Second trimester medical abortion with mifepristone followed by unlimited dosing of buccal misoprostol in Armenia.

OBJECTIVES: The aim of the study was to assess the efficacy and acceptability of a regimen using mifepristone and buccal misoprostol with unlimited dosing for second trimester abortion in Armenia. METHODS: Women seeking to terminate 13-22 week pregnancies were enrolled in the study. Participants swallowed 200 mg mifepristone in the clinic and were instructed to return to the hospital for induction 24-48 h later. During induction, women were given 400 µg buccal misoprostol every 3 h until the fetus and placenta were expelled. The abortion was considered a success if complete uterine evacuation was achieved without oxytocin or surgery. RESULTS: A total of 120 women with a median gestational age of 18 weeks participated in the study. All women began misoprostol induction around 24 h after taking mifepristone. Complete uterine evacuation was achieved in 119 (99.2%) women. The median induction-to-abortion interval was 10.3 h (range 4-17.4) with a mean of 9.5 ± 2.5 h. A median of four misoprostol doses (range 2-6) with a mean of 4 ± 1 misoprostol doses were administered. The induction-to-abortion interval, number of misoprostol doses, pain score and analgesia use increased as gestational age advanced. Acceptability of the method was high among both patients and providers. CONCLUSION: The medical abortion regimen of 200 mg mifepristone followed 24 h later by induction with 400 µg buccal misoprostol administered every 3 h, with no limit on the number of doses used for the termination of pregnancies of 13-22 weeks' gestation is an effective and acceptable option for women.

Acceptability and feasibility of 400 µg buccal misoprostol after 200 mg mifepristone for early medical abortion in Georgia.

OBJECTIVES: The aim of the study was to examine the acceptability and feasibility of early medical abortion using 200 mg mifepristone and 400 µg buccal misoprostol in Georgia, outside the capital city of Tbilisi. METHODS: A total of 622 women in four regions of western and eastern Georgia who presented for termination of pregnancy at up to 63 d of gestation were enrolled in the study. In the western regions, women took one 200 mg pill of mifepristone in the clinic and were given the option of administering 400 µg misoprostol buccally, either at the clinic or at home, 24-48 h later. In the eastern region, women were given the option to take both drugs at home. Abortion status was determined 2 weeks after mifepristone administration. RESULTS: Ninety-five percent of participants had a successful abortion. Twenty-one percent of women in the eastern region elected to take mifepristone at home; nearly all participants in both regions (98%) chose to take misoprostol at home. Ninety-five percent of women were very satisfied or satisfied with the method, and 95% said they would prefer medical abortion for a future procedure. CONCLUSIONS: Medical abortion with mifepristone and 400 µg buccal misoprostol is an acceptable and feasible option for women in Georgia, outside the capital city of Tbilisi.

The introduction of first trimester medical abortion in Armenia.

In Armenia, abortion is the main means of fertility regulation; however, before research activities were initiated only surgical methods were available and the quality of services was low in some areas. Our clinical study from 2008-2011 aimed to show that early medical abortion is an acceptable and feasible option. A total of 700 eligible women with pregnancies up to 63 days LMP presenting for abortion were recruited for the study in five locations. Participants took 200 mg mifepristone and 800 µg buccal misoprostol 24-48 hours later. They returned for a follow-up visit two weeks after mifepristone administration. 95% of the women had successful abortions and 95% were satisfied with the method. In 2012-2013, we conducted a follow-up assessment to examine the ongoing provision and quality of medical abortion services at the former research sites. Medical record reviews, interviews and observations were carried out three times approximately six months apart. The assessment found that all five sites had continued providing medical abortion, with about half of eligible women choosing the medical method. Four of the five sites were achieving high success rates. Staff turnover and the lack of trained providers likely contributed to the higher failure rate at the fifth site. These findings provide evidence that first trimester medical abortion is an acceptable and feasible option for Armenian women and providers, and that high quality services are being delivered.

Acceptability and feasibility of mifepristone medical abortion in the early first trimester in Azerbaijan.

OBJECTIVE: To examine the acceptability and feasibility of early medical abortion using mifepristone and misoprostol in Azerbaijan. METHODS: A total of 863 women in Baku and two regions of Azerbaijan who sought termination of gestations up to 63 days were enrolled in the study. In the capital, women swallowed 200 mg mifepristone in the clinic and were given the option of taking 800 µg misoprostol buccally either at the clinic or at home 24-48 hours later. In the regions, women were given the option of taking both drugs at home. Follow-up visits were to take place two weeks after mifepristone administration to determine abortion status. RESULTS: Seventy-four percent of women in the regions chose home administration of mifepristone, and 92% of women from all locations selected misoprostol home administration. Ninety-seven percent of women had complete abortions, and 97% were satisfied or very satisfied with the method. The vast majority of participants preferred medical abortion for a future procedure (96%). Nearly all women (98%) would recommend medical abortion for pregnancy termination to a friend. CONCLUSION: Mifepristone-misoprostol medical abortion with the option of home administration of both drugs is an acceptable and feasible option for women in Azerbaijan.

White matter predictors of cognitive functioning in older adults.

Few studies have applied multiple imaging modalities to examine cognitive correlates of white matter. We examined the utility of T2-weighted magnetic resonance imaging (MRI) -derived white matter hyperintensities (WMH) and diffusion tensor imaging-derived fractional anisotropy (FA) to predict cognitive functioning among older adults. Quantitative MRI and neuropsychological evaluations were performed in 112 older participants from an ongoing study of the genetics of Alzheimer's disease (AD) in African Americans. Regional WMH volumes and FA were measured in multiple regions of interest. We examined the association of regional WMH and an FA summary score with cognitive test performance. Differences in WMH and FA were compared across diagnostic groups (i.e., normal controls, mild cognitive impairment, and probable AD). Increased WMH volume in frontal lobes was associated with poorer delayed memory performance. FA did not emerge as a significant predictor of cognition. White matter hyperintensity volume in the frontal and parietal lobes was increased in MCI participants and more so in AD patients relative to controls. These results highlight the importance of regionally distributed small vessel cerebrovascular disease in memory performance and AD among African American older adults. White matter microstructural changes, quantified with diffusion tensor imaging, appear to play a lesser role in our sample.

Could second-trimester medical abortion be offered as a day service? Assessing the feasibility of a 1-day outpatient procedure using pooled data from six clinical studies.

OBJECTIVES: Current service delivery models for second-trimester medical abortion typically include routine inpatient admission and overnight stays. To assess the feasibility of a day-service model, we evaluated outpatient administration of abortion medications and analyzed the proportion of clients who could avoid an overnight stay. We also examined additional key elements of medical abortion care to evaluate the practicality of this model. STUDY DESIGN: We pooled data from six clinical studies of second-trimester medical abortion conducted by Gynuity over the past 10 years. We include 868 individuals receiving mifepristone-misoprostol abortion between 13 and 22 weeks' gestation. RESULTS: At 8 h post misoprostol initiation, 309/521 (59.3%) participants at 13-18 weeks' gestation had a successful abortion; by 10 h, 382/521 (73.3%) were successful. Taking the mifepristone at home lowered neither the efficacy of the method nor satisfaction with the experience. Nonphysician providers played a significant role in the provision of care. Needed interventions were relatively rare; serious complications were very rare. CONCLUSIONS: Our findings support the provision of second-trimester medical abortion in a day-clinic setting, especially at ≤18 weeks' gestation. Such a model could increase access to quality care in many settings. IMPLICATIONS: Second-trimester medical abortion can safely and effectively be offered as a day service. Nonphysician providers are well suited to provide the majority of care. Developing guidelines for a 1-day model could increase access to quality care in many settings worldwide.

Semantic network function captured by word frequency in nondemented APOE ε4 carriers.

OBJECTIVE: Accurate identification of the earliest cognitive changes associated with Alzheimer's disease (AD) is critically needed. Item-level information within tests of category fluency, such as lexical frequency, harbors valuable information about the integrity of semantic networks affected early in AD. To determine the potential of lexical frequency as a cognitive marker of AD risk, we investigated whether lexical frequency of animal fluency output differentiated APOE ε4 carriers from noncarriers in a cross-sectional design among older African-American adults without dementia. METHOD: We analyzed animal fluency performance using mean number of items and mean lexical frequency among 230 cognitively normal African Americans with and without the APOE ε4 allele. RESULTS: Lexical frequency was higher in APOE ε4 carriers than noncarriers when analyzed as a mean score and within time bins. In contrast, we found no group difference in the number of items produced. Lexical frequency was particularly sensitive to ε4 status after the first 10 s of the 60-s animal fluency task. CONCLUSION: Our results suggest that psycholinguistic features may hold value as a cognitive biomarker for identifying people at high risk of AD. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Vaginal and Rectal Clostridium sordellii and Clostridium perfringens Presence Among Women in the United States.

OBJECTIVE: To characterize the presence of Clostridium sordellii and Clostridium perfringens in the vagina and rectum, identify correlates of presence, and describe strain diversity and presence of key toxins. METHODS: We conducted an observational cohort study in which we screened a diverse cohort of reproductive-aged women in the United States up to three times using vaginal and rectal swabs analyzed by molecular and culture methods. We used multivariate regression models to explore predictors of presence. Strains were characterized by pulsed-field gel electrophoresis and tested for known virulence factors by polymerase chain reaction assays. RESULTS: Of 4,152 participants enrolled between 2010 and 2013, 3.4% (95% confidence interval [CI] 2.9-4.0) were positive for C sordellii and 10.4% (95% CI 9.5-11.3) were positive for C perfringens at baseline. Among the 66% with follow-up data, 94.7% (95% CI 88.0-98.3) of those positive for C sordellii and 74.4% (95% CI 69.0-79.3) of those positive for C perfringens at baseline were negative at follow-up. At baseline, recent gynecologic surgery was associated with C sordellii presence, whereas a high body mass index was associated with C perfringens presence in adjusted models. Two of 238 C sordellii isolates contained the lethal toxin gene, and none contained the hemorrhagic toxin gene. Substantial strain diversity was observed in both species with few clusters and no dominant clones identified. CONCLUSION: The relatively rare and transient nature of C sordellii and C perfringens presence in the vagina and rectum makes it inadvisable to use any screening or prophylactic approach to try to prevent clostridial infection. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01283828.

Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effects of timing of depot medroxyprogesterone acetate injection on medical abortion outcome and risk of repeat pregnancy within the subsequent 6 months. METHODS: In a multinational randomized trial, we assigned women undergoing medical abortion who wanted depot medroxyprogesterone acetate to administration either with mifepristone (Quickstart group) or after the abortion (Afterstart group). We ascertained abortion outcome, pregnancies, and contraception use over 7 months. RESULTS: From August 2013 to March 2015, we enrolled 461 participants with pregnancy durations of 75 days or less. Of participants included in the abortion outcome analyses, 14 of 220 (6.4%) and 12 of 226 (5.3%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the upper 90% confidence limit on this difference was 4.9%, within our prestipulated 5% noninferiority margin. Ongoing pregnancy after initial abortion treatment was significantly more common in the Quickstart group (8/220 [3.6%]) than in the Afterstart group (2/226 [0.9%]); the difference was 2.7% (90% confidence interval 0.4-5.6%). By 6 months, 5 of 213 (2.3%) and 7 of 217 (3.2%) in the Quickstart and Afterstart groups, respectively, became pregnant (exact log-rank test, P=.64). Use of highly effective contraceptives was significantly more common in the Quickstart group at 31 days (P<.001), but no difference was apparent at 6 months. The Quickstart group was significantly more satisfied with group assignment. CONCLUSION: Depot medroxyprogesterone acetate administration with mifepristone did not appreciably increase the risk of surgery after medical abortion but did increase the risk of ongoing pregnancy. It enhanced patient satisfaction, but we found no evidence that it decreased 6-month risk of repeat pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01902485.

Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of insertion of etonogestrel implants with mifepristone compared with after the abortion on the risks of medical abortion failure and repeat pregnancy over the subsequent 6 months. METHODS: In a randomized trial, we assigned patients undergoing medical abortion to receive etonogestrel implants either with the mifepristone (Quickstart group) or after the abortion (Afterstart group). We followed them for 7 months to ascertain abortion outcome, pregnancies, and contraception use. RESULTS: Between September 2013 and August 2014, we enrolled 236 participants in the Quickstart group and 240 in the Afterstart group. To examine abortion failure, we conducted a noninferiority analysis from which we excluded nine participants who had missing outcome data and four with specified protocol violations. Of the rest, 9 of 229 (3.9%) and 9 of 234 (3.8%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the difference of 0.08% (90% confidence interval -3.1% to 3.3%) excluded our prestipulated noninferiority margin of 5 percentage points. Among participants with pregnancy follow-up through 6 months, 1 of 213 (0.5%) and 3 of 208 (1.4%) in the Quickstart and Afterstart groups, respectively, became pregnant within that time; 6-month pregnancy rates did not differ significantly by group (exact log-rank test, P=.28). At enrollment, significantly more participants in the Quickstart group than in the Afterstart group were satisfied with their group assignments (187/236 [79%] compared with 129/240 [54%], respectively; P<.001). CONCLUSION: Insertion of etonogestrel implants with mifepristone did not appreciably increase medical abortion failure risk and it enhanced patient satisfaction, but we found no evidence that it decreased repeat pregnancy rates. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01902485.

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.