Determination of medical abortion success by women and community health volunteers in Nepal using a symptom checklist.

BACKGROUND: We sought to determine if female community health volunteers (FCHVs) and literate women in Nepal can accurately determine success of medical abortion (MA) using a symptom checklist, compared to experienced abortion providers. METHODS: Women undergoing MA, and FCHVs, independently assessed the success of each woman's abortion using an 8-question symptom checklist. Any answers in a red-shaded box indicated that the abortion may not have been successful. Women's/FCHVs' assessments were compared to experienced abortion providers using standard of care. RESULTS: Women's (n = 1153) self-assessment of MA success agreed with abortion providers' determinations 85% of the time (positive predictive value = 90, 95% CI 88, 92); agreement between FCHVs and providers was 82% (positive predictive value = 90, 95% CI 88, 92). Of the 92 women (8%) requiring uterine evacuation with manual vacuum aspiration (n = 84, 7%) or medications (n = 8, 0.7%), 64% self-identified as needing additional care; FCHVs identified 61%. However, both women and FCHVs had difficulty recognizing that an answer in a red-shaded box indicated that the abortion may not have been successful. Of the 453 women with a red-shaded box marked, only 35% of women and 41% of FCHVs identified the need for additional care. CONCLUSION: Use of a checklist to determine MA success is a promising strategy, however further refinement of such a tool, particularly for low-literacy settings, is needed before widespread use.

Determination of medical abortion eligibility by women and community health volunteers in Nepal: A toolkit evaluation.

OBJECTIVE: To determine if pregnant, literate women and female community health volunteers (FCHVs) in Nepal can accurately determine a woman's eligibility for medical abortion (MA) using a toolkit, compared to comprehensive abortion care (CAC) trained providers. STUDY DESIGN: We conducted a prospective diagnostic accuracy study in which women presenting for first trimester abortion, and FCHVs, independently assessed each woman's eligibility for MA using a modified gestational dating wheel to determine gestational age and a nine-point checklist of MA contraindications or cautions. Ability to determine MA eligibility was compared to experienced CAC-providers using Nepali standard of care. RESULTS: Both women (n = 3131) and FCHVs (n = 165) accurately interpreted the wheel 96% of the time, and the eligibility checklist 72% and 95% of the time, respectively. Of the 649 women who reported potential contraindications or cautions on the checklist, 88% misidentified as eligible. Positive predictive value (PPV) of women's assessment of eligibility based on gestational age was 93% (95% CI 92, 94) compared to CAC-providers' (n = 47); PPV of the medical contraindications checklist and overall (90% [95% CI 88, 91] and 93% [95% CI 92, 94] respectively) must be interpreted with caution given women's difficulty using the checklist. PPV of FCHVs' determinations were 93% (95% CI 92, 94), 90% (95% CI 89,91), and 93% (95% CI 91, 94) respectively. CONCLUSION: Although a promising strategy to assist women and FCHVs to assess MA eligibility, further refinement of the eligibility tools, particularly the checklist, is needed before their widespread use.

Standardizing the classification of abortion incidents: the Procedural Abortion Incident Reporting and Surveillance (PAIRS) Framework.

OBJECTIVES: To develop and validate standardized criteria for assessing abortion-related incidents (adverse events, morbidities, near misses) for first-trimester aspiration abortion procedures and to demonstrate the utility of a standardized framework [the Procedural Abortion Incident Reporting & Surveillance (PAIRS) Framework] for estimating serious abortion-related adverse events. STUDY DESIGN: As part of a California-based study of early aspiration abortion provision conducted between 2007 and 2013, we developed and validated a standardized framework for defining and monitoring first-trimester (≤14weeks) aspiration abortion morbidity and adverse events using multiple methods: a literature review, framework criteria testing with empirical data, repeated expert reviews and data-based revisions to the framework. RESULTS: The final framework distinguishes incidents resulting from procedural abortion care (adverse events) from morbidity related to pregnancy, the abortion process and other nonabortion related conditions. It further classifies incidents by diagnosis (confirmatory data, etiology, risk factors), management (treatment type and location), timing (immediate or delayed), seriousness (minor or major) and outcome. Empirical validation of the framework using data from 19,673 women receiving aspiration abortions revealed almost an equal proportion of total adverse events (n=205, 1.04%) and total abortion- or pregnancy-related morbidity (n=194, 0.99%). The majority of adverse events were due to retained products of conception (0.37%), failed attempted abortion (0.15%) and postabortion infection (0.17%). Serious or major adverse events were rare (n=11, 0.06%). CONCLUSIONS: Distinguishing morbidity diagnoses from adverse events using a standardized, empirically tested framework confirms the very low frequency of serious adverse events related to clinic-based abortion care. IMPLICATIONS: The PAIRS Framework provides a useful set of tools to systematically classify and monitor abortion-related incidents for first-trimester aspiration abortion procedures. Standardization will assist healthcare providers, researchers and policymakers to anticipate morbidity and prevent abortion adverse events, improve care metrics and enhance abortion quality.

Reduction in infection-related mortality since modifications in the regimen of medical abortion.

BACKGROUND: From 2001 to March 2006 Planned Parenthood health centers throughout the United States provided medical abortion by a regimen of oral mifepristone followed 24-48 h later by vaginal misoprostol. In response to concerns about serious infections, in early 2006 Planned Parenthood changed the route of misoprostol administration to buccal and required either routine antibiotic coverage or universal screening and treatment for chlamydia; in July 2007, Planned Parenthood began requiring routine antibiotic coverage for all medical abortions. METHODS: We performed a retrospective analysis of Planned Parenthood cases assessing the rates of mortality caused by infection following medical abortion during a time period when misoprostol was administered vaginally (2001 through March 2006), as compared with the rate from April 2006 to the end of 2012 after a change to buccal administration of misoprostol and after initiation of new infection-reduction strategies. RESULTS: The mortality rate dropped significantly in the 81-month period after the joint change to (1) buccal misoprostol replacing vaginal misoprostol and (2) either sexually transmitted infection (STI) screening or routine preventative antibiotic coverage (15 month period) or universal routine preventative antibiotic coverage as part of the medical abortion (66-month period), from 1.37/100,000 to 0.00/100,000, P=.013 (difference=1.37/100,000, 95% CI 0.47-4.03 per 100,000). CONCLUSION: The infection-caused mortality rate following medical abortion declined by 100% following a change from vaginal to buccal administration of misoprostol combined with screen-and-treat or, far more commonly, routine antibiotic coverage. SIGNIFICANCE: Deaths from infection following medical abortion declined to zero after a change in the regimen.

Severity of infection following the introduction of new infection control measures for medical abortion.

BACKGROUND: In response to concerns about serious infections following medical abortion, in early 2006 the Planned Parenthood Federation of America changed the route of misoprostol administration from vaginal to buccal and required either routine antibiotic coverage or universal screening and treatment for chlamydia; in July 2007, the Planned Parenthood Federation of America began requiring routine antibiotic coverage for all medical abortions. We previously reported a pronounced drop in the rate of serious infections following the adoption of these new infection control measures. Our objective in this study was to assess whether the degree of severity of the serious infections differed in the three infection control groups (vaginal misoprostol and no antibiotics; buccal misoprostol and screen-and-treat method; buccal misoprostol and routine antibiotics) or, equivalently, to assess whether the declines in rates of serious infections after the adoption of new infection control measures differed across the degree of severity categories. Of particular importance is whether the new infection control measures selectively reduced the least severe serious infections but did not diminish the rate of the most severe infections. METHODS: We performed a retrospective analysis assessing the degree of severity of infections before infection controls were implemented and after each of the two new measures was adopted: buccal administration of antibiotics with either screen-and-treat method or routine antibiotic coverage. We ranked the severity of infection from 1 (when treatment occurred in an emergency department) to 4 (when death occurred). We compared the distributions of the severity of serious infections in the three infection control groups (none; buccal misoprostol and screen-and-treat method; buccal misoprostol and routine antibiotics) or, equivalently, assessed whether the declines in rates of serious infections after the adoption of new infection control measures differed across the degree of severity categories using the Jonckheere-Terpstra test for a doubly ordered 4 × 3 table. RESULTS: The distribution of infection by severity was the same for all three infection control groups. Likewise, when the two new infection control groups--buccal misoprostol plus either screen-and-treat method or routine antibiotics--were combined, the distribution of infection by severity was the same before and after the new measures were implemented. CONCLUSION: The pronounced decline in the rate of serious infections occurred in each category of severity.

Effectiveness of medical abortion with mifepristone and buccal misoprostol through 59 gestational days.

BACKGROUND: From 2001 to March 2006, Planned Parenthood Federation of America (Planned Parenthood) health centers throughout the United States provided medical abortions principally by a regimen of oral mifepristone, followed 24-48 h later by vaginal misoprostol. In late March 2006, analyses of serious uterine infections following medical abortions led Planned Parenthood to change the route of misoprostol administration and to employ additional measures to minimize subsequent serious uterine infections. In August 2006, we conducted an extensive audit of medical abortions with the new buccal misoprostol regimen so that patients could be given accurate information about the success rate of the new regimen. OBJECTIVES: We sought to evaluate the effectiveness of the buccal medical abortion regimen and to examine correlates of its success during routine service delivery. METHODS: In 2006, audits were conducted in 10 large urban service points to estimate the success rates of the buccal regimen. Success was defined as medical abortion without vacuum aspiration. These audits also permitted estimates of success rates with oral misoprostol following mifepristone in a subset in which 98% of the subjects stemmed from two sites. RESULTS: The effectiveness of the buccal misoprostol-mifepristone regimen was 98.3% for women with gestational ages below 60 days. The oral misoprostol-mifepristone regimen, used by 278 women with a gestational age below 50 days, had a success rate of 96.8%. CONCLUSION: In conjunction with 200 mg of mifepristone, use of 800 mcg of buccal misoprostol up to 59 days of gestation is as effective as the use of 800 mcg of vaginal misoprostol up to 63 days of gestation.

Unexpected heaping in reported gestational age for women undergoing medical abortion.

BACKGROUND: In August 2006, the Planned Parenthood Federation of America (Planned Parenthood) conducted an extensive audit of first-trimester medical abortions with oral mifepristone plus buccal misoprostol through 56 days of gestation so that patients could be given accurate information about the success rate of the new regimen. OBJECTIVES: We sought to evaluate the effectiveness of this buccal misoprostol regimen and to examine correlates of its success during routine service delivery. METHODS: Audits in 10 large urban service points were conducted in 2006 to estimate the success rates of the buccal regimen. Success was defined as medical abortion without vacuum aspiration. RESULTS: We discovered unexpected heaping of reported gestational age (GA) on days divisible by 7. CONCLUSION: Such heaping, which has not been reported in the literature, would make it more difficult to detect a modest trend in declining effectiveness with increasing GA, if there were one. High coefficients of variation of sac size and crown-rump length characterize the early gestational weeks. We suspect, but are unable to prove, that the source of the heaping found in our investigation is a tendency for operators of ultrasound machines at some sites to simplify reporting by rounding a portion of the results to a date corresponding to the nearest complete gestational week. We believe that immediate supervisory awareness and feedback may reduce the extent of the problem. However, the problem may persist in multiple-site studies given the underlying variability of ultrasound measurements with differently calibrated machines and different rules for recording data, some of which may permit acceptance of an estimate based on the stated date of the last menses, if it differs by no more than 2 or 3 days from the ultrasound result.

Rates of serious infection after changes in regimens for medical abortion.

BACKGROUND: From 2001 through March 2006, Planned Parenthood health centers throughout the United States provided medical abortion (abortion by means of medication) principally by a regimen of oral mifepristone followed 24 to 48 hours later by vaginal misoprostol. In response to concern about serious infections, in early 2006 Planned Parenthood changed the route of misoprostol administration from vaginal to buccal and required either routine provision of antibiotics or universal screening and treatment for chlamydia; in July 2007, Planned Parenthood began requiring routine treatment with antibiotics for all medical abortions. METHODS: We performed a retrospective analysis assessing the rates of serious infection after medical abortion during a time when misoprostol was administered vaginally (through March 2006), as compared with rates after a change to buccal administration of misoprostol and after initiation of additional infection-reduction measures. RESULTS: Rates of serious infection dropped significantly after the joint change to buccal misoprostol from vaginal misoprostol and to either testing for sexually transmitted infection or routine provision of antibiotics as part of the medical abortion regimen. The rate declined 73%, from 0.93 per 1000 abortions to 0.25 per 1000 (absolute reduction, 0.67 per 1000; 95% confidence interval [CI], 0.44 to 0.94; P<0.001). The subsequent change to routine provision of antibiotics led to a further significant reduction in the rate of serious infection - a 76% decline, from 0.25 per 1000 abortions to 0.06 per 1000 (absolute reduction, 0.19 per 1000; 95% CI, 0.02 to 0.34; P=0.03). CONCLUSIONS: The rate of serious infection after medical abortion declined by 93% after a change from vaginal to buccal administration of misoprostol combined with routine administration of antibiotics.