Efficacy, Safety, and Acceptability of Misoprostol in the Treatment of Incomplete Miscarriage: A Systematic Review and Meta-analysis.

OBJECTIVE: To assess the efficacy, safety, and acceptability of misoprostol in the treatment of incomplete miscarriage. DATA SOURCES: The PubMed, Scopus, Embase, Web of Science, Cochrane Library, and Clinical Trials databases (clinicaltrials.gov) were searched for the relevant articles, and search strategies were developed using a combination of thematic Medical Subject Headings terms and text words. The last search was conducted on July 4, 2022. No language restrictions were applied. SELECTION OF STUDIES: Randomized clinical trials with patients of gestational age up to 6/7 weeks with a diagnosis of incomplete abortion and who were managed with at least 1 of the 3 types of treatment studied were included. A total of 8,087 studies were screened. DATA COLLECTION: Data were synthesized using the statistical package Review Manager V.5.1 (The Cochrane Collaboration, Oxford, United Kingdom). For dichotomous outcomes, the odds ratio (OR) and 95% confidence interval (CI) were derived for each study. Heterogeneity between the trial results was evaluated using the standard test, I2 statistic. DATA SYNTHESIS: When comparing misoprostol with medical vacuum aspiration (MVA), the rate of complete abortion was higher in the MVA group (OR = 0.16; 95%CI = 0.07-0.36). Hemorrhage or heavy bleeding was more common in the misoprostol group (OR = 3.00; 95%CI = 1.96-4.59), but pain after treatment was more common in patients treated with MVA (OR = 0.65; 95%CI = 0.52-0.80). No statistically significant differences were observed in the general acceptability of the treatments. CONCLUSION: Misoprostol has been determined as a safe option with good acceptance by patients.

OBJETIVO: Avaliar a eficácia, segurança e aceitabilidade do misoprostol no tratamento do aborto incompleto. FONTES DE DADOS: Os bancos de dados PubMed, Scopus, Embase, Web of Science, Cochrane Library e bancos de dados de Ensaios Clínicos (clinicaltrials.gov) foram pesquisados para os artigos relevantes, e estratégias de busca foram desenvolvidas usando uma combinação de termos temáticos de Medical Subject Headings e palavras de texto. A última pesquisa foi realizada em 4 de julho de 2022. Nenhuma restrição de idioma foi aplicada. SELEçãO DOS ESTUDOS: Foram incluídos ensaios clínicos randomizados com pacientes com idade gestacional até 6/7 semanas com diagnóstico de aborto incompleto e que foram manejadas com pelo menos um dos três tipos de tratamento estudados. Um total de 8.087 estudos foram selecionados. COLETA DE DADOS: Os dados foram sintetizados usando o pacote estatístico Review Manager V.5.1 (The Cochrane Collaboration, Oxford, United Kingdom). Para resultados dicotômicos, o odds ratio (OR, na sigla em inglês) e o intervalo de confiança (IC) de 95% foram derivados para cada estudo. A heterogeneidade entre os resultados do ensaio foi avaliada usando o teste padrão, estatística I2. SíNTESE DOS DADOS: Ao comparar misoprostol com aspiração a vácuo médico (MVA, na sigla em inglês), a taxa de aborto completo foi maior no grupo MVA (OR = 0,16; IC95% = 0,07­0,36). Hemorragia ou sangramento intenso foi mais comum no grupo do misoprostol (OR = 3,00; 95%CI = 1,96­4,59), mas a dor após o tratamento foi mais comum em pacientes tratados com MVA (OR = 0,65; 95%CI = 0,52­0,80). Não foram observadas diferenças estatisticamente significativas na aceitabilidade geral dos tratamentos. CONCLUSãO: O misoprostol tem se mostrado uma opção segura e com boa aceitação pelos pacientes.

Evaluation of different doses of Femoston therapy for incomplete abortion: A prospective observational trial.

This study aimed to compare the efficacy of different doses of femoston with expectant management in patients with incomplete abortions. Patients diagnosed with incomplete abortion were included if they chose to continue medical treatment after relevant contraindications were excluded. Participants were divided into 3 groups: the femoston (1/10) and femoston (2/10) groups received different doses of femoston, and patients in the control group received expectant treatment. The success rate of complete abortion and the rate of menstrual recovery among the 3 groups were compared to evaluate the efficacy of different doses of femoston in patients with incomplete abortions. A total of 197 patients were analyzed: 73 in the femoston (1/10) group, 73 in the femoston (2/10) group, and 51 patients were followed up without treatment in the control group. The femoston group was significantly more effective than the control group P < .0001). The adjusted odds ratio (OR) and 95% confidence interval (CI) were 3.103 and 1.153 to 8.350 (P = .025). The success rate of complete abortion in the femoston (2/10) group was significantly higher than that in the femoston (1/10) group (adjusted OR: 0.403, 95% CI: 0.145-1.118, P = .081). In addition, the rate of menstrual recovery in the femoston group was significantly higher than that in the control group (P = .007), and the rate in the femoston (2/10) group was also higher than the femoston (1/10) group with statistically significant (P = .001). Femoston is effective in treating incomplete abortion, with femostons containing 2 mg estrogen being more effective. Patients with incomplete abortion are treated with femoston, and menstrual recovery time may be shortened. Femostons may be a new option for pharmacological treatment of incomplete abortions.

Outcomes of incomplete abortion related to treatment modality.

PURPOSE: This study evaluated the differences in treatment outcomes between misoprostol and surgical evacuation for the management of incomplete abortion. METHODS: This retrospective cohort study compared patients with a clinical diagnosis of incomplete abortion who underwent surgical or pharmaceutical (misoprostol) intervention, 2014-2017. Demographics, sonographic results, treatment follow-up, and post-intervention data on retained products of conception were retrieved. Women with incomplete abortion who underwent surgical versus pharmaceutical intervention were compared. RESULTS: Among 589 spontaneous abortions, 198 were included in the study, of which 123 (62.1%) underwent surgical evacuation and 75 (37.9%) pharmaceutical intervention with misoprostol. Baseline characteristics were similar between groups. During 130.8 ± 91.7 days of follow-up, no patient who underwent surgical evacuation had retained products of conception or needed surgical hysteroscopy. Four cases (5.3%) in the misoprostol group had retained products of conception and needed hysteroscopy (p = 0.02). Patients who underwent surgical evacuation had higher hemoglobin levels during follow-up (12.1 mg/dL vs. 11.7 mg/dL, p = 0.05). There were no differences in post-treatment pregnancy rates between groups. CONCLUSION: Long-term follow-up after incomplete abortion showed that hemodynamically stable patients treated with misoprostol achieved the desired results in 95% of cases without significant differences in pregnancy intervals compared to surgical management. Further prospective studies with larger sample sizes are required to confirm the outcomes described in this study.

Women's perceptions of and experiences with the use of misoprostol for treatment of incomplete abortion in central Malawi: a mixed methods study.

BACKGROUND: Abortion-related complications are among the common causes of maternal mortality in Malawi. Misoprostol is recommended for the treatment of first-trimester incomplete abortions but is seldom used for post-abortion care in Malawi. METHODS: A descriptive cross-sectional study that used mixed methods was conducted in three hospitals in central Malawi. A survey was done on 400 women and in-depth interviews with 24 women receiving misoprostol for incomplete abortion. Convenience and purposive sampling methods were used and data were analysed using STATA 16.0 for quantitative part and thematic analysis for qualitative part. RESULTS: From the qualitative data, three themes emerged around the following areas: experienced effects, support offered, and women's perceptions. Most women liked misoprostol and reported that the treatment was helpful and effective in expelling retained products of conception. Quantitative data revealed that the majority of participants, 376 (94%) were satisfied with the support received, and 361 (90.3%) believed that misoprostol was better than surgical treatment. The majority of the women 364 (91%) reported they would recommend misoprostol to friends. CONCLUSIONS: The use of misoprostol for incomplete abortion in Malawi is acceptable and regarded as helpful and satisfactory among women.

One of the major causes of maternal mortality is complications after abortion and miscarriages. The importance of post-abortion care in preventing such deaths justifies the necessity of making treatment accessible and available to every woman in need. Misoprostol is one of the approved treatments for incomplete abortion but is rarely used in developing countries. A study was conducted in three hospitals in central Malawi where women filled in a questionnaire and were interviewed after receiving misoprostol for incomplete abortion. The study's goal was to investigate women's experiences and feelings about using misoprostol. The findings showed that the majority of the women received medication and counselling as a form of support. They expressed satisfaction with the support and described misoprostol as being useful in removing retained products of conception from the womb. The medication was preferred and regarded as a reliable treatment that was also good for women. The majority of the women reported tolerable side effects of the drug and would recommend it to friends. In conclusion, the use of misoprostol for early incomplete abortion in Malawi is acceptable and is regarded as helpful, and satisfactory to women receiving post-abortion care. The research findings support expanding use of misoprostol in post-abortion care in Malawi.

Introducing misoprostol for treatment of incomplete abortion: A feasibility and acceptability study in secondary-level health facilities in Myanmar.

OBJECTIVE: To assess the feasibility and acceptability of misoprostol as a treatment option for incomplete abortion in secondary hospitals in Yangon and Mandalay, Myanmar. METHODS: An explanatory sequential mixed methods study was conducted. Women seeking treatment for an incomplete abortion with a uterine size <12 weeks were eligible to participate in the prospective cohort including sublingual administration of 400 µg misoprostol, clinical assessment 7-10 days after administration, and patient interview. Treatment efficacy was assessed, defined as proportion of participants with complete uterine evacuation with misoprostol alone. After the cohort, provider interviews were conducted to understand how their experiences with misoprostol may have influenced cohort findings. Study sites included seventeen secondary health facilities in four townships in Yangon and Mandalay, Myanmar. RESULTS: A total of 110 women were enrolled from July 2018 to January 2019; 96 completed follow-up. In 75 % of cases, incomplete abortion was successfully treated with misoprostol. Treatment efficacy varied significantly by region (Yangon 85 %, Mandalay 67 %; p = 0.048), driven by providers' variable comfort with misoprostol and proclivity to intervene with additional treatment. With experience, all were willing to incorporate the protocol into practice by study end. Patient acceptability and satisfaction were high. CONCLUSION: Misoprostol is an acceptable and feasible treatment option for women seeking postabortion care at secondary facilities in Myanmar. Extensive health provider training and support systems and continued implementation experience are crucial to effectively translate clinical PAC guidelines into practice in Myanmar.

Health care providers' perceptions of using misoprostol in the treatment of incomplete abortion in Malawi.

BACKGROUND: In Malawi, abortion is only legal to save a pregnant woman's life. Treatment for complications after unsafe abortions has a massive impact on the already impoverished health care system. Even though manual vacuum aspiration (MVA) and misoprostol are the recommended treatment options for incomplete abortion in the first trimester, surgical management using sharp curettage is still one of the primary treatment methods in Malawi. Misoprostol and MVA are safer and cheaper, whilst sharp curettage has more risk of complications such as perforation and bleeding and requires general anesthesia and a clinician. Currently, efforts are being made to increase the use of misoprostol in the treatment of incomplete abortions in Malawi. To achieve successful implementation of misoprostol, health care providers' perceptions on this matter are crucial. METHODS: A qualitative approach was used to explore health care providers' perceptions of misoprostol for the treatment of incomplete abortion using semi-structured in-depth interviews. Ten health care providers were interviewed at one urban public hospital. Each interview lasted 45 min on average. Health care providers of different cadres were interviewed in March and April 2021, nine months after taking part in a training intervention on the use of misoprostol. Interviews were recorded, transcribed verbatim and analyzed using 'Systematic Text Condensation'. RESULTS: The health care providers reported many advantages with the increased use of misoprostol, such as reduced workload, less hospitalization, fewer infections, and task-shifting. Availability of the drug and benefits for the patients were also highlighted as important. However, some challenges were revealed, such as deciding who was eligible for the drug and treatment failure. For these reasons, some health care providers still choose surgical treatment as their primary method. CONCLUSION: Findings in this study support the recommendation of increased use of misoprostol as a treatment for incomplete abortion in Malawi, as the health care providers interviewed see many advantages with the drug. To scale up its use, proper training and supervision are essential. A sustainable and predictable supply is needed to change clinical practice. Unsafe abortion is a major contributor to maternal mortality worldwide. Unsafe abortion is the termination of an unintended pregnancy by a person without the required skills or equipment, which might lead to serious complications. In Malawi, post-abortion complications are common, and the maternal mortality ratio is among the highest in the world. Retained products of conception, referred to as an incomplete abortion, are common after spontaneous miscarriages and unsafe induced abortions. There are several ways to treat incomplete abortion, and the drug misoprostol has been successful in the treatment of incomplete abortion in other low-income countries. This study explored perceptions among health care providers using misoprostol to treat incomplete abortions and whether the drug can be fully embraced by Malawian health care professionals. Health personnel at a Malawian hospital were interviewed individually regarding the use of the drug for treating incomplete abortions. This study revealed that health care providers interviewed are satisfied with the increased use of misoprostol. They highlighted several benefits, such as reduced workload and that it enabled task-shifting so that various hospital cadres could now treat patients with incomplete abortions. The health care workers also observed benefits for women treated with the drug compared to other treatments. The challenges mentioned were finding out who was eligible for the drug and drug failure. This study supports scaling up the use of misoprostol in the treatment of incomplete abortions in Malawi; the Ministry of Health and policymakers should support future interventions to increase its use.

Evaluating women's acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians: a mixed methods study.

BACKGROUND: Studies evaluating task sharing in postabortion care have mainly focused on women in first trimester and many lack a qualitative component. We aimed to evaluate patient acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians and also gained a deeper understanding of the patients' lived treatment experiences in Uganda. METHODS: Our mixed methods study combined 1140 structured interview data from a randomized controlled equivalence trial and in-depth interviews (n = 28) among women managed with misoprostol for second trimester incomplete abortion at 14 public health facilities in Uganda. Acceptability, our main outcome, was measured at the 14-day follow-up visit using a structured questionnaire as a composite variable of: 1) treatment experience (as expected/ better than expected/ worse than expected), and 2) satisfaction - if patient would recommend the treatment to a friend or choose the method again. We used generalized mixed effects models to obtain the risk difference in acceptable post abortion care between midwife and physician groups. We used inductive content analysis for qualitative data. RESULTS: From 14th August 2018 to 16th November 2021, we assessed 7190 women for eligibility and randomized 1191 (593 to midwife and 598 to physician). We successfully followed up 1140 women and 1071 (94%) found the treatment acceptable. The adjusted risk difference was 1.2% (95% CI, - 1.2 to 3.6%) between the two groups, and within our predefined equivalence range of - 5 to + 5%. Treatment success and feeling calm and safe after treatment enhanced acceptability while experience of side effects and worrying bleeding patterns reduced satisfaction. CONCLUSIONS: Misoprostol treatment of uncomplicated second trimester incomplete abortion was equally and highly acceptable to women when care was provided by midwives compared with physicians. In settings that lack adequate staffing levels of physicians or where midwives are available to provide misoprostol, task sharing second trimester medical PAC with midwives increases patient's access to postabortion care services. TRIAL REGISTRATION: ClinicalTrials.gov NCT03622073.

Approximately 9.6% of abortion-related deaths occur in Sub-Saharan Africa. These deaths can be prevented if unintended pregnancies are avoided, women can access safe abortions within the expectations of the country's laws, and post abortion care (PAC) services are provided equitably. Previous research shows that women with abortion complications in the first trimester of pregnancy can be treated with misoprostol by either midwives or physicians. This sharing of tasks between the midwives and physicians is safe, effective, and acceptable. However, there is a gap in evidence on task sharing in the second trimester. To check practicability of task sharing in second trimester, we aimed to evaluate patient acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians and also gained a deeper understanding of the patients' lived treatment experiences. Our study therefore combined quantitative and qualitative approaches. Women's acceptability of misoprostol treatment for incomplete second trimester abortion was found to be equally acceptable when provided by midwives compared with physicians. Treatment success, feeling calm and safe after treatment increased acceptability, while experience of side effects and worrying bleeding patterns reduced satisfaction. Counselling of women may address some of these problems since it provides reassurance and reduces anxiety. In settings that lack adequate staffing levels of physicians or where midwives are available to provide misoprostol, task sharing second trimester medical PAC with midwives increases patient's access to PAC services.

Efficacy of Qiancao () and Haipiaoxiao (), a traditional Chinese herb pair, on abnormal uterine bleeding in rats with incomplete abortion.

OBJECTIVE: To investigate the most effective weight ratio of Qiancao () and Haipiaoxiao () used to produce decoction for the treatment of abnormal uterine bleeding (AUB) in rats with incomplete abortion, and to study the possible mechanism. METHODS: The models of AUB were established by incomplete drug abortion with mifepristone and misoprostol in pregnant rats. The therapeutic effects of decoctions made by eight different weight ratios of Qiancao () and Haipiaoxiao () were observed. RESULTS: Statistical analysis revealed that the most effective weight ratio of Qiancao () and Haipiaoxiao () to treat AUB in this study was 2∶1. CONCLUSION: The insights gained from this study would improve understanding of the mechanisms involved in the effect of Qiancao () and Haipiaoxiao () on AUB.

Comparison of the effectiveness and safety of treatment of incomplete second trimester abortion with misoprostol provided by midwives and physicians: a randomised, controlled, equivalence trial in Uganda.

BACKGROUND: To address the knowledge gaps in the provision of post-abortion care by midwives for women in the second trimester, we investigated the effectiveness and safety of treatment for incomplete second trimester abortion with misoprostol, comparing care provision by midwives with that provided by physicians in Uganda. METHODS: Our multicentre, randomised, controlled, equivalence trial undertaken in 14 health facilities in Uganda recruited women with incomplete abortion of uterine size 13-18 weeks. We randomly assigned (1:1) women to clinical assessment and treatment by either midwife or physician. The randomisation sequence was computer generated, in blocks of four to 12, and stratified for study site. Participants received sublingual misoprostol (400 µg once every 3 h for up to five doses). The study was not concealed from the health-care providers and study participants. Primary outcome was complete abortion within 24 h that did not require surgical evacuation. Analysis was per-protocol and intention to treat; the intention-to-treat population consisted of women who were randomised, received at least one dose of misoprostol, and reported primary outcome data, and the per-protocol population excluded women with unexplained discontinuation of treatment. We used generalised mixed-effects models to obtain the risk difference. The predefined equivalence range was -5% to 5%. The trial was registered at ClinicalTrials.gov, NCT03622073. FINDINGS: Between Aug 14, 2018, and Nov 16, 2021, 1191 eligible women were randomly assigned to each group (593 women to the midwife group and 598 to the physician group). 1164 women were included in the per-protocol analysis, and 530 (92%) of 577 women in the midwife group and 553 (94%) of 587 women in the physician group had a complete abortion within 24 h. The model-based risk difference for the midwife versus physician group was -2·3% (95% CI -4·4 to -0·3), and within our predefined equivalence range (-5% to 5%). Two women in the midwife group received blood transfusion. INTERPRETATION: Clinical assessment and treatment of second trimester incomplete abortion with misoprostol provided by midwives was equally effective and safe as when provided by physicians. In low-income settings, inclusion of midwives in the medical management of uncomplicated second trimester incomplete abortion has potential to increase women's access to safe post-abortion care. FUNDING: Swedish Research Council and THRiVE-2.

Buxue Yimu Pills improve angiogenesis and blood flow in experimental zebrafish and rat models.

ETHNOPHARMACOLOGICAL RELEVANCE: Buxue Yimu Pills (BYP) is a well-known traditional Chinese medicine prescription which is clinical used in gynecology and obstetrics, and is documented to exhibit therapeutic potential to defective angiogenesis and impaired blood flow. AIM OF THE STUDY: This study aimed to investigate the effects and biological mechanisms of BYP in improvement of defective angiogenesis and impaired blood flow which represent major health issues associated with various diseases including postpartum or abortion complications. MATERIALS AND METHODS: In this study, VEGFR tyrosine kinase inhibitor II (VRI) was used to establish blood vessel loss model in Tg(fli-1a:EGFP) zebrafish embryos. Blood vessel loss was calculated, and quantitative real-time PCR (qRT-PCR) assay was performed to detect gene expression. Mifepristone and misoprostol were applied to construct a medical-induced incomplete abortion rats model. Whole blood viscosity indexes, hemorheology and coagulation function of the rats were investigated. Immunohistochemistry analysis was used for evaluation of the uterine tissues. RESULTS: BYP treatment significantly promoted angiogenesis as evidenced by the restoration of VRI-induced blood vessel loss in zebrafish embryos. BYP treatment effectively reversed VRI-induced down-regulation of the VEGFRs (Kdr, Kdrl and Flt1). Furthermore, BYP administration significantly suppressed the increase of whole blood viscosity indexes, and remarkably shortened the levels of prothrombin time and activated partial thromboplastin time in the medical-induced incomplete abortion rats, indicating the improvement of hemorheology and coagulation function. Immunohistochemistry analysis suggested that BYP administration increased the expression level of VEGFR2 in uterus tissues of the rats. CONCLUSION: BYP exhibits therapeutic effects in promoting angiogenesis and blood circulation, and mitigating blood stasis, supporting its clinical application for postpartum or abortion complications.

Medical management of induced and incomplete first-trimester abortion by non-physicians in low- and middle-income countries: A systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: Unsafe abortion is the cause of a substantial number of maternal mortalities and morbidities globally, but specifically in low- and middle-income countries. Medical abortion methods provided by non-physicians may be a way to reduce the burden of unsafe abortions. Currently, only one systematic review comparing non-physicians with physicians for medical abortion exists. However, the review does not have any setting restrictions and newer evidence has since been published. Therefore, this review aims to evaluate the effectiveness, acceptability, and safety of first-trimester abortion managed by non-physicians compared with physicians in low- and middle-income countries. MATERIAL AND METHODS: The databases PubMed, Cochrane Library, Global Health Library, and EMBASE were searched using a structured search strategy. Further, the trial registries clinicaltrials.gov and The International Clinical Trial Registry Platform were searched for published and unpublished trials. Randomized controlled trials comparing provision of medical abortion by non-physicians with that by physicians in low- or middle-income countries were included. Risk of bias was assessed using the Cochrane Risk of Bias tool. Trials that reported effect estimates on the effectiveness of medical methods on complete abortion were included in the meta-analysis. The protocol was prospectively registered in the PROSPERO database, ID: CRD42020176811. RESULTS: Six papers from four different randomized controlled trials with a total of 4021 participants were included. Two of the four included trials were assessed to have overall low risk of bias. Four papers had outcome data on complete abortion and were included in the meta-analyses. Medical management of first-trimester abortion and medical treatment of incomplete abortion were found to be equally effective when provided by a non-physician as when provided by a physician (risk ratio 1.00; 95% CI 0.99-1.01). Further, the treatment was equally safe, and women were equally satisfied when a non-physician provided the treatment compared with a physician. CONCLUSIONS: Provision of medical abortion or medical treatment for incomplete abortion in the first trimester is equally effective, safe, and acceptable when provided by non-physicians compared with physicians in low- and middle-income countries. We recommend that the task of providing medical abortion and medical treatment for incomplete abortion in low- and middle-income countries should be shared with non-physicians.

Misoprostol versus expectant management in women with incomplete first-trimester miscarriage after failed primary misoprostol treatment: A randomized clinical trial.

OBJECTIVE: To compare the effectiveness and safety of repeat misoprostol versus expectant management in women with first-trimester incomplete miscarriage who have been initially treated with misoprostol. METHODS: The study was an open-labeled randomized controlled trial including women with an incomplete first-trimester miscarriage after administration of misoprostol. The participants were randomly assigned to vaginal misoprostol or expectant management using a computer-generated table of random numbers. The primary outcome was the number of women with a complete miscarriage at 1 week. RESULTS: Eighty-eight women (44 women in each group) were analyzed. The rate of complete miscarriage at 1 week was significantly higher in the misoprostol group than the expectant management group-29 (69.0%) versus 7 (16.7%) (P < 0.001), respectively. Women in the misoprostol group were more satisfied (7.00 ± 0.77 vs 4.57 ± 1.61, P < 0.001) but reported more pain (7.95 ± 1.85 vs 5.26 ± 1.08, P < 0.001) than women in the expectant group. The misoprostol group reported more adverse effects than the expectant management group (P < 0.001). CONCLUSION: In women with an incomplete first-trimester miscarriage who were initially treated with misoprostol, repeat administration of misoprostol was more effective than expectant management for achieving complete miscarriage at 1 week. However, misoprostol was associated with more adverse effects. REGISTRATION SITE AND NUMBER: Clinicaltrials.gov: NCT03148561.

Misoprostol versus manual vacuum aspiration for treatment of first-trimester incomplete miscarriage in a low-resource setting: A randomized controlled trial.

BACKGROUND: Manual vacuum aspiration is a safe and effective technology for the treatment of incomplete miscarriage but it is not widely available and affordable in rural areas particularly in low-resource countries. Misoprostol is an alternative to manual vacuum aspiration for the treatment of incomplete miscarriage. AIM: To compare the effectiveness, client acceptability and satisfaction, and cost-effectiveness of misoprostol with manual vacuum aspiration for the treatment of the first-trimester incomplete miscarriage. SUBJECTS AND METHODS: This study was conducted between February 1, 2018 and August 31, 2018 at Alex Ekwueme Federal University Teaching Hospital Abakaliki, Nigeria. 100 participants were randomized to treatment with either manual vacuum aspiration or 600 µg oral misoprostol. The main outcome measures assessed at 1-week follow-up were complete uterine evacuation, client acceptability and satisfaction, and cost-effectiveness. Data were analyzed using SPSS version 25. Sociodemographic characteristics, treatment outcomes and other variables were summarized by descriptive statistics. Chi-square test was used for comparison between groups as regard categorical data while Student's't' test was used for comparison between groups for continuous data. P value of <0.05 was regarded as statistically significant. RESULTS: There was a higher failure rate in the misoprostol arm when compared with MVA. Although this difference in complete uterine evacuation rate did not reach statistical significance (81.3% versus 95.7%, RR = 4.3, 95% CI 0.98-18.9, P value = 0.05), more participants in the misoprostol arm would choose the method again when compared with women in the MVA group (47 versus 30, X[2] = 16.95, P < 0.001). The mean client satisfaction score was significantly higher among women in the misoprostol arm compared to MVA group (13.2 (2.1) versus 7.3 (4.6), P < 0.001). The mean cost of primary treatment was higher in the MVA group compared with misoprostol arm ($67.8 (8.9) versus 14.4 (4.0), P < 0.001). There was no significant difference in the mean cost of repeat uterine evacuation in both study arms (MVA, $64.9 (6.3) versus misoprostol, $65.76 (6.6), P = 0.86). CONCLUSION: Although medical treatment was associated with a higher failure rate, there was no statistically significant difference in the effectiveness of both treatment methods. However, medical treatment was associated with higher client acceptance and satisfaction and was more cost-effective than surgical treatment.

Efficacy and safety of myrrh in patients with incomplete abortion: a randomized, double-blind, placebo-controlled clinical study.

BACKGROUND: Myrrh (Commiphora myrrha (Nees) Engl.) has a long history of traditional use as a herbal medicine for different purposes. In ancient traditional Persian manuscripts, it has been noted that myrrh may act as uterine stimulant and probably cause complete abortion. However, there is no evidence to verify this comment. Therefore, the current study was carried out to evaluate the efficacy and safety of Myrrh in the treatment of incomplete abortion. MATERIALS AND METHODS: In a randomized double-blinded placebo controlled clinical trial, 80 patients with ultrasound-documented retained products of conception (RPOC) were assigned to receive capsules containing 500 mg of Myrrh oleo-gum-resin or a placebo three times a day for 2 weeks. The existence of the retained tissue and its size were evaluated by ultrasound examination at the beginning and end of the study. RESULTS: After 2 weeks, the mean diameter of the RPOC in the Myrrh group was significantly reduced compared with the placebo group (P < 0.001). Meanwhile, the rate of successful complete abortion was 82.9% in the intervention group and 54.3% in the placebo group (P = 0.01). The patients in both groups reported no serious drug-related adverse effects. CONCLUSION: This study shows that Myrrh is effective and safe in the resolution of the RPOC and may be considered as an alternative option for treatment of patients with incomplete abortion. However, further studies on active compounds isolated from myrrh and their uterine stimulant effects are needed. TRIAL REGISTRATION: This study was retrospectively registered at Iranian Registry of Clinical Trials (www.irct.ir) IRCT code: IRCT20140317017034N7.

Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: study protocol for a randomized double blinded placebo-controlled comparison (Triple M Trial).

BACKGROUND: Early pregnancy failure (EPF) is a common complication of pregnancy. If women do not abort spontaneously, they will undergo medical or surgical treatment in order to remove the products of conception from the uterus. Curettage, although highly effective, is associated with a risk of complications; medical treatment with misoprostol is a safe and less expensive alternative. Unfortunately, after 1 week of expectant management in case of EPF, medical treatment with misoprostol has a complete evacuation rate of approximately 50%. Misoprostol treatment results may be improved by pre-treatment with mifepristone; its effectiveness has already been proven for other indications of pregnancy termination. This study will test the hypothesis that, in EPF, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). METHODS: The trial will be performed multi-centred, prospectively, two-armed, randomised, double-blinded and placebo-controlled. Women with confirmed EPF by ultrasonography (6-14 weeks), managed expectantly for at least 1 week, can be included and randomised to pre-treatment with oral mifepristone (600 mg) or oral placebo (identical in appearance). Randomisation will take place after receiving written consent to participate. In both arms pre-treatment will be followed by oral misoprostol, which will start 36-48 h later consisting of two doses 400 µg (4 hrs apart), repeated after 24 h if no tissue is lost. Four hundred sixty-four women will be randomised in a 1:1 ratio, stratified by centre. Ultrasonography 2 weeks after treatment will determine short term treatment effect. When the gestational sac is expulsed, expectant management is advised until 6 weeks after treatment when the definitive primary endpoint, complete or incomplete evacuation, will be determined. A sonographic endometrial thickness < 15 mm using only the allocated therapy by randomisation is considered as successful treatment. Secondary outcome measures (patient satisfaction, complications, side effects and costs) will be registered using a case report form, patient diary and validated questionnaires (Short Form 36, EuroQol-VAS, Client Satisfaction Questionnaire, iMTA Productivity Cost Questionnaire). DISCUSSION: This trial will answer the question if, in case of EPF, after at least 1 week of expectant management, sequential treatment with mifepristone and misoprostol is more effective than misoprostol alone to achieve complete evacuation of the products of conception. TRIAL REGISTRATION: Clinicaltrials.gov (d.d. 02-07-2017): NCT03212352. Trialregister.nl (d.d. 03-07-2017): NTR6550. EudraCT number (d.d. 07-08-2017): 2017-002694-19. File number Commisie Mensgebonden Onderzoek (d.d. 07-08-2017): NL 62449.091.17.

Voluntary Contraceptive Uptake Among Postabortion Care Clients Treated With Misoprostol in Rwanda.

INTRODUCTION: Unsafe abortion remains a problem in Rwanda, where abortion is highly restricted by law. To reduce mortality and morbidity from unsafe abortion, Rwanda implemented a national postabortion care (PAC) program in 2012, which included using misoprostol to treat incomplete abortion. Key components of PAC are offering and providing voluntary contraceptive methods and counseling on their use, but little is known about contraceptive uptake among PAC clients treated with misoprostol. The objectives of the current study were (1) to assess the contraceptive uptake of PAC clients treated with misoprostol, including whether extended bleeding hinders uptake; and (2) to assess providers' knowledge of contraception and their willingness to counsel PAC clients on contraception, provide methods, or refer for contraceptive services. METHODS: We surveyed 68 PAC clients treated with misoprostol and 43 providers (84% nurses) in 17 health facilities across 3 districts in Rwanda where misoprostol for PAC had been introduced recently. PAC clients were recruited into the study prior to facility discharge and surveyed between 10 days and 1 month after discharge. We asked PAC clients and providers about demographic characteristics and attitudes toward contraception. We also asked PAC clients about contraceptive counseling received and postabortion contraceptive uptake or reasons for nonuse, and providers about their knowledge about return to fertility, pregnancy and contraceptive counseling, practices related to contraceptive method provision, and their knowledge and potential biases about PAC clients using contraception. We used descriptive statistics for analysis. RESULTS: PAC clients were 19-46 years old, and most (69%) had at least 1 child. Almost all PAC clients (94%) reported being counseled on contraception, but only 47% reported choosing and receiving a method before being discharged from the facility. Nevertheless, by the time of the survey, 71% reported using a method. PAC clients' main reason for not using contraception was wanting to become pregnant. Only 1 woman reported nonuse because of bleeding. Among providers, more than half (56%) reported there are contraceptive methods PAC clients should never use and about a quarter (26%) reported incorrect information on when PAC clients' fertility could return. CONCLUSION: We found no evidence that bleeding associated with misoprostol for PAC influenced women's contraceptive uptake. However, as PAC programs expand to include misoprostol as a treatment option, accurate and high-quality postabortion contraception counseling and method provision at both treatment and follow-up visits must be strengthened.

Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial.

BACKGROUND: A large proportion of abortion-related mortality and morbidity occurs in the second trimester of pregnancy. The Uganda Ministry of Health policy restricts management of second-trimester incomplete abortion to physicians who are few and unequally distributed, with most practicing in urban regions. Unsafe and outdated methods like sharp curettage are frequently used. Medical management of second-trimester post-abortion care by midwives offers an advantage given the difficulty in providing surgical management in low-income settings and current health worker shortages. The study aims to assess the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians. METHODS: A randomized controlled equivalence trial implemented at eight hospitals and health centers in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size > 12 weeks up to 18 weeks. Each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or a physician (control arm). Enrolled participants will receive 400 µg misoprostol administered sublingually every 3 h up to five doses within 24 h at the health facility until a complete abortion is confirmed. Women who do not achieve complete abortion within 24 h will undergo surgical uterine evacuation. Pre discharge, participants will receive contraceptive counseling and information on what to expect in terms of side effects and signs of complications, with follow-up 14 days later to assess secondary outcomes. Analyses will be by intention to treat. Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% confidence interval) and equivalence established if this lies between the predefined range of - 5% and + 5%. Chi-square tests will be used for comparison of outcome and t tests used to compare mean values. P ≤ 0.05 will be considered statistically significant. DISCUSSION: Our study will provide evidence to inform national and international policies, standard care guidelines and training program curricula on treatment of second-trimester incomplete abortion for improved access. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03622073 . Registered on 9 August 2018.

Protective Effect of Taohong Siwu Decoction on Abnormal Uterine Bleeding Induced by Incomplete Medical Abortion in Rats during Early Pregnancy.

Abnormal uterine bleeding (AUB) induced by incomplete abortion is a common gynecological disease. Taohong Siwu decoction (TSD) is a traditional Chinese medicine (TCM) formula, which has been developed to treat AUB for hundreds of years. In this study, rats had incomplete abortion induced in early pregnancy using mifepristone and misoprostol. The duration and quantity of uterine bleeding were recorded and measured. The pathologic histologic grade was evaluated by hematoxylin-eosin staining (HE). Estradiol (E2) and progesterone (P) levels were measured by enzyme linked immunosorbent assays (ELISA). The expression levels of estrogen receptor alpha (ERα) and progesterone receptor (PR) were detected by immunohistochemistry and Western blotting analysis. We demonstrated that TSD significantly reduced the duration and quantity of uterine bleeding. Meanwhile, TSD promoted endometrial repair and significantly up-regulated the E2 levels and the ERα expression. These results suggest that TSD have a protective effect on the uteri; the mechanism may be concerned with up-regulation of the levels of E2 and the ERα expression.