to rates during approved duration of use. Data were limited in quantity and quality, and may not be generalizable to all intrauterine device users.

Summary: Background: In rural Burkina Faso, a package of six low-technology, post-partum contraceptive interventions (ie, refresher training for providers, a counselling tool, supportive supervision, daily availability of contraceptive services, client appointment cards, and invitation letters to attend appointments for partners), aimed at strengthening existing primary health-care services and enhancing demand for them, doubled the use of modern contraceptives at 12 months post partum (ie, 55% uptake in intervention recipients vs 29% in routine-care users). This study assessed the effect of a similar package but in urban settings of Kinshasa province, Democratic Republic of the Congo, in an effort to reduce the unmet need for post-partum family planning. Methods: Yam Daabo was a multi-intervention, single-blinded, cluster-randomised controlled trial done in six primary health-care centres (clusters) in Kinshasa. Centres were randomly allocated to receive the six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings. Only data analysts could be masked to cluster allocation. Health-care facilities were eligible if they provided a continuum of antenatal, delivery, and postnatal care, were well stocked with contraceptives, and were situated close to the main study centre. All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility. The main outcome was prevalence of use of modern contraceptives at 12 months after delivery. Analysis was by modified intention-to-treat using generalised linear mixed models or Fisher's exact test for small groups. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). Findings: From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised. Of 690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters. Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis. At 12 months, 115 (46%) of 252 women in the intervention group and 94 (35%) of 267 in the control group were using modern contraceptives (adjusted prevalence ratio [PR] 1·58, 95% CI 0·74–3·38), with significant differences in the use of contraceptive implants (22% vs 6%; adjusted PR 4·36, 95% CI 1·96–9·70), but without difference in the use of short-acting contraceptives (23% vs 28%; 0·92, 0·29–2·98) and non-modern or inappropriate methods (7% vs 18%; 0·45, 0·13–1·54). There were no serious adverse events or maternal deaths related to the study. Interpretation: The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth. However, interferences from external family planning initiatives in the control group might have diminished differences between the services received. Such an intervention could be potentially relevant in similar contexts in DR Congo and other countries. Funding: Government of France; UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.

BACKGROUND:Post-partum family planning services can prevent maternal and child morbidity and mortality in low-resource settings. We assessed the effect of a family planning intervention package on modern contraceptive use at 12 months post partum in predominantly rural Burkina Faso. METHODS:Yam Daabo was a two group, multi-intervention, single-blinded, cluster randomised controlled trial. Primary health-care centres were randomly allocated to intervention or control clusters in a 1:1 ratio with only data analysts masked to the allocation assignment. Interventions comprised refresher training for the provider, a counselling tool, supportive supervision, availability of contraceptive services 7 days a week, client appointment cards, and invitation letters for partners. The primary outcome was modern contraceptive prevalence at 12 months, and secondary outcomes were modern contraceptive prevalence at 6 weeks and 6 months post partum. Analysis was by modified intention to treat. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). FINDINGS:From July 27-Oct 17, 2016, eight clinics were randomised and 571 women were enrolled and allocated: 286 to four intervention clusters and 285 to four control clusters. Of these, 523 completed the 12-month study exit interview (260 in the intervention group, 263 in the control group) and 523 were included in the intention-to-treat analysis. At 12 months, modern contraceptive prevalence was 55% among women who received the package and 29% among those who received routine care in control clusters (adjusted prevalence ratio 1·79, 95% CI 1·30-2·47). Significant differences in modern contraceptive prevalence were also seen between intervention and control groups at 6 weeks (42% and 10%, respectively; adjusted prevalence ratio 3·88, 95% CI 1·46-10·35) and 6 months (59% and 24%, respectively; 2·31, 1·44-3·71). INTERPRETATION:A package of six low-technology interventions, aimed at strengthening existing primary health-care services and enhancing demand for these services, can effectively increase modern contraceptive use for up to a year post partum in rural settings in Burkina Faso and has the potential to be suitable in similar settings in this country and others. FUNDING:Government of France.

Introduction Making oral contraceptives (OC) available over the counter (OTC) could reduce barriers to use. To inform WHO guidelines on self-care interventions, we conducted a systematic review of OTC availability of OCs. Methods We reviewed data on both effectiveness and values and preferences surrounding OTC availability of OCs. For the effectiveness review, peer-reviewed articles were included if they compared either full OTC availability or pharmacist-prescribing (behind-the-counter availability) to prescription-only availability of OCs and measured an outcome of interest. For the values and preferences review, we included peer-reviewed articles that presented primary data (qualitative or quantitative) examining people’s preferences regarding OTC access to OCs. We searched PubMed, CINAHL, LILACS and EMBASE through November 2018 and extracted data in duplicate. Results The effectiveness review included four studies with 5197 total participants. Two studies from the 2000s compared women who obtained OCs OTC in Mexico to women who obtained OCs from providers in either Mexico or the USA. OTC users had higher OC continuation rates over 9 months of follow-up (adjusted HR: 1.58, 95 % CI 1.11 to 2.26). One study found OTC users were more likely to report at least one WHO category 3 contraindication (13.4% vs 8.6%, p=0.006), but not category 4 contraindications; the other study found no differences in contraindicated use. One study found lower side effects among OTC users and high patient satisfaction with both OTC and prescription access. Two cross-sectional studies from the 1970s in Colombia and Mexico found no major differences in OC continuation, but some indication of slightly higher side effects with OTC access. In 23 values and preference studies, women generally favoured OTC availability. Providers showed more modest support, with pharmacists expressing greater support than physicians. Support was generally higher for progestogen-only pills compared with combination OCs. Conclusion A small evidence base suggests women who obtain OCs OTC may have higher continuation rates and limited contraindicated use. Patients and providers generally support OTC availability. OTC availability may increase access to this effective contraceptive option and reduce unintended pregnancies. Systematic review (PROSPERO) registration number CRD42019119406.

OBJECTIVE:Values and preferences of end users are critical considerations for any health guidelines. We sought to examine the literature about values and preferences for contraceptive methods to inform the World Health Organization (WHO) Medical eligibility criteria (MEC) and Selected practice recommendations (SPR) for contraception use. In this article, we present a detailed protocol and methods for this systematic review. STUDY DESIGN:We searched 10 electronic databases for articles published in a peer-reviewed journal from January 1, 2005 through December 31, 2017. Articles had to present qualitative or quantitative information about patients' and providers' values and preferences for contraceptive methods covered under the MEC and SPR guidelines. There were no language or study location restrictions. Citations were screened in duplicate and included articles underwent data abstraction using standardized forms. Study rigor was assessed using an 8-item measure developed by the Evidence Project for quantitative studies and an adapted CASP checklist for qualitative studies. DISCUSSION:We defined "values and preferences" broadly and designed our search and data extraction strategies accordingly. While this approach has strengths and limitations, we believe it captures the wide range of values and preferences of contraceptive end users and family planning providers that should be considered by WHO in guideline development. We anticipate findings will be useful to inform future research, programmatic, and policy decisions.

Abstract Objectives: In some settings women are advised to return to the clinic after intrauterine contraceptive (IUC) placement, for a follow-up visit to check the strings and identify any expulsions. Our objective was to evaluate whether the number of follow-up visits to check the strings at the external cervical os after IUC placement predicts or prevents future expulsions. Methods: This was a retrospective study conducted at the University of Campinas Medical School, Brazil. We reviewed the medical records of all women who used an IUC between January 1980 and December 2017, to identify women who had experienced IUC expulsion (N = 1974). We excluded women whose IUC was expelled more than once (n = 331) or after 10 years of use (n = 31). We fitted a generalised linear model of the time between IUC placement and expulsion, adjusting for several variables at expulsion. Significance was established at p < .05. Results: Most expulsions (843/1612; 52.3%) occurred within the first 6 months after IUC placement and 691/1612 (42.9%) were within the first three months after placement. The adjusted model showed that the number of visits, the woman’s age, and complaints of pain and bleeding during use were not significantly associated with and had no influence on expulsion. Conclusions: Our results indicate that after IUC insertion more than one follow-up visit within the first four to six months after placement is not necessary, as additional visits to check for IUC strings do not appear to reduce or predict future expulsion.

Objectives: Postpartum family planning (PPFP) is essential for maternal and newborn health but is often not systematically addressed before or after childbirth. This article describes the development and field-testing of a PPFP counseling tool to support providers and women. Methods: Participatory action research involving women, men, providers, policymakers, researchers, and contraceptive experts from Burkina Faso and the Democratic Republic of Congo. Results: The tool consists of an A4-size flipchart with illustrations on the client side and clinical information and counseling tips on the provider side, and can be used during visits of the antenataldelivery-postnatal care continuum. Qualitative results suggest that the tool is easily understandable, user-friendly, relevant, and useful with regard to providing PPFP information to clients, and respectful of clients' rights and choices. It may have a positive influence on clients' attitudes towards PPFP and their decision to use contraception. Conclusions: The tool holds promise in guiding a systematic discussion on birth spacing options among providers and clients. Its impact on contraceptive uptake requires further research. Practice implications: If proven effective, the tool could be disseminated to Ministries of Health and local, regional, and global partners to strengthen national family planning and maternal and child health strategies in low-resource countries. (C) 2018 Published by Elsevier B.V.

Background: Combined oral contraceptives (COCs) containing various progestogens could be associated with differential risks for venous thromboembolism (VTE). Objective: To evaluate the comparative risks of VTE associated with the use of low-dose (less than 50 g ethinyl estradiol) COCs containing different progestogens. Search strategy: PubMed and the Cochrane Library were searched from database inception through September 15, 2016, by combining search terms for oral contraception and venous thrombosis. Selection criteria: Studies reporting VTE risk estimates among healthy users of progestogen-containing low-dose COCs were included. Data collection and analysis: A random-effects model was used to generate pooled adjusted risk ratios and 95% confidence intervals; subgroup and sensitivity analyses assessed the impact of monophasic-COC use and study-level characteristics. Main results: There were 22 articles included in the analysis. The use of COCs containing cyproterone acetate, desogestrel, drospirenone, or gestodene was associated with a significantly increased risk of VTE compared with the use of levonorgestrel-containing COCs (pooled risk ratios 1.5-2.0). The analysis restricted to monophasic COC formulations with 30g of ethinyl estradiol yielded similar findings. After adjustment for study characteristics, the risk estimates were slightly attenuated. Conclusions: Compared with the use of levonorgestrel-containing COCs, the use of COCs containing other progestogens could be associated with a small increase in risk for VTE.

Background As countries continue to improve their family planning (FP) programmes, they may draw on WHO’s evidence-based FP guidance and tools (i.e. materials) that support the provision of quality FP services. Methods To better understand the use and perceived impact of the materials and ways to strengthen their use by countries, we conducted qualitative interviews with WHO regional advisors, and with stakeholders in Ethiopia and Senegal who use WHO materials. Results WHO uses a multi-faceted strategy to directly and indirectly disseminate materials to country-level decision-makers. The materials are used to develop national family planning guidelines, protocols and training curricula. Participants reported that they trust the WHO materials because they are evidence based, and that they adapt materials to the country context (e.g. remove content on methods not available in the country). The main barrier to the use of national materials is resource constraints. Conclusions Although the system and processes for dissemination work, improvements might contribute to increased use of the materials. For example, providers may benefit from additional guidance on how to counsel women with characteristics or medical conditions where contraceptive method eligibility criteria do not clearly rule in or rule out a method.