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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 -
Obstetrics and Gynecology Jul 2015To summarize clinical outcomes and adverse effects of medical abortion regimens consisting of mifepristone followed by buccal misoprostol in pregnancies through 70 days... (Review)
Review
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 relevant studies published between November 2005 and January 2015 using the search terms "mifepristone and medical abortion" and "buccal and misoprostol."
METHODS OF STUDY SELECTION
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.
TABULATION, INTEGRATION, AND RESULTS
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.
CONCLUSION
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.
Topics: Abortifacient Agents; Abortion, Induced; Administration, Buccal; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First
PubMed: 26241251
DOI: 10.1097/AOG.0000000000000897 -
Frontiers in Global Women's Health 2023To compare mifepristone plus a misoprostol-combined regimen with misoprostol alone in the medical abortion of first trimester pregnancy. (Review)
Review
OBJECTIVE
To compare mifepristone plus a misoprostol-combined regimen with misoprostol alone in the medical abortion of first trimester pregnancy.
METHODS
An internet-based search of available literature was performed using text words contained in titles and abstracts. PubMed/Medline, Cochrane CENTRAL, EMBASE, and Google scholar were used to locate English-based articles published until December 2021. Studies fulfilling the inclusion criteria were selected, appraised, and assessed for methodological quality. The included studies were pooled for meta-analysis, and the results were presented in risk ratio at a 95% confidence interval.
FINDINGS
Nine studies comprising 2,052 participants (1,035 intervention and 1,017 controls) were considered. Primary endpoints were complete expulsion, incomplete expulsion, missed abortion, and ongoing pregnancy. The intervention was found to more likely induce complete expulsion irrespective of gestational age (RR: 1.19; 95% CI: 1.14-1.25). The administration of misoprostol 800 mcg after 24 h of mifepristone pre-treatment in the intervention group more likely induced complete expulsion (RR: 1.23; 95% CI: 1.17-1.30) than after 48 h. The intervention group was also more likely to experience complete expulsion when misoprostol was used either vaginally (RR: 1.16; 95% CI: 1.09-1.17) or buccally (RR: 1.23; 95% CI: 1.16-1.30). The intervention was more effective in the subgroup with a negative foetal heartbeat at reducing incomplete abortion (RR: 0.45; 95% CI: 0.26-0.78) compared with the control group. The intervention more likely reduced both missed abortion (RR: 0.21; 95% CI: 0.08-0.91) and ongoing pregnancy (RR: 0.12; 95% CI: 0.05-0.26). Fever was less likely to be reported (RR: 0.78; 95% CI: 0.12-0.89), whereas the subjective experience of bleeding was more likely to be encountered (RR: 1.31; 95% CI: 1.13-1.53) by the intervention group.
CONCLUSION
The review strengthened the theory that a combined mifepristone and misoprostol regimen can be an effective medical management for inducing abortions during first trimester pregnancy in all contexts. Specifically, there is a high-level certainty of evidence on complete expulsion during the early stage and its ability to reduce both missed and ongoing pregnancies.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019134213, identifier CRD42019134213.
PubMed: 36970118
DOI: 10.3389/fgwh.2023.1112392 -
BMJ Clinical Evidence Feb 2012Approximately 1/100 pregnancies are ectopic, with the conceptus usually implanting in the fallopian tube. Some ectopic pregnancies resolve spontaneously, but others... (Review)
Review
INTRODUCTION
Approximately 1/100 pregnancies are ectopic, with the conceptus usually implanting in the fallopian tube. Some ectopic pregnancies resolve spontaneously, but others continue to grow and lead to rupture of the tube. Risks are higher in women with damage to the fallopian tubes due to pelvic infections, surgery, or previous ectopic pregnancy.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What treatments improve outcomes in women with unruptured tubal ectopic pregnancy? We searched: Medline, Embase, The Cochrane Library, and other important databases up to July 2011 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations, such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The authors also separately searched Medline and Pubmed up to July 2011 in addition to the Clinical Evidence systematic search to support the comments and clinical guide sections.
RESULTS
We found 19 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: salpingotomy, salpingectomy, methotrexate, methotrexate following salpingotomy, methotrexate plus mifepristone, and expectant management.
Topics: Animals; Fallopian Tubes; Female; Humans; Incidence; Methotrexate; Pregnancy; Pregnancy, Ectopic; Pregnancy, Tubal
PubMed: 22321966
DOI: No ID Found -
Obstetrics and Gynecology Jun 2004To systematically review the effect of mifepristone on uterine leiomyoma size and symptoms and to summarize its adverse effects. (Review)
Review
OBJECTIVE
To systematically review the effect of mifepristone on uterine leiomyoma size and symptoms and to summarize its adverse effects.
DATA SOURCES
A computerized search in MEDLINE, EMBASE, LILACS, and Cochrane databases from 1985 to 2002 and hand searches of conference proceedings from 1995 to 2002 were performed with the search terms "mifepristone" and "leiomyomata" and publication type "clinical trial."
METHODS OF STUDY SELECTION
Titles and abstracts were reviewed by 2 authors; there were no areas of disagreement. Inclusion criteria were clinical trials of daily mifepristone for uterine leiomyomata that measured uterine or leiomyoma volume before and after treatment.
TABULATION, INTEGRATION, AND RESULTS
Data from each article were abstracted by 2 reviewers. The search identified 6 before-and-after clinical trials involving a total of 166 women with symptomatic uterine leiomyomata. The subjects received 5 to 50 mg/d of mifepristone for 3 to 6 months. No study was placebo-controlled or blinded. Meta-analytic techniques were not performed due to variation in outcome and mifepristone dose. Daily treatment with all doses of mifepristone resulted in reductions in uterine and leiomyoma volumes ranging from 27% to 49% and 26% to 74%, respectively. Mifepristone treatment reduced the prevalence and severity of dysmenorrhea, menorrhagia, and pelvic pressure. Rates of amenorrhea ranged from 63% to 100%. Transient elevations in transaminases occurred in 4%. Endometrial hyperplasia was detected in 10 (28%) of 36 women screened by endometrial biopsy.
CONCLUSION
Published trials of mifepristone showed reduction in leiomyoma size and improvement in symptoms. A notable adverse effect of mifepristone was development of endometrial hyperplasia.
Topics: Adult; Clinical Trials as Topic; Endometrial Hyperplasia; Female; Hormone Antagonists; Humans; Leiomyoma; Middle Aged; Mifepristone; Uterine Neoplasms
PubMed: 15172874
DOI: 10.1097/01.AOG.0000127622.63269.8b -
Contraception: X 2020Mifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen. (Review)
Review
BACKGROUND
Mifepristone and misoprostol are recommended for second-trimester medical abortion, but consensus is unclear on the ideal regimen.
OBJECTIVES
The objectives were to systematically review randomized controlled trials (RCTs) investigating efficacy, safety and satisfaction of medical abortion at ≥ 12 weeks' gestation.
DATA SOURCES
We searched PubMed, Popline, Embase, Global Index Medicus, Cochrane Controlled Register of Trials and International Clinical Trials Registry Platform from January 2008 to May 2017.
STUDY ELIGIBILITY PARTICIPANTS AND INTERVENTIONS
We included RCTs on medical abortion at ≥ 12 weeks' gestation using mifepristone and/or misoprostol. We excluded studies with spontaneous abortion, fetal demise and mechanical cervical ripening and those not reporting ongoing pregnancy (OP).
STUDY APPRAISAL AND SYNTHESIS METHODS
After extracting prespecified data and assessing risk of bias in accordance with the Cochrane handbook, we used Revman5 software to combine data and GRADE to assess certainty of evidence.
RESULTS
We included 43 of the 1894 references identified. Combination mifepristone-misoprostol had lower rates of OP [risk ratio (RR) 0.12, 95% confidence interval (CI) 0.04-0.35] vs. misoprostol only. A 24-h interval between mifepristone and misoprostol had lower OP rate at 24 h than simultaneous dosing (RR 3.13, 95% CI 1.23-7.94). Every 3-h dosing had lower OP rate at 48 h (RR 0.39, 95% CI 0.17-0.88).
LIMITATIONS
Direct comparisons of buccal misoprostol to sublingual or vaginal routes after mifepristone were limited. Evidence from clinical trials on how to best manage women with prior uterine incisions was lacking.
CONCLUSION
Our analysis supports the use of mifepristone 200 mg 1 to 2 days before misoprostol 400 mcg vaginally every 3 h at ≥ 12 weeks' gestation.
IMPLICATIONS
Where available, providers should use mifepristone plus misoprostol for second-trimester medical abortion. Vaginal misoprostol appears to be most efficacious with fewest side effects, but sublingual and buccal routes are also acceptable.
PubMed: 32954250
DOI: 10.1016/j.conx.2020.100037 -
Journal de Gynecologie, Obstetrique Et... Dec 2016To establish guidelines of the French National College of Gynecologists and Obstetricians about post-abortion contraception. (Review)
Review
OBJECTIVE
To establish guidelines of the French National College of Gynecologists and Obstetricians about post-abortion contraception.
MATERIALS AND METHODS
A systematic review of the literature about post-abortion contraception was performed on Medline and Cochrane Database between 1978 and March 2016. The guidelines of the French and foreign scientific societies were also consulted.
RESULTS AND DISCUSSION
After an abortion, if the woman wishes to use a contraception, it should be started as soon as possible because of the very early ovulation resumption. The contraception choice must be done in accordance with the woman's expectations and lifestyle. The contraindications of each contraception must be respected. The long-acting reversible contraception, intra-uterine device (IUD) and implant, could be preferred (grade C) as the efficacy is not dependent on compliance. Thus, they could better prevent repeat abortion (LE3). In case of surgical abortion, IUD should be proposed and inserted immediately after the procedure (grade A), as well as the implant (grade B). In case of medical abortion, the implant can be inserted from the day of mifépristone, the IUD after an ultrasound examination confirming the success of the abortion (no continuing pregnancy or retained sac) (grade C).
Topics: Abortion, Induced; Contraceptive Agents, Female; Drug Implants; Female; Humans; Intrauterine Devices; Pregnancy
PubMed: 27773547
DOI: 10.1016/j.jgyn.2016.09.017 -
Issues in Law & Medicine 2017
Review
Topics: Abortifacient Agents, Steroidal; Embryonic Development; Hormone Antagonists; Humans; Mifepristone
PubMed: 29108160
DOI: No ID Found -
International Journal of Gynaecology... Aug 2021To compare 1- and 2-day drug administration interval between mifepristone and misoprostol for second-trimester pregnancy termination and provide evidence-based... (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVE
To compare 1- and 2-day drug administration interval between mifepristone and misoprostol for second-trimester pregnancy termination and provide evidence-based recommendations.
METHODS
Search strategy: the search was performed in Pubmed, EMBASE, and Cochrane Library for the relevant published studies from their establishment to March 2020.
SELECTION CRITERIA
randomized controlled trials (RCTs) comparing 1- and 2-day time interval of mifepristone-misoprostol for termination of pregnancy during second-trimester pregnancy were considered. Data were processed using Revman 5.3 software.
RESULTS
Meta-analyses of three RCTs showed no significant difference was reported in the induction-to-abortion time and successful abortion rate between 1- and 2-day mifepristone and misoprostol intervals. Statistical difference was not identified in the induction-to-abortion time between the two drug administration intervals in nulliparous or parous women.
CONCLUSIONS
Both 1- and 2-day dosing intervals between mifepristone and misoprostol are suitable for clinical use for second-trimester medical termination of pregnancy.
Topics: Female; Humans; Pregnancy; Abortifacient Agents; Abortifacient Agents, Nonsteroidal; Abortion, Induced; Mifepristone; Misoprostol; Pregnancy Trimester, Second; Randomized Controlled Trials as Topic
PubMed: 33332580
DOI: 10.1002/ijgo.13541 -
Contraception Nov 2023This study aimed to update our 2019 systematic review of data on the effectiveness and safety of misoprostol-only for first-trimester abortion. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This study aimed to update our 2019 systematic review of data on the effectiveness and safety of misoprostol-only for first-trimester abortion.
STUDY DESIGN
We searched PubMed on December 18, 2022, to find published articles describing the outcomes of treatment with misoprostol-only for abortion of viable intrauterine pregnancy at ≤91 days of gestation. From each article identified, two authors independently abstracted relevant data about each group of patients treated with a distinct regimen. We assessed the risk of bias using four defined indicators. We estimated the proportion of patients with treatment failure using meta-analytic methods as well as the proportion hospitalized or transfused after treatment. We examined associations between treatment failure and selected characteristics of the groups.
RESULTS
We identified 49 papers with 66 groups that collectively included 16,354 evaluable patients, of whom 2960 (meta-analytic estimate 15%, 95% CI 12%, 19%) had treatment failures. Of 9228 patients assessed for ongoing pregnancy after treatment, 521 (meta-analytic estimate 6%, 95% CI 5%, 8%) had that condition. Failure risk was significantly associated with misoprostol dose, the total allowed number of doses, the maximum duration of dosing, and certain indicators of risk of bias. Among 11,007 patients allowed to take at least three misoprostol doses, the first consisting of misoprostol 800 mcg administered vaginally, sublingually, or buccally, the meta-analytic estimate of the failure risk was 11% (95% CI 8%, 14%). At most, 0.2% of 15,679 evaluable patients were hospitalized or received transfusions.
CONCLUSIONS
Although some studies in this updated review were adjudicated to have a high risk of bias, the results continue to support the key conclusion of our 2019 analysis: misoprostol-only is effective and safe for the termination of first-trimester intrauterine pregnancy.
IMPLICATIONS
Misoprostol-only is a safe and effective option for medication abortion in the first trimester if mifepristone is unavailable or inaccessible.
Topics: Pregnancy; Female; Humans; Misoprostol; Abortifacient Agents; Pregnancy Trimester, First; Mifepristone; Abortion, Induced; Abortifacient Agents, Nonsteroidal
PubMed: 37517447
DOI: 10.1016/j.contraception.2023.110132