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Nature Apr 2024
Topics: Female; Humans; Pregnancy; Abortion, Induced; Family Planning Services; United States; Mifepristone; Supreme Court Decisions; Legislation, Drug
PubMed: 38538891
DOI: 10.1038/d41586-024-00938-4 -
BMJ (Clinical Research Ed.) Mar 2024
Topics: Humans; United States; Female; Pregnancy; Mifepristone; Abortion, Induced; Family Planning Services; Supreme Court Decisions
PubMed: 38538006
DOI: 10.1136/bmj.q763 -
JAMA May 2024
Topics: Humans; Abortifacient Agents; Abortion, Induced; Abortion, Legal; Health Services Accessibility; Mifepristone; Nonprescription Drugs; Reproductive Health Services; Supreme Court Decisions; United States; United States Food and Drug Administration
PubMed: 38526871
DOI: 10.1001/jama.2024.5376 -
JAMA May 2024The Supreme Court decision in Dobbs v Jackson Women's Health Organization overturned the right to choose abortion in the US, with at least 16 states subsequently...
IMPORTANCE
The Supreme Court decision in Dobbs v Jackson Women's Health Organization overturned the right to choose abortion in the US, with at least 16 states subsequently implementing abortion bans or 6-week gestational limits. Prior research indicates that in the 6 months following Dobbs, approximately 32 360 fewer abortions were provided within the US formal health care setting. However, trends in the provision of medications for self-managed abortion outside the formal health care setting have not been studied.
OBJECTIVE
To determine whether the provision of medications for self-managed abortion outside the formal health care setting increased in the 6 months after Dobbs.
DESIGN, SETTING, AND PARTICIPANTS
Cross-sectional study using data from sources that provided abortion medications outside the formal health care setting to people in the US between March 1 and December 31, 2022, including online telemedicine organizations, community networks, and online vendors. Using a hierarchical bayesian model, we imputed missing values from sources not providing data. We estimated the change in provision of medications for self-managed abortion after the Dobbs decision. We then estimated actual use of these medications by accounting for the possibility that not all provided medications are used by recipients.
EXPOSURE
Abortion restrictions following the Dobbs decision.
MAIN OUTCOMES AND MEASURES
Provision and use of medications for a self-managed abortion.
RESULTS
In the 6-month post-Dobbs period (July 1 to December 31, 2022), the total number of provisions of medications for self-managed abortion increased by 27 838 (95% credible interval [CrI], 26 374-29 175) vs what would have been expected based on pre-Dobbs levels. Excluding imputed data changes the results only slightly (27 145; 95% CrI, 25 747-28 246). Accounting for nonuse of medications, actual self-managed medication abortions increased by an estimated 26 055 (95% CrI, 24 739-27 245) vs what would have been expected had the Dobbs decision not occurred.
CONCLUSIONS AND RELEVANCE
Provision of medications for self-managed abortions increased in the 6 months following the Dobbs decision. Results suggest that a substantial number of abortion seekers accessed services despite the implementation of state-level bans and restrictions.
Topics: Female; Humans; Pregnancy; Abortifacient Agents; Abortion, Induced; Abortion, Legal; Cross-Sectional Studies; Health Services Accessibility; Mifepristone; Misoprostol; Self Care; Supreme Court Decisions; United States
PubMed: 38526865
DOI: 10.1001/jama.2024.4266 -
JAMA Apr 2024
Topics: Female; Humans; Pregnancy; Abortion, Induced; Abortion, Legal; Politics; Supreme Court Decisions; United States; United States Food and Drug Administration; Mifepristone; Abortifacient Agents
PubMed: 38526475
DOI: 10.1001/jama.2024.2229 -
Contraception: X 2024Document the clinical outcomes of an outpatient medical management with procedural evacuation backup procedure for abortions between 18 weeks zero days to 23 weeks six...
OBJECTIVE
Document the clinical outcomes of an outpatient medical management with procedural evacuation backup procedure for abortions between 18 weeks zero days to 23 weeks six days gestation.
STUDY DESIGN
We conducted a retrospective medical records review of adult patients who received mifepristone and repeated misoprostol for second trimester abortion with procedural evacuation backup at an Arizona clinic between October 2017 and November 2021. We extracted patient demographics; pregnancy and medical history; and preoperative, intraoperative, and postoperative data. We assessed abortion outcomes, including procedure timing, mode of completion (medication alone or medications and procedural evacuation), and safety.
RESULTS
All 359 patients had a complete abortion with 63.5% of patients completing with medication alone and 36.5% with procedural evacuation backup. The median time from first dose of misoprostol to fetal expulsion was six hours, among those who completed the abortion with medications alone. Of those who received procedural evacuation as backup, the median time for procedural evacuation was 10 minutes. The vast majority of patients (99.4%) did not have any adverse events. Two safety incidents (0.6%) occurred, a broad right ligament tear and a uterine rupture.
CONCLUSION
Patients in one outpatient setting safely and effectively received medical management of second trimester abortion with procedural evacuation backup, and two thirds completed with medications alone.
IMPLICATIONS
Outpatient settings may consider medical management of abortion between 18 and 24 weeks with procedural evacuation back-up as a safe, effective, and manageable second trimester abortion option. Additional research is needed on patient experience and satisfaction.
PubMed: 38515629
DOI: 10.1016/j.conx.2024.100104 -
Contraception Jun 2024In November 2022, the anti-abortion advocacy group Alliance for Hippocratic Medicine filed a lawsuit against the U.S. Food and Drug Administration challenging the...
OBJECTIVES
In November 2022, the anti-abortion advocacy group Alliance for Hippocratic Medicine filed a lawsuit against the U.S. Food and Drug Administration challenging the initial 2000 approval of mifepristone and its subsequent approvals, which removed unnecessary restrictions on its use, by disputing the medication's safety record. Such challenges relied on a study examining the incidence of emergency room visits following medication abortion with mifepristone and procedural abortion using Medicaid claims data from 1999-2015. In February 2024 that study was retracted by its publisher. In this paper, we analyzed the methods and presentations of the data used in the study.
STUDY DESIGN
We drew upon commonly accepted principles in responsible epidemiologic and scientific research to evaluate the methods and presentations of the data and organized our findings into themes.
RESULTS
We found multiple instances of methodological flaws, mischaracterizations, and obfuscations of data in this study, including use of a misleading research question and framing, analytic flaws, inappropriate use of an unvalidated proxy measure for outcomes of interest, and inappropriate and deceptive visualizations of data. In each instance, the resulting effect obfuscated and misrepresented the safety of medication abortion with mifepristone.
CONCLUSIONS
The misrepresentation and exaggeration of data promoted and exacerbated misinterpretations about the study's findings, resulting in substantial harm before it was retracted. Recognizing that ongoing judicial proceedings threaten access to conventional reproductive health care in the United States, public health policies must be informed by scientific and medical literature that is comprehensive, methodologically sound, and absent any obfuscations or misrepresentations.
IMPLICATIONS
Studnicki et al.'s study of emergency room visits after abortion misrepresented the safety of mifepristone with multiple instances of methodological flaws and obfuscations of data. While the study has now been retracted, it led to irrevocable harm, threatening access to medication abortion, which has an established safety record.
Topics: Humans; Female; Mifepristone; Abortion, Induced; Pregnancy; United States; Longitudinal Studies; Emergency Service, Hospital; Medicaid; United States Food and Drug Administration; Retraction of Publication as Topic; Abortifacient Agents
PubMed: 38494149
DOI: 10.1016/j.contraception.2024.110417 -
American Journal of Obstetrics and... Mar 2024Several systematic reviews and meta-analyses have summarized the evidence on the efficacy and safety of various outpatient cervical ripening methods. However, the method... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Several systematic reviews and meta-analyses have summarized the evidence on the efficacy and safety of various outpatient cervical ripening methods. However, the method with the highest efficacy and safety profile has not been determined conclusively. We performed a systematic review and network meta-analysis of published randomized controlled trials to assess the efficacy and safety of cervical ripening methods currently employed in the outpatient setting.
DATA SOURCES
With the assistance of an experienced medical librarian, we performed a systematic search of the literature using MEDLINE, Embase, Scopus, Web of Science, Cochrane Library, and ClinicalTrials.gov. We systematically searched electronic databases from inception to January 14, 2020.
STUDY ELIGIBILITY CRITERIA
We considered randomized controlled trials comparing a variety of methods for outpatient cervical ripening.
METHODS
We conducted a frequentist random effects network meta-analysis employing data from randomized controlled trials. We performed a direct, pairwise meta-analysis to compare the efficacy of various outpatient cervical ripening methods, including placebo. We employed ranking strategies to determine the most efficacious method using the surface under the cumulative ranking curve; a higher surface under the cumulative ranking curve value implied a more efficacious method. We assessed the following outcomes: time from intervention to delivery, cesarean delivery rates, changes in the Bishop score, need for additional ripening methods, incidence of Apgar scores <7 at 5 minutes, and uterine hyperstimulation.
RESULTS
We included data from 42 randomized controlled trials including 6093 participants. When assessing the efficacy of all methods, 25 μg vaginal misoprostol was the most efficacious in reducing the time from intervention to delivery (surface under the cumulative ranking curve of 1.0) without increasing the odds of cesarean delivery, the need for additional ripening methods, the incidence of a low Apgar score, or uterine hyperstimulation. Acupressure (surface under the cumulative ranking curve of 0.3) and primrose oil (surface under the cumulative ranking curve of 0.2) were the least effective methods in reducing the time to delivery interval. Among effective methods, 50 mg oral mifepristone was associated with the lowest odds of cesarean delivery (surface under the cumulative ranking curve of 0.9).
CONCLUSION
When balancing efficacy and safety, vaginal misoprostol 25 μg represents the best method for outpatient cervical ripening.
Topics: Pregnancy; Female; Humans; Misoprostol; Oxytocics; Cervical Ripening; Network Meta-Analysis; Outpatients; Labor, Induced
PubMed: 38462254
DOI: 10.1016/j.ajog.2022.09.043 -
American Journal of Obstetrics and... Mar 2024This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical... (Review)
Review
This review assessed the efficacy and safety of pharmacologic agents (prostaglandins, oxytocin, mifepristone, hyaluronidase, and nitric oxide donors) and mechanical methods (single- and double-balloon catheters, laminaria, membrane stripping, and amniotomy) and those generally considered under the rubric of complementary medicine (castor oil, nipple stimulation, sexual intercourse, herbal medicine, and acupuncture). A substantial body of published reports, including 2 large network meta-analyses, support the safety and efficacy of misoprostol (PGE1) when used for cervical ripening and labor induction. Misoprostol administered vaginally at doses of 50 μg has the highest probability of achieving vaginal delivery within 24 hours. Regardless of dosing, route, and schedule of administration, when used for cervical ripening and labor induction, prostaglandin E2 seems to have similar efficacy in decreasing cesarean delivery rates. Globally, although oxytocin represents the most widely used pharmacologic agent for labor induction, its effectiveness is highly dependent on parity and cervical status. Oxytocin is more effective than expectant management in inducing labor, and the efficacy of oxytocin is enhanced when combined with amniotomy. However, prostaglandins administered vaginally or intracervically are more effective in inducing labor than oxytocin. A single 200-mg oral tablet of mifepristone seems to represent the lowest effective dose for cervical ripening. The bulk of the literature assessing relaxin suggests this agent has limited benefit when used for this indication. Although intracervical injection of hyaluronidase may cause cervical ripening, the need for intracervical administration has limited the use of this agent. Concerning the vaginal administration of nitric oxide donors, including isosorbide mononitrate, isosorbide, nitroglycerin, and sodium nitroprusside, the higher incidence of side effects with these agents has limited their use. A synthetic hygroscopic cervical dilator has been found to be effective for preinduction cervical ripening. Although a pharmacologic agent may be administered after the use of the synthetic hygroscopic dilator, in an attempt to reduce the interval to vaginal delivery, concomitant use of mechanical and pharmacologic methods is being explored. Combining the use of a single-balloon catheter with dinoprostone, misoprostol, or oxytocin enhances the efficacy of these pharmacologic agents in cervical ripening and labor induction. The efficacy of single- and double-balloon catheters in cervical ripening and labor induction seems similar. To date, the combination of misoprostol with an intracervical catheter seems to be the best approach when balancing delivery times with safety. Although complementary methods are occasionally used by patients, given the lack of data documenting their efficacy and safety, these methods are rarely used in hospital settings.
Topics: Female; Humans; Pregnancy; Abortifacient Agents, Nonsteroidal; Cervical Ripening; Dinoprostone; Hyaluronoglucosaminidase; Labor, Induced; Mifepristone; Misoprostol; Nitric Oxide Donors; Oxytocics; Oxytocin
PubMed: 38462252
DOI: 10.1016/j.ajog.2023.02.009 -
Journal of Obstetrics and Gynaecology... Jun 2024To evaluate the safety and efficacy of first-trimester "No Touch" medication abortion programs at 2 clinics in Toronto, Ontario during their early implementation in...
OBJECTIVES
To evaluate the safety and efficacy of first-trimester "No Touch" medication abortion programs at 2 clinics in Toronto, Ontario during their early implementation in response to the COVID-19 pandemic.
METHODS
This retrospective study included all patients who underwent virtual consultation for mifepristone-misoprostol medication abortion between April 2020-August 2022 at 2 reproductive health clinics. In response to the pandemic, "No Touch" abortion protocols have been developed that align with the Canadian Protocol for the Provision of Medical Abortion via Telemedicine. Records were reviewed for demographic information, clinical course, investigations required, confirmation of complete abortion and adverse events. The primary outcome was complete medication abortion, defined as expulsion of the pregnancy without requiring uterine aspiration.
RESULTS
A total of 277 patients had abortions initiated in the "No Touch" or "Low Touch" care pathways and had sufficient follow-up to determine outcomes. Of these patients, 92.8% (95% CI 89.7%-95.8%) had a complete medication abortion (n = 257) and 76.1% (n = 159) remained "No Touch" throughout their care. Investigations were performed for 102 participants before or after their abortion, classifying them as "Low Touch". Nineteen patients (6.9%) underwent uterine aspiration. The rate of adverse events was low, with 1 case of a missed ectopic pregnancy and 1 patient requiring hospitalization for endometritis.
CONCLUSIONS
"No Touch" provision of mifepristone-misoprostol medication abortion care was safe and effective with outcomes comparable to previous studies. These results provide evidence for the efficacy and safety of a "No Touch" approach in the Canadian context, which has the potential to reduce barriers to accessing abortion care.
Topics: Humans; Female; COVID-19; Abortion, Induced; Pregnancy; Retrospective Studies; Adult; Ontario; Mifepristone; Pandemics; SARS-CoV-2; Misoprostol; Pregnancy Trimester, First; Telemedicine; Abortifacient Agents, Nonsteroidal; Coronavirus Infections; Betacoronavirus; Pneumonia, Viral; Young Adult
PubMed: 38458271
DOI: 10.1016/j.jogc.2024.102429