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Mitchell D Creinin - One of the best experts on this subject based on the ideXlab platform.

  • Medical Abortion reporting of efficacy the mare guidelines
    Contraception, 2016
    Co-Authors: Mitchell D Creinin, Melissa J Chen
    Abstract:

    Contraception 94 (2016) 97 – 103 Commentary Medical Abortion reporting of efficacy: the MARE guidelines ☆,☆☆ Mitchell D. Creinin ⁎ , Melissa J. Chen Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA Received 20 April 2016; accepted 22 April 2016 1. Introduction This commentary introduces the Medical Abortion Reporting of Efficacy (MARE) guidelines as a supplement to CONSORT [1] and STROBE [2]. The goal of the recommendations is to standardize early Medical Abortion efficacy reporting to facilitate comparison of outcomes between studies and to enrich the ability for data synthesis from different studies to create evidence-based guidelines. Although the term Medical Abortion had most commonly referred to the use of Abortion-inducing medication for early pregnancy termination without primary surgical intervention, more recently, the phrase has been used to refer to labor induction Abortions as well [3,4]. Accordingly, we consider early Medical Abortion to refer to procedures in the first trimester. Reports of using Medical agents to cause early Abortion first appeared in the 1950s [5], but the modern era of Medical Abortion research started in the early 1980s with the discovery of test agents that were ultimately developed into mifepristone. Over the past 30 years, research has evolved, with the use of various drugs including mifepristone, methotrexate, tamoxifen, letrozole and various prostaglandin analogs to induce early Abortion [6]. The first drug with a labeled indication for Medical Abortion, mifepristone, was initially approved in China and France more than two decades ago. The United States Food and Drug Administration approved mifepristone in 2000 for use in combination with the prostaglandin analog misoprostol for Abortion through 49 days gestation. Funding: none. Conflicts of Interest: Dr. Chen has no conflicts of interest. Dr. Creinin is a consultant to Danco. ⁎ Corresponding author. Tel.: +1-916-734-6670. E-mail address: mdcreinin@ucdavis.edu (M.D. Creinin). http://dx.doi.org/10.1016/j.contraception.2016.04.013 0010-7824/© 2016 Elsevier Inc. All rights reserved. Over the more than 25 years since mifepristone first became available for women to obtain a Medical Abortion, researchers have continued to evaluate alternative regimens to improve efficacy and the patient experience. Professional and national organizations now lead the way in promoting the best science by providing evidence-based recommendations for the preferred Medical Abortion treatment options [6–8]. Although many individual studies are methodologically strong, the heterogeneity of design, conduct and reporting hinders synthesis of data from multiple studies. Importantly, many studies do not stratify outcomes by week of gestation. These issues became evident during data collation for creation of the 2014 Medical Management of First Trimester Abortion Practice Bulletin written collaboratively by the American College of Obstetricians and Gynecologists and the Society of Family Planning [6,7]. More recently, a systematic review including approximately 30,000 patients who received mifepristone and buccal misoprostol found that only 57% had data identifying week of gestation for a stratified evaluation of overall efficacy; only 51% had such information for evaluation of continuing pregnancy [9]. Well-performed and reported research trials provide the basis for evidence-based guidelines and do more than simply inform providers and patients about more cost-effective or therapeutically effective options — they also affect access to care. Methodologically strong research can counter ideologi- cally motivated arguments for legal restrictions on Medical Abortion regimens and gestational age limits. The Medical community can use this evidence to oppose such legislation. Future synthesis of the large body of available data to inform patient care and regulatory policy can be facilitated with the use of guidelines to ensure that publications of original data are presented in a standardized way. We herein present reporting recommendations for early Medical Abortion as a supplement to the CONSORT guidelines (for

  • predictors of uterine evacuation following early Medical Abortion with mifepristone and misoprostol
    Contraception, 2016
    Co-Authors: Matthew F Reeves, Jessica A Monmaney, Mitchell D Creinin
    Abstract:

    Abstract Objectives We sought to determine predictors of uterine evacuation for women undergoing Medical Abortion using mifepristone and vaginal misoprostol through 63 days' gestation. Study Design We pooled data from two prospective multicenter Medical Abortion trials. In one study, women received mifepristone 200 mg followed either 6–8 or 23–25 h later by misoprostol 800 mcg vaginally. In the second study, women received mifepristone 200 mg followed either t test and Wilcoxon rank-sum tests for continuous variables. We used logistic regression to calculate odds ratios (ORs) of uterine evacuation. Results Uterine evacuation was performed for 75 (3.5%) of 2160 women. In multivariable analysis, 5 or more prior deliveries (AR 11.9%, OR 4.6) and gestational age of 8 weeks or more (AR 4.1%, OR 2.1) were significantly associated with uterine evacuation, while age of 20 years or younger (AR 1.4%, OR 0.4) was significantly and inversely associated with uterine evacuation. Prior cesarean delivery, multiple gestations, smoking, weight, body surface area and body mass index were not predictive of uterine evacuation in univariate or multivariable analysis. Conclusion Uterine evacuation is an uncommon outcome in Medical Abortion with mifepristone and vaginal misoprostol. Five or more deliveries are the only significant predictor that identifies a group with an AR of uterine evacuation of more than 6%. Implications Uterine evacuation is uncommon in Medical Abortion with mifepristone and vaginal misoprostol. Parity of five or more is the only significant predictor of uterine evacuation exceeding 6%. Until additional research is completed, Medical Abortion should not be withheld from women with five or more deliveries.

  • original research article predictors of uterine evacuation following early Medical Abortion with mifepristone and misoprostol
    2016
    Co-Authors: Matthew F Reeves, Jessica A Monmaney, Mitchell D Creinin
    Abstract:

    Objectives: We sought to determine predictors of uterine evacuation for women undergoing Medical Abortion using mifepristone and vaginal misoprostol through 63 days' gestation. Study Design: We pooled data from two prospective multicenter Medical Abortion trials. In one study, women received mifepristone 200 mg followed either 6– 8o r 23–25 h later by misoprostol 800 mcg vaginally. In the second study, women received mifepristone 200 mg followed either b15 min or 23–25 h later by misoprostol 800 mcg vaginally. We examined the absolute risk (AR) of uterine evacuation using Fisher's Exact Tests for categorical variables and Student t test and Wilcoxon rank-sum tests for continuous variables. We used logistic regression to calculate odds ratios (ORs) of uterine evacuation. Results: Uterine evacuation was performed for 75 (3.5%) of 2160 women. In multivariable analysis, 5 or more prior deliveries (AR 11.9%, OR 4.6) and gestational age of 8 weeks or more (AR 4.1%, OR 2.1) were significantly associated with uterine evacuation, while age of 20 years or younger (AR 1.4%, OR 0.4) was significantly and inversely associated with uterine evacuation. Prior cesarean delivery, multiple gestations, smoking, weight, body surface area and body mass index were not predictive of uterine evacuation in univariate or multivariable analysis. Conclusion: Uterine evacuation is an uncommon outcome in Medical Abortion with mifepristone and vaginal misoprostol. Five or more deliveries are the only significant predictor that identifies a group with an AR of uterine evacuation of more than 6%. Implications: Uterine evacuation is uncommon in Medical Abortion with mifepristone and vaginal misoprostol. Parity of five or more is the only significant predictor of uterine evacuation exceeding 6%. Until additional research is completed, Medical Abortion should not be withheld from women with five or more deliveries.

  • mifepristone with buccal misoprostol for Medical Abortion a systematic review
    Obstetrics & Gynecology, 2015
    Co-Authors: Melissa J Chen, Mitchell D Creinin
    Abstract:

    Author(s): Chen, Melissa J; Creinin, Mitchell D | Abstract: To summarize clinical outcomes and adverse effects of Medical Abortion regimens consisting of mifepristone followed by buccal misoprostol in pregnancies through 70 days of gestation.We used PubMed, ClinicalTrials.gov, and reference lists from published reports to identify relevant studies published between November 2005 and January 2015 using the search terms "mifepristone and Medical Abortion" and "buccal and misoprostol."Studies were included if they presented clinical outcomes of Medical Abortion using mifepristone and buccal misoprostol through 70 days of gestation. Studies with duplicate data were excluded.We included 20 studies with a total of 33,846 women through 70 days of gestation. We abstracted efficacy and ongoing pregnancy rates as an overall rate and by gestational age in days in reference to completed weeks (eg, 49 days or less, 50-56 days, 57-63 days, 64-70 days) and adverse effects when reported. The overall efficacy of mifepristone followed by buccal misoprostol is 96.7% (95% confidence interval [CI] 96.5-96.8%) and the continuing pregnancy rate is 0.8% (95% CI 0.7-0.9%) in approximately 33,000 pregnancies through 63 days of gestation. Only 332 women with pregnancies between 64 and 70 days of gestation are reported in the literature with an overall efficacy of 93.1% (95% CI 89.6-95.5%) and a continuing pregnancy rate of 2.9% (95% CI 1.4-5.7%). Currently available data suggest that regimens with a 24-hour time interval between mifepristone and buccal misoprostol administration are slightly less effective than those with a 24- to 48-hour interval. Rates of surgical evacuation for reasons other than ongoing pregnancy range from 1.8% to 4.2%. Severe adverse events like blood transfusion (0.03-0.6%) and hospitalization (0.04-0.9%) are uncommon.Outpatient Medical Abortion regimens with mifepristone followed in 24-48 hours by buccal misoprostol are highly effective for pregnancy termination through 63 days of gestation. More data are needed to evaluate clinical outcomes with regimens containing mifepristone followed in 24 hours by buccal misoprostol and in pregnancies beyond 63 days of gestation.

  • mifepristone with buccal misoprostol for Medical Abortion a systematic review
    Obstetrics & Gynecology, 2015
    Co-Authors: Melissa J Chen, Mitchell D Creinin
    Abstract:

    OBJECTIVE:To summarize clinical outcomes and adverse effects of Medical Abortion regimens consisting of mifepristone followed by buccal misoprostol in pregnancies through 70 days of gestation.DATA SOURCES:We used PubMed, ClinicalTrials.gov, and reference lists from published reports to identify rele

Beverly Winikoff - One of the best experts on this subject based on the ideXlab platform.

  • 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
    Contraception, 2019
    Co-Authors: Tara Shochet, Karmen S. Louie, Ingrida Platais, Tamar Tsereteli, Jennifer Blum, Dina Abbas, Monica Dragoman, Beverly Winikoff
    Abstract:

    Abstract 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.

  • acceptability and feasibility of phone follow up with a semiquantitative urine pregnancy test after Medical Abortion in moldova and uzbekistan
    Contraception, 2015
    Co-Authors: Ingrida Platais, Tamar Tsereteli, Rodica Comendant, Dilfuza Kurbanbekova, Beverly Winikoff
    Abstract:

    Abstract Objective To evaluate the feasibility and acceptability of phone follow-up with a home semiquantitative pregnancy test and standardized checklist, and compare the alternative method of follow-up with in-clinic follow-up after Medical Abortion. Study Design Two thousand four hundred women undergoing Medical Abortion with mifepristone and misoprostol in Moldova and Uzbekistan were randomized to phone or clinic follow-up. All women in the clinic group returned to the clinic 2 weeks later. Women randomized to phone follow-up used a semiquantitative pregnancy test at the initial visit and repeated the test at home 2 weeks later when they also filled out a symptom checklist. Women were called at 2 weeks to review the test results and checklist. Participants who screened “positive” were referred to clinic to verify Abortion completion. Results Most women in the phone group were successfully contacted on the phone (97.6%). Staff were unable to contact one woman in the phone follow-up group, and all women in clinic group returned to the clinic. The ongoing pregnancy rate was similar in both groups (0.4–0.6%), and the semiquantitative pregnancy test identified all ongoing pregnancies in the phone follow-up group. Women in the phone group found the test and checklist easy to use, and most (76.1%) preferred phone follow-up in the future. Overall, 92.8% of women in the phone group did not undergo in-clinic follow-up. Conclusion Phone follow-up with a semiquantitative urine pregnancy test and symptom checklist is a feasible and a highly effective approach in identifying ongoing pregnancy after Medical Abortion. Implications The semiquantitative pregnancy test can make home follow-up after Medical Abortion possible for many women and provide reassurance that ongoing pregnancies will be detected.

  • the introduction of first trimester Medical Abortion in armenia
    Reproductive Health Matters, 2014
    Co-Authors: Karmen S. Louie, Tamar Tsereteli, Erica Chong, G Avagyan, Susanna Vardanyan, Beverly Winikoff
    Abstract:

    Abstract 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
    The European Journal of Contraception & Reproductive Health Care, 2014
    Co-Authors: Karmen S. Louie, Tamar Tsereteli, Erica Chong, Faiza Aliyeva, Gulnara Rzayeva, Beverly Winikoff
    Abstract:

    AbstractObjective 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 (9...

  • ru ok the acceptability and feasibility of remote technologies for follow up after early Medical Abortion
    Contraception, 2014
    Co-Authors: Hillary Bracken, Patricia A. Lohr, Jeanette Taylor, Chelsea Morroni, Beverly Winikoff
    Abstract:

    Abstract Objectives We tested the effectiveness and feasibility of remote communication technologies to increase follow-up after early Medical Abortion. Study design Women ( n =999) were randomized to ‘remote' follow-up incorporating a low-sensitivity pregnancy test and standardized symptom questionnaire administered online, by text message or telephone by a non-clinical call center operator 2 weeks after treatment, or to ‘clinic-based' follow-up with ultrasound at 1 week. Women in the clinic-based group who could not return performed a high-sensitivity pregnancy test at 3 weeks and had a telephone call with clinic staff. The primary outcome was completion of follow-up. Rates of complications, acceptability and preferences were compared. Results The overall follow-up rate did not differ by group {clinic-based, 73% vs. remote, 69%; risk ratio (RR) 1.0 [95% confidence interval (CI) 0.9–1.2]}. In the clinic-based group, 83% did not return for an ultrasound scan and were followed up by phone. In the remote group, follow-up by phone or text was more successful than online (text: 75.4%; phone: 73.7%; online: 46.5%, p Conclusions Follow-up after Medical Abortion using remote communication is feasible and, for most women, preferable to a clinic visit. Implications Medical Abortion protocols typically use follow-up visits to ensure early identification of complications. This study demonstrates that follow-up can be achieved using remote communication technologies. This model may reduce the burden of multiple clinic visits on patients and providers.

Elizabeth G. Raymond - One of the best experts on this subject based on the ideXlab platform.

  • efficacy of misoprostol alone for first trimester Medical Abortion a systematic review
    Obstetrics & Gynecology, 2019
    Co-Authors: Elizabeth G. Raymond, Margo S Harrison, Mark A. Weaver
    Abstract:

    OBJECTIVE:To summarize available data on the effectiveness and safety of single-agent misoprostol for Medical Abortion in the first trimester.DATA SOURCES:We searched MEDLINE, CABI, Cochrane, EMBASE, LILACS, the Web of Science, and ClinicalTrials.gov for English-language studies that evaluated misop

  • simplified Medical Abortion screening a demonstration project
    Contraception, 2017
    Co-Authors: Elizabeth G. Raymond, Yi Ling Tan, Patricio Sanhueza, Rodica Comendant, Irina Sagaidac, Stelian Hodorogea, Melissa Grant, Emigdio Van Pratt, Ginger Gillespie, Christy M Boraas
    Abstract:

    Abstract Objectives The objectives were to evaluate the safety and acceptability of outpatient Medical Abortion in selected women without a pretreatment ultrasound or pelvic examination. Study design We conducted a prospective case-series study to estimate the incidence of serious adverse events (death, life-threatening event, hospitalization, transfusion or any other Medical problem that we judged to be significant), surgical completion of the Abortion and satisfaction in women provided with Medical Abortion without a pretreatment ultrasound or pelvic examination. We enrolled 406 women requesting Medical Abortion in Moldova, Mexico and the United States. To be eligible, a woman must have been certain that her last menstrual period started within the prior 56 days, have had regular menses before the pregnancy, not have used hormonal contraceptives in the prior 2 months (in the United States and Mexico) or 3 months (in Moldova), have no risk factors for or symptoms of ectopic pregnancy, and not have had an ultrasound or pelvic exam in this pregnancy. One site also excluded women with uterine enlargement on abdominal palpation. Each participant received mifepristone (200 mg orally) and misoprostol (400 mcg sublingually in Moldova; 800 mcg buccally at all other sites) and was followed until complete Abortion, defined as requiring no further treatment. Results Of the 365 (90%) participants who provided sufficient follow-up information for analysis, 347 (95%) had complete Abortion without additional treatment, 5 (1%) had surgical aspiration, and 10 (3%) had extra misoprostol. Three participants (1%) had serious adverse events; these included two hospital admissions for heavy bleeding managed with aspiration and one diagnosis of persistent gestational sac 19 days after enrollment. Most (317, 90%) participants were pleased with omitting the pretreatment ultrasound and pelvic exam. Conclusions In this study, Medical Abortion without screening ultrasound or pelvic exam resulted in no serious adverse events that were likely to have been prevented by those tests and was highly acceptable. Implications Screening for Medical Abortion without exam or ultrasound shows promise as a means for increasing access to this service. More research is needed to develop screening criteria that are more inclusive and simpler for clinical use.

  • serial multilevel urine pregnancy testing to assess Medical Abortion outcome a meta analysis
    Contraception, 2017
    Co-Authors: Elizabeth G. Raymond, Mark A. Weaver, Ingrida Platais, Jennifer Blum, Nguyen Thi Nhu Ngoc, Tara Shochet, Rasha Dabash, Hillary Bracken, Wendy R Sheldon, Paul D Blumenthal
    Abstract:

    Abstract Objectives To summarize data on the accuracy of a strategy designed to exclude ongoing pregnancy after Medical Abortion treatment by observing a decline in urine human chorionic gonadotropin (hCG) concentration as estimated by multilevel urine pregnancy tests (MLPTs) performed before and after treatment. Study design We collated original data from seven studies performed by our organization that evaluated the accuracy of the MLPT strategy for assessment of outcome of Medical Abortion. Our first analysis included data from the five studies in which each participant was evaluated both with the MLPT strategy and with ultrasound or other clinical assessment. Our second analysis combined data from two randomized trials that compared the MLPT strategy to assessment by ultrasound. Both analyses included only participants treated at ≤63 days of gestation. Results In the first analysis, 1482 (93%) of 1599 participants had a decline in hCG concentration after treatment. Twenty-one (1.3%) had an ongoing pregnancy, none of whom had a decline (predictive value 100%, 95% CI 93.3%, 100%). The remaining 96 women (6.0%) had no decline without an ongoing pregnancy. The second analysis, which included 3762 participants with follow-up, found no significant difference in the rates of ongoing pregnancy ascertained in the randomized groups (RR 0.88; 95% CI 0.50, 1.54). Nearly all of the post-treatment MLPTs in the seven studies (3484/3535; 99%) were performed by the participants themselves. Conclusions Serial multilevel urine pregnancy testing is a highly reliable and efficient strategy for excluding ongoing pregnancy after Medical Abortion at≤63 days of gestation. Implications statement Serial urine testing using MLPTs can obviate the need for routine ultrasound or examination after Medical Abortion treatment and can allow most women to avoid an in-person follow-up visit to the Abortion facility.

  • effect of immediate compared with delayed insertion of etonogestrel implants on Medical Abortion efficacy and repeat pregnancy a randomized controlled trial
    Obstetrics & Gynecology, 2016
    Co-Authors: Elizabeth G. Raymond, Mark A. Weaver, Karmen S. Louie, Yi Ling Tan, Manuel Bousiéguez, Patricio Sanhueza, Elba M Lugohernandez, Ana Gabriela Arangureperaza, Clair Kaplan, Sarita Sonalkar
    Abstract:

    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 rece

  • Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.
    Obstetrics & Gynecology, 2016
    Co-Authors: Elizabeth G. Raymond, Mark A. Weaver, Karmen S. Louie, Yi Ling Tan, Manuel Bousiéguez, Ana Gabriela Aranguré-peraza, Elba M. Lugo-hernández, Patricio Sanhueza, Alisa B. Goldberg, Kelly R. Culwell
    Abstract:

    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 medroxyproges

Alisa B. Goldberg - One of the best experts on this subject based on the ideXlab platform.

  • serum human chorionic gonadotropin hcg trend within the first few days after Medical Abortion a prospective study
    Contraception, 2016
    Co-Authors: Alisa B. Goldberg, Jennifer Fortin, Katherine D Pocius, Deborah Bartz, Rie Maurer, Asha Stenquist
    Abstract:

    Abstract Objectives To prospectively describe the decline in serum human chorionic gonadotropin (hCG) in the first 5 days after complete Medical Abortion and evaluate the influence of initial hCG and gestational duration. Study design We conducted a prospective, physiologic study of women ≤63 days gestation who underwent Medical Abortion with 200 mg mifepristone and 800 mcg buccal misoprostol. We stratified enrollment into two gestational cohorts, Results We enrolled 66 women; 59 were protocol-adherent and included in our analysis. Mean gestation on Day 1 was 49 days and mean baseline hCG was 72,332 IU. Fifty-seven subjects (97%) had a complete Medical Abortion without further intervention. The mean serum hCG decline among subjects with complete Medical Abortion was 70.0±10.6% [range 36.9–98.6%] on Day 3 and 91.4±4.4% [range 68.4–97.7%] on Day 5. The mean serum hCG decline from Day 1 to routine follow-up on Days 7–9 was 97.1±1.7% [range 92.4–99.2%], from Day 1 to Day 10–11 was 98.5±1.4% [range 94.7–99.6%] and from Day 1 to Day 12–14 was 98.7±2.8% [range 86.7–99.9%]. There was no difference in percent hCG decline stratified by initial hCG or gestation. Conclusions There is a rapid and predictable decline in serum hCG as early as Day 5 after complete Medical Abortion through 63 days gestation. Rate of hCG decline is not affected by initial hCG or gestational duration. Implications For women who require confirmation of complete Abortion sooner than 1 week after mifepristone, due to patient preference, logistical constraints or in the setting of pregnancy of unconfirmed location, a single repeat hCG on Day 5 may be clinically useful.

  • Effects of Depot Medroxyprogesterone Acetate Injection Timing on Medical Abortion Efficacy and Repeat Pregnancy: A Randomized Controlled Trial.
    Obstetrics & Gynecology, 2016
    Co-Authors: Elizabeth G. Raymond, Mark A. Weaver, Karmen S. Louie, Yi Ling Tan, Manuel Bousiéguez, Ana Gabriela Aranguré-peraza, Elba M. Lugo-hernández, Patricio Sanhueza, Alisa B. Goldberg, Kelly R. Culwell
    Abstract:

    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 medroxyproges

  • extending outpatient Medical Abortion services through 70 days of gestational age
    Obstetrics & Gynecology, 2012
    Co-Authors: Beverly Winikoff, Alisa B. Goldberg, Erica Chong, Ilana G Dzuba, E Lichtenberg, Carol Ball, Gillian Dean, Daniel Sacks, William A Crowden, Yael Swica
    Abstract:

    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 57–7

  • can women accurately assess the outcome of Medical Abortion based on symptoms alone
    Contraception, 2012
    Co-Authors: Alisa B. Goldberg, Andrea V Jackson, Ila Dayananda, Jennifer Fortin, Garrett M Fitzmaurice
    Abstract:

    Abstract Background The primary purpose of this study was to evaluate whether women undergoing Medical Abortion can accurately assess Abortion outcome based on symptoms alone. Our secondary aim was to identify predictors of Medical Abortion failure. Study Design We conducted a case–control study of women undergoing Medical Abortion from January 1, 2004, to December 31, 2005, who were 63 days' gestation or less and received 200 mg mifepristone followed by 800 mcg of vaginal misoprostol 6–72 h later. Cases were defined as women who required uterine evacuation for a retained gestational sac or ongoing pregnancy. Separate analyses were conducted for the subset of cases with ongoing pregnancies. Controls were defined as women who successfully expelled the pregnancy without uterine evacuation. Results During the study period, 53 women had a retained gestational sac (N=26) or ongoing pregnancy (N=27), and a total of 53 controls were selected, matched by site and date of procedure. Case subjects were more likely than controls to report minimal vaginal bleeding and ongoing pregnancy symptoms and to express doubt that they expelled the pregnancy. When predictive modeling was performed, ongoing pregnancy symptoms, minimal bleeding and gestational age as determined by ultrasound measurement of gestational sac or crown-rump length accurately identified only 68% of Medical Abortion failures. We also found that the odds of Medical Abortion failure decreased progressively from approximately 4 to 7 weeks' gestational age, was lowest at approximately 7 weeks and increased from 7 to 9 weeks' gestation. Conclusion Patient symptomatology and self-assessment of complete Abortion alone are moderately useful in identifying Medical Abortion failure. An objective measure of complete Abortion, such as a pregnancy test, is still required.

Matthew F Reeves - One of the best experts on this subject based on the ideXlab platform.

  • predictors of uterine evacuation following early Medical Abortion with mifepristone and misoprostol
    Contraception, 2016
    Co-Authors: Matthew F Reeves, Jessica A Monmaney, Mitchell D Creinin
    Abstract:

    Abstract Objectives We sought to determine predictors of uterine evacuation for women undergoing Medical Abortion using mifepristone and vaginal misoprostol through 63 days' gestation. Study Design We pooled data from two prospective multicenter Medical Abortion trials. In one study, women received mifepristone 200 mg followed either 6–8 or 23–25 h later by misoprostol 800 mcg vaginally. In the second study, women received mifepristone 200 mg followed either t test and Wilcoxon rank-sum tests for continuous variables. We used logistic regression to calculate odds ratios (ORs) of uterine evacuation. Results Uterine evacuation was performed for 75 (3.5%) of 2160 women. In multivariable analysis, 5 or more prior deliveries (AR 11.9%, OR 4.6) and gestational age of 8 weeks or more (AR 4.1%, OR 2.1) were significantly associated with uterine evacuation, while age of 20 years or younger (AR 1.4%, OR 0.4) was significantly and inversely associated with uterine evacuation. Prior cesarean delivery, multiple gestations, smoking, weight, body surface area and body mass index were not predictive of uterine evacuation in univariate or multivariable analysis. Conclusion Uterine evacuation is an uncommon outcome in Medical Abortion with mifepristone and vaginal misoprostol. Five or more deliveries are the only significant predictor that identifies a group with an AR of uterine evacuation of more than 6%. Implications Uterine evacuation is uncommon in Medical Abortion with mifepristone and vaginal misoprostol. Parity of five or more is the only significant predictor of uterine evacuation exceeding 6%. Until additional research is completed, Medical Abortion should not be withheld from women with five or more deliveries.

  • original research article predictors of uterine evacuation following early Medical Abortion with mifepristone and misoprostol
    2016
    Co-Authors: Matthew F Reeves, Jessica A Monmaney, Mitchell D Creinin
    Abstract:

    Objectives: We sought to determine predictors of uterine evacuation for women undergoing Medical Abortion using mifepristone and vaginal misoprostol through 63 days' gestation. Study Design: We pooled data from two prospective multicenter Medical Abortion trials. In one study, women received mifepristone 200 mg followed either 6– 8o r 23–25 h later by misoprostol 800 mcg vaginally. In the second study, women received mifepristone 200 mg followed either b15 min or 23–25 h later by misoprostol 800 mcg vaginally. We examined the absolute risk (AR) of uterine evacuation using Fisher's Exact Tests for categorical variables and Student t test and Wilcoxon rank-sum tests for continuous variables. We used logistic regression to calculate odds ratios (ORs) of uterine evacuation. Results: Uterine evacuation was performed for 75 (3.5%) of 2160 women. In multivariable analysis, 5 or more prior deliveries (AR 11.9%, OR 4.6) and gestational age of 8 weeks or more (AR 4.1%, OR 2.1) were significantly associated with uterine evacuation, while age of 20 years or younger (AR 1.4%, OR 0.4) was significantly and inversely associated with uterine evacuation. Prior cesarean delivery, multiple gestations, smoking, weight, body surface area and body mass index were not predictive of uterine evacuation in univariate or multivariable analysis. Conclusion: Uterine evacuation is an uncommon outcome in Medical Abortion with mifepristone and vaginal misoprostol. Five or more deliveries are the only significant predictor that identifies a group with an AR of uterine evacuation of more than 6%. Implications: Uterine evacuation is uncommon in Medical Abortion with mifepristone and vaginal misoprostol. Parity of five or more is the only significant predictor of uterine evacuation exceeding 6%. Until additional research is completed, Medical Abortion should not be withheld from women with five or more deliveries.

  • feasibility of telephone follow up after Medical Abortion
    Contraception, 2009
    Co-Authors: Lisa Perriera, Matthew F Reeves, Beatrice A Chen, Heather L Hohmann, Jennifer L Hayes, Mitchell D Creinin
    Abstract:

    Abstract Background This study was conducted to assess the feasibility of using telephone calls combined with high-sensitivity urine pregnancy testing as a primary method of follow-up after Medical Abortion. Methods We enrolled 139 women up to 63 days of gestation to receive mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, per their choice. Participants were contacted by phone one week after mifepristone administration and interviewed using standardized questions. If the subject or clinician thought the pregnancy was not expelled, the subject returned for an ultrasound examination. Otherwise, subjects performed high-sensitivity home urine pregnancy testing 30 days after the mifepristone and were called within 3 days of the test. Those with positive pregnancy tests returned for an ultrasound examination. Those with negative tests required no further follow-up. Results Six of the 139 (4.3%, 95% CI 1.6–9.1%) subjects presented prior to Phone Call 1 for an in-person visit. All 133 (100%, 95% CI 97.8–100%) subjects eligible for their first telephone follow-up were contacted. Eight of the 133 (6.1%, 95% CI 2.6–11.5%) women were asked to return for evaluation and all did so (100%, 95% CI 63.1–100%). Eight of the 133 women eligible for the 30 day phone call presented for an interim visit prior to the call. After 30 days, 116 of the 117 (99.1%, 95% CI 97.5–100%) eligible subjects were contacted. One subject was not reached for the day 30 phone call. Twenty-seven of the 116 (23.3%, 95% CI 15.6–31.0%) subjects had a positive pregnancy test and required follow-up. Two of these subjects (7.4%, 95% CI 1.0–24.2%) did not return for in-person follow-up. Two of the 116 (1.7%, 95% CI 0.2–6.1%) subjects had inconclusive pregnancy tests and were asked to return for follow-up. One of these subjects (50%, 95% CI 1.2–98.7%) did not return. Complete follow-up was achieved in 135 of the 139 subjects (97.1%, 95% CI 94.3–99.9%). None of the 26 women evaluated for a positive or inconclusive pregnancy test had a gestational sac or continuing pregnancy. Conclusion Telephone follow-up combined with urine pregnancy testing after Medical Abortion is a feasible alternative to routine ultrasonography or serial serum hCG measurements.

  • Endometrial thickness following Medical Abortion is not predictive of subsequent surgical intervention
    Ultrasound in Obstetrics and Gynecology, 2009
    Co-Authors: Matthew F Reeves, M. C. Fox, Patricia A. Lohr, Mitchell D Creinin
    Abstract:

    Objectives To evaluate the ability of endometrial thickness after Medical Abortion to predict the need for subsequent dilatation and curettage (D&C). Methods We pooled data from two multicenter Medical Abortion trials involving 2208 women who received mifepristone orally followed by misoprostol vaginally. Women returned for transvaginal ultrasonography approximately 7 days later. The endometrial thickness was measured if no gestational sac was present. Final status was confirmed by a phone interview at 5 weeks. The area under the receiver–operating characteristics (ROC) curve was calculated to assess the overall ability of endometrial thickness to predict the need for subsequent D&C. Endometrial thickness was dichotomized using threshold values at 5-mm increments from 10 to 30 mm. The sensitivity, specificity, negative predictive value and positive predictive value were calculated to evaluate the ability of each endometrial thickness threshold value to predict subsequent D&C. Multivariable regression analysis was performed to adjust endometrial thickness values for study, treatment group, and study site. Results At 7 days after misoprostol treatment, 1870 women (84.7%) had endometrial thickness assessed. Thirty of these women (1.6%) subsequently underwent D&C. The mean endometrial thickness was 14.5 mm for women who underwent D&C and 10.9 mm for those who did not (difference 3.5 mm (95% CI, 1.8–5.3 mm)). Endometrial thickness was poorly predictive of the need for D&C, with an area under the ROC curve of 0.65. All endometrial thickness thresholds had positive predictive values of 25% or less. The results were unchanged by adjustment of endometrial thickness values by multivariable modeling. Conclusions Although endometrial thickness following successful expulsion of the gestational sac is thicker in women who will eventually require surgical intervention after Medical Abortion, endometrial thickness is not a clinically useful predictor of the subsequent need for D&C. Copyright  2009 ISUOG. Published by John Wiley & Sons, Ltd.

  • Medical Abortion outcomes after a second dose of misoprostol for persistent gestational sac
    Contraception, 2008
    Co-Authors: Matthew F Reeves, Anupa Kudva, Mitchell D Creinin
    Abstract:

    Abstract Background We sought to examine outcomes after a second dose of misoprostol was given at a 1-week follow-up visit after Medical Abortion for the presence of a persistent gestational sac (GS) on ultrasound examination. Study Design We examined outcomes in women who were enrolled in two randomized trials of Medical Abortion regimens. Pregnant women up to 63 days' gestation received mifepristone followed by misoprostol 800 mcg vaginally either 24 h later, 6–8 h later or within 15 min. Participants in both studies returned for an evaluation, including transvaginal ultrasonography, approximately 7 days after initiating treatment. We included women with a GS present at the follow-up visit. Subjects who had not expelled the GS received a second dose of misoprostol 800 mcg vaginally. Participants returned approximately 1 week later and were contacted by telephone 5 weeks after treatment. Results Of 1972 women who had a follow-up ultrasound examination within 11 days of treatment, a persistent GS was identified in 82 women (4.2%) of whom 68 opted to receive a second dose of misoprostol. All 68 women returned for follow-up evaluation and 42 (62%) expelled the GS. In the 26 women with an embryonic pole within the persistent sac, expulsion occurred in 5 (36%) of 14 with and 7 (54%) of 13 without gestational cardiac activity (GCA) (p=.45). Of the 14 pregnancies with GCA, only 5 (36%) had GCA at follow-up. Conclusions More than half of women with a persistent GS after Medical Abortion will expel the pregnancy when treated with a second dose of misoprostol. One-third of women who have a GS with cardiac activity will expel the GS with a second dose of misoprostol, making a second dose a reasonable option.