A non-inferiority study of outpatient mifepristone-misoprostol medical abortion at 64-70 days and 71-77 days of gestation.

OBJECTIVES: This open-label non-inferiority study assessed efficacy of a common outpatient medical abortion regimen among people with pregnancies 64-70 days and 71-77 days of gestation. STUDY DESIGN: We defined non-inferiority by a 6% margin of method success. People with intrauterine pregnancies 64-77 days' gestational age by abdominal ultrasound seeking medical abortion at one of eight clinics and met eligibility criteria were offered participation. Consenting participants took mifepristone 200 mg followed 24-48 h later by misoprostol 800 mcg buccally, and returned after one week for provider evaluation and abdominal ultrasound to determine abortion status. Participants recorded medication use, pregnancy expulsion, daily bleeding and pain scores until the one-week follow up. Clinic staff interviewed participants prior to study discharge to assess acceptability. RESULTS: Seven hundred and nineteen participants were enrolled, 393 and 326 in the respective groups. Successful expulsion without surgical intervention was achieved in 92.3% of the earlier gestational age group and 86.7% of the later group (difference in proportions 5.6%, 1-sided 95% CI 9.6). Ongoing pregnancy accounted for 3.6% and 8.7% (p = 0.007) of outcomes, respectively. Participants in the 71-77 day group reported nausea and weakness more frequently. Pain, bleeding and acceptability measures between groups were similar. CONCLUSION: Although the success rate at 71-77 days of gestation was within the non-inferiority margin, we cannot rule out that it is statistically worse than in the previous gestational week. Significantly more ongoing pregnancies in the later group raise concerns about using the regimen at 71-77 days.

First-trimester aspiration abortion practices: a survey of United States abortion providers.

OBJECTIVES: To assess whether first-trimester aspiration abortion practices of US providers agree with evidence-based policy guidelines. STUDY DESIGN: We sent surveys by mail or electronically to all abortion facilities in the United States identified via professional networks and websites from June through December 2013. Administrators reported on the volume of procedures performed at their site(s) through 13 weeks 6 days' gestation and on clinic services. Clinicians reported on personal demographic characteristics and abortion practices. We reviewed guidelines from key US professional organizations to determine how well reported practices aligned with available recommendations and the extent to which guidelines have changed since the time of the survey. RESULTS: We identified 703 clinical sites in the United States; 383 (54%) sites responded, 256 of which offer first-trimester aspiration abortions. Most providers identified as obstetrician-gynecologists (74%) and female (64%); 52% were less than 50 years old compared to 36% in 2002. Overall, reported practices follow evidence-based guidelines, including routine administration of periprocedure antibiotics (85%), use of misoprostol for cervical ripening in the late first trimester (94%), pain management practices, and same-day contraception provision (98%) including long-acting devices (76%). Less evidence-based practices include routine preprocedure ultrasound (99%), not providing abortion before 5 weeks' gestation (66%), restrictive fasting policies, and prolonged and postprocedure antibiotic provision. CONCLUSION: Overall, the first-trimester aspiration abortion practices revealed in our survey agree with professional evidence-based policy guidelines, though some related to preprocedure ultrasound use, very early abortion provision, preanesthesia fasting protocols, and antibiotic regimens deserve attention. IMPLICATIONS: In this third cross-sectional survey of US abortion practices (prior surveys 1997 and 2002), first-trimester aspiration abortion providers are younger than before, reflecting an improvement in the "graying" of the abortion provider workforce. Research and education are needed to further improve evidence-based practice in abortion care.

Do women want to talk about birth control at the time of a first-trimester abortion?

OBJECTIVE: To investigate if women desire talking to a counselor or physician about contraception when seeking first-trimester medical or surgical abortion. STUDY DESIGN: We conducted a cross-sectional study by distributing self-administered anonymous surveys to women at three clinics in Sacramento, California; Chicago, Illinois; and Cleveland, Ohio, from October 2014 to February 2015. Participants completed surveys after registration and before any in-office counseling. We asked whether women want to discuss contraception, specific topics they want to discuss, reasons why they may not want to talk about contraception and whether they want to receive contraception services as part of their abortion care. We conducted regression analyses to assess associations between patient characteristics and the desire for counseling. RESULTS: Among 3041 eligible women, 1959 (64.4%) completed surveys. Overall, 1208 (61.7%) did not want to discuss contraception prior to having an abortion, primarily citing that they already know which method they want. We found no association between the desire to discuss contraception and age, race, planned abortion method, clinic site and number of unplanned pregnancies. Among those who desired to talk about contraception, subjects preferred to discuss which contraceptive methods are easier to use and more effective as compared to previously used methods. Regardless of their desire for a discussion about contraception, 1386 (70.8%) of subjects wanted to leave the clinic with a specific method, including a long-acting reversible method [intrauterine device or implant (190, 13.7%)] or other hormonal method [pills, patch, ring or injectable (680, 49.1%)]. CONCLUSIONS: The majority of women seeking first-trimester abortion do not come to the clinic wanting to discuss contraception, most commonly because they have a preferred method in mind. IMPLICATIONS: Providers should ask women presenting for abortion if they want to discuss contraception and not assume that they need or desire such information. Focused discussions, starting with the preferred method if known, may better satisfy women's preferences. Providers should account for such desires when allocating resources for contraception services during abortion care.

Second-trimester surgical abortion practices in the United States.

OBJECTIVE: To assess whether second-trimester surgical abortion practices of U.S. providers agree with evidence-based policy guidelines. STUDY DESIGN: We conducted a cross-sectional survey of abortion facilities in the U.S. identified via publicly available resources and professional networks from June through December 2013. RESULTS: Of 703 identified facilities, 383 (54%) participated, including 172 clinicians providing second-trimester surgical abortions (dilation and evacuations [D&Es]). The majority of clinicians were obstetrician-gynecologists (87%), female (67%), and less than 50 years old (62%). Most clinicians (93%) ever use misoprostol as a cervical preparation agent, including in the setting of a uterine scar (87%). Some clinicians refer to a hospital-based provider if the patient has a placenta previa and a history of cesarean section (31%) or a complete previa alone (17%). Many clinicians have weight or body mass index restrictions for cases performed under iv moderate sedation (32/97, 33%) or deep sedation (23/50, 46%). Most clinicians (69%) who report performing D&Es at 18 weeks last menstrual period or greater do not routinely induce fetal demise preoperatively. Clinicians employ routine intraoperative ultrasound (79%) more commonly than routine postoperative ultrasound (47%), with no difference by years of provider experience. Most clinicians routinely use prophylactic uterotonic agents, most often postoperatively. Most clinicians (80%) routinely give perioperative antibiotics, most often doxycycline (75%). CONCLUSION: Overall, the second-trimester surgical abortion practices revealed in our survey agree with professional evidence-based policy guidelines. Wider variability was reported for practices lacking a strong evidence base. IMPLICATIONS: In this third cross-sectional survey of U.S. abortion practices (prior 1997 and 2002), second-trimester surgical abortion providers are younger than before, reflecting an improvement in the "graying" of the abortion provider workforce. Facility restrictions on gestational age along with hospital restrictions on referrals pose barriers to outpatient abortion access.

First trimester medication abortion practice in the United States and Canada.

We conducted a cross-sectional survey of abortion facilities from professional networks in the United States (US, n = 703) and Canada (n = 94) to estimate the prevalence of medication abortion practices in these settings and to look at regional differences. Administrators responded to questions on gestational limits, while up to five clinicians per facility reported on 2012 medication abortion practice. At the time of fielding, mifepristone was not approved in Canada. 383 (54.5%) US and 78 (83.0%) Canadian facilities participated. In the US, 95.3% offered first trimester medication abortion compared to 25.6% in Canada. While 100% of providers were physicians in Canada, just under half (49.4%) were advanced practice clinicians in the US, which was more common in Eastern and Western states. All Canadian providers used misoprostol; 85.3% with methotrexate. 91.4% of US providers used 200 mg of mifepristone and 800 mcg of misoprostol, with 96.7% reporting home misoprostol administration. More than three-quarters of providers in both countries required an in-person follow-up visit, generally with ultrasound. 87.7% of US providers routinely prescribed antibiotics compared to 26.2% in Canada. Nonsteroidal anti-inflammatory drugs were the most commonly reported analgesic, with regional variation in opioid narcotic prescription. In conclusion, medication abortion practice follows evidence-based guidelines in the US and Canada. Efforts to update practice based on the latest evidence for reducing in-person visits and increasing provision by advanced practice clinicians could strengthen these services and reduce barriers to access. Research is needed on optimal antibiotic and analgesic use.

Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial.

OBJECTIVE: To evaluate operative time after adjunctive misoprostol or mifepristone compared with overnight osmotic dilators alone for cervical preparation before dilation and evacuation at 16-23 6/7 weeks of gestation. METHODS: This double-blind, three-arm, multicenter, randomized trial compared overnight osmotic dilators alone, dilators plus 400 micrograms buccal misoprostol 3 hours preoperatively, and dilators plus 200 mg oral mifepristone during dilator placement for dilation and evacuation. Our primary outcome was dilation and evacuation operative time within two cohorts: 16-18 6/7 weeks of gestation (N=150) and 19-23 6/7 weeks of gestation (N=150). Three hundred women were required for 80% power to detect a 2-minute difference in operative time. Secondary outcomes included initial cervical dilation, side effects, physician satisfaction by Likert scale, and complications. RESULTS: Between February 2013 and February 2014 we randomized 300 women evenly across treatment arms. Group demographics were similar. We found no difference in operative time in either gestational cohort (early cohort [minutes]: 5.11±3.0 dilators alone, 4.99±3.3 misoprostol, 4.33±2.0 mifepristone, P=.34; late cohort [minutes]: 7.50±3.7 dilators alone, 7.62±5.4 misoprostol, 6.74±3.2 mifepristone, P=.53). In the early cohort, initial dilation was greater with misoprostol than dilators alone (2.4 compared with 2.0 cm, P=.007). Patients given misoprostol had significantly more pain, fever, and chills. In the late cohort, dilation and evacuation procedures were less difficult after mifepristone (4.1%, 95% confidence interval [CI] 0.0-9.6) than misoprostol (18.8%, 95% CI 7.7-29.8) or dilators alone (18.8%, 95% CI 7.7-29.8; P=.04). We had inadequate power to infer differences in complications: dilators alone (10%, 95% CI 4.2-16.0) compared with misoprostol (2%, 95% CI 0-4.7) compared with mifepristone (2%, 95% CI 0-4.8). CONCLUSION: Despite no difference in operative time, adjunctive mifepristone facilitates later dilation and evacuation compared with osmotic dilators alone and is better tolerated than misoprostol. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01751087. LEVEL OF EVIDENCE: I.

Medication abortion failure in women with and without previous cesarean delivery.

OBJECTIVE: To investigate the association between previous cesarean delivery and medication abortion failure and the association between parity and failure. METHODS: Data were abstracted from 2035 consecutive charts of women who underwent medication abortion in 2011. All women were at 63 days gestation or less and received mifepristone 200mg orally and misoprostol 800 mcg buccally. We used multivariate logistic regression to assess the relationship between failure, defined as requiring either curettage or additional medication, and prior cesarean delivery. We also examined the relationship between failure and parity. RESULTS: Follow-up was available on 1609 (79%) patients. Overall, 4.5% of patients experienced failure. Neither cesarean delivery nor parity was associated with failure; 6.5% of women with prior cesarean delivery experienced failure, compared to 3.7% of nulliparous women [adjusted odds ratio (aOR), 1.79, 95% confidence interval (CI), 0.83-3.87]. With regard to parity, 4.7% of women with two or more previous births experienced failure, compared to 3.7% of nulliparous women (aOR, 1.07, 95% CI, 0.54-2.14). CONCLUSION: We did not find significant associations between prior cesarean delivery and failure or parity and failure. A previous study of patients who had received a less effective regimen reported significant associations between cesarean delivery and failure and parity and failure. While our results do not rule out the possibility of modest associations due to our limited statistical power, they are reassuring relative to previous findings. IMPLICATIONS: Our results suggest that if there are differences in women's odds of medication abortion failure by obstetric history, such differences are unlikely to be large. Providers and patients may factor this information into decision making about methods of pregnancy termination.

Misoprostol 1 to 3 h preprocedure vs. overnight osmotic dilators prior to early second-trimester surgical abortion.

OBJECTIVES: We sought to compare the effectiveness of at least 1 h of 400 mcg of buccal misoprostol to overnight osmotic dilators for early second-trimester surgical abortion cervical preparation. DESIGN: We conducted a retrospective cohort study, reviewing 145 consecutive charts to compare procedure duration for women who received 400 mcg of buccal misoprostol at least 1 h preprocedure vs. overnight osmotic dilators before dilation and evacuation between 14 weeks, 0 days and 15 weeks, 6 days' gestation. Primary outcome was procedure duration and secondary outcomes included maximum mechanical dilator size, estimated blood loss and side effects. RESULTS: Sixty-four women (44.1%) received buccal misoprostol (mean 1.6 h), and 81 women (55.9%) received overnight osmotic dilators. Groups did not differ regarding mean gestational age or gynecologic history. All procedures in both groups were completed. Procedure duration was not significantly different between the misoprostol and osmotic dilator groups (median 11.0 min vs. 10.0 min, p=.22), even after multivariable linear regression (p=.17). The mean total cervical preparation duration was 1.6 h for women in the misoprostol group compared to 20.3 h in the osmotic dilator group (p<.001). Secondary outcomes did not differ between groups. CONCLUSIONS: We found that at least 1 h of preprocedure misoprostol decreased the duration of cervical preparation for early second-trimester procedures performed by an experienced surgeon. IMPLICATIONS: In this small, retrospective review, at least 1 h of preprocedure buccal misoprostol decreased the duration from cervical preparation initiation to procedure completion in early second-trimester procedures performed by an experienced surgeon. These results should be considered as a pilot evaluation, and further prospective study is needed to further clarify whether this short interval could be applied in general practice.

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.

Prophylactic compared with therapeutic ibuprofen analgesia in first-trimester medical abortion: a randomized controlled trial.

OBJECTIVE: To compare the effectiveness of two oral analgesic regimens in first-trimester medical abortion. METHODS: We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimens: therapeutic (800 mg every 4-6 hours as needed for pain) or prophylactic (800 mg starting 1 hour before the misoprostol dose, then every 4-6 hours for 48 hours regardless of pain, then as needed). We asked each participant to record her maximum pain on a scale of 0-10 daily thereafter. RESULTS: Of participants assigned to the prophylactic and therapeutic regimens, 111 of 123 (90%) and 117 of 127 (92%), respectively, provided follow-up data. More than 80% of the participants in each group complied with their assigned treatment. Participants in the prophylactic group used substantially more ibuprofen than those in the therapeutic group (median of nine and four tablets, respectively). The mean maximum pain score was 7.1 in the prophylactic group and 7.3 in the therapeutic group (standard deviations 2.5 and 2.2, respectively); the difference was not statistically significant (P=.87, adjusted for site). Duration of pain, verbal pain ratings reported at follow-up, and use of other analgesics did not differ significantly by group (all P>.05). No significant benefit of the prophylactic regimen was apparent in any population subgroup. Abortion failure and ibuprofen side effects in the two groups were similar. CONCLUSION: We found no evidence that prophylactic administration of ibuprofen reduces pain severity or duration in first-trimester medical abortion. The average pain severity experienced by participants using both regimens was high. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01457521. LEVEL OF EVIDENCE: I.

Surgical abortion prior to 7 weeks of gestation.

The following guidelines reflect a collation of the evaluable medical literature about surgical abortion prior to 7 weeks of gestation. Early surgical abortion carries lower risks of morbidity and mortality than procedures performed later in gestation. Surgical abortion is safe, practicable and successful as early as 3 weeks from the start of last menses (no gestational sac visible on vaginal ultrasound) provided that (a) routine sensitive pregnancy testing verifies pregnancy, (b) the tissue aspirate is immediately examined for the presence of a gestational sac plus villi and (c) a protocol to identify ectopic pregnancy expeditiously--including calculation of readily obtained serial serum quantitative human chorionic gonadotropin titers when clinically appropriate--is in place and strictly adhered to. Manual and electric vacuum aspiration methods for early abortion demonstrate comparable efficacy, safety and acceptability. Current data are inadequate to determine if any of the following techniques substantially improve procedure success or safety: use of rigid versus flexible cannulae, light metallic curettage following uterine aspiration, uterine sounding or routine use of intraoperative ultrasound.

Extending outpatient medical abortion services through 70 days of gestational age.

OBJECTIVE: To estimate the efficacy and acceptability of medical abortion at 64-70 days from last menstrual period (LMP) and to compare it with the already proven 57-63 days from LMP gestational age range. METHODS: This prospective, comparative, open-label trial enrolled 729 women with pregnancies 57-70 days from LMP requesting abortion at six U.S. clinics. Medical abortions were managed with 200 mg mifepristone and 800 micrograms buccal misoprostol and sites' service delivery protocols. Follow-up visits occurred 7-14 days after mifepristone, with an abortion considered complete if surgical intervention was not performed. Success, ongoing pregnancy, and acceptability rates were compared. RESULTS: A total of 629 cases were analyzable for efficacy. Success rates were similar in the two groups (57-63 days group: 93.5%, 95% confidence interval [CI] 90-96; 64-70 days group: 92.8%, 95% CI 89-95). Ongoing pregnancy rates also did not differ significantly (57-63 days: 3.1%, 95% CI 1.6-5.8; 64-70 days: 3.0%, 95% CI 1.5-5.7). Acceptability was high and similar in both arms, with most women (57-63 days: 87.4%; 64-70 days: 88.3%) reporting that their experience was either very satisfactory or satisfactory. CONCLUSION: Medical abortion with mifepristone and misoprostol in current outpatient settings is an efficacious and acceptable method of ending pregnancies 64-70 days from LMP and can be offered without alteration of existing services. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, www.clinicaltrials.gov, NCT00997347. LEVEL OF EVIDENCE: II.

Can at-home semi-quantitative pregnancy tests serve as a replacement for clinical follow-up of medical abortion? A US study.

BACKGROUND: Medical abortion in the United States requires clinic-based follow-up, representing additional time and cost to women and clinics. We studied a semi-quantitative home pregnancy test as a possible replacement for in-person follow-up. STUDY DESIGN: Four hundred and ninety women participated in the clinical study and used a pregnancy test to determine baseline human chorionic gonadotropin (hCG) on the day of mifepristone administration and follow-up hCG 1 week later. One hundred and eighty-nine other women completed a user comprehension survey. Accuracy, feasibility and acceptability of the test were assessed in both the clinical study and the survey. RESULTS: The test identified the one ongoing pregnancy in the clinical study cohort. Sensitivity and specificity were calculated at 100.0% and 97.0%. The majority of participants in both the clinical study and the user comprehension survey found the test to be "very easy" or "easy" to use. CONCLUSION: At-home follow-up with a semi-quantitative pregnancy test is feasible for service delivery in the United States.

Characteristics of presumptive idiopathic disseminated intravascular coagulation during second-trimester induced abortion.

BACKGROUND: Disseminated intravascular coagulation (DIC) is a serious and relatively uncommon complication of induced or spontaneous abortion or delivery. Occasionally, it has been reported in the absence of predisposing conditions. Little information in the literature describing idiopathic DIC or the treatment of patients with DIC exists. STUDY DESIGN: From 2002 through 2008, 24 cases of presumptive idiopathic DIC occurred following dilation and evacuation (D&E) abortion between 13 5/7 and 23 6/7 weeks' estimated gestational age at a Midwestern ambulatory surgical center. The characteristics of each patient, their pregnancies and surgical experiences were examined and compared with a temporally matched control group of D&E patients. We explored whether the index cases had a predominance of any historical, clinical or reproductive characteristics compared with controls matched for demographic and reproductive landmarks. RESULTS: Overall incidence of presumptive idiopathic DIC was 1.8 per 1000 D&E cases. Compared with matched controls, there was a greater likelihood of DIC with more advanced gestation (p=.009); no case of DIC was under 17 weeks' gestational age. Increased bleeding occurred at a mean time of 153 min after completion of surgery (range, 55-491 min; median, 131 min). Nineteen of 24 cases were successfully treated at the surgical center after receiving 6 to 8 units of fresh-frozen plasma (FFP); 5 cases were transferred to a hospital for further treatment. CONCLUSIONS: The abnormal bleeding of presumptive DIC typically begins to appear within 2 h after uncomplicated D&E and is more likely to occur at 17 weeks' estimated gestational age and more. With rapid diagnosis and treatment, most patients were able to be treated in an outpatient setting with up to 6 to 8 units of FFP and rehydration.

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.

Alternatives to a routine follow-up visit for early medical abortion.

OBJECTIVE: To evaluate the ability of women and their providers to assess abortion outcome without the routine use of ultrasonography. METHODS: This multicenter trial enrolled 4,484 women seeking medical abortion at 10 clinics in the United States. Women received the standard medical abortion care with mifepristone-misoprostol in those clinics and blinded clinical assessments before follow-up ultrasonography. Data were collected prospectively on abortion outcomes, receipt of additional treatment, and clinical, laboratory, and ultrasound assessments associated with the procedure. We constructed five model algorithms for evaluating women's postabortion status, each using a different assortment of data. Four of the algorithms (algorithms 1-4) rely on data collected by the woman and on the results of the low-sensitivity pregnancy test. Algorithm 5 relies on the woman's assessment, the results of the pregnancy test, and follow-up physician assessment (sometimes including bimanual or speculum examination). RESULTS: A total of 3,054 women received medical abortion and had adequate data for evaluation. Twenty women (0.7%) had an ongoing pregnancy; 26 (0.9%) received curettage for retained tissue, empiric treatment for possible infection, or both; and 55 (1.8%) received additional uterotonics or other medical abortion-related care. Screening algorithms including patient-observed outcomes, a low-sensitivity pregnancy test, and nonsonographic clinical evaluation were as effective as sonography in identifying women who received interventions at or after the follow-up visit. CONCLUSION: Relying on women's observations, a low-sensitivity pregnancy test, and clinical examination, women and their providers can accurately assess whether follow-up care is required after medical abortion without routine ultrasonography. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00120224. LEVEL OF EVIDENCE: II.

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.

First-trimester surgical abortion practices: a survey of National Abortion Federation members.

BACKGROUND: Designated providers in specialized clinics perform the majority of approximately 1.1 million first-trimester abortions carried out in the United States each year. Our objective was to assess the first-trimester surgical abortion practices of National Abortion Federation (NAF) members. STUDY DESIGN: We mailed questionnaires to NAF administrators and providers at their 364 active-member facilities in 2002. RESULTS: Two hundred eighty-nine (79%) facilities responded; we received administrative questionnaires from 273 facilities and 293 individual clinicians. NAF facilities provided at least 325,000 first-trimester surgical abortions in the United States in 2001. The majority of providers are obstetrician-gynecologists (63%), male (62%) and at least 50 years old (64%). Half of clinicians (49%) selectively utilize manual vacuum aspiration. Almost half (47%) routinely use a metal curette to verify procedure completion; these providers are more likely to be over 50 years of age or to have 20 years or more of abortion experience. Other practices are more uniform, including routine tissue examination (93%), postoperative antibiotics (88%) and contraceptive provision (oral contraceptives, 99%; depot medroxyprogesterone acetate, 79%). CONCLUSIONS: Most perioperative practices for first-trimester abortions are similar among these respondents, in accord with evidence-based guidelines. The aging of skilled practitioners raises concerns about the future availability of surgical abortion.