Women's experiences of induction of labour with misoprostol tablets compared with vaginal insert.

INTRODUCTION: The aim of this study was to compare nulliparous women's experiences with induction of labour using two different regimens of misoprostol. METHODS: We adapted a validated questionnaire regarding experience with induced labour. In two different hospitals, 123 women undergoing medical induction of labour completed a questionnaire after delivery. An independent-samples T-test was used for comparison of parametric continuous variables and Pearson's χ2 test was used for categorical data. The two groups differed regarding BMI and pregnancy complications. No adjusted estimates were calculated. RESULTS: Women induced with oral misoprostol experienced more painful induction of labour (p = 0.019) and described feeling that their length of stay at hospital was excessive (p = 0.028). Overall, the experience of giving birth after induction of labour was reported as "good" among 87.8% of women induced with oral misoprostol compared with 72.7% of the women induced with a slow-release misoprostol vaginal insert (p = 0.039). CONCLUSION: In two departments characterized by several differences, including whether vaginal or oral misoprostol was used, induction with oral misoprostol in an out-patient setting was associated with a better experience of labour than induction with a slow-release misoprostol vaginal insert. FUNDING: Region Zealand Health Scientific Research Foundation supported the study financially. TRIAL REGISTRATION: The study was registered with clinicaltrials.gov ID: NCT02693587 on 26 February 2016 and with EudraCT number 2020-000366-42 on 23 January 2020 (retrospectively registered).

Women's perceptions of and experiences with the use of misoprostol for treatment of incomplete abortion in central Malawi: a mixed methods study.

BACKGROUND: Abortion-related complications are among the common causes of maternal mortality in Malawi. Misoprostol is recommended for the treatment of first-trimester incomplete abortions but is seldom used for post-abortion care in Malawi. METHODS: A descriptive cross-sectional study that used mixed methods was conducted in three hospitals in central Malawi. A survey was done on 400 women and in-depth interviews with 24 women receiving misoprostol for incomplete abortion. Convenience and purposive sampling methods were used and data were analysed using STATA 16.0 for quantitative part and thematic analysis for qualitative part. RESULTS: From the qualitative data, three themes emerged around the following areas: experienced effects, support offered, and women's perceptions. Most women liked misoprostol and reported that the treatment was helpful and effective in expelling retained products of conception. Quantitative data revealed that the majority of participants, 376 (94%) were satisfied with the support received, and 361 (90.3%) believed that misoprostol was better than surgical treatment. The majority of the women 364 (91%) reported they would recommend misoprostol to friends. CONCLUSIONS: The use of misoprostol for incomplete abortion in Malawi is acceptable and regarded as helpful and satisfactory among women.

One of the major causes of maternal mortality is complications after abortion and miscarriages. The importance of post-abortion care in preventing such deaths justifies the necessity of making treatment accessible and available to every woman in need. Misoprostol is one of the approved treatments for incomplete abortion but is rarely used in developing countries. A study was conducted in three hospitals in central Malawi where women filled in a questionnaire and were interviewed after receiving misoprostol for incomplete abortion. The study's goal was to investigate women's experiences and feelings about using misoprostol. The findings showed that the majority of the women received medication and counselling as a form of support. They expressed satisfaction with the support and described misoprostol as being useful in removing retained products of conception from the womb. The medication was preferred and regarded as a reliable treatment that was also good for women. The majority of the women reported tolerable side effects of the drug and would recommend it to friends. In conclusion, the use of misoprostol for early incomplete abortion in Malawi is acceptable and is regarded as helpful, and satisfactory to women receiving post-abortion care. The research findings support expanding use of misoprostol in post-abortion care in Malawi.

Short-Term Adverse Outcomes After Mifepristone-Misoprostol Versus Procedural Induced Abortion : A Population-Based Propensity-Weighted Study.

BACKGROUND: Prior studies comparing first-trimester pharmaceutical induced abortion (IA) with procedural IA were prone to selection bias, were underpowered to assess serious adverse events (SAEs), and did not account for confounding by indication. Starting in 2017, mifepristone-misoprostol was dispensed at no cost in outpatient pharmacies across Ontario, Canada. OBJECTIVE: To compare short-term risk for adverse outcomes after early IA by mifepristone-misoprostol versus by procedural IA. DESIGN: Population-based cohort study. SETTING: Ontario, Canada. PATIENTS: All women who had first-trimester IA. MEASUREMENTS: A total of 39 856 women dispensed mifepristone-misoprostol as outpatients were compared with 65 176 women undergoing procedural IA at 14 weeks' gestation or earlier within nonhospital outpatient clinics (comparison 1). A total of 39 856 women prescribed mifepristone-misoprostol were compared with 8861 women undergoing ambulatory hospital-based procedural IA at an estimated 9 weeks' gestation or less (comparison 2). The primary composite outcome was any SAE within 42 days after IA, including severe maternal morbidity, end-organ damage, intensive care unit admission, or death. A coprimary broader outcome comprised any SAE, hemorrhage, retained products of conception, infection, or transfusion. Stabilized inverse probability of treatment weighting accounted for confounding between exposure groups. RESULTS: Mean age at IA was about 29 years (SD, 7); 33% were primigravidae. Six percent resided in rural areas, and 25% resided in low-income neighborhoods. In comparison 1, SAEs occurred among 133 women after mifepristone-misoprostol IA (3.3 per 1000) versus 114 after procedural IA (1.8 per 1000) (relative risk [RR], 1.87 [95% CI, 1.44 to 2.43]; absolute risk difference [ARD], 1.5 per 1000 [CI, 0.9 to 2.2]). The respective rates of any adverse event were 28.9 versus 12.4 per 1000 (RR, 2.33 [CI, 2.11 to 2.57]; ARD, 16.5 per 1000 [CI, 14.5 to 18.4]). In comparison 2, SAEs occurred among 133 (3.4 per 1000) and 27 (3.3 per 1000) women, respectively (RR, 1.04 [CI, 0.61 to 1.78]). The respective rates of any adverse event were 31.2 versus 24.9 per 1000 (RR, 1.25 [CI, 1.04 to 1.51]). LIMITATION: A woman prescribed mifepristone-misoprostol may not have taken the medication, and the exact gestational age at IA was not always known. CONCLUSION: Although rare, short-term adverse events are more likely after mifepristone-misoprostol IA than procedural IA, especially for less serious adverse outcomes. PRIMARY FUNDING SOURCE: Canadian Institutes of Health Research.

No-Test Medication Abortion: A Systematic Review.

OBJECTIVE: To summarize the effectiveness and safety outcomes of medication abortion performed without prior pelvic examination or ultrasonogram ("no-test medication abortion"). DATA SOURCES: We searched the MEDLINE, Scopus, Web of Science, Cochrane (including ClinicalTrials.gov), CINAHL, Global Index Medicus, and CAB Direct databases to identify relevant studies published before April 2022 using a peer-reviewed search strategy including terms such as "medication abortion" and "ultrasonography." We contacted experts in the field for unpublished data and ongoing studies. METHODS OF STUDY SELECTION: We reviewed 2,423 studies using Colandr. We included studies if they presented clinical outcomes of medication abortion performed with mifepristone and misoprostol and without prior pelvic examination or ultrasonogram. We excluded studies with duplicate data. We abstracted successful abortion rates overall, as well as rates by gestational age through 63 days, 70 days and past 84 days. We abstracted complication rates, including the need for surgical evacuation, additional medications, blood transfusion, and ectopic pregnancy. TABULATION, INTEGRATION AND RESULTS: We included 21 studies with a total of 10,693 patients with outcome data reported. The overall efficacy of no-test medication abortion was 96.4%; 93.8% (95% CI 92.8-94.6%) through 63 days of gestation and 95.2% (95% CI 94.7-95.7%) through 70 days of gestation. The overall rate of surgical evacuation was 4.4% (95% CI 4.0-4.9), need for additional misoprostol 2.2% (95% CI 1.8-2.6), blood transfusion 0.5% (95% CI 0.3-0.6), and ectopic pregnancy 0.06% (95% CI 0.02-0.15). CONCLUSION: Medication abortion performed without prior pelvic examination or ultrasonogram is a safe and effective option for pregnancy termination. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42021240739.

In-country availability of medical abortion medicines: a description of the framework and methodology of the WHO landscape assessments.

BACKGROUND: Availability of quality-assured medical abortion medicines plays a crucial role in providing comprehensive abortion care. However, access to these medicines is still restricted for many abortion seekers. Increasing availability of affordable, quality-assured mifepristone and misoprostol is important to improve access to safe medical abortion services. Driven by the outcomes of a global consultation hosted by the World Health Organization and the Swedish International Development Cooperation Agency in 2018, we decided to holistically examine access to medical abortion medicines from supply to demand. The overarching principle of the national landscape assessments was to generate evidence to support policy dialog and policymaking that is contextual to the needs of the country. This paper aims to describe the framework and methodological approach used in the World Health Organization landscape assessments of medical abortion medicines at country-level. METHODS: A country assessment protocol was developed to guide the methodology of the World Health Organization landscape assessments. The assessment protocol included adaptation of an existing availability framework, an online desk review and literature review for existing data available for the country of interest, country-level key informant interviews, and analysis of the data to identify barriers and opportunities to improve medical abortion availability. CONCLUSION: The availability framework and methodology will allow the identification of key barriers that limit readiness of medical abortion medicines, and the development of opportunities to overcome those barriers. The national landscape assessments will provide directions for future investments and offer guidance for policy and programming on medical abortion care.

Increasing availability of affordable, safe, and effective medical abortion medicines is necessary to improve access to safe medical abortion services. Driven by the results of a meeting hosted by the World Health Organization and the Swedish International Development Cooperation Agency in 2018, we decided to examine access to medical abortion medicines from supply to demand in selected countries. The overarching goal of the national landscape assessments was to generate evidence to support advocacy efforts and policymaking that is appropriate to the needs of the country. This paper aims to describe the assessment protocol and the steps taken in the World Health Organization landscape assessments of medical abortion medicines at country-level. The assessment allows for a determination of the enabling environment surrounding the provision of medical abortion services. This in turn allows for the identification of key barriers that limit availability of abortion medicines, and the identification of opportunities to overcome those barriers. The availability framework includes both supply and demand sides of commodity availability, considering factors from product introduction to use. This approach can be used for future national assessments for any health commodity or service. The assessment findings will be informative to policymakers and programme managers in developing plans to safeguard availability of safe and effective medical abortion medicines.

At-home urine pregnancy test assessment after mifepristone and misoprostol for undesired pregnancy of unknown location.

OBJECTIVES: The ideal assessment after mifepristone and misoprostol for undesired pregnancy of unknown location (PUL) is unknown. STUDY DESIGN: We prospectively followed patients at Planned Parenthood League of Massachusetts (2019-2021) with PUL who received immediate mifepristone and misoprostol with serial at-home urine pregnancy tests (UPT) and in-office serum HCGs. RESULTS: Of 13 patients, 10 had a successful medication abortion. For those who completed UPTs (N = 9), all were negative by Day 14. Two abnormal pregnancies had positive UPTs on Day 14. CONCLUSION: A negative UPT on Day 14 may help determine complete abortion after medication abortion for undesired PUL. A positive UPT on Day 14 warrants further evaluation. IMPLICATION: Patients taking mifepristone and misoprostol in the setting of undesired PUL who cannot access serum testing may consider an at-home UPT to confirm complete abortion.

The influence of various induction methods on adverse outcomes in small for gestational age neonates: A secondary analysis of the PROBAAT 1 and 2 trials.

OBJECTIVE: To evaluate the safety aspects of different induction methods in pregnancies with small-for-gestational-age neonates. STUDY DESIGN: This was a secondary analysis of two previously reported multicenter, randomized controlled trials conducted in the Netherlands. In the original trials, women were randomized to either a 30 cc Foley catheter, vaginal prostaglandin E2 (PROBAAT-1) or oral misoprostol (PROBAAT-2). A total of 425 patients with a term, singleton pregnancy in cephalic presentation with an indication for labor induction and a small-for-gestational-age neonate were included in this secondary analysis. Our primary outcome was a composed adverse neonatal outcome of Apgar score < 7 after 5 min and/or a pH in the umbilical artery < 7.05 and/or NICU admission. Secondary outcomes were mode of birth, operative birth for fetal distress and pH < 7.10 in the umbilical artery. For these outcome measures, multivariate as well as bivariate analyses were performed. RESULTS: An adverse neonatal outcome occurred in 4.7 % (10/214) induction with a Foley catheter, versus 12.8 % (19/149) after misoprostol (RR 0.36; 95 % CI 0.17-0.76) and 4.7 % (3/64) after Prostaglandin E2 (RR 0.98; 95 %CI 0.28-3.51). For individual components of the composed outcome of adverse events, a difference was found between a Foley catheter and misoprostol for Apgar score < 7 at 5 min (0.5 % versus 3.4; RR 0.14; 95 %CI 0.02-1.16) and NICU admission (1.9 % versus 6.1 %; RR 0.31; 0.10-0.97). No differences were found for mode of birth. CONCLUSIONS: For women who gave birth to a small-for-gestational-age neonate, a Foley catheter is probably a safer induction method compared to oral misoprostol.

Foley catheter plus misoprostol versus misoprostol alone for labor induction.

OBJECTIVE: This study aimed to analyze the effects of Foley catheter combined with misoprostol in the labor induction process. METHODS: This is a nonblinded, block randomized, controlled trial that compared the association between transcervical Foley catheter/vaginal misoprostol 25 µg combination and vaginal misoprostol 25 µg alone in normal-risk and healthy pregnant women undergoing labor induction in the south of Brazil. RESULTS: A total of 230 patients with indications for labor induction were evaluated and classified into the "combined" group (Foley catheter plus misoprostol), consisting of 107 patients, and the "misoprostol" group (misoprostol only), consisting of 123 patients. The "combined" group was observed to have a shorter labor induction time (p=0.008). In addition, there was a lower need for misoprostol use for overall cervical ripening (p<0.001) and a lower relative risk of needing a second, third, or fourth misoprostol tablet in the "combined" group (risk ratio [RR] 0.80, 95% confidence interval [CI] 0.71-0.91; RR 0.41; 95%CI 0.31-0.56; and RR 0.29, 95%CI 0.17-0.52, respectively) (p<0.001). No statistically significant difference was found in induction failure rate, cesarean section rate, or perinatal outcomes. CONCLUSION: A combination of methods leads to shorter labor induction, lower need for misoprostol doses, and lower risk of cesarean section, with no increase in the rate of perinatal complications. REBEC number is RBR-7xcjz3z.

Comparison of the effect of oral and vaginal misoprostol on labor induction: updating a systematic review and meta-analysis of interventional studies.

OBJECTIVES: This study is aimed to compare the effect of oral misoprostol with vaginal misoprostol to induce labor as a systematic review and meta-analysis. METHODS: Electronic databases including PubMed [Medline], Scopus, Web of science, Embase, Ovid, Cochrane library, and ClinicalTrials.gov were searched using the relevant keywords. All RCTs comparing the effect of oral vs vaginal misoprostol on labor induction were considered. The Cochrane Risk of Bias checklist was used for assessing quality of included RCTs. All statistical analyses were completed using STATA (Version 16) and Revman (Version 5). RESULTS: Thirty-three RCTs with 5162 patients (1560 in oral and 2602 in vaginal groups) were included in this meta-analysis. Labor induction length did differ significantly between the two routes of misoprostol administration [Standardized Mean Difference: 0.40 h, 95% confidence interval (CI) 0.34, 0.46; I2: 66.35%; P = 0.04]. In addition, the risk of neonatal death, tachysystole, uterine hyperstimulation, preeclampsia, non-FHR and abortion was lower in the oral misoprostol group and the risk of hypertonus, PROM, oxytocin need and cesarean fever was higher in this group than the vaginal misoprostol group. CONCLUSIONS: Based on results of this meta-analysis, it can be inferred that currently, clinical specialists can decide to use this drug orally or vaginally on a case-by-case basis, depending on the condition of the pregnant mother and the baby.

Intracervical Foley catheter plus intravaginal misoprostol compared to intravaginal misoprostol-only for cervical ripening: A systematic review and meta-analysis.

To compare the combination of intracervical Foley catheter and intravaginal misoprostol administration versus intravaginal misoprostol administration-only for cervical ripening. The Medline, EMBASE, ClinicalTrials.gov, PROSPERO, Scopus, and Cochrane Collaboration databases were searched systematically. Randomized controlled trials that included patients with a singleton viable fetus who underwent induction of labor that required cervical ripening with an unfavorable cervix (Bishop ≤ 6) were eligible for inclusion. Primary outcomes was time to delivery and rate of cesarean delivery. Thirteen trials with 2978 subjects met the inclusion criteria. There was no difference in the incidence of cesarean delivery between the two groups (RR, 0.90; 95 % CI, 0.72-1.14; I2 = 69 %). The combination group resulted in comparable time to delivery (MD -2.50 h; 95 % CI 0.38, -5.38; I2 = 97 %), shorter time to vaginal delivery (MD -3.49 h; 95 % CI -4.89, -2.09; I2 = 81 %), lower risk of neonatal intensive care unit (NICU) admission (RR 0.72, 95 % CI 0.58-0.90, I2 = 0 %), meconium-stained fluid (RR 0.48, 95 % CI 0.31-0.73, I2 = 28 %), and tachysystole with fetal heart trace changes (RR 0.49, 95 % CI 0.27-0.86, I2 = 43 %), compared with intravaginal misoprostol-only group. There was no statistical difference in rates of terbutaline use, endometritis or chorioamnionitis between the two groups. The combination of intravaginal misoprostol with intracervical Foley catheter for cervical ripening is not associated with shorter time to delivery. However, the combination group shows significant difference in shorter time to vaginal delivery, NICU admission, meconium-stained fluid, and tachysystole with fetal heart trace changes.

Complications of second trimester induction for abortion or fetal demise for patients with and without prior cesarean delivery.

OBJECTIVE: Compare complication rates of second trimester induction for abortion or fetal demise for patients with and without prior cesarean delivery. STUDY DESIGN: Retrospective cohort study examining induction for abortion or fetal demise for pregnancies from 14w0d to 23w6d gestation at 2 urban academic medical centers from 2009 to 2019. Exclusion criteria included preterm labor or cervical insufficiency, neonatal interventions, or if misoprostol was not the primary induction method. Complication rates were compared between those with no prior, 1 prior, and 2 or more (2+) prior cesarean deliveries. Complications analyzed were retained placenta, failed induction, infection, hemorrhage, blood transfusion, uterine rupture, intensive care unit admission, death, and readmission. Secondary analysis included cumulative misoprostol dosages and complete abortion rate within 24 hours. RESULTS: Of 520 patients, 411 patients had no prior cesarean delivery, 77 had 1 prior cesarean delivery, and 32 had 2+ prior cesarean deliveries. Eleven patients had a prior vertical uterine incision. About 26.5% of all patients received mifepristone. The 2+ prior cesarean delivery group was significantly older (35 vs 32 vs 32, p < 0.001) and more likely to be induced for fetal demise (62.5 vs 41.56 vs 39.17%, p = 0.04). Both cesarean groups were more likely to be obese (58.62 vs 49.35 vs 34.26%, p = 0.003). Patients with 2+ prior cesarean deliveries were more likely to experience uterine rupture (6.25 vs 0 vs 0%, p = 0.004), and require ICU admission (6.45 vs 1.3 vs 0.49%, p = 0.02). Secondary analysis outcomes were similar. Logistic regression showed patients with 2+ prior cesarean deliveries were more likely to experience a complication than those with 1 prior (adjusted odds ratio [aOR] 2.71, confidence interval [CI] 1.09-6.86, p = 0.03) or 0 prior cesarean deliveries (aOR 3.00, CI 1.30-7.02, p = 0.01). Patients with 1 prior or no prior cesarean deliveries had a similar risk of experiencing a complication (aOR 1.11, CI 0.64-1.89, p = 0.7). CONCLUSIONS: Most patients with prior cesarean deliveries can safely undergo induction in the second trimester for abortion or fetal demise. Patients with 2+ prior cesarean deliveries had a higher rate of at least 1 complication when compared to those with one or no prior cesarean delivery, despite similar misoprostol dosages and rates of complete abortion. IMPLICATIONS: This large 10-year retrospective study examines the impact of prior cesarean delivery on the safety of second trimester induction. While second trimester labor induction abortion remains an option for all patients, specialized counseling for patients with 2 or more prior cesarean deliveries may be warranted.

Acute complications with same-day versus overnight cervical preparation before dilation and evacuation at 14 to 16 weeks.

OBJECTIVE: Evaluate if same-day cervical preparation is associated with a clinically acceptable complication rate compared with overnight osmotic dilators for dilation and evacuation (D&E). STUDY DESIGN: This retrospective, noninferiority, cohort study compared complication rates for same-day versus overnight cervical preparation with D&E between 14 and 16 weeks gestation. Cervical preparation was achieved with misoprostol, osmotic dilators, or both. Our primary outcome was the acute complication rate, defined as: hemorrhage (≥500 mL); hospitalization or hospital transfer; transfusion; or unplanned procedure occurring within 24 hours of the index procedure. Secondarily we evaluated nonmajor (re-aspiration, suture repair of cervical laceration, uterine tamponade, or emergency department only transfer) and major (transfusion, uterine artery embolization, abdominal surgery, or hospital admission) complications separately. Inverse probability of treatment weighting using the propensity score was used to perform an adjusted analysis, taking into account age, ethnicity, clinic location, insurance, gestational age, gravidity, and prior pregnancy outcomes. RESULTS: We analyzed 1,319 subjects (n = 864 same-day, n = 455 overnight). Same-day cervical preparation patients were more likely to have Medicaid and a prior vaginal delivery. In both unadjusted and adjusted analyses, acute complication rates for same-day were noninferior to overnight preparation (unadjusted 0.93% vs 1.98%, difference of -1.05%, CI: -2.48% to 0.38%; adjusted difference -0.50%, CI: -1.45 to 0.44%). Only one major complication in the same-day group, a cervical laceration resulting in hemorrhage requiring transfusion, occurred in the entire sample. CONCLUSIONS: In this retrospective review, same-day cervical preparation was noninferior to overnight preparation for D&E between 14 and 16 weeks gestation, both with low complication rates. IMPLICATIONS: For early second trimester dilation and evacuation, same-day cervical preparation should be considered a safe alternative to overnight cervical preparation.

Integrative transcriptomics and proteomics analyses to reveal the therapeutic effect and mechanism of Buxue Yimu Pills in medical-induced incomplete abortion rats.

ETHNOPHARMACOLOGICAL RELEVANCE: Medical abortions using mifepristone and misoprostol have been approved in many countries for early pregnancy loss. Despite its high success rate, this medication regimen can result in incomplete abortion, which is responsible for endometrial damage, prolonged uterine bleeding, abdominal pain, etc. Buxue Yimu Pills (BYP) is a famous Chinese medicine prescription that is widely used in the field of gynecology and obstetrics for treating patients with postpartum complications. However, the therapeutic effect and mechanism of BYP remain to be explored. AIM OF THE STUDY: This study aimed to clarify the therapeutic effect and mechanism of action of BYP in postpartum complications using mifepristone and misoprostol-induced incomplete abortion in rats. MATERIALS AND METHODS: Experimental medical-induced incomplete abortion model rats were constructed using mifepristone and misoprostol, and further treated with saline or BYP by intragastric administration. Detailed information regarding the changes in mRNA and protein levels in the uterine tissues of rats regulated by BYP was illustrated by RNA sequencing (RNA-seq) analysis and quantitative proteomics analysis. The differentially expressed genes and proteins were further subjected to Gene Ontology (GO) and pathway enrichment analyses and further verified using quantitative Real-time PCR (qRT-PCR) analysis and western blot assay. RESULTS: BYP administration markedly alleviated the increase in serum prostaglandin F2α (PGF2α) and expression of PGF2α receptor (PGF2αR) in uterine tissues and inhibited the decrease in serum chorionic gonadotrophin (CG). Compared with the model group, 674 genes were upregulated and 344 genes were downregulated by BYP administration; 108 proteins were upregulated and 48 proteins were downregulated by BYP administration. qRT-PCR analysis of the uterine tissues showed that BYP treatment reversed the variation tendency of genes, including Mmp7, Mmp14, Timp2, Col6a4, Jak2, Wnt7a, and Mylk compared with the model group. Western blot analysis showed that BYP administration affected PKCδ, Collagen VI, MMP7, TIMP2, MLCK, and p-MLC protein levels. CONCLUSION: BYP administration facilitated uterine recovery in medical-induced incomplete abortion rats, and this therapeutic effect involved various targets and biological processes, including the TIMP2/MMP7 and MLCK/p-MLC signaling pathways, etc.

Single dose letrozole and misoprostol for termination of pregnancy through 63 days' gestation: A pilot study.

OBJECTIVES: We conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion STUDY DESIGN: We enrolled 40 participants seeking medication abortion up to 63 days' gestation at a site in Salt Lake City, UT. Participants received a single dose of letrozole 30 mg in-clinic followed 2 days later by misoprostol 800 mcg buccally at home. They took a second dose of misoprostol if they had no bleeding within 24 hours of the first. Participants returned 7 to 10 days later for assessment of abortion outcome and side effects RESULTS: Thirty-seven participants (93%) returned for follow-up and 2 (5%) went to another facility from which research staff obtained outcome data. Three-fourths (29/39, 74%, 95% CI: 60%-89%) had a complete abortion; 4 (10%, 95% CI: 0.3%-20%) had an incomplete abortion and opted for aspiration, and 6 (15%, 95% CI: 4%-27%) had an ongoing pregnancy. All subjects with follow-up reported taking the first dose of misoprostol. Ten (27%) took the second dose as well; only three did so due to no bleeding. Nineteen participants (51%) reported side effects after letrozole prior to misoprostol and two people (5%) rated these effects as severe. Side effects following misoprostol occurred in 33 participants (89%) and were as expected based on previous literature. No serious adverse events were reported CONCLUSION: A single dose of letrozole 30 mg followed by misoprostol had lower than desirable efficacy and does not warrant further study. IMPLICATIONS: A single dose of letrozole does not appear to be an effective adjunct to misoprostol for medication abortion.

Accounting for Misclassification and Selection Bias in Estimating Effectiveness of Self-managed Medication Abortion.

BACKGROUND: Studies on the effectiveness of self-managed medication abortion may suffer from misclassification and selection bias due to self-reported outcomes and loss of follow-up. Monte Carlo sensitivity analysis can estimate self-managed abortion effectiveness accounting for these potential biases. METHODS: We conducted a Monte Carlo sensitivity analysis based on data from the Studying Accompaniment model Feasibility and Effectiveness Study (the SAFE Study), to generate bias-adjusted estimates of the effectiveness of self-managed abortion with accompaniment group support. Between July 2019 and April 2020, we enrolled a total of 1051 callers who contacted accompaniment groups in Argentina and Nigeria for self-managed abortion information; 961 took abortion medications and completed at least one follow-up. Using these data, we calculated measures of effectiveness adjusted for ineligibility, misclassification, and selection bias across 50,000 simulations with bias parameters drawn from pre-specified Beta distributions in R. RESULTS: After accounting for the potential influence of various sources of bias, bias-adjusted estimates of effectiveness were similar to observed estimates, conditional on chosen bias parameters: 92.68% (95% simulation interval: 87.80%, 95.74%) for mifepristone in combination with misoprostol (versus 93.7% in the observed data) and 98.47% (95% simulation interval: 96.79%, 99.39%) for misoprostol alone (versus 99.3% in the observed data). CONCLUSIONS: After adjustment for multiple potential sources of bias, estimates of self-managed medication abortion effectiveness remain high. Monte Carlo sensitivity analysis may be useful in studies measuring an epidemiologic proportion (i.e., effectiveness, prevalence, cumulative incidence) while accounting for possible selection or misclassification bias.

Does lesion type or severity predict outcome of therapy for horses with equine glandular gastric disease? - A retrospective study.

BACKGROUND: Equine glandular gastric disease (EGGD) is a common condition of the horse. Misoprostol is reported to be superior to oral omeprazole and sucralfate for treatment. Long-acting intramuscular injectable omeprazole (LAIOMEP) is a novel treatment shown to be effective in a small population. OBJECTIVES: This study aimed to determine LAIOMEP efficacy compared to misoprostol and oral omeprazole and identify characteristics that predict treatment outcome. METHODS: All horses that underwent gastroscopy between 2012 and 2019 were reviewed. Lesions were characterised by 4 blinded observers, all of whom are diplomates in equine internal medicine, using established descriptors from the ECEIM consensus statement and subjective severity. Treatment outcome was ranked as worsened, improved or healed. Consensus lesion type, lesion severity and treatment choice were compared to outcome and data screened using univariate analysis (chi-squared) to determine whether each predicted outcome. Lesion types where univariate analysis predicted a trend (p<0.2) were included in a multiple-regression analysis to identify predictors of outcome irrespective of treatment. RESULTS: Only severity significantly predicted final outcome (p = 0.025) with severe lesions being more likely to improve. Treatment choice did not significantly predict outcome. Overall healing rate was 29% (24 horses), and 43% (44 horses) improved. Treatment healing rates were 23% (10), 12% (7) and 27% (7) for LAIOMEP, misoprostol and oral omeprazole, respectively, with improvement in 69% (14), 76% (21) and 61% (9). 64% of the latter group received sucralfate. Worsening occurred in 7% (6). Treatment length varied with a median of 4 weeks (range 4-20 weeks). CONCLUSIONS: This study showed poorer therapy outcome compared to previous studies. The only initial lesion descriptor to predict outcome was severity and treatment choice did not affect outcome.