The Success of Mifepristone and Misoprostol in the Management of Early Pregnancy Loss at a Community Hospital: A Prospective Study.

BACKGROUND: This prospective single-arm study was conducted to understand the expulsion rate of the gestational sac in the management of early pregnancy loss (EPL). METHODS: We recruited 441 participants; 188 met eligibility criteria. Participants were 18 years of age and older who experienced a confirmed early pregnancy loss (<12 weeks gestational age) defined by an intrauterine pregnancy with a non-viable embryonic or anembryonic gestational sac with no fetal heart activity. Participants were given 200 mg of mifepristone pretreatment orally followed by two doses of misoprostol 800 mcg vaginally after 24 and 48 hours. Participants were seen in follow-up on day 14 to confirm the absence of a gestational sac, classified as treatment success. For failed treatment (defined by retained gestational sac), we offered expectant management or a third dose of misoprostol and/or dilatation and curettage (D & C). We followed all participants for 30 days. We collected data on overtreatment for retained products of conception and hospital admissions for adverse events. RESULTS: 181 participants followed the protocol, and 169 (93.3%) participants had a complete expulsion of the gestational sac by the second visit (day 14). Twelve (6.6%) failed the treatment and one had an adverse event of heavy vaginal bleeding requiring D & C. Despite the expulsion of the gestational sac, 29 cases (17.1%) at subsequent follow-up were diagnosed as retained products of conception based on ultrasound assessment of thickened endometrium. CONCLUSION: Pretreatment with mifepristone followed by 2 doses of misoprostol with a 14-day follow-up resulted in a high expulsion rate and is a safe management option for EPL.

The Sustained Value of an Early Pregnancy Assessment Clinic in the Management of Early Pregnancy Complications: A 10-Year Retrospective Study.

OBJECTIVE: This study sought to evaluate the sustained value of an early pregnancy assessment clinic (EPAC) in the management of early pregnancy complications and its effect on the incidence emergency room (ER) visits. METHODS: A 10-year retrospective study (January 2006 to December 2015) was conducted. The number of patients assessed, sources and reasons for referral, and treatments provided were reviewed. The numbers of ER assessments and reassessments for abortion, hemorrhage, and ectopic pregnancy from January 2004 to December 2005 (pre-EPAC) and January 2006 to December 2015 (post-EPAC) were also reviewed. RESULTS: There were 11 349 new referrals and 10 764 follow-up visits. The reasons for referral were threatened miscarriage (n = 3568, 31.4%), missed miscarriage (n = 3056, 26.9%), incomplete miscarriage (n = 1064, 9.4%), complete miscarriage (n = 991, 8.7%), ectopic pregnancy (n = 857, 7.6%), hyperemesis gravidarum (n = 139, 1.2%), and others (n = 1674, 14.8%). There has been a significant decreasing trend (tau = -0.60, P = 0.0127) and a significant decrease in the post-EPAC rate of ER reassessments (P = 0.0396) for hemorrhage, with a concomitant decrease in EPAC visits for hemorrhage. In addition, there has been a significant increasing trend (tau = 0.64, P = 0.0081) and a significant increase in the post-EPAC rate of ER assessments (P = 0.00001) for ectopic pregnancies. CONCLUSION: Over the 10-year period, the EPAC has remained a vital service for managing early pregnancy complications for women. However, the clinic has not yet had a sustained impact on ER visits for miscarriage, ectopic pregnancy, and hemorrhage. It is possible that a reduction in ER assessments and reassessments for early pregnancy complications can be achieved through a clinic with daily access.

A Comparison of the Number of Patient Visits Required for Different Management Options for Early Pregnancy Loss at an Early Pregnancy Assessment Clinic.

OBJECTIVE: To compare the total number of patient visits required for the conservative, medical, or surgical management of early pregnancy loss in an early pregnancy assessment clinic (EPAC). METHODS: A retrospective study of the number of patient visits at an EPAC for conservative, medical, or surgical management of early spontaneous abortion from October 2013 to September 2015 was undertaken. Visits counted included initial assessment, follow-up visits, and surgery date, if separate from a clinic visit. RESULTS: A total of 945 patients were seen, with 2144 visits during the study period. Conservative management required an average of 3.01 visits (n = 159, median = 3, SD = 1.16, range [1,7]) and misoprostol treatment required an average of 2.51 visits (n = 329, median = 2, SD = 0.83, range [1,6]) to achieve a complete abortion. Dilatation and curettage (D&C) required an average of 1.60 visits (n = 417, median = 1, SD = 0.80, range [1-6]), when including scheduling limitations or an average of 1.13 visits when excluding these limitations. The difference in the number of visits required for the three management options was statistically significant (P <0.0001). Management with D&C was more likely to require less than two visits to achieve complete abortion compared with the other options (93.8% for D&C vs. 64.5% for misoprostol vs. 37.8% for conservative). CONCLUSION: An EPAC provides a significant value in the management of early pregnancy losses. There is a significant difference in the total number of visits required for different treatment options. Patients may find this information helpful when considering and deciding upon their preferred treatment option.

The birth control pill, thromboembolic disease, science and the media: a historical review of the relationship.

The introduction of the birth control pill (the Pill) in 1960 revolutionized the options for contraception, sparking vibrant discussion in the scientific and social science literature and in the media. Much attention focused on issues of women's rights, including ethics and personal choice. But the Pill also introduced new questions about risk. Shortly after its introduction, the risk of thromboembolic disease was recognized [1]. After more than half a century, controversies about the relationship between the Pill and thromboembolic disease have persisted. The scientific and media communities have been active in the discussion, debate and delivery of information about this risk. Scientific and public attention to thromboembolism and the Pill has had dramatic consequences, both good and bad. The spotlight on risk has helped to change norms regarding the public's right to know and assess dangers; it has sparked Pill scares linked to increased unplanned pregnancy, birth and abortion rates; and it has led to a change in federally mandated policies regarding how new contraceptive products are studied and brought to market. This paper charts the narrative of the thromboembolic risk of the Pill from its introduction in 1960 until today and reviews the corresponding media response to this history. How does the story of the thromboembolic risk of the Pill - explored through the lens of science, media and contemporary social dynamics - frame contemporary understanding of risk for researchers, clinicians, individuals and the public?

Early surgical abortion: efficacy and safety.

OBJECTIVE: Because of concern over the higher rates of failed abortion, many clinicians defer surgical abortion until 7 menstrual weeks or later. We conducted this study to evaluate the efficacy and safety of early surgical abortions that are performed by numerous physicians in a community-based setting. STUDY DESIGN: We prospectively gathered data on all eligible patients who had surgical abortions at <6 weeks of gestation at 3 Planned Parenthood clinics from January 1, 1998, to August 31, 2000. Outcomes were evaluated with the use of proportions with 95% CI and chi(2) analysis. RESULTS: A total of 1132 women had early surgical abortions during the study interval, and follow-up was available for 750 of those women (66%). Seventeen women (2.3%; 95% CI, 1.4%, 3.7%) had failed attempted abortions. Other complications occurred in 13 women. CONCLUSION: Early surgical abortion is safe and effective. In this series, the frequency of complications that required curettage was similar to that reported with mifepristone and vaginal misoprostol.

Is pathology examination useful after early surgical abortion?

OBJECTIVE: To study if the pathologist's examination of surgical abortion tissue offers more information than immediate fresh tissue examination by the surgeon. Immediate examination of the fresh tissue aspirate after surgical abortion helps reduce the risk of failed abortion and other complications. Regulations in some states also require a pathologist to analyze abortion specimens at added cost to providers. We conducted this study to evaluate the incremental clinical benefit of pathology examination after surgical abortion at less than 6 weeks' gestation. METHODS: As part of a prospective case series of women who had early surgical abortions at the Planned Parenthood League of Massachusetts during a 32-month period, we collected data on clinical outcomes and the results of postoperative tissue examinations. Using outcomes verified by in-person follow-up as the "gold standard," we calculated the validity of the tissue examinations by the surgeons and the outside pathologists. RESULTS: A total of 676 women had documented outcomes and complete tissue examination data. The sensitivity (ability of the examiner to detect an outcome other than complete abortion) was 57% (95% confidence interval [CI] 35, 76) for the surgeons' tissue inspections and 22% (95% CI 8, 44) for the pathologists' examinations. The predictive value of a positive (abnormal) tissue screen was 14% (95% CI 8, 24) and 7% (95% CI 3, 17) for the surgeons and pathologists, respectively. CONCLUSION: Routine pathology examination of the tissue aspirate after early surgical abortion confers no incremental clinical benefit. Although the surgeons' tissue inspections predicted abnormal outcomes poorly, the pathologists did no better. Our results challenge the rationale for state regulations requiring pathologic analysis of all surgical abortion specimens.