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Current Obstetrics and Gynecology... 2023This review aims to provide up-to-date information about self-managed abortion in the USA. (Review)
Review
PURPOSE OF REVIEW
This review aims to provide up-to-date information about self-managed abortion in the USA.
RECENT FINDINGS
Evidence indicates that there is growing demand for self-managed abortion in the USA as obstacles to facility-based care increase, especially since the Supreme Court overturned . Self-managed abortion with medications is safe and effective.
SUMMARY
Based on a nationally representative survey, the lifetime prevalence of self-managed abortion in the USA in 2017 was estimated to be 7%. People experiencing barriers to abortion care, including people of color, people with lower incomes, people in states that have restrictive abortion laws, and those living farther from facilities providing abortion care are more likely to attempt self-managed abortion. While people may use a range of methods to self-manage abortion, there is growing use of safe and effective medications, including mifepristone used together with misoprostol and misoprostol used alone; use of traumatic and dangerous methods is rare. While many people attempt to self-manage their abortion because of barriers to facility-based care, others have a preference for self-care because it is convenient, accessible, and private. While the medical risks of self-managed abortion may be few, the legal risks may be significant. Sixty-one people have been criminally investigated or arrested between 2000 and 2020 for allegedly self-managing their abortion or helping someone else do so. Clinicians play an important role in providing evidence-based information and care to patients considering or attempting self-managed abortion, as well as minimizing legal risks.
PubMed: 37305376
DOI: 10.1007/s13669-023-00354-x -
JAMA Network Open Oct 2023Misoprostol-alone regimens for abortion may be more effective than previously thought. (Observational Study)
Observational Study
IMPORTANCE
Misoprostol-alone regimens for abortion may be more effective than previously thought.
OBJECTIVE
To estimate the effectiveness of medication abortion with misoprostol alone among individuals self-managing their abortion.
DESIGN, SETTING, AND PARTICIPANTS
For this prospective observational cohort study of callers to safe abortion hotlines and accompaniment groups in Argentina, Nigeria, and Southeast Asia, participants were recruited between July 31, 2019, and October 1, 2020, prior to starting their medication abortion. Eligible participants were 13 years or older, had no contraindications to medication abortion, and were not currently bleeding. Participants completed a baseline and 2 follow-up surveys. The analysis was restricted to participants who reported using misoprostol alone and was performed between January 6, 2022 and September 8, 2023.
EXPOSURE
Self-managed medication abortion using misoprostol alone.
MAIN OUTCOMES AND MEASURES
The primary outcome was effectiveness, defined as participant self-report of complete abortion without procedural intervention, measured at 1 week and 3 weeks after taking misoprostol. Secondary outcomes included method safety, measured by self-report of experiencing warning signs (eg, heavy bleeding, pain, fever, discharge) indicative of a potential complication and by medical treatment (eg, blood transfusion, intravenous fluids, overnight hospital stay) indicative of a potential adverse event. Additional outcomes included length of bleeding and cramping, time to expulsion, and experience of adverse effects.
RESULTS
Among 1352 enrolled participants, 637 used misoprostol-alone regimens for abortion and were included in the analysis (591 [92.8%] from Nigeria, 45 [7.1%] from Southeast Asia, and 1 [0.2%] from Argentina; 384 [60.2%] aged 20-29 years; 317 [49.8%] with pregnancy durations <7 weeks and 205 [32.2%] with pregnancy durations between 7 and <9 weeks). At last follow-up after taking medication (median, 22 days; IQR, 21-26 days), 625 participants (98.1%; 95% CI, 96.7%-98.9%) had a complete abortion without procedural intervention. Potential adverse events were reported by 6 participants (0.9%; 95% CI, 0.4%-2.1%). Most participants experienced bleeding for less than 1 week (median, 4 days; IQR, 3-6 days) and expelled their pregnancy within 24 hours of starting the abortion process (median, 12 hours; IQR, 9-15 hours). Common side effects included nausea (335 participants [52.6%]), fever (232 [36.4%]), and diarrhea (181 [28.4%]).
CONCLUSIONS AND RELEVANCE
The findings suggest that misoprostol alone is a highly effective method of pregnancy termination. Future research should explore strategies to maximize the effectiveness of misoprostol alone in clinical and nonclinical settings.
Topics: Pregnancy; Female; Humans; Misoprostol; Prospective Studies; Mifepristone; Abortion, Induced; Abortion, Spontaneous
PubMed: 37889485
DOI: 10.1001/jamanetworkopen.2023.40042 -
Ciencia & Saude Coletiva Aug 2022The use of misoprostol for abortifacient purposes is a phenomenon observed in Brazil since the late 1980s. The drug started to be used at that time for self-induced... (Review)
Review
The use of misoprostol for abortifacient purposes is a phenomenon observed in Brazil since the late 1980s. The drug started to be used at that time for self-induced abortion, when it began to be commercialized for the treatment of peptic ulcer. Its access was restricted from 1998 onwards, but the drug continues to be commercialized illegally. The objective of this article is to summarize the knowledge produced by research in Brazil about induced abortion and the use of misoprostol. An integrative review of original studies carried out in Brazil and published in journals indexed in SciELO, PubMed and Lilacs databases was performed. The search found 68 titles, and 28 articles were included in the review. Most women who induced pregnancy interruption were young and did it before 15 gestational weeks. The rate of misoprostol use ranged from 89% to 36%. This drug is effective for terminating pregnancy in the first trimester and has a low rate of complications. However, the more socially vulnerable the woman is, the greater are the health risks in the abortion process. The conclusion is that the purchase of misoprostol as an abortifacient is facilitated, despite it being prohibited, and its complications are associated with the context of vulnerability of the pregnant woman.
Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortion, Criminal; Abortion, Induced; Female; Humans; Misoprostol; Pregnancy
PubMed: 35894320
DOI: 10.1590/1413-81232022278.03102022 -
Maedica Sep 2019Hysteroscopy is a diagnostic and therapeutic modality, while cervical ripening before hysteroscopy is an issue of concern and different agents have been used for this...
Hysteroscopy is a diagnostic and therapeutic modality, while cervical ripening before hysteroscopy is an issue of concern and different agents have been used for this purpose. The goal of this study is to compare the effectiveness of misoprostol and isosorbide mononitrate (IMN) for cervical ripening before hysteroscopy. In this randomized clinical trial, 56 women who were candidates for hysteroscopy were randomly assigned to misoprostol or isosorbide mononitrate groups. During the early follicular phase of the cycle, a gynecology expert performed the hysteroscopies. Cervical dilation was measured by insertion of Hegar dilators up to size 9 without force. Vaginal bleeding, headache, abdominal pain, nausea, and vital signs were recorded by a specialized nurse. There was no significant difference regarding age, systolic and diastolic blood pressure in the two groups. Heart rate was significantly higher in the IMN group. Bleeding rate was not significantly different between the two groups (25.8% in the misoprostol group and 24% in the isosorbide mononitrate group, p=0.8). Headache was significantly more frequent in the isosorbide group, while abdominal pain, nausea, vomiting were significantly prevalent in the misoprostol group. The mean Hegar number used in the misoprostol and IMN groups was 7.3±1.1 vs 6.7±0.8 (p=0.03) Isosorbide mononitrate (IMN) is more effective than misoprostol for cervical ripening before hysteroscopy and complications are more frequent in the misoprostol group.
PubMed: 31798742
DOI: 10.26574/maedica.2019.14.3.260 -
Contraception Dec 2022Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks' gestation using medical methods, specifically using a combination of... (Review)
Review
INTRODUCTION
Abortion is common worldwide and increasingly abortions are performed at less than 14 weeks' gestation using medical methods, specifically using a combination of mifepristone and misoprostol. Medical abortion is known to be a painful process, but the optimal method of pain management is unclear. We sought to identify and compare pain management regimens for medical abortion before 14 weeks' gestation.
STUDY DESIGN
We conducted our search in August 2019 and included randomized controlled trials (RCT) and observational studies of any pain relief intervention (pharmacological and non-pharmacological) for mifepristone-misoprostol combination medical abortion of pregnancies less than 14 weeks' gestation.
RESULTS
We included four RCTs and one observational study. Due to the heterogeneity of study designs, interventions and outcome reporting, meta-analysis was not possible. Only one study found evidence of an effect between interventions on pain score: a prophylactic dose of ibuprofen 1600mg likely reduces the pain score when compared to a dose of paracetamol 2000mg (MD 2.26/10 [CI 3-1.52 lower]). For other interventions (pregabalin 300mg vs placebo; ibuprofen 800mg vs placebo; therapeutic vs prophylactic administration of ibuprofen 800mg; ambulation vs non-ambulation during treatment) there appeared to be little to no difference with comparator.
CONCLUSIONS
The findings of this review provide some support for the use of ibuprofen as a single dose given with misoprostol prophylactically, or in response to pain as needed. The optimal dosing of ibuprofen is unclear, but a single dose of ibuprofen 1600mg was shown to be effective and it was less certain whether 800mg was effective.
Topics: Humans; Female; Pregnancy; Pain Management; Misoprostol; Mifepristone; Ibuprofen; Pain; Observational Studies as Topic
PubMed: 36055363
DOI: 10.1016/j.contraception.2022.08.005 -
BMC Pregnancy and Childbirth Mar 2020Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low- and middle-income countries (LMICs). Oxytocin and misoprostol are used for the prevention...
BACKGROUND
Postpartum haemorrhage (PPH) is the leading cause of maternal mortality in low- and middle-income countries (LMICs). Oxytocin and misoprostol are used for the prevention and treatment of PPH. However, both medicines are chemically unstable and sensitive to environmental conditions. Previous studies reported a high prevalence of substandard oxytocin and misoprostol preparations in LMICs.
METHODS
In randomly selected health facilities of four districts of Malawi, the availability of oxytocin and misoprostol was determined, and the knowledge of health workers on storage requirements and use of oxytocics was assessed. Temperature loggers were used to record the storage temperature of oxytocics. Samples of oxytocin injections and misoprostol tablets were collected from the health facilities and from wholesalers. Oxytocin samples were analysed for identity, assay (= quantity of oxytocin) and for pH value according to United States Pharmacopeia 40. Misoprostol samples were analysed for identity, assay, dissolution and related substances according to the International Pharmacopeia 2017.
RESULTS
All visited hospitals and health centers had oxytocin available. At non-refrigerated storage sites, the recorded mean kinetic temperature exceeded the oxytocic's storage temperature stated on the labels in 42% of the sites. At refrigerated storage sites, the required temperature of 2-8 °C was exceeded in 33% of the sites. Out of 65 oxytocin samples, 7 (11%) showed moderate deviations from specification, containing 82.2-86.8% of the declared amount of oxytocin. Out of 30 misoprostol samples, 5 (17%) showed extreme deviations, containing only 12.7-30.2% of the declared amount. The extremely substandard misoprostol was reported to the national authorities and to WHO, leading to an immediate recall of the respective brand in Malawi. The UK-based distributor of this brand closed its business shortly thereafter.
CONCLUSION
Availability of oxytocin was excellent in Malawi, and its quality was better than reported in previous studies in other LMICs. However, storage conditions at the health facilities often did not meet the requirements. Extremely substandard misoprostol tablets were found, representing a serious risk to maternal health. This shows the need for continued efforts for quality assurance in medicine procurement and registration, as well as for post-marketing surveillance.
Topics: Drug Storage; Health Facilities; Health Knowledge, Attitudes, Practice; Health Personnel; Humans; Malawi; Misoprostol; Oxytocics; Oxytocin; Quality Assurance, Health Care; Quality Control
PubMed: 32223759
DOI: 10.1186/s12884-020-2810-9 -
PloS One 2021Sustainable Development Goal 3.1 calls for a reduction of the maternal mortality ratio to less than 70 per 100,000 live births by 2030. The most important cause of...
Sustainable Development Goal 3.1 calls for a reduction of the maternal mortality ratio to less than 70 per 100,000 live births by 2030. The most important cause of maternal mortality is post-partum haemorrhage (PPH). Oxytocin injections and misoprostol tablets are medicines of first choice for the management of PPH in low- and middle-income countries (LMICs). Unfortunately, both substances are chemically unstable, and previous studies have revealed serious quality problems of these medicines in LMICs. The present study is the first report on their quality in Rwanda. From 40 randomly selected health facilities (hospitals, health centers, retail pharmacies and private clinics) in different parts of Rwanda, as well as from six wholesalers and government stores, oxytocin injections and misoprostol tablets were collected. Oxytocin storage temperatures in the health facilities were monitored for six months using temperature data loggers, and found to correctly follow the storage requirements stated by the manufacturers (2-8°C, or room temperature) with few minor deviations. Oxytocin injections (57 samples, representing seven batches of four brands) were tested for their oxytocin content and pH value according to the United States Pharmacopeia. Twenty-four samples from three European manufacturers passed all tests. However, all nine samples of one batch of a Chinese manufacturer showed an excessive content of oxytocin (range 117.2-121.5% of the declared amount). Another batch of the same manufacturer showed extreme variations of the concentration of the preservative benzyl alcohol. Misoprostol tablets (25 samples, representing ten batches of six brands) were tested for content and dissolution according to the International Pharmacopoeia. Fifteen samples passed, but all 10 samples of two brands from India failed with extreme deviations, containing only 42.5-48.7% of the stated amount of misoprostol. In conclusion, oxytocin quality in Rwanda was better than reported from other African countries. However, two extremely substandard brands of misoprostol tablets were found. The Rwandan authorities reacted quickly and efficiently, and recalled these substandard medicines from the market. For oxytocin and misoprostol, with their well-known problems of quality and stability, procurement should possibly be restricted to medicines which are WHO-prequalified or which have been manufactured in countries with stringent regulatory authorities.
Topics: Drug Storage; Health Facilities; Humans; Oxytocics; Quality Assurance, Health Care; Quality Control; Rwanda
PubMed: 33417602
DOI: 10.1371/journal.pone.0245054 -
BMJ Open Gastroenterology Jun 2024The management of non-alcoholic steatohepatitis (NASH) is an unmet clinical need. Misoprostol, a structural analogue of naturally occurring prostaglandin E1, has been... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
The management of non-alcoholic steatohepatitis (NASH) is an unmet clinical need. Misoprostol, a structural analogue of naturally occurring prostaglandin E1, has been reported to decrease proinflammatory cytokine production and may have a potential role in treating NASH. We aimed to evaluate the efficacy and safety of misoprostol in treating patients with NASH.
METHODS
In this phase 2, double-blind, randomised, placebo-controlled trial, patients with NASH were randomly assigned in a 1:1 ratio to receive 200 µg of misoprostol or placebo thrice daily for 2 months. The primary endpoint was an improvement in liver function tests (LFTs), interleukin-6 (IL-6) and endotoxin levels. The secondary endpoint was improvement in insulin resistance, dyslipidaemia, hepatic fibrosis and hepatic steatosis.
RESULTS
A total of 50 patients underwent randomisation, of whom 44 (88%) were males. The age range was 25-64 years (mean±SE of mean (SEM) 38.1±1.4). 19 (38%) patients had concomitant type 2 diabetes mellitus. 32 (64%) patients were either overweight or obese. At the end of 2 months' treatment, a reduction in total leucocyte count (TLC) (p=0.005), alanine aminotransferase (ALT) (p<0.001), aspartate aminotransferase (AST) (p=0.002) and controlled attenuation parameter (CAP) (p=0.003) was observed in the misoprostol group, whereas placebo ensued a decline in ALT (p<0.001), AST (p=0.018), gamma-glutamyl transferase (GGT) (p=0.003), CAP (p=0.010) and triglycerides (p=0.048). There was no diminution in insulin resistance, hepatic fibrosis (elastography) and dyslipidaemia in both groups. However, misoprostol resulted in a significant reduction in CAP as compared with the placebo group (p=0.039). Moreover, in the misoprostol group, pretreatment and post-treatment IL-6 and endotoxin levels remained stable, while in the placebo group, an increase in the IL-6 levels was noted (p=0.049). Six (12%) patients had at least one adverse event in the misoprostol group, as did five (10%) in the placebo group. The most common adverse event in the misoprostol group was diarrhoea. No life-threatening events or treatment-related deaths occurred in each group.
CONCLUSION
Improvement in the biochemical profile was seen in both misoprostol and placebo groups without any statistically significant difference. However, there was more improvement in steatosis, as depicted by CAP, in the misoprostol group and worsening of IL-6 levels in the placebo group.
TRIAL REGISTRATION NUMBER
NCT05804305.
Topics: Humans; Male; Female; Non-alcoholic Fatty Liver Disease; Middle Aged; Double-Blind Method; Adult; Misoprostol; Interleukin-6; Treatment Outcome; Insulin Resistance; Liver Cirrhosis; Liver Function Tests; Liver
PubMed: 38844374
DOI: 10.1136/bmjgast-2023-001342 -
American Family Physician Apr 2021Medication regimens using mifepristone and misoprostol are safe and effective for outpatient treatment of early pregnancy loss for up to 84 days' gestation and for...
Medication regimens using mifepristone and misoprostol are safe and effective for outpatient treatment of early pregnancy loss for up to 84 days' gestation and for medication abortion up to 77 days' gestation. Gestational age is determined using ultrasonography or menstrual history. Ultrasonography is needed when gestational dating cannot be confirmed using clinical data alone or when there are risk factors for ectopic pregnancy. The most effective regimens for medication management of early pregnancy loss and medication abortion include 200 mg of oral mifepristone (a progesterone receptor antagonist) followed by 800 mcg of misoprostol (a prostaglandin E1 analogue) administered buccally or vaginally. Cramping and bleeding are expected effects of the medications, with bleeding lasting an average of nine to 16 days. The adverse effects of misoprostol (e.g., low-grade fever, gastrointestinal symptoms) can be managed with nonsteroidal anti-inflammatory drugs or antiemetics. Ongoing pregnancy, infection, hemorrhage, undiagnosed ectopic pregnancy, and the need for unplanned uterine aspiration are rare complications. Clinical history, combined with serial quantitative beta human chorionic gonadotropin levels, urine pregnancy testing, or ultrasonography, is used to establish complete passage of the pregnancy tissue.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Abortion, Spontaneous; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Prenatal Care
PubMed: 33856168
DOI: No ID Found