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To assess abortion patients' perspectives about a hypothetical option to access medication abortion over the counter without a prescription.From October 2019 to March 2020, people ages 15 and over seeking abortion at 7 facilities across the United States completed a cross-sectional, self-administered survey regarding their personal interest in and general support for accessing medication abortion over the counter, including the advantages and disadvantages of over-the-counter access. We used multivariable logistic regression with generalized estimating equations to assess associations between experiencing barriers that led to delay in obtaining abortion care and personal interest in and general support for accessing medication abortion over the counter.Of the 1687 people approached, 1202 (71%) wanted to participate, and 1178 completed the survey. Most people were personally interested in (725/1119, 65%) and in favor of (925/1120, 83%) over-the-counter medication abortion. The most common advantages noted of the over-the-counter model included privacy (772/1124, 69%), earlier access (774/1124, 69%), and convenience (733/1124, 65%). The most common disadvantages noted included incorrect use (664/1124, 59%), not seeing a clinician beforehand (439/1124, 39%), and could be less effective (271/1124, 24%). In adjusted analyses, cost barriers that resulted in delays to the appointment, White race/ethnicity (vs Black), and higher educational attainment were significantly associated with greater personal interest in and support for over-the-counter medication abortion.People accessing facility-based abortion care are very supportive of and interested in being able to access abortion over the counter. Those facing financial barriers obtaining facility-based care may benefit from allowing medication abortion to be available over the counter without a prescription.Given people's interest in over-the-counter access to medication abortion, research is needed to assess whether people can use medication abortion appropriately without clinical supervision. Such research could help determine whether medication abortion is suitable for an over-the counter switch.

The majority of abortions are performed early in pregnancy, but later abortion accounts for a large proportion of abortion-related morbidity and mortality. People who need this care are often the most vulnerable-the poor, the young, those who experience violence, and those with significant health issues. In settings with access to safe care, studies demonstrate significant declines in abortion-related morbidity and mortality. This review focuses on evidence-based practices for induced abortion beyond 13 weeks' gestation and post-abortion care in both high- and low-resource settings. We also highlight key programmatic issues to consider when expanding the gestational age for abortion services.

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-middle-income 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. Implications Initiating a hormonal contraceptive method after an abortion and as early as the same day as the first pill of the medical abortion is an option if contraception is desired. The slight increase in ongoing pregnancy with immediate DMPA initiation highlights the importance of information provision during contraceptive counseling.

Introduction We aimed to assess whether ultrasonography prior to dilation and evacuation or medical abortion ≥13 weeks was correlated with safety. Material and methods We conducted a retrospective chart review of patients undergoing abortion ≥13 weeks at eight sites in Nepal from 2015 to 2019. Results We included 2294 women undergoing abortion ≥13 weeks (no upper gestational age limit); 593 underwent dilation and evacuation and 1701 had a medical abortion. Demographics differed by procedure for parity (19% vs 33% nulliparous, dilation and evacuation, and medical abortion) and gestational age (90% vs 52% were 13‐15 weeks, dilation and evacuation, and medical abortion). Ultrasonography was performed in 81% of cases overall. Complications were rare (

Abortion care is a fundamental part of women's reproductive health care. Surgical and medical abortion methods are safe and effective throughout the gestational age range wherein abortions are performed. Although risks increase with the gestational age of the pregnancy being terminated, rates of complications remain low and comparable between surgical and medical techniques. A high-quality abortion service should offer women a choice between abortion methods and provide the one they prefer.

Objectives As an important next step in developing an over-the-counter (OTC) misoprostol-mifepristone product, this study aims to assess the comprehension of a medical abortion label. Study design We conducted a pilot study utilizing convenience sampling to enroll women in rural and urban communities at four sites in two South African provinces. Trained, female recruiters prescreened and consented potential participants. Included women were aged 16–45 with some literacy (assessed by Rapid Estimate of Adult Literacy in Medicine). Exclusion criteria were having ever used or assisted someone with a medical abortion. Demographic data were collected after enrolment. We gave women time to read the prototype label, then asked a series of 35 questions to assess key concepts for correct use of the drug. For all questions but the indication, women could refer to the label while answering. We used descriptive, chi-square and regression analyses to assess comprehension of concepts. Results 100 women aged 16–45 years participated. Most reported prior sexual intercourse (91%), pregnancy (75%), and prior contraceptive use (male condom, 45%). Messages clear to participants (>90%) regardless of literacy were: when to consult a doctor before use (history of anemia or ectopic pregnancy), to respect the mifepristone- misoprostol interval, when to seek medical attention (heavy, prolonged or no bleeding) and that fertility returns quickly after abortion. The average scores were moderate for comprehension of all medical abortion label comprehension concepts: 79% for questions about the indication of the product; 73% for assessment of appropriate gestational age; 76% for screening out ectopic pregnancy; 80% for identifying contraindications to the medicines; 69% for instructions on use; 76% for when and for what conditions to seek medical care; and 60% for how to follow-up after abortion with a pregnancy test. Questions with lowest comprehension regarded medication timing, where women with higher literacy were significantly more likely to understand the label than among lower literacy levels. Conclusions Our prototype over-the-counter label for a combined mifepristone-misoprostol product for medical abortion in early pregnancy was moderately understandable to participants. Comprehension scores were largely dependent on literacy levels. To demonstrate an understanding of at least 80% for key concepts, the prototype label for a combined medical abortion product requires revision.

Mifepristone, used together with misoprostol, is approved by the United States Food and Drug Administration for medication abortion through 10 weeks' gestation. Although in-person ultrasound is frequently used to establish medication abortion eligibility, previous research demonstrates that people seeking abortion early in pregnancy can accurately self-assess gestational duration using the date of their last menstrual period.In this study, we establish the screening performance of a broader set of questions for self-assessment of gestational duration among a sample of people seeking abortion at a wide range of gestations.We surveyed patients seeking abortion at 7 facilities before ultrasound and compared self-assessments of gestational duration using 11 pregnancy dating questions with measurements on ultrasound. For individual pregnancy dating questions and combined questions, we established screening performance focusing on metrics of diagnostic accuracy, defined as the area under the receiver operating characteristic curve, sensitivity (or the proportion of ineligible participants who correctly screened as ineligible for medication abortion), and proportion of false negatives (ie, the proportion of all participants who erroneously screened as eligible for medication abortion). We tested for differences in sensitivity across individual and combined questions using McNemar's test, and for differences in accuracy using the area under the receiver operating curve and Sidak adjusted P values.One-quarter (25%) of 1089 participants had a gestational duration of70 days on ultrasound. Using the date of last menstrual period alone demonstrated 83.5% sensitivity (95% confidence interval, 78.4-87.9) in identifying participants with gestational durations of70 days on ultrasound, with an area under the receiver operating characteristic curve of 0.82 (95% confidence interval, 0.79-0.85) and a proportion of false negatives of 4.0%. A composite measure of responses to questions on number of weeks pregnant, date of last menstrual period, and date they got pregnant demonstrated 89.1% sensitivity (95% confidence interval, 84.7-92.6) and an area under the receiver operating curve of 0.86 (95% confidence interval, 0.83-0.88), with 2.7% of false negatives. A simpler question set focused on being10 weeks or2 months pregnant or having missed 2 or more periods had comparable sensitivity (90.7%; 95% confidence interval, 86.6-93.9) and proportion of false negatives (2.3%), but with a slightly lower area under the receiver operating curve (0.82; 95% confidence interval, 0.79-0.84).In a sample representative of people seeking abortion nationally, broadening the screening questions for assessing gestational duration beyond the date of the last menstrual period resulted in improved accuracy and sensitivity of self-assessment at the 70-day threshold for medication abortion. Ultrasound assessment for medication abortion may not be necessary, especially when requiring ultrasound could increase COVID-19 risk or healthcare costs, restrict access, or limit patient choice.

Little consensus exists about how to measure quality of care in abortion. Our purpose is to (a) provide common language for healthcare quality definitions, frameworks and measurement; (b) synthesize literature about quality measurement in abortion; and (c) present criteria for quality metric development. Quality includes effectiveness, patient centeredness, timeliness, efficiency and equity of care. Information about structure, process and outcomes of care is used to measure quality. We do not have good evidence about expected population-level health and behavioral outcomes associated with improving abortion service quality. Abortion patients overwhelmingly report high satisfaction with services, but it is not clear if their satisfaction indicates high-quality care. Guidance exists for quality metric selection; measures must focus on priority topics, be scientifically sound and be feasible. Technical quality standards and clinical guidelines exist, but we lack a standard set of quality metrics. Partners in the Abortion Service Quality Initiative (https://asq-initiative.org/) are collaborating to develop the first-ever global standard for measuring abortion service quality in low- and middle-income countries, both in and out of health care facilities. Standardized and validated quality metrics would move our field forward and contribute to quality improvement activities and, ultimately, to improved health outcomes for women and families. IMPLICATIONS: We define quality of health care, synthesize the evidence about quality of care in abortion and advocate for standardized and validated quality metrics to improve health outcomes for women.

OBJECTIVE To validate recommended reprocessing methods for Ipas manual vacuum aspiration (MVA) devices. METHODS All recommended reprocessing methods for Ipas MVA devices were tested for effectiveness in cleaning, achieving high-level disinfection (HLD) and/or sterilization, and any physical effects on instruments. Worst-case scenario testing was performed using artificial soil and microorganisms. Study protocols replicated standard steps for reprocessing. The specified method for reprocessing was performed 25 times on multiple devices, including controls. After runs 1, 2, 3, 15, and 25, devices and controls were analyzed for: microbial growth; residual soils; surface damage; and functionality. RESULTS All samples were negative for microbial growth and residual soils. On inspection and functionality testing, no damage was observed for aspirators and cannulae except with STERRAD and Cidex OPA. Other methods of HLD and sterilization did not affect surfaces or functionality through 25 cycles. DISCUSSION Ipas MVA devices were not negatively affected following validated instrument reprocessing methods for HLD or sterilization for up to 25 reuse cycles. STERRAD and Cidex OPA did not meet assessed standards and are therefore not recommended. Strict adherence to guidance is critical for effective reprocessing of instruments.

Objective To describe the efficacy, safety, and acceptability of medical abortion in the late first trimester. Study design We searched PubMed and Cochrane databases for articles in any language that examined the success of medical abortion at gestational ages (>63 to≤84 days gestation). We sought articles that compared: medical abortion with surgical abortion at this gestational age, combination mifepristone and misoprostol and/or misoprostol alone); different dosages of misoprostol; different routes of misoprostol administration; frequency of dosing; and location of medical abortion (in health care facility vs. outpatient management). Our primary outcome was complete abortion. Data was independently abstracted by two authors, graded for evidence quality, and assessed for risk of bias. Results The search strategy returned 3384 articles, nine of which met inclusion criteria. Medical abortion, as compared with surgical abortion, was effective in the late first trimester (94.6% versus 97.9% complete abortion). A combined regimen of mifepristone and misoprostol was significantly more effective than misoprostol alone (90.4 versus 81.6% complete abortion). Complete abortion rates for all regimens investigated ranged from 78.6% to 94.6%. Success rates were higher with repeat dosing of misoprostol both in combination regimens and alone, and with vaginal compared with oral administration for repeat dosing. Conclusion A limited body of evidence indicates a range of efficacy of medical abortion in the late first trimester and highlights the need for well-designed trials in this gestational age range. Implications This review highlights the need for research focused on the late first trimester to strengthen the body of evidence. The available evidence is limited but offers reassurance that adverse events are rare for later first trimester abortion. Importantly, new research demonstrates that efficacy remains unchanged in the 10th gestational week regardless of whether the medication is taken in a facility or at a woman's home.

Background: To determine whether clinical outcomes differ among women accessing a combined medical abortion regimen from a health clinic when compared with those accessing it from a pharmacy. Methods: We conducted a multicenter, prospective, comparative study of women aged ≥15 years seeking medical abortion from 5 clinics and 5 adjacent pharmacy-clusters in 3 provinces of Cambodia. Women were recruited in-person at the point of purchase (clinic or pharmacy). Follow-up for self-reported pill use, acceptability, and clinical outcomes occurred by telephone at day 10 and 30 after mifepristone administration. Findings: Over 10 months, we enrolled 2083 women with 1847 providing outcome data: 937 from clinics and 910 from pharmacies. Most were early in their pregnancy (mean gestational age of 6.3 and 6.1 weeks, respectively) and almost all took the pills correctly (98% and 96%; p=.126). Additional treatment needed to complete the abortion was non-inferior for the pharmacy group (9.3%) compared with the clinic group (12.7%). More women from the clinic group received additional care from a provider, such as antibiotics or diagnostics tests than those from the pharmacy group (11% and 2%; p=0.149), and one ectopic pregnancy (pharmacy group) was successfully treated. Most women said they felt prepared for what happened after taking the pills (91% and 81%, respectively; p=0.055). Interpretation: Self-use of a combined medical abortion product resulted in comparable clinical outcomes as use following a clinical visit. Registration and availability of medical abortion as an over-the-counter product would likely increase women’s access to safe abortion. Clinical Trial Registration Details: Registered with ClinicalTrials.gov (NCT03727308). Funding Information: Funding was provided by Ipas. Declaration of Interests: None to declare. Ethics Approval Statement: This study received ethical approval from the National Ethics Committee for Health Research in Cambodia.

Objectives To evaluate medical abortion effectiveness and safety in women at 13 or more weeks gestation provided care through Women on Web's telemedicine service. Study Design We conducted a retrospective case study of abortions at 13 or more weeks gestation provided by Women on Web between 2016 and 2019. Women received mifepristone and misoprostol or misoprostol alone for abortion. We extracted demographic characteristics and outcome data for cases with pregnancy continuation outcomes. Results We identified 144 women who used medical abortion at 13 or more weeks; 131 (91%) provided abortion outcome data. Almost all, 118 (90%) received mifepristone and misoprostol. The population had an average age of 26 ± 5.8 years, 102 (78%) reported a gestational age of 13 to 15 weeks, 114 (87%) had experienced prior pregnancy, and represented all world regions. Overall, 13 (10%) women reported a continuing pregnancy, with 5 (5%) among women 13 to 15 weeks and 8 (28%) among those ≥16 weeks (p = 0.001); 38 (29%) reported adverse events (heavy bleeding, fever), 53 (43%) sought additional care from a health provider, and 18% of all cases received treatment with D&C/aspiration. Conclusions Efficacy of self-administered medical abortion decreases as gestational age increases, risking continuation of pregnancy. Provision through telemedicine at 13 to 15 weeks appears safe and effective. Implications Limited data suggest that medical abortion through telemedicine services may be a safe option through 15 weeks gestation in settings where there is ready access to the formal health system. More research with adequate sample sizes and high rates of follow-up is needed to inform on the safety of telemedicine for pregnancies 13 weeks and greater.

Background Reducing the burden of unsafe abortion rests considerably on women’s ability to access appropriate and timely treatment or services. A critical component of that care relies on a functional supply chain to ensure availability of abortion drugs and supplies within the health system. Disruptions in the supply of medical abortion drugs delay provision of abortion services and can increase the risks to a woman’s health. We examine the ways in which supply chain management (SCM) affects women’s ability to access safe and timely abortion to meet their reproductive health needs and highlight the gap in evaluation research on which SCM interventions best improve access to safe abortion care. SCM comprises a critical component of efficient and sustainable abortion service provision and is a requisite for expansion of services. Furthermore, governments are responsible for safeguarding links in the abortion supply chain, from registration to distribution of abortion drugs and supplies. Strategic public–private partnerships and use of innovative local or community-based distribution mechanisms can strengthen supply chain systems. Finally, alternatives to the pull-based models of distribution could alleviate bottlenecks in the final steps of abortion supply chains. Programs aimed at increasing access to safe and comprehensive abortion care must include SCM as a foundational component of service provision. Without access to a sustainable and affordable supply of abortion drugs and equipment, any attempt at providing abortion services will be critically limited. More implementation research is needed to identify the most effective interventions for improving SCM.

Abortions beyond 12 weeks’ gestation comprise the minority of cases globally, namely 10%–40% of all services, depending on country.1 2 Later abortions are critical to facilitate as their safe provision can mitigate significant abortion-related mortality and morbidity.1 People seeking later abortions often face financial and logistical barriers, are more likely to have experienced violence, and be young.1 2 In March 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Since then, we have witnessed strains on health services, travel restrictions, stay-at-home orders and physical distancing measures to curtail disease spread.3 The resulting disruptions in supply chains, economic instability, interruptions in health services, and fear of seeking treatment have impacted both the need for and access to abortion care, which is considered an essential service by WHO.3 4 While all abortion services are essential, ensuring access to later care is crucial given the numerous barriers and delays women face which may be exacerbated by the pandemic, particularly among the most vulnerable and underserved.3 In many settings, particularly low-resource and legally restricted countries, accessing facility-based later abortion care was challenging prior to the pandemic.1 It has become even more difficult during lockdowns, public transportation stoppages and travel restrictions.3 Strategies to mitigate the COVID-19 impact and maintain or expand access to later abortion care must draw on key innovations, including task-sharing (both provider cadre and facility level), expansion …

To determine if either prophylactic tramadol 50 mg or ibuprofen 400 mg/metoclopramide 10 mg result in lower maximal pain compared to placebo in women ≤63 days' gestation having a mifepristone-misoprostol medical abortion.We conducted a randomized, placebo-controlled trial in Nepal, South Africa, and Vietnam. Participants seeking medical abortion received active treatment or placebo, taken at time of misoprostol and repeated 4 hours later. All had access to additional analgesia. The primary outcome was mean maximum pain score within 8 hours. Participants self-assessed maximum pain using an 11-point numeric rating scale recorded in paper diaries; we analyzed these data using intention-to-treat analysis. Secondary outcomes included use of additional analgesia, side effects, and satisfaction.We enrolled 563 patients between June 2016 and October 2017; 5 participants failed to follow up. Mean adjusted maximum pain scores within 8 hours in both active arms were lower than placebo (tramadol: n = 188, 6.78 (95% confidence interval [CI] 6.46, 7.11); ibuprofen/metoclopramide: n = 187, 6.43 (95% CI 6.10, 6.75); placebo: n = 188, 7.42 (95% CI 7.10, 7.74); p = 0.0001). Additional analgesia was used by 97 (52.2%) participants in the tramadol group, 80 (43.0%) in the ibuprofen/metoclopramide group, and 103 (55.7%) in the placebo group, p = 0.04. More dizziness (p = 0.004), headache (p = 0.03), and vomiting (p0.001) occurred in the tramadol group. More participants reported experienced pain was the same or less than expected in the ibuprofen/metoclopramide group (p = 0.05); overall abortion satisfaction did not differ by group (p = 0.44).Compared with placebo, tramadol or ibuprofen/metoclopramide co-administered with misoprostol and repeated 4 h later resulted in lower mean maximum pain scores that failed to achieve clinical significance. Women who received ibuprofen/metoclopramide were least likely to use additional analgesia and reported fewer side effects.Given that tramadol, ibuprofen, and metoclopramide are inexpensive, globally available; and, ibuprofen and metoclopramide are included on the World Health Organization Essential Medicines List, these medicines could be considered for prophylactic pain management during medical abortion.

Research has not kept abreast of women’s self-use of medical abortion, leaving many gaps in the scientific literature regarding the ideal conditions for safe and effective use. Therefore, our main objectives were to assess the research gaps highlighted during the conference, identify specific challenges to conducting research on medical abortion self-use, and to share promising research methodologies to advance this research. Although there are overlaps with the recommended and wellresearched practice of women’s self-management of the abortion process at home after receiving medical abortion medicines, screening and information from a clinician [1], our intent was focused on the emerging practice of self-use.

Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone–misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria for over‐the‐counter (OTC) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviours necessary for a successful OTC application for medical termination at ≤10 weeks of gestation and identified crucial research gaps. If we were to embark on a development programme for OTC or more generally, self‐use of medical termination, the critical elements missing are the label comprehension, self‐selection and actual use studies. Tweetable abstract Considering medical pregnancy termination through the over‐the‐counter regulatory lens clarifies critical evidence gaps., Tweetable abstract Considering medical pregnancy termination through the over‐the‐counter regulatory lens clarifies critical evidence gaps.

BackgroundContraception is important for women who are postpartum, including those who are breastfeeding. Use of combined hormonal contraceptives (CHCs) may affect breastfeeding performance and infant health outcomes.ObjectiveThe objective was to identify evidence examining clinical outcomes for breastfeeding and infant health among breastfeeding women using CHCs compared to nonusers.Search strategyWe searched the PubMed database for all articles published from database inception through September 30, 2014.Selection criteriaWe included primary research studies that compared breastfeeding women using CHCs with breastfeeding women using nonhormonal or no contraception, or compared breastfeeding women initiating combined hormonal contraception at early versus later times postpartum. Breastfeeding outcomes of interest included duration, rate of exclusive breastfeeding and timing of supplementation. Infant outcomes of interest included growth, health and development.ResultsFifteen articles describing 13 studies met inclusion criteria for this review. Studies ranged from poor to fair methodological quality and demonstrated inconsistent effects of combined oral contraceptives (COCs) on breastfeeding performance with COC initiation before or after 6 weeks postpartum; some studies demonstrated greater supplementation and decreased breastfeeding continuation among COC users compared with nonusers, and others demonstrated no effect. For infant outcomes, some studies found decreases in infant weight gain for COC users compared with nonusers when COCs were initiated at

Background Postpartum women need effective contraception. Concerns have been raised that use of progestogen-only contraceptives (POCs) may affect breastfeeding performance and infant health outcomes. Objectives We investigated the clinical outcomes of breastfeeding duration, initiation of supplemental feeding and weaning, as well as infant outcomes including infant growth, health and development among breastfeeding women using POCs compared with breastfeeding women not using POCs. Search strategy We searched the PubMed database for all articles published from database inception through December 2014. Selection criteria We included primary research studies of breastfeeding women of any age or parity who received POCs, including progestogen-only pills, injectables, implants or hormonal intrauterine devices (IUDs). The main outcomes were breastfeeding performance (as measured by initiation, continuation, frequency and exclusivity of breastfeeding) and infant health (as measured by growth, development or adverse health effects). Results Forty-nine articles reporting on 47 different studies were identified that investigated the use of POCs in breastfeeding women and reported clinically relevant outcomes of infant growth, health or breastfeeding performance. Studies ranged from poor to fair methodological quality and generally failed to show negative effects of the use of POCs on breastfeeding outcomes or on infant growth or development. One randomized controlled trial (RCT) raises concerns that immediate insertion of the levonorgestrel IUD postpartum may be associated with poorer breastfeeding performance when compared with delayed insertion, although two other RCTs evaluating early etonogestrel implants compared with delayed initiation of implants or depot medroxyprogesterone acetate failed to find such an association. Conclusion The preponderance of evidence fails to demonstrate adverse breastfeeding outcomes or negative health outcomes in infants such as restricted growth, health problems or impaired development. Evidence newly added to this review was largely consistent with previous evidence.

STUDY QUESTION Will the use of levonorgestrel (LNG) 1.5 mg taken at each day of coitus by women who have relatively infrequent sex be an efficacious, safe and acceptable contraceptive method? SUMMARY ANSWER Typical use of LNG 1.5 mg taken pericoitally, before or within 24 h of sexual intercourse, provides contraceptive efficacy of up to 11.0 pregnancies per 100 women-years (W-Y) in the primary evaluable population and 7.1 pregnancies per 100 W-Y in the evaluable population. WHAT IS KNOWN ALREADY LNG 1.5 mg is an effective emergency contraception following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. STUDY DESIGN, SIZE, DURATION This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus (on up to 6 days a month). Each woman had a follow-up visit at 2.5, 4.5 and 6.5 months after admission or until pregnancy occurs if sooner, or she decided to interrupt participation. The study was conducted between 10 January 2012 and 15 November 2014. PARTICIPANTS/MATERIALS, SETTING, METHODS A total of 330 healthy fertile women aged 18–45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.5 mg pericoitally (24 h before or after coitus) as their primary method of contraception. The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any 24-h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns. Anaemia was assessed by haemoglobin evaluation. Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.5-month and final visit at 6.5 months, acceptability questions were administered. MAIN RESULTS AND THE ROLE OF CHANCE There were 321 women included in the evaluable population (which includes all eligible women enrolled), with 141.9 woman-years (W-Y) of observation and with a rate (95% confidence interval [CI]) of 7.1 (3.8; 13.1) pregnancies per 100 W-Y of typical use (which reflects use of the study drug as main contraceptive method, but also includes possible use of other contraceptives from admission to end of study) and 7.5 (4.0; 13.9) pregnancies per 100 W-Y of sole use. In the primary evaluable population (which includes only eligible enrolled women

Governments, advocates, providers, policymakers and other stakeholders who want to fully support women’s rights to access abortion across the globe must address quality of care, in addition to efforts to change abortion laws, train providers and expand service provision. Documenting and working to improve the quality of abortion care is necessary in order to improve service delivery and health outcomes, expand access to safe abortion especially in legally restricted settings, and to ensure the human right to the highest attainable standard of health, as outlined by the WHO.1 Quality of healthcare services is the degree to which services produce desired health outcomes and rely on best available evidence.2 Domains of quality as defined by the WHO3 and the Institute of Medicine (IOM)2 ask whether healthcare is effective, efficient, accessible, acceptable/patient-centred, equitable and safe. The safety of abortion is well established in settings where abortion is legal,4 despite claims to the contrary from those who seek to restrict access to abortion. A safe abortion is understood to mean a medical (medication), aspiration, or surgical abortion that conforms to WHO guidelines.5 Well-managed self-use of medical abortion is on the spectrum of safe abortion. In settings with high-quality clinical data and access to legal abortion such as the United States, first-trimester abortions carry an extremely low risk …

To further evaluate the effect of weight and body mass index (BMI) on the efficacy of levonorgestrel emergency contraception.Data from two large, multicenter, randomized controlled trials designed to assess emergency contraceptive efficacy were pooled to evaluate the effect of weight and BMI on pregnancy rates among women who received levonorgestrel. Descriptive methods (comparison of means and distributions according to pregnancy status and pregnancy rates across weight and BMI categories) as well as cubic spline modeling were used to describe the relationship between pregnancy risk and weight/BMI.The analysis population comprised 1731 women, among whom 38 pregnancies were reported. Women for whom levonorgestrel was not effective in preventing pregnancy had a significantly higher mean body weight and BMI than women who did not become pregnant (76.7 vs. 66.4 kg, p.0001; 28.1 vs. 24.6 kg/m², p.0001). The estimated pregnancy rate increased significantly from 1.4% [95% confidence interval (CI): 0.5%-3.0%] among the group of women weighing 65-75 kg to 6.4% (95% CI: 3.1%-11.5%) and 5.7% (95% CI: 2.9%-10.0%) in the 75-85 kg and85 kg groups, respectively. Statistical modeling demonstrated a steep increase in pregnancy risk starting from a weight near 70-75 kg to reach a risk of pregnancy of 6% or greater around 80 kg. Similar results were obtained for statistical modeling of BMI as well as when the two studies were analyzed individually.All analyses showed a significant drop in the efficacy of levonorgestrel emergency contraception with increasing body weight, with pregnancy risk in the higher weight categories similar to expected rates in the absence of contraception. Like body weight, increasing BMI was highly correlated with increased pregnancy risk.

Background The provision of safe abortion services to women who need them has the potential to drastically reduce or eliminate maternal deaths due to unsafe abortion. The World Health Organization recently updated its evidence-based guidance for safe and effective clinical practices using data from systematic reviews of the literature. Materials and Methods Systematic reviews pertaining to the evidence for safe abortion services, from pre-abortion care, medical and surgical methods of abortion and post-abortion care were evaluated for relevant outcomes, primarily those relating to safety, effectiveness and women's preference. Results Sixteen systematic reviews were identified and evaluated. The available evidence does not support the use of pre-abortion ultrasound to increase safety. Routine use of cervical preparation with osmotic dilators, mifepristone or misoprostol after 14 weeks gestation reduces complications; at early gestational ages, surgical abortions have very few complications. Prophylactic antibiotics result in lower rates of post-surgical abortion infection. Pain medication such as non-steroidal anti-inflammatories should be offered to women undergoing abortion procedures; acetaminophen, however, is not effective in reducing pain. Women who are eligible should be offered a choice between surgical (vacuum aspiration or dilation and evacuation) and medical methods (mifepristone and misoprostol) of abortion when possible. Modern methods of contraception can be safely initiated immediately following abortion procedures. Conclusions Evidence-based guidelines assist health care providers and policymakers to utilize the best data available to provide safe abortion care and prevent the millions of deaths and disabilities that result from unsafe abortion.

Background Initiation of contraceptive progestogen-only injections conventionally require that women delay starting them until menses begin, during which time interval a woman may be at risk of unintended pregnancy. Our objective was to determine from the literature when a woman can initiate progestogen-only injectables for contraception. Study Design We searched MEDLINE and Cochrane databases for all articles (in all languages) published in peer-reviewed journals between database inception to February 2012, for evidence relevant to starting injectables on different days of the menstrual cycle and its impact upon contraceptive effectiveness or those that examined different strategies for initiation and their effects on compliance and continuation. Results Eight articles met our criteria for inclusion. All studies examined initiation of depot medroxyprogesterone (DMPA); no studies of norethisterone enantate were identified. Three articles, reported that when DMPA was initiated later than Cycle Day 7, ovulation occurred in some women. Approximately 90% of women had poor quality cervical mucus within 24 h after they received an injection. Five studies of compliance and continuation demonstrated that the use of another contraceptive method as a “bridging option” was not successful in helping women initiate DMPA. When DMPA was given throughout the menstrual cycle, more women were eligible to receive their first injection but only about half returned on time for their subsequent injection and some pregnancies occurred. Conclusion Ovulation is rare when DMPA is provided within the first 7 days of the menstrual cycle. Use of another contraceptive as a “bridging option” until DMPA can be initiated has been unsuccessful in helping women initiate DMPA and is associated with higher rates of pregnancy.

Background Misoprostol, a prostaglandin E 1 analog, stimulates uterine contractility and cervical ripening. A number of randomized trials and systematic reviews have evaluated its use in obstetric and gynecologic conditions. Misoprostol is inexpensive, stable at room temperature, and available in more than 80 countries, making it particularly useful in resource-poor settings. WHO recognizes the crucial role of misoprostol in reproductive health and has incorporated recommendations for its use into 4 reproductive health guidelines focused on induction of labor, prevention and treatment of postpartum hemorrhage, and management of spontaneous and induced abortion. Methods and results All guidelines were prepared in accordance with the WHO Handbook for Guideline Development . The process included: identification of priority questions and critical outcomes; retrieval of evidence; assessment and synthesis of evidence; formulation of recommendations; and planning for dissemination, implementation, impact evaluation, and updating. The present report summarizes recommendations for misoprostol use in line with each guideline. Conclusion The present comprehensive reference document was designed to enable clinicians and policy makers to quickly access and compare recommendations for the use of misoprostol in various reproductive health settings.

Pain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting. We propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days’ gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women’s physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion. Although pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed. ACTRN12613000017729 (Prospectively registered 8/1/2013).

Background Unsafe termination of pregnancy is a major contributor to maternal morbidity and mortality. Task sharing termination of pregnancy services between physicians and mid-level providers, a heterogeneous group of trained healthcare providers, such as nurses, midwives and physician assistants, has become a key strategy to increase access to safe pregnancy termination care. Objectives To systematically review the evidence to assess whether termination of pregnancy services by nonphysician providers can be performed safely and effectively. Search strategy We searched the Cochrane Central Register of Controlled Trials, MEDLINE, MEDLINE in process and other nonindexed citations and POPLINE. Selection criteria We included randomised controlled trials (RCTs), as well as clinical studies, using study designs that compared efficacy, safety and acceptability of termination of pregnancy services by physicians versus other provider groups. Data collection and analysis Two reviewers independently extracted the data, and we performed a meta-analysis where appropriate using RevMan. Quality assessment of the data used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Main results We identified five controlled studies comprising 8908 women undergoing first-trimester surgical termination of pregnancy (one RCT and three prospective cohort studies) and medical termination of pregnancy (one RCT). The mid-level provider group included midwives, nurses, auxiliary nurse midwives and physician assistants trained in termination of pregnancy services. Safety and efficacy outcomes, including incomplete termination of pregnancy, haemorrhage, injury to the uterus or cervix, did not differ significantly between providers. Author’s conclusions Limited evidence indicates that trained mid-level providers may effectively and safely provide first-trimester surgical and medical termination of pregnancy services. Data are limited by the scarcity of RCTs and biases of the cohort studies.

Please cite this paper as: Rodriguez M, Seuc A, Kapp N, von Hertzen H, Huong N, Wojdyla D, Mittal S, Arustamyan K, Shah R, the World Health Organization Research Group on Post-Ovulatory Methods of Fertility Regulation. Acceptability of misoprostol-only medical termination of pregnancy compared with vacuum aspiration: an international, multicentre trial. BJOG 2012;119:817–823. Objective To compare women’s acceptance of misoprostol-only medical termination of pregnancy (TOP) with surgical TOP. Design Prospective cohort study. Setting Termination of pregnancy clinics in New Delhi, Mumbai, Hanoi, Tbilisi, Trivandrum and Yerevan. Population Women requesting TOP, at 63 days of gestation or less, at study sites where both medical and surgical methods were available. Methods Serial surveys eliciting measures of women’s satisfaction and acceptance of TOP method were administered. Data were analysed using cross-tabulation and logistic regression to determine if TOP method was predictive of acceptability. Main outcome measures Patient acceptance. Results High acceptability of both surgical and misoprostol-only TOP. Conclusions Where medical TOP with mifepristone is not available, misoprostol-only medical TOP is acceptable to women who have the choice between medical or surgical techniques.

Background This review was conducted to evaluate the evidence regarding the safety and effectiveness of intrauterine device (IUD) insertion immediately following spontaneous or induced abortion. Study Design We searched MEDLINE databases for all articles (in all languages) published in peer-reviewed journals from January 1966 through March 2010 for evidence comparing immediate postabortion IUD insertion with either no IUD insertion, insertion at a different time, insertion following first-trimester compared with second-trimester abortion or copper IUD insertion compared with hormone-releasing IUD insertion postabortion. We used standard abstraction forms to summarize and assess the quality of the evidence. Results The search strategy identified a total of 990 articles, of which 19 met our inclusion criteria for this review. Studies comparing immediate postabortion IUD insertion with no IUD insertion found that both groups experienced similar rates of pain and infection and a similar number of bleeding days, but one study reported that women with copper IUD insertion experienced a greater amount of bleeding than women without IUD insertion after abortion. Results from studies comparing immediate postabortion IUD insertion and insertion at a time not associated with pregnancy did not report differences between the two groups in the duration of bleeding, pain, expulsions or pelvic inflammatory disease (PID). One study however reported a greater amount of bleeding and another reported more removals for medical reasons among women with postabortion IUD insertion. Evidence from studies that examined immediate vs. delayed postabortion insertion reported minimal differences in bleeding, pain, expulsion and PID between groups. Studies comparing immediate IUD insertion after first- vs. second-trimester abortion reported no difference in removals for pain and bleeding, and an increased risk of expulsion among those women who had insertions after second-trimester abortion. In addition, women with insertions immediately after abortions occurring later in the first trimester had higher expulsion rates than those with insertions after early first-trimester abortions. Studies examining women using a copper IUD compared with a hormone-releasing IUD reported inconsistent results, with one paper reporting more bleeding days in the copper IUD group and another finding higher rates of removal for bleeding in the progesterone-releasing IUD group. Conclusion Intrauterine device insertion immediately after abortion is not associated with an increased risk of adverse outcomes compared with use of other contraceptive methods or with no IUD insertion after abortion and compared with IUD insertion at times other than immediately after abortion. Intrauterine device expulsion rates, while generally low, were higher with insertions that occurred after later first-trimester abortion compared with after early first-trimester abortion and higher with IUD insertion after second-trimester abortion compared with after first-trimester abortion.

Labor induction abortion is effective throughout the second trimester. Patterns of use and gestational age limits vary by locality. Earlier gestations (typically 12 to 20 weeks) have shorter abortion times than later gestational ages, but differences in complication rates within the second trimester according to gestational age have not been demonstrated. The combination of mifepristone and misoprostol is the most effective and fastest regimen. Typically, mifepristone 200 mg is followed by use of misoprostol 24-48 h later. Ninety-five percent of abortions are complete within 24 h of misoprostol administration. Compared with misoprostol alone, the combined regimen results in a clinically significant reduction of 40% to 50% in time to abortion and can be used at all gestational ages. However, mifepristone is not widely available. Accordingly, prostaglandin analogues without mifepristone (most commonly misoprostol or gemeprost) or high-dose oxytocin are used. Misoprostol is more widely used because it is inexpensive and stable at room temperature. Misoprostol alone is best used vaginally or sublingually, and doses of 400 mcg are generally superior to 200 mcg or less. Dosing every 3 h is superior to less frequent dosing, although intervals of up to 12 h are effective when using higher doses (600 or 800 mcg) of misoprostol. Abortion rates at 24 h are approximately 80%-85%. Although gemeprost has similar outcomes as compared to misoprostol, it has higher cost, requires refrigeration, and can only be used vaginally. High-dose oxytocin can be used in circumstances when prostaglandins are not available or are contraindicated. Osmotic dilators do not shorten induction times when inserted at the same time as misoprostol; however, their use prior to induction using misoprostol has not been studied. Preprocedure-induced fetal demise has not been studied systematically for possible effects on time to abortion. While isolated case reports and retrospective reviews document uterine rupture during second-trimester induction with misoprostol, the magnitude of the risk is not known. The relationship of individual uterotonic agents to uterine rupture is not clear. Based on existing evidence, the Society of Family Planning recommends that, when labor induction abortion is performed in the second trimester, combined use of mifepristone and misoprostol is the ideal regimen to effect abortion quickly and completely. The Society of Family Planning further recommends that alternative regimens, primarily misoprostol alone, should only be used when mifepristone is not available.

Background: Postpartum women need effective contraception, but using hormonal contraceptives may affect breastfeeding performance and infant health outcomes. Study design: We searched the MEDLINE and Cochrane databases for all articles published through May 2009 for primary research studies that investigated clinical outcomes among breastfeeding women who used hormonal contraception or their infants. Results: Three randomized controlled trials reported decreased mean duration of breastfeeding and higher rates of supplemental feeding among combined oral contraceptive (COC) users than among nonusers, while one multicountry trial found no differences in these parameters. Only one study demonstrated lower average weights during the first year of life for infants whose mothers used COCs while breastfeeding. None of the eight studies, four of which were observational, included in this review documented adverse infant health outcomes. Conclusions: Limited evidence demonstrates an inconsistent effect of COC on breastfeeding duration and success. The evidence is inadequate to determine whether a mother's use of these drugs affects breastfeeding duration or the infant's health.

Background Women diagnosed with gestational trophoblastic disease (GTD) need safe and effective contraception because they are advised to delay a subsequent pregnancy. Study Design We searched MEDLINE and The Cochrane Library for articles in any language on use of combined oral contraceptives (COC), copper-bearing or levonorgestrel-releasing IUDs among women with benign or malignant GTD, from database inception through November 2008. One review and nine articles were identified and evaluated. Results Incidence of postmolar trophoblastic disease was lower among COC users compared with nonusers in six studies, but higher among COC users in three studies. Five studies reported shorter human chorionic gonadotropin (hCG) regression duration among COC users compared with other methods. Development of postmolar trophoblastic disease did not differ significantly among IUD users compared with COC users or nonusers in three studies. Conclusions Evidence shows that postmolar trophoblastic disease risk does not increase among women using COCs or an IUD following molar pregnancy evacuation compared with use of other contraceptive methods or no method.

Background Insertion of an intrauterine device (IUD) at different times or by different routes during the postpartum period may increase the risk of complications. Methods We searched Medline, Lilacs and Cochrane Collaboration databases for articles in any language, between database inception until December 2008, which compared outcomes of postpartum IUD insertion time intervals. Search terms included postpartum , puerperium , postcesarean delivery , cesarean section, IUD(s) , IUCD(s) , intrauterine device(s) and insertion . Results From 297 articles, we identified 15 for inclusion in this review: all studies examined the outcomes from copper IUD insertions within the postpartum time period compared to other time intervals or compared routes (vaginal or via hysterotomy) of postpartum insertion. No studies of levonorgestrel IUDs were identified. Immediate IUD insertion (within 10 min of placental delivery) was safe when compared with later postpartum time periods and interval insertion. Immediate postpartum IUD insertion demonstrated lower expulsion rates when compared with delayed postpartum insertion but with higher rates than interval insertion. Immediate insertion following cesarean delivery demonstrated lower expulsion rates than immediate insertion following vaginal delivery. Conclusion Poor to fair quality evidence from 15 articles demonstrated no increase in risk of complications among women who had an IUD inserted during the postpartum period; however, some increase in expulsion rates occurred with delayed postpartum insertion when compared to immediate insertion and with immediate insertion when compared to interval insertion. Postplacental placements during cesarean delivery are associated with lower expulsion rates than postplacental vaginal insertions, without increasing rates of postoperative complications.

Background: This report evaluates the effects of hormonal contraceptive use among women with viral hepatitis or cirrhosis of the liver. Methods: PubMed and Cochrane databases were searched from inception to June 2008 for publications that examined the use of hormonal contraceptives among women with viral hepatitis or cirrhosis of the liver. Results: Six studies met the inclusion criteria. In one study of acute hepatitis, combined oral contraceptive (COC) use did not affect duration of hospitalization or successful disease resolution. The remainder of the studies examined chronic hepatitis or its sequelae. Women recovered from hepatitis experienced transaminase elevation with COC use which resolved after 4 weeks in one study or increased slightly over 6 months in another study. Hepatitis B virus carriers using COCs had similar transaminase levels as nonusing carriers over 6 months. Studies of chronic hepatitis C infection demonstrated no influence of COC use on progression or severity of liver fibrosis or development of hepatocellular carcinoma. Conclusion: Data from one study suggest that COCs do not affect the course of acute hepatitis. Limited data from studies on chronic hepatitis or its sequelae suggest that COC use does not affect the rate of progression or severity of cirrhotic fibrosis, the risk of hepatocellular carcinoma in women with chronic hepatitis, or the risk of liver dysfunction in hepatitis B virus carriers.

OBJECTIVE To investigate the adjunctive use of mifepristone in second-trimester induction abortions using misoprostol 1 day after feticidal digoxin. METHODS This is a randomized, placebo-controlled, double-blind trial of mifepristone in second-trimester induction termination using misoprostol after feticidal digoxin. Women seeking abortion between 18 and 23 weeks of gestation were offered enrollment. At the time of digoxin amnioinfusion, participants received a randomly allocated, identical-appearing capsule containing either mifepristone, 200 mg, or placebo. Patients returned the following day for induction with buccal misoprostol. The primary outcome was the time interval from the first misoprostol dose to abortion. Analysis utilized survival curves with log-rank testing. RESULTS Of 64 women, 32 received mifepristone and 32 received placebo. The groups did not differ by ethnicity, age, parity, reason for termination, or gestational age. Median procedure time was significantly shorter for those who received mifepristone, 10 hours (95% confidence interval [CI] 8-12), than those who did not, 18 hours (95% CI 15-22), P

Mifepristone was compared with laminaria for cervical ripening in second-trimester induction of labor (IOL).We performed a randomized, controlled, open-label study of women undergoing second-trimester IOL for fetal demise, aneuploidy or anomalies at a single tertiary care center from January 2004 to May 2006. Main outcome measures were induction-to-delivery time and pain with cervical ripening.Of 50 eligible women, 37 were enrolled in the study, of whom 33 completed the study: 16 were randomized to laminaria and 17 to mifepristone. Induction-to-delivery time was significantly shorter in the mifepristone arm (mean=10 h vs. 16 h, p=.01; median=7.5 h vs. 13.4 h, p=.01). Pain with cervical ripening was also significantly less in the mifepristone group than in the laminaria group (median=1 vs. 6 on an 11-point visual analogue scale, p.001). Maternal age, parity, gestational age, fetal demise prior to induction, need for postpartum curettage, blood loss, pain during induction, delivery and at the time of discharge were not significantly different between the two groups.Mifepristone shortens the induction-to-delivery time and decreases pain with cervical ripening when compared with laminaria for second-trimester induction.

To determine the kinetics of the short-term clearance of cell-free nucleic acids in maternal plasma, we conducted a prospective cohort study of 36 women who underwent first-trimester elective surgical termination. By using real-time polymerase chain reaction (PCR) amplification and measurement of the sex-determining region of the Y chromosome (SRY) gene (as a marker of fetal DNA), beta-hCG (a placental messenger RNA transcript), and glyceraldehyde phosphate dehydrogenase (GAPDH; as a marker of both total DNA and mitochondrial RNA), we found that cell-free nucleic acids in maternal plasma are not cleared within 90 minutes after the procedure, in contrast to the case of term delivery, in which levels decrease rapidly after birth.

Objective Ulipristal acetate (UPA) 30mg is safe and effective for emergency contraception (EC). This prospective open-label exploratory study was conducted to obtain additional data on the pharmacodynamic effects of repeated dose of UPA 30mg during an 8-week period (effects on ovulation inhibition, hormonal levels, endometrium and cervical mucus). Safety and tolerability data of repeated use of UPA EC were also collected. Study design A total of 23 healthy female, healthy sterilized women participated in two substudies receiving UPA for 8 consecutive weeks. In substudy 1, UPA 30mg was administered every 7days (Q7D n =12); while in substudy 2, every 5days (Q5D n =11). Subjects were monitored three times a week in a baseline cycle and during treatment with transvaginal ultrasounds, hormonal measurements and cervical mucus evaluation. Laboratory safety measurements and standard surrogate thrombosis risk markers were measured at baseline and within a few days of the last tablet. A luteal phase endometrial biopsy was taken in the baseline cycle and posttreatment. Results A total of 11/12 (91.7%) and 8/11 (72.7%) of the subjects ovulated at least once in substudy Q7D and Q5D, respectively, with similar, normal hormonal profiles. No effect on cervical mucus was observed. All biopsies were classified as benign in both substudies; 5/11 biopsies on Q5D posttreatment were classified as nonphysiological with some of typical progesterone receptor modulator-associated endometrial changes. UPA was well tolerated in both treatment arms while clinical laboratory results and surrogate thrombosis markers were reassuring. Conclusions Repeat use of 30mg oral UPA every 5 or 7days for 8weeks initially delays follicular rupture but ovulation eventually occurs with time in most subjects. Safety data indicate that UPA 30mg could be safely administered if needed more than once for EC in a given menstrual cycle. Implications These data demonstrate that repeated use of UPA 30mg is safe. However, ovulation eventually occurs in a high proportion of women in spite of repeated treatments in both studied regimens. Nevertheless, since the stage of follicular development of women seeking initial or repeat EC use is generally unknown, the repeated use of UPA may still delay follicular rupture and prevent an unintended pregnancy in the event of further unprotected intercourse.

Given new research on postpartum placement of levonorgestrel and copper intrauterine devices (IUDs), our objective was to update a prior systematic review of the safety and expulsion rates of postpartum IUDs.We searched MEDLINE, CENTRAL, LILACS, POPLINE, Web of Science, and ClinicalTrials.gov databases for articles between the database inception until July 2013. We included studies that compared IUD insertion time intervals and routes during the postpartum period. We used standard abstract forms and the United States Preventive Services Task Force grading system to summarise and assess the quality of the evidence.We included 18 articles. New evidence suggests that a levonorgestrel releasing-intrauterine system (LNG-IUS) insertion within 48 hours of delivery is safe. Postplacental insertion and insertion between 10 minutes and 48 hours after delivery result in higher expulsion rates than insertion 4 to 6 weeks postpartum, or non-postpartum insertion. Insertion at the time of caesarean section is associated with lower expulsion rates than postplacental insertion at the time of vaginal delivery.This review supports the evidence that insertion of an intrauterine contraceptive within the first 48 hours of vaginal or caesarean delivery is safe. Expulsion rates should be further studied in larger randomised controlled trials.

Objective This pilot study was designed to evaluate the outcome of medical abortion following simultaneous mifepristone (100 mg) and misoprostol (800 μg). Methods Enrollees had gestational ages up to 56 days and desired a medical abortion. They received 100 mg of mifepristone orally and 800 μg of misoprostol vaginally. Follow-up examination occurred in 2–7 days. A phone call 3 weeks later assessed symptoms and acceptability. A 95% success rate, as seen in higher dose studies, gives a 95% confidence interval of 88–100% for 40 subjects. Results Forty women were enrolled; 39 women had follow-up visits. Completed medical abortion was confirmed for 35 (90%) of 39 women. Four women had uterine aspiration. Two patients required repeat misoprostol. Median time from medication to abortion was 7 h. Most women (92%) strongly preferred taking all medications in the clinic. Conclusions The simultaneous administration of vaginal misoprostol with 100 mg of oral mifepristone had the outcome of completed abortion within the predicted confidence interval. In addition, simultaneous dosing was highly acceptable.

article i nfo Background: Emergency contraception has been known for several decades, and dedicated products have been on the market for close to 20 years. Yet it is unclear whether women, particularly in low-resource countries, have access to this important second-chance method of contraception. Objectives: To review relevant policies, regulations, and other factors related to access to emergency contraception worldwide. Search strategy: A wide range of gray literature was reviewed, several specific studies were commissioned, and a number of online databases were searched. Main results: Several positive policies and regulations are in place: emergency contra- ception products are registered in the majority of countries around the world, listed in many countries' essential medicines lists, included in widely used guidance, and supported by most donors. Yet analysis of demographic data shows that the majority of women in low-income countries have never heard of emergency contraception, and surveys find that many providers have negative attitudes toward providing emergency contraception. Conclusions: Despite more than a decade of concerted international and country-level efforts to ensure that