RESUMO
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.
Assuntos
Abortivos não Esteroides , Aborto Incompleto , Aborto Induzido , Aborto Espontâneo , Misoprostol , Gravidez , Feminino , Humanos , Misoprostol/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Aborto Incompleto/cirurgia , Abortivos não Esteroides/uso terapêutico , Estudos Transversais , Malaui , Aborto Induzido/métodosRESUMO
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.
Assuntos
Abortivos não Esteroides , Aborto Incompleto , Aborto Induzido , Aborto Espontâneo , Misoprostol , Gravidez , Humanos , Feminino , Aborto Espontâneo/tratamento farmacológico , Aborto Incompleto/tratamento farmacológico , Aborto Incompleto/cirurgia , Misoprostol/uso terapêutico , Abortivos não Esteroides/uso terapêutico , Estudos Prospectivos , Estudos Retrospectivos , Preparações FarmacêuticasRESUMO
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.
Assuntos
Abortivos não Esteroides , Aborto Incompleto , Aborto Induzido , Tocologia , Misoprostol , Médicos , Gravidez , Humanos , Feminino , Misoprostol/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Abortivos não Esteroides/uso terapêutico , Segundo Trimestre da Gravidez , Primeiro Trimestre da GravidezRESUMO
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.
Assuntos
Aborto Incompleto , Aborto Induzido , Aborto Espontâneo , Misoprostol , Gravidez , Humanos , Feminino , Aborto Incompleto/tratamento farmacológico , Misoprostol/uso terapêutico , Malaui , Aborto Induzido/efeitos adversos , Pessoal de Saúde , Hospitais PúblicosRESUMO
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.
Assuntos
Aborto Incompleto/tratamento farmacológico , Pessoal Técnico de Saúde , Abortivos/uso terapêutico , Países em Desenvolvimento , Feminino , Humanos , Gravidez , Primeiro Trimestre da Gravidez , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
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.
Assuntos
Abortivos não Esteroides/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Aborto Incompleto/cirurgia , Misoprostol/uso terapêutico , Curetagem a Vácuo/métodos , Abortivos não Esteroides/administração & dosagem , Administração Oral , Adulto , Feminino , Humanos , Misoprostol/administração & dosagem , Nigéria , Satisfação do Paciente , Gravidez , Primeiro Trimestre da Gravidez , Resultado do TratamentoRESUMO
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.
Assuntos
Abortivos não Esteroides/uso terapêutico , Abortivos Esteroides/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Mifepristona/uso terapêutico , Misoprostol/uso terapêutico , Abortivos não Esteroides/administração & dosagem , Abortivos Esteroides/administração & dosagem , Aborto Incompleto/diagnóstico por imagem , Adolescente , Adulto , Análise Custo-Benefício , Método Duplo-Cego , Quimioterapia Combinada/efeitos adversos , Feminino , Humanos , Mifepristona/administração & dosagem , Misoprostol/efeitos adversos , Estudos Multicêntricos como Assunto , Satisfação do Paciente , Gravidez , Primeiro Trimestre da Gravidez , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Ultrassonografia , Conduta Expectante , Adulto JovemRESUMO
OBJECTIVE: To compare vaginal misoprostol treatment with expectant management in early non-viable pregnancy with vaginal bleeding with regard to complete evacuation of the uterine cavity within 10 days after randomization. METHODS: This was a parallel randomized controlled, open-label trial conducted in Skåne University Hospital, Sweden. Patients with anembryonic pregnancy or early fetal demise (crown-rump length ≤ 33 mm) and vaginal bleeding were randomly allocated to either expectant management or treatment with a single dose of 800 µg misoprostol administered vaginally. Patients were evaluated clinically and by ultrasound until complete evacuation of the uterus was achieved (no gestational sac in the uterine cavity and maximum anteroposterior diameter of the intracavitary contents < 15 mm as measured by transvaginal ultrasound on midsagittal view). Follow-up visits were planned at 10, 17, 24 and 31 days. Dilatation and evacuation (D&E) was recommended if miscarriage was not complete within 31 days, but was performed earlier at patient's request, or if there was excessive bleeding as judged clinically. Analysis was by intention to treat. The main outcome measure was number of patients with complete miscarriage without D&E ≤ 10 days. RESULTS: Ninety-four patients were randomized to misoprostol treatment and 95 to expectant management. After exclusion of three patients and withdrawal of consent by two patients in the expectant management group, 90 women were included in this group. Miscarriage was complete ≤ 10 days in 62/94 (66%) of the patients in the misoprostol group and in 39/90 (43%) of those in the group managed expectantly (risk difference (RD) = 23%; 95% CI, 8-37%). At 31 days, the corresponding figures were 81/94 (86%) and 55/90 (61%) (RD = 25%; 95% CI, 12-38%). Two patients from each group underwent emergency D&E because of excessive bleeding and one of these in each group received blood transfusion. The number of patients undergoing D&E at their own request was higher in the expectantly managed group, 15/90 (17%) vs 3/94 (3%) in the misoprostol group (RD = 14%; 95% CI, 4-23%), as was the number of patients making out-of-protocol visits, 50/90 (56%) vs 27/94 (29%) (RD = 27%; 95% CI, 12-40%). Compared with the expectant management group, more patients in the misoprostol group experienced pain (71/77 (92%) vs 91/91 (100%); RD = 8%; 95% CI, 1-17%) and used painkillers (59/77 (77%) vs 85/91 (93%); RD = 17%; 95% CI, 5-29%). No major side effect was reported in any group. CONCLUSIONS: In women with early non-viable pregnancy and vaginal bleeding, misoprostol treatment is more effective than is expectant management for complete evacuation of the uterus. Both methods are safe but misoprostol treatment is associated with more pain than is expectant management. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.
Assuntos
Abortivos não Esteroides , Aborto Incompleto/tratamento farmacológico , Aborto Espontâneo/tratamento farmacológico , Tratamento Conservador , Misoprostol , Abortivos não Esteroides/uso terapêutico , Aborto Incompleto/cirurgia , Aborto Espontâneo/cirurgia , Adulto , Dilatação e Curetagem/métodos , Feminino , Seguimentos , Humanos , Misoprostol/uso terapêutico , Gravidez , Primeiro Trimestre da Gravidez , Suécia , Resultado do Tratamento , Hemorragia UterinaRESUMO
Many Patients with persistent retained products of conception prefers to avoid surgical interventions, such as a dilatation and curettage (D&C) that might pose an additional future risk to their already compromised fertility or obstetric performance. The aim of this study was to the possibility of induced withdrawal bleeding following oral contraceptive administration as a non-surgical treatment for patients with persistent retained products of conception (RPOC). A retrospective study of patients presenting with retained products of conception (RPOC) after failed expectant management or after treatment with PGE1 was performed. Twelve women presenting with RPOC at ≤8 weeks gestation with minimal to mild vaginal bleeding and no signs of infection were treated with oral contraceptive pill (OCP) containing 0.03 mg ethinylestradiol and 0.15 mg of desogestrel for 3 weeks. Out of the 12 patients treated, nine women (75%) successfully expelled the RPOC after completing the three-week course of OCPs. The three cases (25%) that did not resolve following OCP treatment had pregnancy products with positive blood flow on Doppler examination. We conclude that OCPs may be a useful medical treatment option for persisting RPOC in selected patients with absence blood flow on Doppler examination wishing to avoid surgical intervention.
Assuntos
Aborto Incompleto/tratamento farmacológico , Comportamento de Escolha , Anticoncepcionais Orais Combinados/uso terapêutico , Desogestrel/uso terapêutico , Etinilestradiol/uso terapêutico , Aborto Incompleto/epidemiologia , Aborto Incompleto/etiologia , Aborto Induzido/efeitos adversos , Aborto Induzido/métodos , Aborto Induzido/estatística & dados numéricos , Aborto Espontâneo/tratamento farmacológico , Aborto Espontâneo/cirurgia , Adulto , Dilatação e Curetagem , Feminino , Humanos , Misoprostol/uso terapêutico , Projetos Piloto , Gravidez , Primeiro Trimestre da Gravidez , Estudos Retrospectivos , Comprimidos , Falha de Tratamento , Hemorragia Uterina/tratamento farmacológico , Hemorragia Uterina/epidemiologia , Hemorragia Uterina/etiologia , Hemorragia Uterina/cirurgiaRESUMO
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.
Assuntos
Aborto Incompleto/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Hemorragia Uterina/tratamento farmacológico , Hemorragia Uterina/etiologia , Aborto Induzido/efeitos adversos , Animais , Medicamentos de Ervas Chinesas/administração & dosagem , Feminino , Gravidez , Ratos , Ratos Sprague-DawleyRESUMO
STUDY QUESTION: Does repeat administration of misoprostol for early pregnancy loss increase the treatment success rate? SUMMARY ANSWER: Repeat administration of misoprostol does not increase the treatment success rate, and is associated with more analgesics use. WHAT IS KNOWN ALREADY: Misoprostol reduces the need for surgical evacuation and shortens the time to complete expulsion in patients with early pregnancy loss. However, the impact of repeat doses of misoprostol is not clear. STUDY DESIGN, SIZE, DURATION: A randomized clinical trial was conducted in a single tertiary hospital, recruiting women with early pregnancy loss (<12 weeks), seeking medical treatment, between August 2015 and June 2016. A sample size of 160 patients was sufficient to detect a 30% decrease in treatment success. PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants received 800 µg of misoprostol vaginally on Day 1, and were then randomly assigned into two groups: Patients in the single-dose group were evaluated on Day 8. Patients in the repeat-dose group were evaluated on Day 4, when they were given a repeat dose if required, and scheduled for re-evaluation on Day 8. If complete expulsion was not achieved on Day 8 (endometrial thickness >15 mm or the presence of gestational sac on transvaginal sonography), participants underwent surgical evacuation. The primary outcome was treatment success, defined as no need for surgical intervention up to Day 8. MAIN RESULTS AND THE ROLE OF CHANCE: Final analysis included 87 participants in the single-dose group and 84 participants in the repeat-dose group, out of whom 41 (48.8%) received a second dose. Treatment succeeded in 67 (77%) patients in the single-dose group and 64 (76%) patients in the repeat-dose group (RR 0.98; 95% CI 0.83-1.16; P = 0.89). Patients in the repeat-dose group reported more use of over the counter analgesics (82.1% versus 69.0%, P = 0.04). LIMITATIONS, REASONS FOR CAUTION: The study was not blinded and our definition of complete expulsion may be debated. Follow-up time was not equal in all participants, since some had a complete expulsion on Day 4 and some underwent emergent D&C before Day 8. This, however, should not affect the primary outcome. WIDER IMPLICATIONS OF THE FINDINGS: Our results suggest that a single-dose protocol is superior to a repeat-dose protocol due to a comparable success rate and more favorable outcomes regarding the need for analgesic drugs. STUDY FUNDING/COMPETING INTEREST(S): We did not receive funding for this study and we declare no conflict of interest. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT02515604). TRIAL REGISTRATION DATE: 2 August 2015. DATE OF FIRST PATIENT'S ENROLMENT: 19 August 2015.
Assuntos
Aborto Incompleto/tratamento farmacológico , Aborto Espontâneo/fisiopatologia , Perda do Embrião/fisiopatologia , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Dor Abdominal/tratamento farmacológico , Dor Abdominal/etiologia , Aborto Incompleto/diagnóstico por imagem , Aborto Incompleto/etiologia , Aborto Incompleto/cirurgia , Centros Médicos Acadêmicos , Adulto , Analgésicos/administração & dosagem , Analgésicos/uso terapêutico , Terapia Combinada/efeitos adversos , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Análise de Intenção de Tratamento , Israel , Perda de Seguimento , Misoprostol/efeitos adversos , Misoprostol/uso terapêutico , Ocitócicos/efeitos adversos , Ocitócicos/uso terapêutico , Pacientes Desistentes do Tratamento , Gravidez , Centros de Atenção Terciária , Ultrassonografia , Curetagem a Vácuo/efeitos adversosRESUMO
BACKGROUND: Misoprostol is established for the treatment of incomplete abortion but has not been systematically assessed when provided by midwives at district level in a low-resource setting. We investigated the effectiveness and safety of midwives diagnosing and treating incomplete abortion with misoprostol, compared with physicians. METHODS: We did a multicentre randomised controlled equivalence trial at district level at six facilities in Uganda. Eligibility criteria were women with signs of incomplete abortion. We randomly allocated women with first-trimester incomplete abortion to clinical assessment and treatment with misoprostol either by a physician or a midwife. The randomisation (1:1) was done in blocks of 12 and was stratified for study site. Primary outcome was complete abortion not needing surgical intervention within 14-28 days after initial treatment. The study was not masked. Analysis of the primary outcome was done on the per-protocol population with a generalised linear-mixed effects model. The predefined equivalence range was -4% to 4%. The trial was registered at ClinicalTrials.gov, number NCT01844024. FINDINGS: From April 30, 2013, to July 21, 2014, 1108 women were assessed for eligibility. 1010 women were randomly assigned to each group (506 to midwife group and 504 to physician group). 955 women (472 in the midwife group and 483 in the physician group) were included in the per-protocol analysis. 452 (95·8%) of women in the midwife group had complete abortion and 467 (96·7%) in the physician group. The model-based risk difference for midwife versus physician group was -0·8% (95% CI -2·9 to 1·4), falling within the predefined equivalence range (-4% to 4%). The overall proportion of women with incomplete abortion was 3·8% (36/955), similarly distributed between the two groups (4·2% [20/472] in the midwife group, 3·3% [16/483] in the physician group). No serious adverse events were recorded. INTERPRETATION: Diagnosis and treatment of incomplete abortion with misoprostol by midwives is equally safe and effective as when provided by physicians, in a low-resource setting. Scaling up midwives' involvement in treatment of incomplete abortion with misoprostol at district level would increase access to safe post-abortion care. FUNDING: The Swedish Research Council, Karolinska Institutet, and Dalarna University.
Assuntos
Abortivos não Esteroides/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Tocologia/estatística & dados numéricos , Misoprostol/uso terapêutico , Médicos/estatística & dados numéricos , Aborto Incompleto/diagnóstico , Adolescente , Adulto , Países em Desenvolvimento , Feminino , Humanos , Pessoa de Meia-Idade , Gravidez , Primeiro Trimestre da Gravidez , Uganda , Curetagem a Vácuo , Adulto JovemRESUMO
BACKGROUND: Study objective To assess the efficacy of outpatient misoprostol administration versus inpatient misoprostol administration for the treatment of first trimester incomplete miscarriage. MATERIALS AND METHODS: A prospective randomised controlled trial was conducted at a tertiary hospital from May 2012 to April 2013. A total of 154 patients with first trimester incomplete miscarriage were randomised to receive misoprostol either as outpatient or inpatient. Intra-vaginal misoprostol 800 mcg was administered eight hourly to a maximum of three doses. Complete evacuation is achieved when the cervical os was closed on vaginal examination or ultrasound showed no more retained products of conception evidenced by endometrial thickness of less than 15 mm. Treatment failure was defined as failure in achieving complete evacuation on day seven hence surgical evacuation is offered. RESULTS: Outpatient administration of misoprostol was as effective as inpatient treatment with success rate of 89.2 and 85.7 % (p = 0.520). The side effects were not significantly different between the two groups. Side effects that occurred were minor and only required symptomatic treatment. Duration of bleeding was 6.0 days in both groups (p = 0.317). Mean reduction in haemoglobin was lesser in the outpatient group (0.4 g/dl) as compared to in the inpatient group (0.6 g/dl) which was statistically significant (p = 0.048). CONCLUSION: Medical evacuation using intra-vaginal misoprostol 800 mcg eight hourly for a maximum of three doses in an outpatient setting is as effective as in inpatient setting with tolerable side effects.
Assuntos
Abortivos não Esteroides/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Misoprostol/uso terapêutico , Abortivos não Esteroides/administração & dosagem , Abortivos não Esteroides/efeitos adversos , Aborto Induzido/métodos , Administração Intravaginal , Adulto , Assistência Ambulatorial/métodos , Colo do Útero , Feminino , Humanos , Pacientes Internados , Misoprostol/administração & dosagem , Misoprostol/efeitos adversos , Pacientes Ambulatoriais , Gravidez , Primeiro Trimestre da Gravidez , Estudos ProspectivosRESUMO
The purpose of this study was to examine the effectiveness, side-effects and acceptability of a single dose of oral misoprostol 600 µg for treatment of 1st trimester pregnancy failure. A prospective descriptive study was conducted on pregnant women of < 13 weeks' gestation, diagnosed as 1st trimester pregnancy failure. Patients were assigned to receive a single dose of misoprostol 600 µg orally and then evaluated 48 h after drug administration for complete abortion. A total of 55 women were recruited to the study. The complete abortion rate was 65.5%. Pain and diarrhoea were the most common side-effects. Acceptability and satisfactory rates were 70.9% and 70.9%, respectively. In conclusion, a single dose of oral misoprostol 600 µg is a fair method for the management of 1st trimester pregnancy failure. Side-effects are tolerable and satisfaction is high. Thus, this method may be used as an alternative treatment.
Assuntos
Abortivos não Esteroides/administração & dosagem , Aborto Incompleto/tratamento farmacológico , Misoprostol/administração & dosagem , Abortivos não Esteroides/efeitos adversos , Adulto , Feminino , Humanos , Misoprostol/efeitos adversos , Satisfação do Paciente/estatística & dados numéricos , Gravidez , Primeiro Trimestre da Gravidez , Estudos ProspectivosRESUMO
BACKGROUND: Complications following spontaneous or induced abortion are a major cause of maternal morbidity. To manage these complications, post-abortion care (PAC) services should be readily available and easy to access. Standard PAC treatment includes surgical interventions that are highly effective but require surgical providers and medical centers that have the necessary space and equipment. Misoprostol has been shown to be an effective alternative to surgical evacuation and can be offered by lower level clinicians. This study sought to assess whether 400 mcg sublingual misoprostol could effectively evacuate the uterus after incomplete abortion and to confirm its applicability for use at lower level settings. METHODS: All women presenting with incomplete abortion at one of three hospitals in Vietnam were enrolled. Providers were not asked to record if the abortion was spontaneous or induced. It is likely that all were spontaneous given the legal status and easy access to abortion services in Vietnam. Participants were given 400 mcg sublingual misoprostol and instructed to hold the pills under their tongue for 30 minutes and then swallow any remaining fragments. They were then asked to return one week later to confirm their clinical status. Study clinicians were instructed to confirm a complete expulsion clinically. All women were asked to complete a questionnaire regarding satisfaction with the treatment. RESULTS: Three hundred and two women were enrolled between September 2009 and May 2010. Almost all participants (96.3%) had successful completions using a single dose of 400 mcg misoprostol. The majority of women (87.2%) found the side effects to be tolerable or easily tolerable. Most women (84.3%) were satisfied or very satisfied with the treatment they received; only one was dissatisfied (0.3%). Nine out of ten women would select this method again and recommend it to a friend (91.0% and 90.0%, respectively). CONCLUSIONS: This study confirms that 400 mcg sublingual misoprostol effectively evacuates the uterus for most women experiencing incomplete abortion. The high levels of satisfaction and side effect tolerability also attest to the ease of use of this method. From these data and given the international consensus around the effectiveness of misoprostol for incomplete abortion care, it seems timely that use of the drug for this indication be widely expanded both throughout Vietnam and wherever access to abortion care is limited. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00670761.
Assuntos
Abortivos não Esteroides/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Misoprostol/uso terapêutico , Papel do Médico , Aborto Incompleto/diagnóstico por imagem , Administração Sublingual , Adolescente , Adulto , Feminino , Administração Hospitalar , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Inquéritos e Questionários , Ultrassonografia , Vietnã , Adulto JovemRESUMO
OBJECTIVE: To observe the effect of Taohong Siwu decoction (THSWD) on micro-vascular density (MVD) in rat uterus, the content of angiopoietin-1 (Ang-1) and angiopoietin-2 (Ang-2) in serum, and the expression of tyrosine kinasa receptor (Tie-2) in uterus. METHOD: Early pregnancy rats were intragastrically administrated with misoprostol (100 microg x kg(-1)) and mifepristong (8.3 mg x kg(-1)) to established the incomplete-abortion model. The incomplete-abortion rats were randomly divided into the model group (the same volume of distilled water), the positive control group (at the daily dose of 4.3 g x kg(-1) Motherwort Particles), and THSWD-treated groups (at the daily dose of 18.0, 9.0 and 4.5 g x kg(-1)). Pregnant rats were taken as the control group (the same volume of distilled water). After the successive oral administration for 7 days, blood was collected from aorta abdominalis, and rat uterine tissues were collected. The content of serum Ang-1 and Ang-2 were detected by ELISA; And the levels of Tie-2 and MVD in uterine tissues were detected by SP immunohistochemistry. RESULT: THSWD remarkably increased the levels of MVD in uterus of medicine-induced abortion rats, the content of Ang-1 and Ang-2 in serum, and the expression of Tie-2 in uterine tissues. CONCLUSION: THSWD has the effect in markedly promoting angiogenesis in incomplete-abortion rats. Its mechanism may be related to the regulation of concentrations of Ang-1 and Ang-2 in serum and Tie-2 in uterine tissues.
Assuntos
Aborto Incompleto/tratamento farmacológico , Aborto Incompleto/genética , Angiopoietina-1/genética , Angiopoietina-2/genética , Medicamentos de Ervas Chinesas/uso terapêutico , Receptor TIE-2/genética , Útero/irrigação sanguínea , Aborto Incompleto/sangue , Angiopoietina-1/sangue , Angiopoietina-2/sangue , Animais , Feminino , Expressão Gênica/efeitos dos fármacos , Humanos , Gravidez , Ratos , Ratos Sprague-Dawley , Receptor TIE-2/metabolismo , Útero/efeitos dos fármacos , Útero/metabolismoRESUMO
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.
Assuntos
Abortivos não Esteroides , Aborto Incompleto , Aborto Induzido , Misoprostol , Gravidez , Feminino , Humanos , Misoprostol/uso terapêutico , Aborto Incompleto/tratamento farmacológico , Abortivos não Esteroides/uso terapêutico , Estudos Prospectivos , Estudos de Viabilidade , Mianmar , Satisfação do Paciente , Aborto Induzido/métodos , Instalações de SaúdeRESUMO
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.