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.

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.

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.

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.

A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg.

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 <35 years old), the rate was 10.3 (5.4; 19.9) pregnancies per 100 W-Y of typical use, and 11.0 (5.7; 13.1) pregnancies per 100 W-Y of sole use. There were three reported severe adverse events and 102 other mild adverse events (most common were headache, nausea, abdominal and pelvic pain), with high recovery rate. The vaginal bleeding patterns showed a slight decrease in volume of bleeding and the number of bleeding-free days increased over time. There was only one case of severe anaemia, found at the final visit (0.4%). The method was considered acceptable, as over 90% of participants would choose to use it in the future or would recommend it to others. LIMITATIONS, REASONS FOR CAUTION: This was a single-arm study with small sample size, without a control group, designed as a proof of concept study to explore the feasibility of this type of contraception. WIDER IMPLICATIONS OF THE FINDINGS: A larger clinical study evaluating pericoital contraception with LNG is feasible and our data show that this method would be acceptable to many women. STUDY FUNDING/COMPETING INTERESTS: This study received partial financial support from the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR) and the World Health Organization. Gynuity and the Bill and Melinda Gates Foundation (BMGF) provided financial support for project monitoring. HRA Pharma donated the LNG product. N.K. was the initial project manager when she was with WHO/HRP and was employed by HRA Pharma, which distributes LNG for emergency contraception. The other authors declare no conflicts of interest. TRIAL REGISTRATION NUMBER: This study was registered on ANZCTR, Trial ID ACTRN12611001037998. TRIAL REGISTRATION DATE: 4 October 2011. DATE OF FIRST PATIENT'S ENROLMENT: 10 January 2012.

Two prophylactic medication approaches in addition to a pain control regimen for early medical abortion < 63 days' gestation with mifepristone and misoprostol: study protocol for a randomized, controlled trial.

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: ACTRN12613000017729 (Prospectively registered 8/1/2013).

Intrauterine device insertion in the postpartum period: a systematic review.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

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.

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.

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 2000 medical abortion users (1000 from each source). RESULTS: Complete outcome data was available and analyzed from 1958 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).

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.

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.

Perioperative antibiotics to prevent infection after first-trimester abortion.

BACKGROUND: There are two main strategies for the prevention of post-abortal upper genital tract infection: antibiotics given around the time of surgery for all women; and 'screen-and-treat', in which all women presenting for abortion are screened for genital infections and those with positive results are treated. OBJECTIVES: To determine:1. the effectiveness of antibiotic prophylaxis in preventing post-abortal upper genital tract infection; 2. the most effective antibiotic regimen; 3. the most effective strategy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, POPLINE and LILACS. The search was last updated in May 2011. SELECTION CRITERIA: Randomised controlled trials (RCTs) in any language including women undergoing induced first trimester surgical or medical abortion, comparing: 1) any antibiotic regimen to placebo, nothing, or another antibiotic; 2) screen-and-treat versus antibiotics. The primary outcome was the proportion of women diagnosed with post-abortal upper genital tract infection. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected references and extracted data. We calculated risk ratios (RR) with 95% confidence intervals (CI). We used meta-analysis where appropriate and examined between trial heterogeneity using the I(2) statistic. In the presence of between trial heterogeneity we also estimated the 95% prediction interval (PI). MAIN RESULTS: A total of 703 unique items was identified. We included 19 RCTs. There was evidence of small study biases (Egger test, P = 0.002). In 15 placebo-controlled RCTs there was an effect of antibiotic prophylaxis (pooled RR 0.59, 95% CI 0.46 to 0.75, 95% PI 0.30 to 1.14, I(2) = 39%). There were insufficient data (three trials) to determine whether one regimen was superior to another. In one trial, the incidence of post-abortal upper genital tract infection was higher in women allocated to the screen-and-treat strategy (RR 1.53, 95% CI 0.99 to 2.36). AUTHORS' CONCLUSIONS: Antibiotic prophylaxis at the time of first trimester surgical abortion is effective in preventing post-abortal upper genital tract infection. Evidence of between trial heterogeneity suggests that the effect might not apply to all settings, population groups or interventions.This review did not determine the most effective antibiotic prophylaxis regimen. Antibiotic choice should take into account the local epidemiology of genital tract infections, including sexually transmitted infections.Further RCTs comparing different antibiotics or combinations of antibiotics with each other would be useful. Such trials could be done in low and middle income countries and where the prevalence of genital tract infections in women presenting for abortion is high.

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.

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.

Medical methods for first trimester abortion.

BACKGROUND: Surgical abortion by vacuum aspiration or dilatation and curettage has been the method of choice for early pregnancy termination since the 1960s. Medical abortion became an alternative method of first trimester pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins. OBJECTIVES: To compare different medical methods for first trimester abortion. SEARCH METHODS: The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted. SELECTION CRITERIA: Types of studies Randomised controlled trials comparing different medical methods for abortion during first trimester (e.g. single drug, combination) were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant during the first trimester, undergoing medical abortion were the participants. The outcomes were mortality, failure to achieve complete abortion, surgical evacuation, ongoing pregnancy at follow-up, time until passing of conceptus, blood transfusion, side effects and women's dissatisfaction with the procedure. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion from the results of the search strategy described previously.The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. Data were processed using Revman software. MAIN RESULTS: Fifty-eight trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. Sublingual and buccal routes were similarly effective compared to the vaginal route, but had higher rates of side effects. 2) Mifepristone alone is less effective when compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Five trials compared prostaglandin alone to the combined regimen (mifepristone/prostaglandin). All but one reported higher effectiveness with the combined regimen. The results of these studies could not be combined but the RR of failure with prostaglandin alone is reportedly between 1.4 to 3.75 with the 95% confidence intervals indicating statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference in effectiveness with use of a divided dose compared to a single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin demonstrates similar rates of failure to complete abortion when comparing intramuscular to oral methotrexate administration (RR 2.04, 95% CI 0.51 to 8.07). Similarly, day 3 vs. day 5 administration of prostaglandin following methotrexate administration showed no significant differences (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs. methotrexate and no statistically significant differences were observed in effectiveness between the groups. AUTHORS' CONCLUSIONS: Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Vaginal misoprostol is more effective than oral administration, and has less side effects than sublingual or buccal. Some results are limited by the small numbers of participants on which they are based. Almost all trials were conducted in settings with good access to emergency services, which may limit the generalizability of these results.

Medical methods for mid-trimester termination of pregnancy.

BACKGROUND: With the improvement of ultrasound technology, the likelihood of detection of major fetal structural anomalies in mid-pregnancy has increased considerably. Upon the detection of serious anomalies, women typically are offered the option of pregnancy termination. Additionally, there are still many reasons other than fetal anomalies why women seek abortion in the mid-trimester. OBJECTIVES: To compare different methods of second trimester medical termination of pregnancy for their efficacy and side-effects. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, Popline and reference lists of retrieved papers and other sources. SELECTION CRITERIA: All randomised controlled trials (RCTs) examining medical regimens for termination of pregnancy of a singleton living fetus between 12-28 weeks' gestation were analysed. The outcome measures were the induction to abortion interval, abortion rate within 24 hours, need for surgical evacuation, blood loss, uterine rupture, pain, and side-effects.Trials including >20% fetal death, multiple pregnancies, previous uterine scars and regimens which involved cervical preparation were excluded. DATA COLLECTION AND ANALYSIS: Two authors selected the trials and three authors extracted data. MAIN RESULTS: Fourty RCTs were included, addressing various agents for pregnancy termination and methods of administration. When used alone, misoprostol was an effective inductive agent, though it appeared to be more effective in combination with mifepristone. However, the evidence from RCTs is limited.Misoprostol was preferably administered vaginally, although among multiparous women sublingual administration appeared equally effective. A range of doses of vaginally administered misoprostol has been used. No randomised trials comparing doses of misoprostol were identified; however low doses of misoprostol appear to be associated with fewer side-effects while moderate doses appear to be more efficient in completing abortion. Four RCTs showed that the induction to abortion interval with 3-hourly vaginal administration of prostaglandins is shorter than 6-hourly administration without an increase in side-effects.Many studies reported the need for surgical evacuation. Indications for surgical evacuation include retained products of the placenta and heavy vaginal bleeding. Fewer women required surgical evacuation when misoprostol was administrated vaginally compared with women receiving intra-amniotical PGF(2a) . Mild, self-limiting diarrhoea was more common among women who received misoprostol compared to other agents. AUTHORS' CONCLUSIONS: Medical abortion in the second trimester using the combination of mifepristone and misoprostol appeared to have the highest efficacy and shortest abortion time interval. Where mifepristone is not available, misoprostol alone is a reasonable alternative. The optimal route for administering misoprostol is vaginally, preferably using tablets at 3-hourly intervals. Apart from pain, the side-effects of vaginal misoprostol are usually mild and self limiting. Conclusions from this review are limited by the gestational age ranges and variable medical regimens, including dosing, administrative routes and intervals of medication, of the included trials.

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.

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.

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.