Maximizing the effectiveness of 1.5 mg levonorgestrel for emergency contraception: The case for precoital use.

Objectives: U.S. and World Health Organization Selected Practice Recommendations for Contraceptive Use state people may have an advanced supply of emergency contraception (EC) to minimize treatment delays. We sought to characterize the potential improvement in effectiveness of 1.5 mg levonorgestrel (LNG-EC) if it were taken up to a few hours before unprotected sex. Study design: We expanded on an existing mathematical model for the maximum attainable effectiveness of LNG-EC, assuming it exclusively works to disrupt ovulation, and compared results with point estimates from nine studies when it was taken up to 72 hours after sex. We then modelled how effectiveness might have improved if subjects had taken LNG-EC up to 3 hours before sex. Results: Taking LNG-EC immediately after sex could potentially reduce the risk of unintended pregnancy by 91%. However, population-average maximum attainable effectiveness levels ranged from just 49% to 67% when accounting for the distributions of postcoital treatment delays in the example studies. If half the subjects had taken it 3 hours before sex, then maximum effectiveness levels would have ranged from 70% to 81%. Conclusions: At the individual level, taking LNG-EC a few hours before sex is a logical extension of Selected Practice Recommendations regarding an advanced supply of EC and, based on our modeling, should be advocated for people who can reasonably anticipate an unprotected sex act. In the absence of more clinical data, however, people should not routinely rely on precoital use of LNG-EC to prevent pregnancy unless modern, effective contraceptives are inaccessible to them. Implications: Based on mathematical modeling, individuals who anticipate needing to take LNG-EC for an impending unprotected act of sex could further reduce their chance of an undesired pregnancy by taking it a few hours in advance.

Medical abortion in Ghana: a non-randomized, non-inferiority study of access through pharmacies compared with clinics.

OBJECTIVES: To compare self-reported clinical outcomes following medical abortion with mifepristone and misoprostol sourced from either a pharmacy or health clinic. STUDY DESIGN: We conducted a prospective, non-randomized, non-inferiority cohort study across four regions in Ghana, from high-volume pharmacies and health clinics. Participants seeking medical abortion (less than nine weeks' gestation) who met usual medical abortion eligibility criteria were recruited. Data collection included baseline surveys, follow-up phone interviews, and self-reported assessments of medical abortion outcomes. The study aimed to enroll 2,000 medical abortion users (1,000 from each source). RESULTS: Complete outcome data was available and analyzed from 1,958 participants (of 2208 enrolled), with the adjusted risk difference of need for additional treatment to complete the abortion indicating non-inferiority of the pharmacy group compared to the clinic group [-2.3% (95% CI -5.3% to 0.7%)]. Both groups reported low rates of additional treatment (4.9%) and adhered similarly to the abortion regimen. Secondary outcomes showed no significant differences, with moderate acceptability in both groups (65.4% pharmacy, 52.3% facility). Adverse outcomes were rare: one ectopic pregnancy, one blood transfusion and no deaths or other major complications were reported. CONCLUSIONS: Accessing medical abortion pills directly from pharmacies without prior consultation from a provider demonstrated non-inferior self-reported clinical outcomes compared to seeking care from health clinics. The findings align with the growing global evidence supporting the safety and effectiveness of medical abortion self-care. IMPLICATIONS: This study contributes data which support future registration of over-the-counter use of medical abortion drugs up to nine weeks' gestation. Such measures could expand options for safe abortion care, especially in regions where unsafe abortion poses a substantial maternal health risk. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03727308).

Can mid-level providers manage medical abortion after 12 weeks' gestation as safely and effectively as physicians? A non-inferiority, randomized controlled trial in Addis Ababa, Ethiopia.

OBJECTIVE: To determine whether clinical outcomes among clients undergoing medical abortion after 12 weeks' gestation differ by provider cadre. METHODS: Randomized controlled trial conducted among eligible clients seeking abortion between 13 and 20 weeks' gestation. Participants seeking in-facility abortion were randomized to receive care from a mid-level provider (nurse/midwife) or physician. The primary outcome was median time to expulsion with non-inferiority margin of -1.5 h between provider groups. Quantile median regression models assessed non-inferiority. Secondary outcomes included retained placenta, complications, and patient acceptability. RESULTS: After randomization and eligibility assessment by the provider, 171 women participated in the study: 81 in the physician group and 90 in the mid-level provider group. Their average age was 24 years, the mean gestational age was 16 weeks, and 65% were nulliparous in both groups. The median time to expulsion did not differ significantly, being 8.1 h for the mid-level group and 6.6 h for the physician group. The adjusted median difference was 0.8 h (95% confidence interval [CI] -1.15 to 2.66), within the non-inferiority margin. Retained placenta occurred similarly: 30.0% (n = 24) of the physician group and 20.5% (n = 18) of the mid-level provider group (adjusted risk difference [ARD] 7.6%, 95% CI -2.81 to 18.06). Complications occurred in 7% of cases, including 5.0% (n = 4) of patients in the physician group and 8.9% (n = 8) in the mid-level provider group (ARD -4.7%, 95% CI -12.43 to 3.12). Patient acceptability did not differ by group. CONCLUSIONS: Training mid-level providers to provide abortion services after 12 weeks' gestation independently of physicians is feasible and may result in comparable clinical outcomes.

Examining reuse and replacement procedures for Ipas manual vacuum aspiration and cannulae in nine countries.

OBJECTIVE: To determine how many times Ipas manual vacuum aspiration (MVA) instruments are reused, for what reasons, when the instruments are replaced and/or discarded, and what the barriers are to replacing them. METHODS: We conducted a mixed-methods cross-sectional study of health care providers who provide MVA services and key stakeholders in the supply chain to understand reuse and replacement of Ipas MVA aspirators and cannulae. Qualitative interviews focused on procurement and replacement of Ipas MVA instruments. RESULTS: The authors interviewed 352 health care providers from nine countries from 2019 to 2021. Providers reported reusing MVA instruments an average of 34.4 times (standard deviation, 45). The reuse averages ranged from one time (Democratic Republic of the Congo) to 500 times (India), with figures varying between providers within the same country. Instrument malfunctioning rather than a specific number of uses drove reuse and subsequent replacement. The decision to replace was most commonly made by the provider during use. Half of the providers said that they knew of no issues with the supply chain, and 85% said they were always able to replace Ipas MVA instruments when needed. CONCLUSION: Tracking reuse of MVA instruments was uncommon at participating providers' health facilities. Providers' estimates revealed great variability in reuse frequency and tracking procedures.

A prospective, comparative study of clinical outcomes following clinic-based versus self-use of medical abortion.

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 multicentre, prospective, comparative, non-inferiority study of participants aged ≥15 years seeking medical abortion from five clinics and five adjacent pharmacy clusters in three provinces of Cambodia. Participants 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 days 10 and 30 after mifepristone administration. RESULTS: 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%,). Additional treatment needed to complete the abortion was non-inferior for the pharmacy group (9.3%) compared with the clinic group (12.7%). More from the clinic group received additional care from a provider, such as antibiotics or diagnostics tests, than those from the pharmacy group (11.5% and 3.2%,), and one ectopic pregnancy (pharmacy group) was successfully treated. Most said they felt prepared for what happened after taking the pills (90.9% and 81.3%, respectively, p=0.273). CONCLUSIONS: Self-use of a combined medical abortion product resulted in comparable clinical outcomes as use following a clinical visit, consistent with existing literature on its safety and efficacy. Registration and availability of medical abortion as an over-the-counter product would likely increase women's access to safe abortion.

Comprehension of an Over-the-Counter Drug Facts Label Prototype for a Mifepristone and Misoprostol Medication Abortion Product.

OBJECTIVE: To develop a drug facts label prototype for a combination mifepristone and misoprostol product and to conduct a label-comprehension study to assess understanding of key label concepts. METHODS: We followed U.S. Food and Drug Administration guidance, engaged a multidisciplinary group of experts, and conducted cognitive interviews to develop a drug facts label prototype for medication abortion. To assess label comprehension, we developed 11 primary and 13 secondary communication objectives related to indications for use, eligibility, dosing regimen, contraindications, warning signs, side effects, and recognizing the risk of treatment failure, with corresponding target performance thresholds (80-90% accuracy). We conducted individual structured video interviews with people with a uterus aged 12-49 years, recruited through social media. Participants reviewed the drug facts label and responded to questions to assess their understanding of each communication objective. After transcribing and coding interviews, we estimated the proportion of correct responses and exact binomial 95% CIs by age and literacy group. RESULTS: We interviewed 851 people (of 1,507 people scheduled); responses from 844 were eligible for analysis, and 35.7% (n=301) of participants were aged 12-17 years. The overall sample met performance criteria for 10 of the 11 primary communication objectives (93-99% correct) related to indications for use, eligibility for use, the dosing regimen, and contraindications; young people met nine and people with limited literacy met eight of the 11 performance criteria. Only 79% (95% CI 0.76-0.82) of the overall sample understood to contact a health care professional if little or no bleeding occurred soon after taking misoprostol, not meeting the prespecified threshold of 85.0%. CONCLUSION: Overall, high levels of comprehension suggest that people can understand most key drug facts label concepts for a medication abortion product without clinical supervision and recommend minor modifications.

A cross-sectional survey of U.S. abortion patients' interest in obtaining medication abortion over the counter.

OBJECTIVE: To assess abortion patients' perspectives about a hypothetical option to access medication abortion over the counter without a prescription. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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. IMPLICATIONS: 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.

Accuracy of self-assessment of gestational duration among people seeking abortion.

BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: One-quarter (25%) of 1089 participants had a gestational duration of >70 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 of >70 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 being >10 weeks or >2 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). CONCLUSION: 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.

Abortion Care Beyond 13 Weeks' Gestation: A Global Perspective.

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.

Medical abortion at 13 or more weeks gestation provided through telemedicine: A retrospective review of services.

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.

Systemic hormonal contraception initiation after abortion: A systematic review and meta-analysis.

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.

Challenges in the abortion supply chain: a call to action for evaluation research.

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.

Two prophylactic pain management regimens for medical abortion ≤63 days' gestation with mifepristone and misoprostol: A multicenter, randomized, placebo-controlled trial.

OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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 (p < 0.001) 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). CONCLUSIONS: 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. IMPLICATIONS: 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.

Does prior ultrasonography affect the safety of induced abortion at or after 13 weeks' gestation? A retrospective study.

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 (<1% of dilations and evacuations, 1.4% of medical abortions). The most common adverse events with dilation and evacuation were hemorrhage and cervical laceration; three women required re-aspiration. Following medical abortion, 13.5% had retained products, 12.9% with prior ultrasound and 16.3% who had not had an ultrasound. Hemorrhage and severe side-effects occurred at similarly low rates regardless of whether ultrasonography was performed. In a logistic regression model where patient characteristics and case clustering within facilities were controlled for, we found a correlation between ultrasonography and complications when retained placenta was included in the model, but there was no correlation between ultrasonography and complications when retained placenta was excluded. CONCLUSIONS: This study confirms low complication rates among women having an abortion ≥13 weeks' gestation in healthcare facilities. Settings without universal availability of ultrasound may still maintain low, comparable complication rates.

Modern methods to induce abortion: Safety, efficacy and choice.

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.

Label comprehension of a combined mifepristone and misoprostol product for medical abortion: A pilot study in South Africa.

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.

Validation of instrument reprocessing methods for the Ipas manual vacuum aspiration devices.

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.

Definitions, measurement and indicator selection for quality of care in abortion.

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.

Medical abortion in the late first trimester: a systematic review.

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.