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BJOG : An International Journal of... Aug 2021To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
To assess the cost-effectiveness of mifepristone and misoprostol (MifeMiso) compared with misoprostol only for the medical management of a missed miscarriage.
DESIGN
Within-trial economic evaluation and model-based analysis to set the findings in the context of the wider economic evidence for a range of comparators. Incremental costs and outcomes were calculated using nonparametric bootstrapping and reported using cost-effectiveness acceptability curves. Analyses were performed from the perspective of the UK's National Health Service (NHS).
SETTING
Twenty-eight UK NHS early pregnancy units.
SAMPLE
A cohort of 711 women aged 16-39 years with ultrasound evidence of a missed miscarriage.
METHODS
Treatment with mifepristone and misoprostol or with matched placebo and misoprostol tablets.
MAIN OUTCOME MEASURES
Cost per additional successfully managed miscarriage and quality-adjusted life years (QALYs).
RESULTS
For the within-trial analysis, MifeMiso intervention resulted in an absolute effect difference of 6.6% (95% CI 0.7-12.5%) per successfully managed miscarriage and a QALYs difference of 0.04% (95% CI -0.01 to 0.1%). The average cost per successfully managed miscarriage was lower in the MifeMiso arm than in the placebo and misoprostol arm, with a cost saving of £182 (95% CI £26-£338). Hence, the MifeMiso intervention dominated the use of misoprostol alone. The model-based analysis showed that the MifeMiso intervention is preferable, compared with expectant management, and this is the current medical management strategy. However, the model-based evidence suggests that the intervention is a less effective but less costly strategy than surgical management.
CONCLUSIONS
The within-trial analysis found that based on cost-effectiveness grounds, the MifeMiso intervention is likely to be recommended by decision makers for the medical management of women presenting with a missed miscarriage.
TWEETABLE ABSTRACT
The combination of mifepristone and misoprostol is more effective and less costly than misoprostol alone for the management of missed miscarriages.
Topics: Abortifacient Agents; Abortion, Missed; Adolescent; Adult; Cost-Benefit Analysis; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Young Adult
PubMed: 33969614
DOI: 10.1111/1471-0528.16737 -
Journal of Healthcare Engineering 2022In order to systematically evaluate the clinical efficacy and safety of misoprostol versus oxytocin in the prevention of postpartum hemorrhage, this paper provides... (Meta-Analysis)
Meta-Analysis
In order to systematically evaluate the clinical efficacy and safety of misoprostol versus oxytocin in the prevention of postpartum hemorrhage, this paper provides evidence-based reference for clinical medication, computerized retrieval of Chinese biomedical literature database (CBM), PubMed, Embase, Cochrane Library, and clinical trials. The retrieval period is from the establishment of each database to October 1, 2021. Published randomized controlled trials (RCTS) are included in this study. The literature is screened and evaluated according to inclusion and exclusion criteria, and meta-analysis is performed using RevMan 5.3 software. A total of 13 RCTS are included, with a total of 24754 parturients. The meta-analysis shows the average blood loss (SMD = 0.10, 95% CI (-0.11, 0.32), =0.35), the time of the third stage of labor (SMD = 0, 95% CI (-0.07, 0.08), =0.95), and blood transfusion rate (RR = 0.80, 95% CI (0.63, 1.02), =0.07). However, the incidences of shivering (RR = 2.61, 95% CI (1.79, 0.81), < 0.00001) and vomiting (RR = 2.78, 95% CI (1.85, 4.18), < 0.00001) are significantly higher than those in oxytocin group. The effect of misoprostol on preventing postpartum hemorrhage is similar to that of oxytocin, but the incidence of adverse reactions is high, and the occurrence of adverse reactions should be closely watched in the use process. Due to the limitations of the included studies, multicenter, large-sample, and high-quality RCTS are still needed in the future to further verify this conclusion.
Topics: Female; Humans; Misoprostol; Multicenter Studies as Topic; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 35449871
DOI: 10.1155/2022/3254586 -
Contraception Sep 2019To evaluate outcomes with mifepristone 200 mg orally followed 24-48 h later by misoprostol 800 mcg vaginally for medical abortion at 64-70 days of gestation.
OBJECTIVE
To evaluate outcomes with mifepristone 200 mg orally followed 24-48 h later by misoprostol 800 mcg vaginally for medical abortion at 64-70 days of gestation.
STUDY DESIGN
We reviewed electronic databases and medical records for medical abortion cases at 64-70 days' gestation at British Pregnancy Advisory Service clinics in England and Wales from May 2015 through October 2016. Women selected in-office follow-up or self-evaluation of abortion outcome using a checklist along with low-sensitivity urine pregnancy testing. We excluded cases in which we could not locate records and when women did not proceed with medical abortion, did not use misoprostol following mifepristone if abortion had not occurred and did not attend a scheduled follow-up assessment. We analyzed demographic characteristics, treatment outcomes and significant adverse events. We defined treatment success as complete abortion without surgical evacuation and without continuing pregnancy.
RESULTS
Of 2743 cases identified, we could not locate 40 charts and excluded 30 cases, leaving a final sample of 2673. Overall, 2538 (94.9%, 95% CI 94.1-95.8) women had a successful medical abortion. Reasons for failure included continuing pregnancy (n=90, 3.4%, 95% CI 2.7-4.1), retained nonviable pregnancy (n=2, 0.1%, 95% CI 0-0.2) and incomplete abortion (n=43, 1.6%, 95% CI 1.1-2.1). Of those with continuing pregnancies, 81 underwent a uterine aspiration and 9 opted to continue the pregnancy. Thirty-five (1.3%, 95% CI 0.9-1.7) women had significant adverse events; 16 (0.6%, 95% CI 0.3-0.9) underwent an in-hospital aspiration. Pelvic infection (n=4, 0.2%) and transfusion (n=1, 0.03%) occurred rarely.
CONCLUSION
Medical abortion from 64 to 70 days with mifepristone and vaginal misoprostol is effective with a low rate of serious adverse events.
IMPLICATIONS
Medical abortion between 64 and 70 days of gestation may be offered on an outpatient basis using mifepristone and vaginal misoprostol. Service provision without an in-person follow-up is feasible. Not all women with a continuing pregnancy after medical abortion treatment opt to have an aspiration procedure.
Topics: Abortifacient Agents; Abortion, Incomplete; Abortion, Induced; Administration, Intravaginal; Administration, Oral; Adolescent; Adult; Drug Therapy, Combination; Female; Humans; Middle Aged; Mifepristone; Misoprostol; Patient Satisfaction; Pregnancy; Pregnancy Trimester, First; Treatment Outcome; United Kingdom; Young Adult
PubMed: 31102629
DOI: 10.1016/j.contraception.2019.05.006 -
The American Journal of Emergency... Nov 2022On June 24, 2022, the Supreme Court overturned Roe v. Wade, which will limit legal abortion in many areas of the U.S. Over half of abortions in the U.S. are performed... (Review)
Review
BACKGROUND
On June 24, 2022, the Supreme Court overturned Roe v. Wade, which will limit legal abortion in many areas of the U.S. Over half of abortions in the U.S. are performed using medication as opposed to surgical techniques. With widespread access to agents that are used for medication abortion, there may be an increase in emergency department presentations related to improper or unsupervised use of these medications.
METHODS
This narrative review focuses on the contraindications, adverse effects, and toxicities of the most common agents used for medication abortion in the U.S.
RESULTS
Medications included in this review are mifepristone, misoprostol, and methotrexate. Each of these medications has a unique adverse effect and toxicity profile.
CONCLUSION
Agents used for medication abortion have unique contraindications and adverse effects. Improper or unsupervised use may occur in the setting of limited abortion access and emergency medicine physicians are on the front lines in managing these presentations.
Topics: Humans; Pregnancy; Female; United States; Abortifacient Agents; Mifepristone; Misoprostol; Methotrexate; Abortion, Induced; Physicians
PubMed: 36007432
DOI: 10.1016/j.ajem.2022.08.027 -
Studies in Family Planning Jun 2021Little is known about the link between health literacy and women's ability to safely and successfully use misoprostol to self-induce an abortion. While abortion is only...
Little is known about the link between health literacy and women's ability to safely and successfully use misoprostol to self-induce an abortion. While abortion is only allowed to save a woman's life in Nigeria, misoprostol is widely available from drug sellers. We interviewed 394 women in 2018 in Lagos State, Nigeria, who induced abortion using misoprostol obtained from a drug seller to determine their sexual and reproductive health literacy (SRHL) and misoprostol knowledge levels; and how these were associated with ending the pregnancy successfully or seeking care for (perceived) complications. Our results show that women's misoprostol knowledge (measured both quantitatively and qualitatively) was low, but that almost all women were nevertheless able to use the drug effectively and safely. Higher SRHL was associated with being more likely to end the pregnancy successfully and also seeking postabortion health care. Our study is the first to examine this association and adds to the scarce literature examining the relationship between health literacy and self-use of misoprostol to induce abortions in restrictive settings.
Topics: Abortion, Induced; Abortion, Spontaneous; Female; Health Literacy; Humans; Male; Misoprostol; Nigeria; Pregnancy; Reproductive Health
PubMed: 34043236
DOI: 10.1111/sifp.12156 -
Journal of Obstetrics and Gynaecology... Dec 2020Abortion-related complications remain one of the leading causes of maternal morbidity and mortality worldwide. Nearly half of all abortions are unsafe, and the vast... (Review)
Review
OBJECTIVE
Abortion-related complications remain one of the leading causes of maternal morbidity and mortality worldwide. Nearly half of all abortions are unsafe, and the vast majority of these occur in low- and middle-income countries. The use of mifepristone with misoprostol for medical abortion has been proposed and implemented to improve abortion safety.
DATA SOURCES
A systematic review of the literature was conducted in PubMed, Embase, Cochrane, and CINAHL.
STUDY SELECTION
Criteria for study inclusion were first-trimester abortion, use of mifepristone with misoprostol, and low- or middle-income country status as designated by the World Health Organization.
DATA EXTRACTION
Results for effectiveness, safety, acceptability, and qualitative information were assessed.
DATA SYNTHESIS
The literature search resulted in 181 eligible articles, 52 of which met our criteria for inclusion. A total of 34 publications reported effectiveness data on 25 385 medical abortions. The average effectiveness rate with mifepristone 200 mg and misoprostol 800 µg was 95% up to 63 days gestation. A sensitivity analysis was performed to assume that all women lost to follow-up failed treatment, and the recalculated effectiveness rate remained high at 93%. The average continuing pregnancy rate was 0.6%. A total of 22 publications reported safety and acceptability data on 17 381 medical abortions. Only 0.8% abortions required presentation to hospital, and 87% of patients found the side effects of treatment acceptable. Overall, 95% of women were satisfied with their medical abortion, 94% would choose the method again, and 94% would recommend this method to a friend. A total of 16 publications reported qualitative results and the majority supported positive patient experiences with medical abortion.
CONCLUSIONS
Mifepristone and misoprostol is highly effective, safe, and acceptable to women in low- and middle-income countries, making it a feasible option for reducing maternal morbidity and mortality worldwide.
Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Developing Countries; Female; Humans; Mifepristone; Misoprostol; Patient Acceptance of Health Care; Pregnancy; Treatment Outcome
PubMed: 32912726
DOI: 10.1016/j.jogc.2020.04.006 -
BMC Pregnancy and Childbirth Nov 2015While inferior to oxytocin injection in both efficacy and safety, orally administered misoprostol has been included in the World Health Organization Model List of... (Review)
Review
BACKGROUND
While inferior to oxytocin injection in both efficacy and safety, orally administered misoprostol has been included in the World Health Organization Model List of Essential Medicines for use in the prevention of postpartum haemorrhage (PPH) in low-resource settings. This study evaluates the costs and health outcomes of use of oral misoprostol to prevent PPH in settings where injectable uterotonics are not available.
METHODS
A cost-consequences analysis was conducted from the international health system perspective, using data from a recent Cochrane systematic review and WHO's Mother-Baby Package Costing Spreadsheet in a hypothetical cohort of 1000 births in a mixed hospital (40% births)/community setting (60% births). Costs were estimated based on 2012 US dollars.
RESULTS
Using oxytocin in the hospital setting and misoprostol in the community setting in a cohort of 1000 births, instead of oxytocin (hospital setting) and no treatment (community setting), 22 cases of PPH could be prevented. Six fewer women would require additional uterotonics and four fewer women a blood transfusion. An additional 130 women would experience shivering and an extra 42 women fever. Oxytocin/misoprostol was found to be cost saving (US$320) compared to oxytocin/no treatment. If misoprostol is used in both the hospital and community setting compared with no treatment (i.e. oxytocin not available in the hospital setting), 37 cases of PPH could be prevented; ten fewer women would require additional uterotonics; and six fewer women a blood transfusion. An additional 217 women would experience shivering and 70 fever. The cost savings would be US$533. Sensitivity analyses indicate that the results are sensitive to the incidence of PPH-related outcomes, drug costs and the proportion of hospital births.
CONCLUSIONS
Our findings confirm that, even though misoprostol is not the optimum choice in the prevention of PPH, misoprostol could be an effective and cost-saving choice where oxytocin is not or cannot be used due to a lack of skilled birth attendants, inadequate transport and storage facilities or where a quality assured oxytocin product is not available. These benefits need to be weighed against the large number of additional side effects such as shivering and fever, which have been described as tolerable and of short duration.
Topics: Administration, Oral; Cost-Benefit Analysis; Female; Fever; Humans; Labor Stage, Third; Misoprostol; Oxytocics; Oxytocin; Parturition; Postpartum Hemorrhage; Pregnancy; Shivering
PubMed: 26596797
DOI: 10.1186/s12884-015-0749-z -
Molecules (Basel, Switzerland) Oct 2022The aim of this study was establishment of an UHPLC-QqQ-MS/MS method for the deter-mination of misoprostol acid in biological specimens in cases of pharmacological... (Review)
Review
The aim of this study was establishment of an UHPLC-QqQ-MS/MS method for the deter-mination of misoprostol acid in biological specimens in cases of pharmacological abortions. Forensic toxicological examination was performed in three different biological samples (whole blood, placenta and fetal liver). The validation parameters of the method were as follows: limit of detection: 25 pg/mL; limit of quantification: 50 pg/mL, coefficient of determination: >0.999 (R2), intra- and interday accuracy and precision: not greater than 13.7%. The recovery and matrix effect were in the range of 88.3−95.1% and from −11.7 to −4.9%, respectively. Toxicological analysis of the mother’s blood (collected two days after pregnancy termination) did not reveal any abortifacients; however, misoprostol acid was found in the placenta (793 pg/g) and fetal liver (309 pg/g). The second case involved a fetus found near a garbage container. The concentration of misoprostol acid in the placenta was 2332 pg/g. In the presented study, an extensive literature review of misoprostol pharmacokinetics studies was performed. To our knowledge, the UHPLC-QqQ-MS/MS technique presented in this paper is the first quantitative method applied for forensic toxicological purposes. In addition, postmortem concentrations of misoprostol acid in miscarried fetuses due to illegal abortions were reported for the first time.
Topics: Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Female; Humans; Misoprostol; Pregnancy; Tandem Mass Spectrometry
PubMed: 36235071
DOI: 10.3390/molecules27196534 -
American Journal of Obstetrics &... May 2019The aim of the present systematic review was to investigate the efficacy and safety of cervical ripening for the combination of mechanical dilation and misoprostol... (Meta-Analysis)
Meta-Analysis Review
Maternal and neonatal outcomes with mechanical cervical dilation plus misoprostol compared to misoprostol alone for cervical ripening; a systematic review of literature and metaanalysis.
OBJECTIVE DATA
The aim of the present systematic review was to investigate the efficacy and safety of cervical ripening for the combination of mechanical dilation and misoprostol administration compared with misoprostol alone by evaluating 2 primary outcomes: time to delivery and rate of cesarean delivery.
STUDY
The Medline, EMBASE, and Web-of-Science electronic databases (from conception to end-of-search date December 31, 2018) were searched systematically. Randomized controlled trials that included patients with a singleton viable fetus who underwent induction of labor that required cervical ripening with an unfavorable cervix (Bishop ≤7) were eligible for inclusion.
STUDY APPRAISAL AND SYNTHESIS METHODS
Data were pooled with the use of the random effects and fixed effects model after the assessment for the presence of heterogeneity. Risk of bias for each included study was assessed based on the criteria outlined in the Cochrane Handbook for Systematic Reviews of Interventions.
RESULTS
Eleven trials met the inclusion criteria and included a total of 922 and 947 subjects in the combination and misoprostol-only groups, respectively. There was no difference in the incidence of cesarean delivery between the 2 groups (relative risk, 0.95; 95% confidence interval, 0.80-1.13). The combination of mechanical dilation and misoprostol resulted in overall shorter time to delivery (mean difference, -3.65 hours; 95% confidence interval, 5.23 to -2.07), shorter time to vaginal delivery (mean difference, -4.53 hours; 95% confidence interval, -5.79 to -3.27), lower risk of neonatal intensive care unit admission (relative risk, 0.71; 95% confidence interval, 0.53-0.96), meconium-stained fluid (relative risk, 0.62; 95% confidence interval, 0.43-0.90), tachysystole with fetal heart trace changes (relative risk, 0.53; 95% confidence interval, 0.30-0.94), and terbutaline use (relative risk, 0.63; 95% confidence interval, 0.47-0.85) compared with the use of misoprostol alone. Risk of endometritis (relative risk, 1.07; 95% confidence interval, 0.43-2.61) and chorioamnionitis (relative risk, 1.58; 95% confidence interval, 0.88-2.84) was comparable between the 2 groups.
CONCLUSION
The combination of mechanical cervical dilation with misoprostol for cervical ripening is associated with a shorter time to delivery, a similar rate of cesarean delivery, and a lower incidence of neonatal intensive care unit admission compared with the use of misoprostol alone.
Topics: Administration, Intravaginal; Adult; Cervical Ripening; Dilatation; Female; Humans; Infant, Newborn; Labor, Induced; Misoprostol; Outcome and Process Assessment, Health Care; Oxytocics; Pregnancy
PubMed: 33345815
DOI: 10.1016/j.ajogmf.2019.06.003 -
The Journal of Maternal-fetal &... Dec 2024This study aims to compare the safety and efficacy of misoprostol administered orally and vaginally in obese pregnant women at term with either gestational hypertension...
OBJECTIVE
This study aims to compare the safety and efficacy of misoprostol administered orally and vaginally in obese pregnant women at term with either gestational hypertension or diabetes.
METHODS
A total of 264 pregnant women were enrolled and categorized into two groups based on their primary condition: hypertension (134 cases) or diabetes mellitus (130 cases) and were further divided into subgroups for misoprostol administration: orally (Oral group) or vaginally (Vaginal group). The primary outcomes measured were changes in the Bishop score following treatment, induction of labor (IOL) success rates, requirement for oxytocin augmentation, duration of labor, mode of delivery, and cesarean section rates.
RESULTS
Significant enhancements in Bishop scores, decreased cesarean section rates and increased success rates of IOL were noted in both administration groups. The incidence of vaginal delivery within 24 h was significantly higher in the Vaginal group compared to the Oral group. Adverse effects, including nausea, uterine overcontraction, hyperfrequency of uterine contraction and uterine hyperstimulation without fetal heart rate deceleration, were significantly more prevalent in the Vaginal group than in the Oral group.
CONCLUSION
Misoprostol administration, both orally and vaginally, proves effective for labor induction in obese pregnant women with hypertension or diabetes. However, the oral route presents a lower risk of adverse maternal and neonatal outcomes, suggesting its preference for safer labor induction in this demographic.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Misoprostol; Oxytocics; Pregnant Women; Administration, Intravaginal; Cesarean Section; Labor, Induced; Administration, Oral; Hypertension, Pregnancy-Induced; Diabetes Mellitus
PubMed: 38485520
DOI: 10.1080/14767058.2024.2327573