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JNMA; Journal of the Nepal Medical... 2018During the last decade, medical methods for second trimester abortion have considerably improved and become safe and more accessible. The combination of mifepristone and... (Comparative Study)
Comparative Study
INTRODUCTION
During the last decade, medical methods for second trimester abortion have considerably improved and become safe and more accessible. The combination of mifepristone and misoprostol is now an established and highly effective method for second trimester abortion. But where mifepristone is not available or affordable, misoprostol alone has also been shown to be effective. The objective of this study is to compare the efficacy of mifepristone with misoprostol and misoprostol alone for second trimester termination of pregnancy.
METHODS
It is a comparative study conducted on 60 patients from 13 to 18 weeks of gestation admitted for second trimester termination on legal indications.
RESULTS
Mean induction abortion interval was comparable in both the groups. Of the 30 cases in each group, nine cases in each Group A and six cases in Group B had incomplete/failed expulsion. Among these 15 cases, only nine required check curettage for complete evacuation while others received oxytocics only for completion. The distribution of these cases was also comparable in both the groups. Only one patient in Group B had complete failure of expulsion and underwent surgical evacuation. However, the difference in dosage of misoprostol required for complete expulsion and incidence of side effects were significantly higher in the group B.
CONCLUSIONS
Mifepristone and misoprostol combined together is now an established, highly effective and safe method for medical method of second trimester termination. However, when mifepristone is not available or affordable, misoprostol alone can also be used effectively, although a higher total dose is needed and side effects are higher than with the combined regimen.
Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Legal; Adult; Dilatation and Curettage; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Oxytocics; Pregnancy; Pregnancy Trimester, Second; Treatment Failure; Young Adult
PubMed: 31065120
DOI: 10.31729/jnma.3690 -
European Journal of Obstetrics,... Feb 2022The purpose of this integrative literature review was to appraise studies conducted worldwide using misoprostol and estradiol in converting Type 3 transformation zone... (Review)
Review
The purpose of this integrative literature review was to appraise studies conducted worldwide using misoprostol and estradiol in converting Type 3 transformation zone (TZ) of the cervix into Types 1 or 2 and to assess which regimen could be more feasible in low-and-middle-income countries (LMICs). We reviewed the English language literature for peer-reviewed studies that evaluated strategies to convert Type 3 TZs to Types 1 or 2 for cervical cancer screening. Web of Science and PubMed searches were performed up to July 2020. Search terms included: "cervical colposcopy," "inadequate colposcopy", "cervical cancer screening", "transformation zone," "estrogen", "estradiol", and "misoprostol." Inclusion criteria were articles published in the English language, original research, and peer reviewed articles. A total of 127 articles were abstracted, 24 articles were reviewed, and 9 articles met all inclusion criteria. We found that intravaginal misoprostol, intravaginal estradiol, and oral estradiol can successfully convert Type 3 TZ to Types 1 or 2. A single dose of vaginal misoprostol had a similar maximum response rate (20-80%) to a multi-dose regimen over several days or weeks of both intravaginal estradiol (64-83%) and oral estradiol (50-70%). Misoprostol administration was associated with more side effects such as abdominal cramping and vaginal bleeding compared to estradiol, although these were generally mild. In conclusion, Oral estradiol, intravaginal estradiol, and intravaginal misoprostol can be used to convert Type 3 TZ to Types 1 or 2. Intravaginal misoprostol is well tolerated and more feasible in LMICs due to availability and shorter treatment schedule compared to oral or intravaginal estradiol.
Topics: Administration, Intravaginal; Cervical Ripening; Early Detection of Cancer; Estradiol; Female; Humans; Misoprostol; Oxytocics; Pregnancy; Uterine Cervical Neoplasms
PubMed: 34952401
DOI: 10.1016/j.ejogrb.2021.11.431 -
Archives of Gynecology and Obstetrics Mar 2019To compare several strategies for second trimester labor induction for termination of pregnancy (TOP) using misoprostol and mifepristone and to determine which one is...
OBJECTIVE
To compare several strategies for second trimester labor induction for termination of pregnancy (TOP) using misoprostol and mifepristone and to determine which one is more effective in accelerating the time to delivery.
METHOD
This was a retrospective study in which pregnancies that underwent second and third trimester TOP due to fetal anomalies between 2007 and 2017 were classified into a group that received misoprostol alone, a group that received mifepristone followed by misoprostol on the same day, one where misoprostol was given 1 day after mifepristone and one where the medications were administered 2 days apart. The primary outcome measure was the induction to delivery interval.
RESULTS
481 pregnancies fulfilled the inclusion criteria. In 140 cases, mifepristone was not administered. 341 women received mifepristone prior to induction, which was administered on the day of induction in 85 cases, and 1 or 2 days prior to induction in 140 and 19 cases. Median time interval between first induction and delivery was 15.0 (IQR 10.0-24.1) h in case no mifepristone was given and 13.2 (9.7-18.2) h if mifepristone was given on the same day and 9.3 (6.6-14.9) and 10.5 (7.2-22.3) h, if mifepristone was given 1 or 2 days prior to induction. After 24 h, the proportion of terminated pregnancies in each of the four groups was 75.0, 83.5, 93.2 and 78.9%.
CONCLUSION
A 1 day interval between mifepristone and misoprostol is more effective in second and third trimester TOP compared to other strategies in terms of reducing the induction to abortion interval.
Topics: Abortifacient Agents, Steroidal; Abortion, Induced; Adult; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Retrospective Studies
PubMed: 30578439
DOI: 10.1007/s00404-018-5017-9 -
Health Technology Assessment... Nov 2021A randomised, parallel-group, double-blind, placebo-controlled multicentre study with health economic and nested qualitative studies to determine if mifepristone... (Randomized Controlled Trial)
Randomized Controlled Trial
TRIAL DESIGN
A randomised, parallel-group, double-blind, placebo-controlled multicentre study with health economic and nested qualitative studies to determine if mifepristone (Mifegyne, Exelgyn, Paris, France) plus misoprostol is superior to misoprostol alone for the resolution of missed miscarriage.
METHODS
Women diagnosed with missed miscarriage in the first 14 weeks of pregnancy were randomly assigned (1 : 1 ratio) to receive 200 mg of oral mifepristone or matched placebo, followed by 800 μg of misoprostol 2 days later. A web-based randomisation system allocated the women to the two groups, with minimisation for age, body mass index, parity, gestational age, amount of bleeding and randomising centre. The primary outcome was failure to pass the gestational sac within 7 days after randomisation. The prespecified key secondary outcome was requirement for surgery to resolve the miscarriage. A within-trial cost-effectiveness study and a nested qualitative study were also conducted. Women who completed the trial protocol were purposively approached to take part in an interview to explore their satisfaction with and the acceptability of medical management of missed miscarriage.
RESULTS
A total of 711 women, from 28 hospitals in the UK, were randomised to receive either mifepristone plus misoprostol (357 women) or placebo plus misoprostol (354 women). The follow-up rate for the primary outcome was 98% (696 out of 711 women). The risk of failure to pass the gestational sac within 7 days was 17% (59 out of 348 women) in the mifepristone plus misoprostol group, compared with 24% (82 out of 348 women) in the placebo plus misoprostol group (risk ratio 0.73, 95% confidence interval 0.54 to 0.98; = 0.04). Surgical intervention to resolve the miscarriage was needed in 17% (62 out of 355 women) in the mifepristone plus misoprostol group, compared with 25% (87 out of 353 women) in the placebo plus misoprostol group (risk ratio 0.70, 95% confidence interval 0.52 to 0.94; = 0.02). There was no evidence of a difference in the incidence of adverse events between the two groups. A total of 42 women, 19 in the mifepristone plus misoprostol group and 23 in the placebo plus misoprostol group, took part in an interview. Women appeared to have a preference for active management of their miscarriage. Overall, when women experienced care that supported their psychological well-being throughout the care pathway, and information was delivered in a skilled and sensitive manner such that women felt informed and in control, they were more likely to express satisfaction with medical management. The use of mifepristone and misoprostol showed an absolute effect difference of 6.6% (95% confidence interval 0.7% to 12.5%). The average cost per woman was lower in the mifepristone plus misoprostol group, with a cost saving of £182 (95% confidence interval £26 to £338). Therefore, the use of mifepristone and misoprostol for the medical management of a missed miscarriage dominated the use of misoprostol alone.
LIMITATIONS
The results from this trial are not generalisable to women diagnosed with incomplete miscarriage and the study does not allow for a comparison with expectant or surgical management of miscarriage.
FUTURE WORK
Future work should use existing data to assess and rank the relative clinical effectiveness and safety profiles for all methods of management of miscarriage.
CONCLUSIONS
Our trial showed that pre-treatment with mifepristone followed by misoprostol resulted in a higher rate of resolution of missed miscarriage than misoprostol treatment alone. Women were largely satisfied with medical management of missed miscarriage and would choose it again. The mifepristone and misoprostol intervention was shown to be cost-effective in comparison to misoprostol alone.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN17405024.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 68. See the NIHR Journals Library website for further project information.
Topics: Abortion, Spontaneous; Cost-Benefit Analysis; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Technology Assessment, Biomedical
PubMed: 34821547
DOI: 10.3310/hta25680 -
European Journal of Obstetrics,... Oct 2023To evaluate the efficacy of combined mifepristone and misoprostol compared to misoprostol alone in outpatient medical treatment of first trimester miscarriage.... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
To evaluate the efficacy of combined mifepristone and misoprostol compared to misoprostol alone in outpatient medical treatment of first trimester miscarriage. Additionally, the study intends to compare the rate of complications, adverse effects, and treatment acceptability between groups.
STUDY DESIGN
Single-center double-blind randomized placebo-controlled trial including women with diagnosis of missed first trimester miscarriage up to 9 weeks of gestation.
RESULTS
Between April 2019 and November 2021, 216 women diagnosed with first trimester miscarriage up to 9 weeks of gestation were randomly assigned to mifepristone group or to misoprostol-alone group. Data from 105 women in mifepristone group and 103 women in misoprostol-alone group were analyzed, with no differences in baseline characteristics. The median time between medications (oral mifepristone/placebo and vaginal misoprostol) was nearly 43 h in both groups (p = 0.906). The median time to first follow-up was 2.6 weeks (IQR 1.0) in mifepristone group and 2.4 weeks (IQR 1.0) in misoprostol-alone group (p = 0.855). The overall success rate of medical treatment was significantly higher in the mifepristone-group comparing to misoprostol-alone group (94.3% vs. 82.5%, RR 1.14, 95% CI, 1.03-1.26; p = 0.008). Accordingly, the rate of surgical treatment was significantly lower in the mifepristone-group (5.7% vs.14.6%, RR 0.39, 95% CI, 0.16-0.97; p = 0.034). The composite complication rate was similar and lower than 4% in both groups. No case of complicated pelvic infection, hemodynamic instability or inpatient supportive treatment was reported. There were no significant differences in the rates of adverse events, median score for vaginal bleeding intensity or analgesics use. Despite the same median value, the score of abdominal pain intensity was significantly higher in the mifepristone-group (p = 0.011). In both groups, more than 65% of the women classified the treatment as "good" and 92% would recommend it to a friend on the same clinical situation.
CONCLUSION
The mifepristone plus vaginal misoprostol combined treatment for medical resolution of first trimester miscarriage resulted in significant higher success rate and lower rate of surgical uterine evacuation comparing to misoprostol-alone treatment, with no relevant differences in adverse events or treatment acceptability.
Topics: Female; Humans; Pregnancy; Abortion, Spontaneous; Mifepristone; Misoprostol; Pregnancy Trimester, First; Abortion, Missed
PubMed: 37678127
DOI: 10.1016/j.ejogrb.2023.08.391 -
Archives of Gynecology and Obstetrics Sep 2023Misoprostol is a synthetic PGE analogue that is used for induction of labour. Current guidelines support the use of doses that do not exceed 25 mcg in order to limit... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Misoprostol is a synthetic PGE analogue that is used for induction of labour. Current guidelines support the use of doses that do not exceed 25 mcg in order to limit maternal and neonatal adverse outcomes. The present meta-analysis investigates the efficacy and safety of oral compared to vaginally inserted misoprostol in terms of induction of labor and adverse peripartum outcomes.
METHODS
We searched Medline, Scopus, the Cochrane Central Register of Controlled Trials CENTRAL, Google Scholar, and Clinicaltrials.gov databases from inception till April 2022. Randomized controlled trials that assessed the efficacy of oral misoprostol (per os or sublingual) compared to vaginally inserted misoprostol. Effect sizes were calculated in R. Sensitivity analysis was performed to evaluate the possibility of small study effects, p-hacking. Meta-regression and subgroup analysis according to the dose of misoprostol was also investigated. The methodological quality of the included studies was assessed by two independent reviewers using the risk of bias 2 tool. Quality of evidence for primary outcomes was evaluated under the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, ranging from very low to high.
RESULTS
Overall, 57 studies were included that involved 10,975 parturient. Their risk of bias ranged between low-moderate. There were no differences among the routes of intake in terms of successful vaginal delivery within 24 h (RR 0.90, 95% CI 0.80) and cesarean section rates (RR 0.92, 95% CI 0.82, 1.04). Sublingual misoprostol was superior compared to vaginal misoprostol in reducing the interval from induction to delivery (MD - 1.11 h, 95% CI - 2.06, - 0.17). On the other hand, per os misoprostol was inferior compared to vaginal misoprostol in terms of this outcome (MD 3.45 h, 95% CI 1.85, 5.06). Maternal and neonatal morbidity was not affected by the route or dose of misoprostol.
CONCLUSION
The findings of our study suggest that oral misoprostol intake is equally safe to vaginal misoprostol in terms of inducing labor at term. Sublingual intake seems to outperform the per os and vaginal routes without increasing the accompanying morbidity. Increasing the dose of misoprostol does not seem to increase its efficacy.
CLINICAL TRIAL REGISTRATION
Open Science Framework ( https://doi.org/10.17605/OSF.IO/V9JHF ).
Topics: Infant, Newborn; Pregnancy; Humans; Female; Misoprostol; Oxytocics; Cesarean Section; Labor, Induced; Administration, Sublingual
PubMed: 36472645
DOI: 10.1007/s00404-022-06867-9 -
Obstetrics and Gynecology Mar 2024Early pregnancy loss (EPL) is common, but patients face barriers to the most effective medication (mifepristone followed by misoprostol) and procedural (uterine...
Early pregnancy loss (EPL) is common, but patients face barriers to the most effective medication (mifepristone followed by misoprostol) and procedural (uterine aspiration) management options. This cross-sectional geospatial analysis evaluated access in New Mexico to mifepristone and misoprostol and uterine aspiration in emergency departments (comprehensive) and to uterine aspiration anywhere in a hospital (aspiration) for EPL. Access was defined as a 60-minute car commute. We collected data from hospital key informants and public databases and performed logistical regression to evaluate associations between access and rurality, area deprivation, race, and ethnicity. Thirty-five of 42 (83.3%) hospitals responded between October 2020 and August 2021. Two hospitals (5.7%) provided comprehensive management; 24 (68.6%) provided aspiration. Rural and higher deprivation areas had statistically significantly lower adjusted odds ratios for comprehensive management (0.03-0.07 and 0.3-0.4, respectively) and aspiration (0.03-0.06 and 0.1-0.3, respectively) access. Mifepristone and uterine aspiration implementation would address disparate access to EPL treatment.
Topics: Pregnancy; Female; Humans; Mifepristone; Abortion, Spontaneous; Misoprostol; Abortion, Induced; Cross-Sectional Studies; Respiratory Aspiration
PubMed: 38207328
DOI: 10.1097/AOG.0000000000005505 -
International Journal of Gynaecology... Jun 2015The effectiveness of Foley catheter plus misoprostol for cervical ripening has not been convincingly shown in trials. (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
The effectiveness of Foley catheter plus misoprostol for cervical ripening has not been convincingly shown in trials.
OBJECTIVES
To summarize the evidence comparing Foley catheter plus misoprostol versus misoprostol alone for cervical ripening.
SEARCH STRATEGY
Embase, Medline, and Cochrane Collaboration databases were searched with the terms "Foley catheter," "misoprostol," "cervical ripening," and "labor induction."
SELECTION CRITERIA
Randomized controlled trials comparing the methods of cervical ripening for delivery of a viable fetus were included.
DATA COLLECTION AND ANALYSIS
Study characteristics, quality, and outcomes were recorded. Random-effects models were used to combine data.
MAIN RESULTS
Eight trials were included, with 1153 patients overall. In a pooled analysis of seven high-quality studies, the combination group had a decreased time to delivery (mean difference -2.36 hours, 95% confidence interval [CI] -4.07 to -0.66; P=0.007). Risk of chorioamnionitis was significantly increased in the combination group (risk ratio [RR] 2.07, 95% CI 1.04-4.13; P=0.04), and that of tachysystole with fetal heart rate changes was decreased (RR 0.58, 95% CI 0.38-0.91; P=0.02). Frequency of cesarean did not differ (P=0.77).
CONCLUSIONS
The combined use of Foley catheter and misoprostol results in a reduced time to delivery, a reduced frequency tachysystole with fetal heart rate changes, and an increased incidence of chorioamnionitis.
Topics: Cervical Ripening; Chorioamnionitis; Delivery, Obstetric; Female; Humans; Misoprostol; Oxytocics; Pregnancy; Randomized Controlled Trials as Topic; Time Factors; Urinary Catheterization
PubMed: 25794821
DOI: 10.1016/j.ijgo.2015.01.005 -
The Journal of Maternal-fetal &... Sep 2016The efficacy and safety were assessed of a misoprostol regimen used alone or in combination with foley catheter for second trimester pregnancy termination. (Comparative Study)
Comparative Study
OBJECTIVE
The efficacy and safety were assessed of a misoprostol regimen used alone or in combination with foley catheter for second trimester pregnancy termination.
METHODS
A retrospective examination was made of the records of patients who underwent pregnancy termination at 14-24 weeks of gestation in our university hospital between January 2011 and June 2014. Records were available for patients 378 who underwent terminations. Group 1 comprised patients with no history of cesarean section. An initial dose of 200 μg misoprostol was administered intravaginally and then until the termination was completed an additional 200 μgr dose was administered sublingually every 4 hours (Group 1: 234 patients). Group 2 comprised patients with a history of cesarean section. An initial dose of 200 μg misoprostol was administered intravaginally and 2 hours later an intracervical foley catheter was inserted (Group 2: 144 patients).
RESULTS
The total misoprostol dosage used was 1160 μg and 560 μg (p< 0.001), intervals from the administration of the first misoprostol tablet until termination were 854.8 and 704.2 minutes (p= 0.03) in Groups 1 and 2, respectively.
CONCLUSIONS
The misoprostol + foley catheter combination reduces the total dosage of misoprostol required for termination and shortens the termination interval, thereby increasing patient's comfort. Based on these results, the usage of the misoprostol + foley catheter combination can be recommended especially for patients with a history of caesarian section.
Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Catheters; Female; Humans; Misoprostol; Pregnancy; Pregnancy Trimester, Second; Young Adult
PubMed: 26452400
DOI: 10.3109/14767058.2015.1105950 -
BMC Research Notes Oct 2023The complications associated with miscarriages have surfaced as a major concern in maintaining women's physical and mental health. The present study evaluated the... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
The complications associated with miscarriages have surfaced as a major concern in maintaining women's physical and mental health. The present study evaluated the efficacy of three medication regimes for the complete expulsion of retained intrauterine tissues in patients who underwent a miscarriage.
METHODS
In this randomized clinical trial, 90 patients participated with their gestational age below 12 weeks, each having undergone a recent miscarriage. After being screened for underlying diseases and coagulative blood disorders, they were randomly allocated into three groups. For the first group, labeled as the control group, misoprostol was administered alone. In contrast, the combination of misoprostol plus methylergometrine and misoprostol plus oxytocin was prescribed for the second and third groups, respectively. Further, the data obtained were analyzed by descriptive and inferential statistics using Stata software version 14.
RESULTS
The mean age of participants and gestational age were 29.76 ± 5.53 years and 8.23 ± 2.29 weeks, respectively. There was no significant difference between the three treatment groups regarding the amount of bleeding after the abortion(P = 0.627). Regarding pain severity, the group that received Misoprostol plus Methylergometrine had less pain intensity than the other two groups(p = 0.004). The mean rate of RPOC expulsion was in the Misoprostol plus Oxytocin (9.68 ± 10.36) group, Misoprostol plus Methylergometrine (11.73 ± 12.86), and Misoprostol groups (19.07 ± 14.31)(p = 0.013). The success rate in outpatient medical abortion in the misoprostol plus oxytocin and misoprostol plus methylergonovine group was 93.33%, but in patients treated by misoprostol alone was 83.33%.
CONCLUSION
The effectiveness of the drugs in the two drug groups combined with oxytocin and methylergometrine is higher than the misoprostol group alone. An outpatient approach was deemed more satisfactory against surgical maneuvers and hospitalizations by patients since family support influenced their pain coping mechanism.
TRIAL REGISTRATION
The trial was registered in the Iranian registry of clinical trials on 04/10/2019. ( https://fa.irct.ir/trial/34519 ; registration number: IRCT20150407021653N19).
Topics: Pregnancy; Humans; Female; Young Adult; Adult; Infant; Misoprostol; Oxytocin; Methylergonovine; Oxytocics; Abortion, Spontaneous; Outpatients; Iran; Abortion, Induced
PubMed: 37798748
DOI: 10.1186/s13104-023-06509-6