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Human Reproduction Update May 2019First-trimester miscarriage affects up to a quarter of women worldwide. With many competing treatment options available, there is a need for a comprehensive evidence... (Meta-Analysis)
Meta-Analysis
BACKGROUND
First-trimester miscarriage affects up to a quarter of women worldwide. With many competing treatment options available, there is a need for a comprehensive evidence synthesis.
OBJECTIVES AND RATIONALE
We conducted a systematic review and network meta-analysis to assess the effectiveness and safety of treatment options for first-trimester miscarriage: expectant management (EXP), sharp dilation and curettage (D+C), electric vacuum aspiration (EVAC), manual vacuum aspiration (MVA), misoprostol alone (MISO), mifepristone+misoprostol (MIFE+MISO) and misoprostol plus electric vacuum aspiration (MISO+EVAC).
SEARCH METHODS
We searched MEDLINE, Embase, CINAHL, AMED and Cochrane Library from inception till June 2018. We included randomized trials of women with first-trimester miscarriage (<14 weeks gestation) and conducted a network meta-analysis generating both direct and mixed evidence on the effectiveness and side effects of available treatment options. The primary outcome was complete evacuation of products of conception. We assessed the risk of bias and the global network inconsistency. We compared the surface under the cumulative ranking curve (SUCRA) for each treatment.
OUTCOMES
A total of 46 trials (9250 women) were included. The quality of included studies was overall moderate with some studies demonstrating a high risk of bias. We detected unexplained inconsistency in evidence loops involving MIFE+MISO and adjusted for it. EXP had lower effectiveness compared to other treatment options. The effectiveness of medical treatments was similar compared to surgery. Mixed evidence of low confidence suggests increased effectiveness for MIFE+MISO compared to MISO alone (RR 1.49, 95% CI: 1.09-2.03). Side effects were similar among all options. Fewer women needed analgesia following EVAC compared to MISO (RR for MISO 0.43, 95% CI: 0.27-0.68) and in the EXP group compared to EVAC (RR 2.07, 95% CI: 1.25-3.41). MVA had higher ranking (low likelihood) for post-treatment infection and serious complications (SUCRA 87.6 and 79.2%, respectively) with the highest likelihood for post-treatment satisfaction (SUCRA 98%).
WIDER IMPLICATIONS
Medical treatments for first-trimester miscarriage have similar effectiveness and side effects compared to surgery. The addition of MIFE could increase the effectiveness of MISO and reduce side effects, although evidence is limited due to inconsistency. EXP has lower effectiveness compared to other treatment options.Systematic review registration: Prospero CRD42016048920.
Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Spontaneous; Female; Gestational Age; Humans; Mifepristone; Misoprostol; Network Meta-Analysis; Pregnancy; Pregnancy Trimester, First; Vacuum Curettage
PubMed: 30753490
DOI: 10.1093/humupd/dmz002 -
The Cochrane Database of Systematic... Apr 2006Miscarriage is a common complication of early pregnancy that can have both medical and psychological consequences like depression and anxiety. The need for routine... (Review)
Review
BACKGROUND
Miscarriage is a common complication of early pregnancy that can have both medical and psychological consequences like depression and anxiety. The need for routine surgical evacuation with miscarriage has been questioned because of potential complications such as cervical trauma, uterine perforation, hemorrhage, or infection.
OBJECTIVES
To compare the safety and effectiveness of expectant management versus surgical treatment for early pregnancy loss.
SEARCH STRATEGY
We searched the Cochrane Pregnancy and Childbirth Group Trials Register (December 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2004, Issue 3), PubMed (1966 to March 2005), POPLINE (inception to March 2005), and LILACS (1982 to March 2005) and reference lists of reviews.
SELECTION CRITERIA
Randomized trials comparing expectant care and surgical treatment (vacuum aspiration or dilation and curettage (D & C)) for miscarriage were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed trial quality and extracted data. We contacted study authors for additional information.
MAIN RESULTS
Five trials were included in this review with 689 total participants. The expectant-care group was more likely to have an incomplete miscarriage (RR 5.37; 95% CI 2.57 to 11.22). However, the time frames for declaring the process incomplete varied across the studies. The need for unplanned surgical treatment (such as vacuum aspiration or D&C) was greater for the expectant-care group (RR 4.78; 95% CI 1.99 to 11.48). The expectant-care group had more days of bleeding (WMD 1.59; 95% CI 0.74 to 2.45) and a greater amount of bleeding (WMD 1.00; 95% CI 0.60 to 1.40). Post-procedure diagnosis of infection was lower in the expectant-care group (RR 0.29; 95% CI 0.09 to 0.87). Information on psychological outcomes and pregnancy was too limited to draw conclusions.
AUTHORS' CONCLUSIONS
Expectant management led to a higher risk of incomplete miscarriage, need for surgical emptying of the uterus, and bleeding. None of these were serious. In contrast, surgical evacuation was associated with a significantly higher risk of infection. Given the lack of clear superiority of either approach, the woman's preference should play a dominant role in decision making. Medical management has added choices for women and their clinicians, but these were not reviewed here.
Topics: Abortion, Incomplete; Abortion, Spontaneous; Anti-Bacterial Agents; Bed Rest; Dilatation and Curettage; Female; Humans; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic; Ultrasonography; Vacuum Curettage
PubMed: 16625583
DOI: 10.1002/14651858.CD003518.pub2 -
The Cochrane Database of Systematic... Jul 2015The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system. Training mid-level providers, such as midwives,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system. Training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct first trimester aspiration abortions and manage medical abortions has been proposed as a way to increase women's access to safe abortion procedures.
OBJECTIVES
To assess the safety and effectiveness of abortion procedures administered by mid-level providers compared to doctors.
SEARCH METHODS
We searched the CENTRAL Issue 7, MEDLINE and POPLINE databases for comparative studies of doctor and mid-level providers of abortion services. We searched for studies published in any language from January 1980 until 15 August 2014.
SELECTION CRITERIA
Randomised controlled trials (RCTs) (clustered or not clustered), prospective cohort studies or observational studies that compared the safety or effectiveness (or both) of any type of first trimester abortion procedure, administered by any type of mid-level provider or doctors, were eligible for inclusion in the review.
DATA COLLECTION AND ANALYSIS
Two independent review authors screened abstracts for eligibility and double-extracted data from the included studies using a pre-tested form. We meta-analysed primary outcome data using both fixed-effect and random-effects models to obtain pooled risk ratios (RR) with 95% confidence intervals (CIs). We carried out separate analyses by study design (RCT or cohort) and type of abortion procedure (medical versus surgical).
MAIN RESULTS
Eight studies involving 22,018 participants met our eligibility criteria. Five studies (n = 18,962) assessed the safety and effectiveness of surgical abortion procedures administered by mid-level providers compared to doctors. Three studies (n = 3056) assessed the safety and effectiveness of medical abortion procedures. The surgical abortion studies (one RCT and four cohort studies) were carried out in the United States, India, South Africa and Vietnam. The medical abortion studies (two RCTs and one cohort study) were carried out in India, Sweden and Nepal. The studies included women with gestational ages up to 14 weeks for surgical abortion and nine weeks for medical abortion.Risk of selection bias was considered to be low in the three RCTs, unclear in four observational studies and high in one observational study. Concealment bias was considered to be low in the three RCTs and high in all five observational studies. Although none of the eight studies performed blinding of the participants to the provider type, we considered the performance bias to be low as this is part of the intervention. Detection bias was considered to be high in all eight studies as none of the eight studies preformed blinding of the outcome assessment. Attrition bias was low in seven studies and high in one, with over 20% attrition. We considered six studies to have unclear risk of selective reporting bias as their protocols had not been published. The remaining two studies had published their protocols. Few other sources of bias were found.Based on an analysis of three cohort studies, the risk of surgical abortion failure was significantly higher when provided by mid-level providers than when procedures were administered by doctors (RR 2.25, 95% CI 1.38 to 3.68), however the quality of evidence for this outcome was deemed to be very low. For surgical abortion procedures, we found no significant differences in the risk of complications between mid-level providers and doctors (RR 0.99, 95% CI 0.17 to 5.70 from RCTs; RR 1.38, 95% CI 0.70 to 2.72 from observational studies). When we combined the data for failure and complications for surgical abortion we found no significant differences between mid-level providers and doctors in both the observational study analysis (RR 1.36, 95% CI 0.86 to 2.14) and the RCT analysis (RR 3.07, 95% CI 0.16 to 59.08). The quality of evidence of the outcome for RCT studies was considered to be low and for observational studies very low. For medical abortion procedures the risk of failure was not different for mid-level providers or doctors (RR 0.81, 95% CI 0.48 to 1.36 from RCTs; RR 1.09, 95% CI 0.63 to 1.88 from observational studies). The quality of evidence of this outcome for the RCT analysis was considered to be high, although the quality of evidence of the observational studies was considered to be very low. There were no complications reported in the three medical abortion studies.
AUTHORS' CONCLUSIONS
There was no statistically significant difference in the risk of failure for medical abortions performed by mid-level providers compared with doctors. Observational data indicate that there may be a higher risk of abortion failure for surgical abortion procedures administered by mid-level providers, but the number of studies is small and more robust data from controlled trials are needed. There were no statistically significant differences in the risk of complications for first trimester surgical abortions performed by mid-level providers compared with doctors.
Topics: Abortifacient Agents; Abortion, Legal; Abortion, Therapeutic; Allied Health Personnel; Clinical Competence; Cohort Studies; Female; Humans; Midwifery; Mifepristone; Misoprostol; Nurses; Nursing Assistants; Observational Studies as Topic; Physician Assistants; Physicians; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic; Vacuum Curettage
PubMed: 26214844
DOI: 10.1002/14651858.CD011242.pub2 -
BMC Health Services Research Mar 2022Despite the increasing trend of Postabortion Care (PAC) needs and provision, the evidence related to its cost is lacking. This study aims to review the costs of...
BACKGROUND
Despite the increasing trend of Postabortion Care (PAC) needs and provision, the evidence related to its cost is lacking. This study aims to review the costs of Postabortion Care (PAC) per patient at a national level.
METHODS
A systematic review of literature related to PAC cost published in 1994 - October 2020 was performed. Electronic databases such as PubMed, Medline, The Cochrane Library, CINAHL, and PsycINFO were used to search the literature. Following the title and abstract screening, reporting quality was appraised using the Consolidates Health Economic Evaluation (CHEERS) checklist. PAC costs were extrapolated into US dollars ($US) and international dollars ($I), both in 2019.
RESULTS
Twelve studies met the inclusion criteria. All studies reported direct medical cost per patient in accessing PAC, but only three of them included indirect medical cost. All studies reported either average or range of cost. In terms of range, the highest direct cost of PAC with MVA (Medical Vacuum Aspiration) services can be found in Colombia, between $US50.58-212.47, while the lowest is in Malawi ($US15.2-139.19). The highest direct cost of PAC with D&C (Dilatation and Curettage), services is in El Salvador ($US65.22-240.75), while the lowest is in Bangladesh ($US15.71-103.85). Among two studies providing average indirect cost data, Uganda with $US105.04 has the highest average indirect medical cost, while Rwanda with $US51.44 has the lowest.
CONCLUSIONS
Our review shows variability in the cost of PAC across countries. This study depicts a clearer picture of how costly it is for women to access PAC services, although it is still seemingly underestimated. When a study compared the use of UE (Uterine Evacuation) method between MVA and D&C, it is confirmed that MVA treatments tend to have lower costs and potentially reduce a significant cost. Therefore, by looking at both clinical and economic perspectives, improving and strengthening the quality and accessibility of PAC with MVA is a priority.
Topics: Abortion, Induced; Aftercare; Cost-Benefit Analysis; Female; Humans; Malawi; Pregnancy; Vacuum Curettage
PubMed: 35337323
DOI: 10.1186/s12913-022-07765-1 -
BJOG : An International Journal of... Jan 2008As an alternative to electric vacuum aspirations (EVA), there is an increasing interest in using manual vacuum aspiration (MVA). (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
As an alternative to electric vacuum aspirations (EVA), there is an increasing interest in using manual vacuum aspiration (MVA).
OBJECTIVE
To compare the safety, efficacy and acceptability of MVA with those of EVA for first-trimester abortion.
SEARCH STRATEGY
We searched MEDLINE, EMBASE, Cochrane Library and Chinese Biomedical Database in all language, together with reference lists of retrieved papers.
SELECTION CRITERIA
Randomised controlled trials comparing MVA with EVA for first-trimester abortion were included. The outcomes are complete abortion rate, uterine perforation rate, blood loss, pain perception and acceptability.
DATA COLLECTION AND ANALYSIS
Two reviewers independently extracted the data. Results from the trials were combined to calculate relative risks (RRs) or risk differences for dichotomous outcomes and weighted mean differences (WMDs) for continuous outcomes, together with 95% CIs.
MAIN RESULTS
Ten trials were included, involving 1660 women. Generally, the methodological quality was poor. There were no statistically significant differences, comparing MVA with EVA, in complete abortion rate (RR 1.00; 95% CI 0.99-1.02) and participants' satisfaction (RR 1.02; 95% CI 0.87-1.20). In participants with less than 50 days of gestational age, less blood loss (WMD -1.84; 95% CI -2.45 to -1.23) and less severe pain perception (RR 0.04; 95% CI 0.01-0.12) were reported during the MVA procedure, whereas the operation time was shorter (WMD 0.32; 95% CI 0.02-0.63) in the EVA procedure.
AUTHOR'S CONCLUSIONS
There is some evidence that MVA is as effective and acceptable as EVA and might be safer than EVA.
Topics: Abortion, Induced; Female; Humans; Pain; Patient Satisfaction; Postpartum Hemorrhage; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic; Vacuum Curettage; Vacuum Extraction, Obstetrical
PubMed: 18053098
DOI: 10.1111/j.1471-0528.2007.01572.x -
The Cochrane Database of Systematic... Nov 2011Surgical abortion by vacuum aspiration or dilatation and curettage has been the method of choice for early pregnancy termination since the 1960s. Medical abortion became... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Surgical abortion by vacuum aspiration or dilatation and curettage has been the method of choice for early pregnancy termination since the 1960s. Medical abortion became an alternative method of first trimester pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins.
OBJECTIVES
To compare different medical methods for first trimester abortion.
SEARCH METHODS
The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted.
SELECTION CRITERIA
Types of studies Randomised controlled trials comparing different medical methods for abortion during first trimester (e.g. single drug, combination) were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant during the first trimester, undergoing medical abortion were the participants. The outcomes were mortality, failure to achieve complete abortion, surgical evacuation, ongoing pregnancy at follow-up, time until passing of conceptus, blood transfusion, side effects and women's dissatisfaction with the procedure.
DATA COLLECTION AND ANALYSIS
Two reviewers independently selected trials for inclusion from the results of the search strategy described previously.The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. Data were processed using Revman software.
MAIN RESULTS
Fifty-eight trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. Sublingual and buccal routes were similarly effective compared to the vaginal route, but had higher rates of side effects. 2) Mifepristone alone is less effective when compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Five trials compared prostaglandin alone to the combined regimen (mifepristone/prostaglandin). All but one reported higher effectiveness with the combined regimen. The results of these studies could not be combined but the RR of failure with prostaglandin alone is reportedly between 1.4 to 3.75 with the 95% confidence intervals indicating statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference in effectiveness with use of a divided dose compared to a single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin demonstrates similar rates of failure to complete abortion when comparing intramuscular to oral methotrexate administration (RR 2.04, 95% CI 0.51 to 8.07). Similarly, day 3 vs. day 5 administration of prostaglandin following methotrexate administration showed no significant differences (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs. methotrexate and no statistically significant differences were observed in effectiveness between the groups.
AUTHORS' CONCLUSIONS
Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Vaginal misoprostol is more effective than oral administration, and has less side effects than sublingual or buccal. Some results are limited by the small numbers of participants on which they are based. Almost all trials were conducted in settings with good access to emergency services, which may limit the generalizability of these results.
Topics: Abortifacient Agents; Abortion, Incomplete; Abortion, Induced; Drug Therapy, Combination; Female; Humans; Methotrexate; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First; Prostaglandins; Randomized Controlled Trials as Topic; Tamoxifen
PubMed: 22071804
DOI: 10.1002/14651858.CD002855.pub4 -
The Cochrane Database of Systematic... Nov 2015Medications or mechanical dilators are often used to soften and dilate the cervix prior to surgical evacuation of the uterus for non-viable pregnancy, or miscarriage.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Medications or mechanical dilators are often used to soften and dilate the cervix prior to surgical evacuation of the uterus for non-viable pregnancy, or miscarriage. The majority of miscarriages occur in the first trimester. The aim of cervical ripening is to reduce the possibility of injury to the uterus and cervix and improve the surgical ease of the procedure. Cervical ripening agents can have adverse effects and it is uncertain as to whether these risks outweigh the benefits of their use.
OBJECTIVES
To systematically review the benefits and harms of using cervical ripening agents prior to surgical evacuation of non-viable pregnancy prior to 14 weeks' gestation.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2015) and reference lists of retrieved papers.
SELECTION CRITERIA
Randomised controlled trials (published in full-text form, or as abstracts only), which assessed the use of pharmacological or mechanical agents to ripen the cervix in women undergoing dilation and curettage or vacuum aspiration for non-viable pregnancy at less than 14 weeks' gestation were eligible for inclusion. Cluster-randomised controlled trials and trials using a cross-over design were not eligible for inclusion.Unpublished randomised controlled trials and quasi-randomised trials would have been eligible for inclusion but none were identified.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the studies for inclusion, assessed risk of bias and carried out data extraction. Data were checked for accuracy.
MAIN RESULTS
We included nine trials with 469 women. A diverse set of medications and regimens were studied in these trials, making the comparisons available for meta-analysis limited. The comparisons draw data from six trials with 383 participants. All trials were relatively small and had several aspects of unclear risk of bias with few of this review's outcomes reported. Due to this, no data from three trials were able to be used despite them meeting inclusion criteria.We carried out four comparisons: isosorbide mononitrate or dinitrate compared with misoprostol; misoprostol compared with placebo; chemical dilation (use of medications) compared with mechanical dilation; and any cervical preparation compared with placebo.None of the included studies reported data on the review's primary outcome: cervical or uterine injury (perforation, laceration, creation of a false passage).No clear difference was shown between isosorbide compounds and misoprostol for the outcome need for manual cervical dilation (average risk ratio (RR) 0.76, 95% confidence interval (CI) 0.10 to 5.64; three trials, 150 women; Tau² = 2.11; I² = 69%), however the data were heterogenous. In terms of adverse effects, misoprostol was associated with more vomiting (RR 0.11, 95% CI 0.01 to 0.85; two trials, 120 women), however there were no clear differences between isosorbide compounds and misoprostol in relation to other reported adverse effects (headache, nausea or hypotension). The dosing regimens differed in terms of dose, number of administrations and route of administration in the different trials. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators in a single trial (65 women) that measured difficulty in cervical dilation, excessive bleeding and adverse effects.Misoprostol was shown to be more effective than placebo for cervical ripening (reduced need for manual cervical dilation) (RR 0.14, 95% CI 0.08 to 0.26; one trial, 120 women), and surgical time was reduced when misoprostol was used (mean difference (MD) -3.15, 95% CI -3.59 to -2.70; one trial, 120 women). However, compared to placebo, misoprostol, was associated with more abdominal pain (RR 29.00, 95% CI 1.77 to 475.35; one trial, 120 women), although no clear differences in the risk of other adverse effects (nausea, vomiting, headache or fever) were observed between groups.There was no clear differences between chemical dilation and mechanical dilators for the outcomes: difficulty in cervical dilation, excessive bleeding or adverse effects.Compared with placebo, any cervical preparation reduced the need for manual cervical dilatation (average RR 0.25, 95% CI 0.07 to 0.89; two trials, 168 women; Tau² = 0.67; I² = 81%), and reduced surgical time (MD -2.55, 95% CI -3.67 to -1.43, two trials, 168 women; Tau² = 0.63; I² = 96%).None of the included trials reported on the review's other secondary outcomes, including: injury to bladder or bowel, miscarriage/preterm birth in a subsequent pregnancy, analgesia use after administration of ripening agent but before surgery, or analgesia use after surgery.
AUTHORS' CONCLUSIONS
This review found no evidence to evaluate cervical ripening prior to first trimester surgical evacuation for miscarriage for reducing the rate of cervical or uterine injury, however, this may be because these outcomes are very rare. Cervical preparation was shown to reduce the need for manual cervical dilatation compared with placebo.Misoprostol and isosorbide mononitrate and dinitrate were similarly effective in ripening the cervix, however there was more vomiting with misoprostol. Mechanical (Dilapan-S hygroscopic) dilators performed similarly to chemical dilators.The nine studies included in this review were small and the methodological quality of the trials was mixed, and for the most part, not well-described; thus any conclusions drawn from the data included in this review must be treated with caution. Consequently, large, high-quality trials are required to determine whether the benefits of this treatment outweigh the risks. Further research should be powered to assess the rate of cervical and uterine injury between interventions. Future research should also guide clinicians in deciding whether the benefits of reduced manual cervical dilatation outweigh the risks of adverse effects associated with these agents (nausea, vomiting, headache, fever, diarrhoea and pain). Women's satisfaction and outcomes of future pregnancies should also be assessed.
Topics: Abortion, Eugenic; Abortion, Spontaneous; Adult; Cervical Ripening; Dilatation; Female; Humans; Isosorbide Dinitrate; Labor Stage, First; Misoprostol; Oxytocics; Pregnancy; Pregnancy Trimester, First; Randomized Controlled Trials as Topic
PubMed: 26559875
DOI: 10.1002/14651858.CD009954.pub2 -
The Cochrane Database of Systematic... 2004Surgical abortion up to 63 days by vacuum aspiration or dilatation and curettage has been the method of choice since the 1960s. Medical abortion became an alternative... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Surgical abortion up to 63 days by vacuum aspiration or dilatation and curettage has been the method of choice since the 1960s. Medical abortion became an alternative method of first trimester pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins.
OBJECTIVES
To compare different medical methods for first trimester abortion.
SEARCH STRATEGY
The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted.
SELECTION CRITERIA
Types of studies. Randomised controlled trials comparing different medical methods (e.g. single drug, combination), ways of application, or different dose regimens, single or combined, for medical abortion, were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant in the first trimester, undergoing medical abortion were the participants. Different medical methods used for first trimester abortion, compared with each other or placebo were included. The outcomes sought include mortality, failure to achieve complete abortion, surgical evacuation (as emergency procedure, non-emergency procedure, or undefined), ongoing pregnancy at follow-up, time until passing of conceptus (> 3-6 hours), blood transfusion, blood loss (measured or clinically relevant drop in haemoglobin), days of bleeding, pain resulting from the procedure (reported by the women or measured by use of analgesics), additional uterotonics used, women's dissatisfaction with the procedure, nausea, vomiting, diarrhoea.
DATA COLLECTION AND ANALYSIS
Two reviewers independently selected trials for inclusion from the results of the search strategy described previously. The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. A form was designed to facilitate the data extraction. Data were processed using Revman software.
MAIN RESULTS
Thirty-nine trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. 2) Mifepristone alone is less effective compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Similarly, the 5 trials included in the comparison of prostaglandin compared to the combined regimen reported in all but one higher effectiveness with the combined regime compared to prostaglandin. The results of these studies were not pooled but the RR of failure with prostaglandin alone is between 1.4 to 3.75 and the 95% confidence intervals indicate statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference when using split dose compared to single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin: there was no statistically significant difference in failure to achieve complete abortion comparing methotrexate administered intramuscular to oral (RR 2.04, 95% CI 0.51 to 8.07). Similarly, early (day 3) vs late (day 5) administration of prostaglandin showed no significant of prostaglandin showed no significant difference (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs methotrexate and no statistically significant differences were observed in effectiveness between the groups.
REVIEWERS' CONCLUSIONS
Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Misoprostol vaginally is more effective than orally. Some of the results are based on small studies only and therefore carry some uncertainty. Almost all trials were conducted in hospital settings with good access to support and emergency services. It is therefore not clear if the results are readily applicable to under-resourced settings where such services are lacking even if the agents used are available.
Topics: Abortifacient Agents; Abortion, Incomplete; Abortion, Induced; Drug Therapy, Combination; Female; Humans; Methotrexate; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First; Prostaglandins; Randomized Controlled Trials as Topic; Tamoxifen
PubMed: 15106180
DOI: 10.1002/14651858.CD002855.pub3 -
The Cochrane Database of Systematic... 2004Surgical abortion up to 63 days by vacuum aspiration or dilatation and curettage has been the method of choice since the 1960s. Medical abortion became an alternative... (Review)
Review
BACKGROUND
Surgical abortion up to 63 days by vacuum aspiration or dilatation and curettage has been the method of choice since the 1960s. Medical abortion became an alternative method of first trimester pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins.
OBJECTIVES
To compare different medical methods for first trimester abortion.
SEARCH STRATEGY
The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted.
SELECTION CRITERIA
Types of studies. Randomised controlled trials comparing different medical methods (e.g. single drug, combination), ways of application, or different dose regimens, single or combined, for medical abortion, were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant in the first trimester, undergoing medical abortion were the participants. Different medical methods used for first trimester abortion, compared with each other or placebo were included. The outcomes sought include mortality, failure to achieve complete abortion, surgical evacuation (as emergency procedure, non-emergency procedure, or undefined), ongoing pregnancy at follow-up, time until passing of conceptus (> 3-6 hours), blood transfusion, blood loss (measured or clinically relevant drop in haemoglobin), days of bleeding, pain resulting from the procedure (reported by the women or measured by use of analgesics), additional uterotonics used, women's dissatisfaction with the procedure, nausea, vomiting, diarrhoea.
DATA COLLECTION AND ANALYSIS
Two reviewers independently selected trials for inclusion from the results of the search strategy described previously. The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. A form was designed to facilitate the data extraction. Data were processed using Revman software.
MAIN RESULTS
Thirty-nine trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. 2) Mifepristone alone is less effective compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Similarly, the 5 trials included in the comparison of prostaglandin compared to the combined regimen reported in all but one higher effectiveness with the combined regime compared to prostaglandin. The results of these studies were not pooled but the RR of failure with prostaglandin alone is between 1.4 to 3.75 and the 95% confidence intervals indicate statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference when using split dose compared to single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin: there was no statistically significant difference in failure to achieve complete abortion comparing methotrexate administered intramuscular to oral (RR 2.04, 95% CI 0.51 to 8.07). Similarly, early (day 3) vs late (day 5) administration of prostaglandin showed no significant of prostaglandin showed no significant difference (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs methotrexate and no statistically significant differences were observed in effectiveness between the groups.
REVIEWER'S CONCLUSIONS
Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Misoprostol vaginally is more effective than orally. Some of the results are based on small studies only and therefore carry some uncertainty. Almost all trials were conducted in hospital settings with good access to support and emergency services. It is therefore not clear if the results are readily applicable to under-resourced settings where such services are lacking even if the agents used are available.
Topics: Abortifacient Agents; Abortion, Incomplete; Abortion, Induced; Drug Therapy, Combination; Female; Humans; Methotrexate; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First; Prostaglandins; Tamoxifen
PubMed: 14973995
DOI: 10.1002/14651858.CD002855.pub2 -
Obstetrics and Gynecology Jan 2020To estimate the incidence of gestational trophoblastic neoplasia following complete and partial molar pregnancy after reaching normal human chorionic gonadotropin (hCG)... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To estimate the incidence of gestational trophoblastic neoplasia following complete and partial molar pregnancy after reaching normal human chorionic gonadotropin (hCG) levels to guide evidence-based follow-up recommendations.
DATA SOURCES
MEDLINE, EMBASE, Web of Science, POPLINE, Cochrane, and ClinicalTrials.gov were searched from inception to November 2018, using the intersection of "gestational trophoblastic disease," "molar pregnancy," and "human chorionic gonadotropin" themes.
METHODS OF STUDY SELECTION
Search results were screened to identify cohort studies of molar pregnancy reporting gestational trophoblastic neoplasia development, with at least 6 months of intended normal hCG follow-up.
TABULATION, INTEGRATION, AND RESULTS
Two reviewers independently identified articles for inclusion. Data were extracted using a standardized form. For meta-analysis, cumulative incidence of gestational trophoblastic neoplasia, with CIs by the Agresti-Coull method, and pooled risk ratios (RRs) comparing complete and partial mole were calculated. Among the 19 eligible studies that reported adequate data for inclusion in the primary meta-analysis, we found low incidence of gestational trophoblastic neoplasia after normal hCG level following both complete mole (64/18,357, 0.35%, 95% CI 0.27-0.45%), and partial mole (5/14,864, 0.03%, 95% CI 0.01-0.08%). There was a significantly higher risk of gestational trophoblastic neoplasia after complete compared with partial molar pregnancy (RR 4.72, 95% CI 1.81-12.3, P=.002). Among gestational trophoblastic neoplasia cases after normal hCG level following complete mole, 89.6% occurred when the time from evacuation to normalization was 56 days or longer, and 60.7% were diagnosed beyond the commonly recommended 6-month surveillance interval. Sensitivity analyses, including those limiting to studies at low risk of bias, did not significantly affect results. We found an overall incidence of gestational trophoblastic neoplasia of 15.7% for complete mole (1,354/8,611, 95% CI 15.0-16.5%) and 3.95% for partial mole (221/5,593, 95% CI 3.47-4.50%).
CONCLUSION
Gestational trophoblastic neoplasia development after normal hCG level following molar pregnancy is rare. Recommendations for frequency and duration of hCG follow-up can be minimized to lessen burden on patients and informed by the type of molar pregnancy and time interval from uterine evacuation to hCG normalization.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42019116414.
Topics: Chorionic Gonadotropin; Female; Gestational Trophoblastic Disease; Humans; Hydatidiform Mole; Incidence; Pregnancy; Risk Factors; Uterine Neoplasms; Vacuum Curettage
PubMed: 31809433
DOI: 10.1097/AOG.0000000000003566