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Journal of General Internal Medicine Aug 2020Abortion and miscarriage are common, affecting millions of US women each year. By age 45, one in four women in the USA will have had an abortion, and at least as many... (Review)
Review
Abortion and miscarriage are common, affecting millions of US women each year. By age 45, one in four women in the USA will have had an abortion, and at least as many will have had a miscarriage. Most individuals seeking abortion services do so before 10 weeks' gestation when medication abortions are a safe and effective option, using a regimen of oral mifepristone followed by misoprostol tablets. When a pregnancy is non-viable before 13 weeks' gestation, it is referred to as an early pregnancy loss or miscarriage and can be managed using the same mifepristone and misoprostol regimen. Given their safety and efficacy, mifepristone and misoprostol can be offered in ambulatory settings without special equipment or on-site emergency services. As more patients find it difficult to access clinical care when faced with an undesired pregnancy or a miscarriage, it is important for general internists and primary care providers to become familiar with how to use medications to manage these common conditions. We summarize the most recent evidence regarding the use of mifepristone with misoprostol for early abortion and miscarriage. We discuss clinical considerations and resources for integrating mifepristone and misoprostol into clinical practice. By learning to prescribe mifepristone and misoprostol, clinicians can expand access to time-sensitive health services for vulnerable populations.
Topics: Abortion, Induced; Abortion, Spontaneous; Female; Gestational Age; Humans; Middle Aged; Mifepristone; Misoprostol; Pregnancy
PubMed: 32410127
DOI: 10.1007/s11606-020-05836-9 -
European Journal of Obstetrics,... Jan 2023Identification of patients at risk for postpartum hemorrhage (PPH) may allow for prompt diagnosis and intervention. Individual risk factors, risk assessment tools and... (Review)
Review
Identification of patients at risk for postpartum hemorrhage (PPH) may allow for prompt diagnosis and intervention. Individual risk factors, risk assessment tools and prediction models have been used for determining a patient's risk of PPH. Measures for the prevention of PPH include identification and management of iron deficiency anemia, unit readiness and preparedness through performing regular simulations and having a PPH cart or medication kit readily available, prophylactic uterotonic - carbetocin alone or dual agents such as oxytocin and misoprostol or oxytocin and methylergometrine or antifibrinolytic (oxytocin and tranexamic acid) use in the third stage of labor immediately after fetal head delivery, and controlled cord traction.
Topics: Pregnancy; Female; Humans; Postpartum Hemorrhage; Oxytocin; Oxytocics; Delivery, Obstetric; Misoprostol
PubMed: 36455391
DOI: 10.1016/j.ejogrb.2022.11.021 -
Journal of Veterinary Internal Medicine Nov 2018The gastrointestinal (GI) mucosal barrier is continuously exposed to noxious toxins, reactive oxygen species, microbes, and drugs, leading to the development of...
The gastrointestinal (GI) mucosal barrier is continuously exposed to noxious toxins, reactive oxygen species, microbes, and drugs, leading to the development of inflammatory, erosive, and ultimately ulcerative lesions. This report offers a consensus opinion on the rational administration of GI protectants to dogs and cats, with an emphasis on proton pump inhibitors (PPIs), histamine type-2 receptor antagonists (H RAs), misoprostol, and sucralfate. These medications decrease gastric acidity or promote mucosal protective mechanisms, transforming the management of dyspepsia, peptic ulceration, and gastroesophageal reflux disease. In contrast to guidelines that have been established in people for the optimal treatment of gastroduodenal ulcers and gastroesophageal reflux disease, effective clinical dosages of antisecretory drugs have not been well established in the dog and cat to date. Similar to the situation in human medicine, practice of inappropriate prescription of acid suppressants is also commonplace in veterinary medicine. This report challenges the dogma and clinical practice of administering GI protectants for the routine management of gastritis, pancreatitis, hepatic disease, and renal disease in dogs and cats lacking additional risk factors for ulceration or concerns for GI bleeding. Judicious use of acid suppressants is warranted considering recent studies that have documented adverse effects of long-term supplementation of PPIs in people and animals.
Topics: Animals; Cat Diseases; Cats; Dog Diseases; Dogs; Gastrointestinal Agents; Gastrointestinal Diseases; Misoprostol; Proton Pump Inhibitors; Sucralfate
PubMed: 30378711
DOI: 10.1111/jvim.15337 -
American Family Physician Feb 2022Induction of labor is a common obstetric procedure, and approximately one-fourth of pregnant patients undergo the procedure. Although exercise and nipple stimulation can...
Induction of labor is a common obstetric procedure, and approximately one-fourth of pregnant patients undergo the procedure. Although exercise and nipple stimulation can increase the likelihood of spontaneous labor, sexual intercourse may not be effective. Acupuncture has been used for labor induction; however, it has not been shown to increase vaginal delivery rates. There is strong evidence that membrane sweeping can increase the likelihood of spontaneous labor within 48 hours. Cervical preparation or ripening is often needed before induction. Some evidence shows that the use of nonpharmacologic approaches such as osmotic dilators and cervical ripening balloons reduce time to delivery. The effect of amniotomy on labor is uncertain. Pharmacologic intervention with oxytocin or prostaglandins is effective for cervical ripening and induction of labor. Combining a balloon catheter with misoprostol is a common practice and has been shown to decrease time to delivery in a small study.
Topics: Cervical Ripening; Female; Humans; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Pregnancy
PubMed: 35166491
DOI: No ID Found -
Lancet (London, England) Sep 2020The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The anti-progesterone drug mifepristone and the prostaglandin misoprostol can be used to treat missed miscarriage. However, it is unclear whether a combination of mifepristone and misoprostol is more effective than administering misoprostol alone. We investigated whether treatment with mifepristone plus misoprostol would result in a higher rate of completion of missed miscarriage compared with misoprostol alone.
METHODS
MifeMiso was a multicentre, double-blind, placebo-controlled, randomised trial in 28 UK hospitals. Women were eligible for enrolment if they were aged 16 years and older, diagnosed with a missed miscarriage by pelvic ultrasound scan in the first 14 weeks of pregnancy, chose to have medical management of miscarriage, and were willing and able to give informed consent. Participants were randomly assigned (1:1) to a single dose of oral mifepristone 200 mg or an oral placebo tablet, both followed by a single dose of vaginal, oral, or sublingual misoprostol 800 μg 2 days later. Randomisation was managed via a secure web-based randomisation program, with minimisation to balance study group assignments according to maternal age (<30 years vs ≥30 years), body-mass index (<35 kg/mvs ≥35 kg/m), previous parity (nulliparous women vs parous women), gestational age (<70 days vs ≥70 days), amount of bleeding (Pictorial Blood Assessment Chart score; ≤2 vs ≥3), and randomising centre. Participants, clinicians, pharmacists, trial nurses, and midwives were masked to study group assignment throughout the trial. The primary outcome was failure to spontaneously pass the gestational sac within 7 days after random assignment. Primary analyses were done according to intention-to-treat principles. The trial is registered with the ISRCTN registry, ISRCTN17405024.
FINDINGS
Between Oct 3, 2017, and July 22, 2019, 2595 women were identified as being eligible for the MifeMiso trial. 711 women were randomly assigned to receive either mifepristone and misoprostol (357 women) or placebo and misoprostol (354 women). 696 (98%) of 711 women had available data for the primary outcome. 59 (17%) of 348 women in the mifepristone plus misoprostol group did not pass the gestational sac spontaneously within 7 days versus 82 (24%) of 348 women in the placebo plus misoprostol group (risk ratio [RR] 0·73, 95% CI 0·54-0·99; p=0·043). 62 (17%) of 355 women in the mifepristone plus misoprostol group required surgical intervention to complete the miscarriage versus 87 (25%) of 353 women in the placebo plus misoprostol group (0·71, 0·53-0·95; p=0·021). We found no difference in incidence of adverse events between the study groups.
INTERPRETATION
Treatment with mifepristone plus misoprostol was more effective than misoprostol alone in the management of missed miscarriage. Women with missed miscarriage should be offered mifepristone pretreatment before misoprostol to increase the chance of successful miscarriage management, while reducing the need for miscarriage surgery.
FUNDING
UK National Institute for Health Research Health Technology Assessment Programme.
Topics: Abortion, Missed; Adult; Double-Blind Method; Drug Therapy, Combination; Humans; Mifepristone; Misoprostol; Oxytocics; Treatment Outcome
PubMed: 32853559
DOI: 10.1016/S0140-6736(20)31788-8 -
Obstetrics and Gynecology Oct 2020Medication abortion, also referred to as medical abortion, is a safe and effective method of providing abortion. Medication abortion involves the use of medicines rather...
Medication abortion, also referred to as medical abortion, is a safe and effective method of providing abortion. Medication abortion involves the use of medicines rather than uterine aspiration to induce an abortion. The U.S. Food and Drug Administration (FDA)-approved medication abortion regimen includes mifepristone and misoprostol. The purpose of this document is to provide updated evidence-based guidance on the provision of medication abortion up to 70 days (or 10 weeks) of gestation. Information about medication abortion after 70 days of gestation is provided in other ACOG publications ().
Topics: Abortifacient Agents; Abortion, Induced; Clinical Protocols; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First; United States
PubMed: 32804884
DOI: 10.1097/AOG.0000000000004082 -
BMJ (Clinical Research Ed.) Mar 2022
Topics: Abortifacient Agents, Steroidal; Humans; Mifepristone; Misoprostol
PubMed: 35351689
DOI: 10.1136/bmj.o819 -
Best Practice & Research. Clinical... Nov 2021Oral and vaginal misoprostol are effective induction methods, but there is a delicate balance between a quicker labour and avoiding side effects. In randomised... (Review)
Review
Oral and vaginal misoprostol are effective induction methods, but there is a delicate balance between a quicker labour and avoiding side effects. In randomised comparisons with balloon catheters, oral misoprostol resulted in more vaginal births in the first 24 h as well as fewer caesarean sections without an increase in hyperstimulation events. Vaginal misoprostol was most effective when used concurrently with a balloon catheter. In comparison with dinoprostone, oral misoprostol had lower rates of caesarean section and uterine hyperstimulation with foetal heart rate changes, but fewer babies were born vaginally within 24 h. In contrast, vaginal misoprostol resulted in more vaginal births within 24 h, with no significant differences in caesarean section rates. There were no differences in perinatal adverse events with either route. When oral and vaginal misoprostol were compared, vaginal misoprostol resulted in more vaginal births in the first 24 h, but with more maternal and neonatal complications.
Topics: Cesarean Section; Dinoprostone; Female; Humans; Infant, Newborn; Labor, Induced; Misoprostol; Oxytocics; Pregnancy
PubMed: 34607746
DOI: 10.1016/j.bpobgyn.2021.09.003 -
The Cochrane Database of Systematic... Nov 2020Postpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more after birth, is the leading cause of maternal death worldwide. The World Health Organization... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Postpartum haemorrhage (PPH), defined as a blood loss of 500 mL or more after birth, is the leading cause of maternal death worldwide. The World Health Organization (WHO) recommends that all women giving birth should receive a prophylactic uterotonic agent. Despite the routine administration of a uterotonic agent for prevention, PPH remains a common complication causing one-quarter of all maternal deaths globally. When prevention fails and PPH occurs, further administration of uterotonic agents as 'first-line' treatment is recommended. However, there is uncertainty about which uterotonic agent is best for the 'first-line' treatment of PPH.
OBJECTIVES
To identify the most effective uterotonic agent(s) with the least side-effects for PPH treatment, and generate a meaningful ranking among all available agents according to their relative effectiveness and side-effect profile.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 May 2020), and the reference lists of all retrieved studies.
SELECTION CRITERIA
All randomised controlled trials or cluster-randomised trials comparing the effectiveness and safety of uterotonic agents with other uterotonic agents for the treatment of PPH were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed all trials for inclusion, extracted data and assessed each trial for risk of bias. Our primary outcomes were additional blood loss of 500 mL or more after recruitment to the trial until cessation of active bleeding and the composite outcome of maternal death or severe morbidity. Secondary outcomes included blood loss-related outcomes, morbidity outcomes, and patient-reported outcomes. We performed pairwise meta-analyses and indirect comparisons, where possible, but due to the limited number of included studies, we were unable to conduct the planned network meta-analysis. We used the GRADE approach to assess the certainty of evidence.
MAIN RESULTS
Seven trials, involving 3738 women in 10 countries, were included in this review. All trials were conducted in hospital settings. Randomised women gave birth vaginally, except in one small trial, where women gave birth either vaginally or by caesarean section. Across the seven trials (14 trial arms) the following agents were used: six trial arms used oxytocin alone; four trial arms used misoprostol plus oxytocin; three trial arms used misoprostol; one trial arm used Syntometrine® (oxytocin and ergometrine fixed-dose combination) plus oxytocin infusion. Pairwise meta-analysis of two trials (1787 participants), suggests that misoprostol, as first-line treatment uterotonic agent, probably increases the risk of blood transfusion (risk ratio (RR) 1.47, 95% confidence interval (CI) 1.02 to 2.14, moderate-certainty) compared with oxytocin. Low-certainty evidence suggests that misoprostol administration may increase the incidence of additional blood loss of 1000 mL or more (RR 2.57, 95% CI 1.00 to 6.64). The data comparing misoprostol with oxytocin is imprecise, with a wide range of treatment effects for the additional blood loss of 500 mL or more (RR 1.66, 95% CI 0.69 to 4.02, low-certainty), maternal death or severe morbidity (RR 1.98, 95% CI 0.36 to 10.72, low-certainty, based on one study n = 809 participants, as the second study had zero events), and the use of additional uterotonics (RR 1.30, 95% CI 0.57 to 2.94, low-certainty). The risk of side-effects may be increased with the use of misoprostol compared with oxytocin: vomiting (2 trials, 1787 participants, RR 2.47, 95% CI 1.37 to 4.47, high-certainty) and fever (2 trials, 1787 participants, RR 3.43, 95% CI 0.65 to 18.18, low-certainty). According to pairwise meta-analysis of four trials (1881 participants) generating high-certainty evidence, misoprostol plus oxytocin makes little or no difference to the use of additional uterotonics (RR 0.99, 95% CI 0.94 to 1.05) and to blood transfusion (RR 0.95, 95% CI 0.77 to 1.17) compared with oxytocin. We cannot rule out an important benefit of using the misoprostol plus oxytocin combination over oxytocin alone, for additional blood loss of 500 mL or more (RR 0.84, 95% CI 0.66 to 1.06, moderate-certainty). We also cannot rule out important benefits or harms for additional blood loss of 1000 mL or more (RR 0.76, 95% CI 0.43 to 1.34, moderate-certainty, 3 trials, 1814 participants, one study reported zero events), and maternal mortality or severe morbidity (RR 1.09, 95% CI 0.35 to 3.39, moderate-certainty). Misoprostol plus oxytocin increases the incidence of fever (4 trials, 1866 participants, RR 3.07, 95% CI 2.62 to 3.61, high-certainty), and vomiting (2 trials, 1482 participants, RR 1.85, 95% CI 1.16 to 2.95, high-certainty) compared with oxytocin alone. For all outcomes of interest, the available evidence on the misoprostol versus Syntometrine® plus oxytocin combination was of very low-certainty and these effects remain unclear. Although network meta-analysis was not performed, we were able to compare the misoprostol plus oxytocin combination with misoprostol alone through the common comparator of oxytocin. This indirect comparison suggests that the misoprostol plus oxytocin combination probably reduces the risk of blood transfusion (RR 0.65, 95% CI 0.42 to 0.99, moderate-certainty) and may reduce the risk of additional blood loss of 1000 mL or more (RR 0.30, 95% CI 0.10 to 0.89, low-certainty) compared with misoprostol alone. The combination makes little or no difference to vomiting (RR 0.75, 95% CI 0.35 to 1.59, high-certainty) compared with misoprostol alone. Misoprostol plus oxytocin compared to misoprostol alone are compatible with a wide range of treatment effects for additional blood loss of 500 mL or more (RR 0.51, 95% CI 0.20 to 1.26, low-certainty), maternal mortality or severe morbidity (RR 0.55, 95% CI 0.07 to 4.24, low-certainty), use of additional uterotonics (RR 0.76, 95% CI 0.33 to 1.73, low-certainty), and fever (RR 0.90, 95% CI 0.17 to 4.77, low-certainty).
AUTHORS' CONCLUSIONS
The available evidence suggests that oxytocin used as first-line treatment of PPH probably is more effective than misoprostol with less side-effects. Adding misoprostol to the conventional treatment of oxytocin probably makes little or no difference to effectiveness outcomes, and is also associated with more side-effects. The evidence for most uterotonic agents used as first-line treatment of PPH is limited, with no evidence found for commonly used agents, such as injectable prostaglandins, ergometrine, and Syntometrine®.
Topics: Bias; Blood Transfusion; Confidence Intervals; Drug Therapy, Combination; Ergonovine; Female; Humans; Misoprostol; Network Meta-Analysis; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 33232518
DOI: 10.1002/14651858.CD012754.pub2 -
NEJM Evidence Jun 2024AbstractWith recent severe restrictions to abortion accessibility in the United States and a pending Supreme Court case challenging the Food and Drug Administration's... (Review)
Review
AbstractWith recent severe restrictions to abortion accessibility in the United States and a pending Supreme Court case challenging the Food and Drug Administration's approval of mifepristone, evidence-based strategies to protect and expand access to abortion care are needed. Two safe and effective regimens for medication abortion are widely used globally - misoprostol-only and misoprostol in combination with mifepristone. However, misoprostol-only regimens are rarely used in the United States. In 2023, the National Abortion Federation and the Society of Family Planning updated their recommended protocol for misoprostol-only for medication abortion to 800 μg of misoprostol administered buccally, sublingually, or vaginally every 3 hours for three or more doses. To characterize the data supporting this specific regimen, this article reviews the relevant literature to address the question of how effective misoprostol-only is for medication abortion. The authors conclude that the updated misoprostol regimen is highly effective and a potential strategy for expanding access to abortion.
Topics: Misoprostol; Humans; Female; Abortion, Induced; Pregnancy; Abortifacient Agents, Nonsteroidal; Mifepristone; United States
PubMed: 38804786
DOI: 10.1056/EVIDccon2300129