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1.
Contraception ; 103(5): 291-304, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33548267

RESUMO

BACKGROUND: Immediate contraceptive initiation, including start of a method before abortion completion, is a convenient option for women seeking abortion care. OBJECTIVES: To evaluate the effect of systemic hormonal contraception initiation on medical abortion effectiveness and the safety of hormonal contraceptive methods following abortion. DATA SOURCES: PubMed, Popline, Cochrane Library, and Clinicaltrials.gov. STUDY ELIGIBILITY CRITERIA: Studies that assessed medical abortion effectiveness after systemic hormonal contraception initiation and the safety of hormonal contraception initiation after abortion. PARTICIPANTS: Pregnant persons undergoing or who had recently undergone an abortion. INTERVENTIONS: Initiation of systemic hormonal contraception post abortion or on the day of the first pill of the medical abortion. STUDY APPRAISAL AND SYNTHESIS METHODS: We assessed study quality using the US Preventive Services Task Force evidence grading system. We created narrative summaries and calculated pooled relative risks when appropriate. RESULTS: We identified 16 studies for inclusion, 7 randomized controlled trials, and 9 cohorts. Nine studies assessed medical abortion effectiveness with hormonal contraception initiation and generally found no decreased risk of abortion success or increased risk of additional treatment. One fair-quality study reported a small increase in ongoing pregnancy rate with immediate depot medroxyprogesterone (DMPA) compared with delayed DMPA initiation (3.6% vs 0.9%, risk difference 2.7%, 90% confidence interval 0.4-5.6). We identified no bleeding-related safety concerns following hormonal contraception initiation after medical or surgical abortion. Pooled results were too imprecise to draw firm conclusions. LIMITATIONS: Included studies were poor or fair quality and primarily in high-income or upper-middle-income settings. CONCLUSIONS: Abortion effectiveness did not differ between immediate vs delayed initiation of most systemic hormonal contraceptive methods after a first trimester medical abortion. However, immediate DMPA initiation did show increased ongoing pregnancy. Bleeding effects with hormonal contraception initiation postabortion appeared minimal. IMPLICATIONS: Initiating a hormonal contraceptive method after an abortion and as early as the same day as the first pill of the medical abortion is an option if contraception is desired. The slight increase in ongoing pregnancy with immediate DMPA initiation highlights the importance of information provision during contraceptive counseling.

2.
BMJ Glob Health ; 6(1)2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33514590

RESUMO

INTRODUCTION: Complications due to unsafe abortions are an important cause of morbidity and mortality in many sub-Saharan African countries. We aimed to characterise abortion-related complication severity, describe their management, and to report women's experience of abortion care in Africa. METHODS: A cross-sectional study was implemented in 210 health facilities across 11 sub-Saharan African countries. Data were collected on women's characteristics, clinical information and women's experience of abortion care (using the audio computer-assisted self-interviewing (ACASI) system). Severity of abortion complications were organised in five hierarchical mutually exclusive categories based on indicators present at assessment. Descriptive bivariate analysis was performed for women's characteristics, management of complications and reported experiences of abortion care by severity. Generalised linear estimation models were used to assess the association between women's characteristics and severity of complications. RESULTS: There were 13 657 women who had an abortion-related complication: 323 (2.4%) women were classified with severe maternal outcomes, 957 (7.0%) had potentially life-threatening complications, 7953 (58.2%) had moderate complications and 4424 (32.4%) women had mild complications. Women who were single, multiparous, presenting ≥13 weeks of gestational age and where expulsion of products of conception occurred prior to arrival to facility were more likely to experience severe complications. For management, the commonly used mechanical methods of uterine evacuation were manual vacuum aspiration (76.9%), followed by dilation and curettage (D&C) (20.1%). Most frequently used uterotonics were oxytocin (50∙9%) and misoprostol (22.7%). Via ACASI, 602 (19.5%) women reported having an induced abortion. Of those, misoprostol was the most commonly reported method (54.3%). CONCLUSION: There is a critical need to increase access to and quality of evidence-based safe abortion, postabortion care and to improve understanding around women's experiences of abortion care.

3.
BMJ Glob Health ; 6(1)2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33514592

RESUMO

Consensus is lacking on the most appropriate indicators to document progress in safe abortion at programmatic and country level. We conducted a scoping review to provide an extensive summary of abortion indicators used over 10 years (2008-2018) to inform the debate on how progress in the provision and access to abortion care can be best captured. Documents were identified in PubMed and Popline and supplemented by materials identified on major non-governmental organisation websites. We screened 1999 abstracts and seven additional relevant documents. Ultimately, we extracted information on 792 indicators from 142 documents. Using a conceptual framework developed inductively, we grouped indicators into seven domains (social and policy context, abortion access and availability, abortion prevalence and incidence, abortion care, abortion outcomes, abortion impact and characteristics of women) and 40 subdomains. Indicators of access and availability and of the provision of abortion care were the most common. Indicators of outcomes were fewer and focused on physical health, with few measures of psychological well-being and no measures of quality of life or functioning. Similarly, there were few indicators attempting to measure the context, including beliefs and social attitudes at the population level. Most indicators used special studies either in facilities or at population level. The list of indicators (in online supplemental appendix) is an extensive resource for the design of monitoring and evaluation plans of abortion programmes. The large number indicators, many specific to one source only and with similar concepts measured in a multitude of ways, suggest the need for standardisation.

4.
Lancet Glob Health ; 9(3): e366-e371, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33340453

RESUMO

Inclusion of pregnant women in COVID-19 clinical trials would allow evaluation of effective therapies that might improve maternal health, pregnancy, and birth outcomes, and avoid the delay of developing treatment recommendations for pregnant women. We explored the inclusion of pregnant women in treatment trials of COVID-19 by reviewing ten international clinical trial registries at two timepoints in 2020. We identified 155 COVID-19 treatment studies of non-biological drugs for the April 7-10, 2020 timepoint, of which 124 (80%) specifically excluded pregnant women. The same registry search for the July 10-15, 2020 timepoint, yielded 722 treatment studies, of which 538 (75%) specifically excluded pregnant women. We then focused on studies that included at least one of six drugs (remdesivir, lopinavir-ritonavir, interferon beta, corticosteroids, chloroquine and hydroxychloroquine, and ivermectin) under evaluation for COVID-19. Of 176 such studies, 130 (74%) listed pregnancy as an exclusion criterion. Of 35 studies that evaluated high-dose vitamin treatment for COVID-19, 27 (77%) excluded pregnant women. Despite the surge in treatment studies for COVID-19, the proportion excluding pregnant women remains consistent. Exclusion was not well justified as many of the treatments being evaluated have no or low safety concerns during pregnancy. Inclusion of pregnant women in clinical treatment trials is urgently needed to identify effective COVID-19 treatment for this population.


Assuntos
/tratamento farmacológico , Ensaios Clínicos como Assunto/normas , Seleção de Pacientes/ética , Complicações Infecciosas na Gravidez/tratamento farmacológico , Ensaios Clínicos como Assunto/ética , Definição da Elegibilidade , Feminino , Humanos , Gravidez
5.
Contracept X ; 2: 100046, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33294839

RESUMO

Clinicians have used feticidal agents prior to second trimester abortion for many years. Despite the widespread use of various agents to induce fetal demise, a comprehensive or systematic review of the evidence is lacking on the safety, effectiveness, and most effective routes of administration. Objectives: To evaluate the existing drugs and routes of administration used in inducing fetal demise prior to abortion, and to determine the safety, effectiveness, and acceptability of these feticidal agents. Methods: We searched PubMed, EMBASE, CINAHL, POPLINE, and Global Index Medicus to identify studies describing pharmacologic agents used to induce fetal demise prior to termination of pregnancy. We included randomized controlled trials and observational studies comparing digoxin, potassium chloride (KCL), and lidocaine to induce fetal demise. We included studies that evaluated the primary outcomes of safety and effectiveness, including success in achieving fetal demise, induction to expulsion time for medical abortion, dilation and evacuation time, as well as maternal side effects and complications. Two authors independently screened abstracts and full texts. One reviewer extracted data from the included studies, which was counterchecked by a second reviewer. Results: We identified eight studies that met inclusion criteria: three randomized controlled trials, and five observational studies. A total of 4505 women received drugs to induce fetal demise at 17 to 38 weeks' gestation, including digoxin (n = 4174), KCL (n = 324), and lidocaine (n = 7). Intra-fetal digoxin was superior to intra-amniotic digoxin in achieving fetal demise (OR 3.51, 95% CI 1.60, 7.78). Intracardiac KCL 15% 2-3 mL reduced induction to expulsion time by 320 min (p <.006).Similarly, intracardiac KCL 15% 1-3 ml reduced dilation and evacuation time from 16.1 ± 7.9 min to 12.7 ± 5 min (p < 0.001). Intracardiac lidocaine 2% 10 mL was more effective at achieving fetal demise than intracardiac KCL 6 mmol (85.7% vs. 57.9%). Intra-amniotic and intra-fetal digoxin 1 mg, as compared to no feticidal agent, led to greater pre-procedure expulsion, hospital readmission, and the presence of one or more signs of infection. Conclusions: Evidence from included cohort studies demonstrates that digoxin, KCL, and lidocaine are all effective in inducing fetal demise. Intra-fetal administration of digoxin is superior to intra-amniotic digoxin administration. Administration of feticide using intracardiac KCL may shorten the abortion experience. Limited data from observational studies also supports an increase in maternal side effects and/or complications related to the administration of digoxin. Implications: Intra-fetal administration of digoxin is more effective in achieving fetal demise when compared to intra-amniotic administration. There is a knowledge gap in determining the single best drug for inducing fetal demise prior to abortion. Additional research is needed to compare different feticidal agents in terms of safety and effectiveness.

6.
BMJ Open ; 10(12): e041868, 2020 12 02.
Artigo em Inglês | MEDLINE | ID: mdl-33268430

RESUMO

INTRODUCTION: Rapid, robust and continually updated evidence synthesis is required to inform management of COVID-19 in pregnant and postpartum women and to keep pace with the emerging evidence during the pandemic. METHODS AND ANALYSIS: We plan to undertake a living systematic review to assess the prevalence, clinical manifestations, risk factors, rates of maternal and perinatal complications, potential for mother-to-child transmission, accuracy of diagnostic tests and effectiveness of treatment for COVID-19 in pregnant and postpartum women (including after miscarriage or abortion). We will search Medline, Embase, WHO COVID-19 database, preprint servers, the China National Knowledge Infrastructure system and Wanfang databases from 1 December 2019. We will supplement our search with studies mapped by Cochrane Fertility and Gynaecology group, Evidence for Policy and Practice Information and Co-ordinating Centre (EPPI-Centre), COVID-19 study repositories, reference lists and social media blogs. The search will be updated every week and not be restricted by language. We will include observational cohort (≥10 participants) and randomised studies reporting on prevalence of COVID-19 in pregnant and postpartum women, the rates of clinical manifestations and outcomes, risk factors in pregnant and postpartum women alone or in comparison with non-pregnant women with COVID-19 or pregnant women without COVID-19 and studies on tests and treatments for COVID-19. We will additionally include case reports and series with evidence on mother-to-child transmission of SARS-CoV-2 in utero, intrapartum or postpartum. We will appraise the quality of the included studies using appropriate tools to assess the risk of bias. At least two independent reviewers will undertake study selection, quality assessment and data extraction every 2 weeks. We will synthesise the findings using quantitative random effects meta-analysis and report OR or proportions with 95% CIs and prediction intervals. Case reports and series will be reported as qualitative narrative synthesis. Heterogeneity will be reported as I2 and τ2 statistics. ETHICS AND DISSEMINATION: Ethical approval is not required as this is a synthesis of primary data. Regular updates of the results will be published on a dedicated website (https://www.birmingham.ac.uk/research/who-collaborating-centre/pregcov/index.aspx) and disseminated through publications, social media and webinars. PROSPERO REGISTRATION NUMBER: CRD42020178076.

7.
Glob Health Action ; 13(1): 1811482, 2020 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-32867629

RESUMO

Maternal mortality is unacceptably high in our region. In 2015, the Latin American Center for Perinatology and Women´s Reproductive Health (CLAP) created a regional network of institutions including 16 countries, committed to improving epidemiological surveillance and healthcare of women in a situation of abortion or near miss event, using a common platform, the Perinatal Information System (SIP). The objective of the current pilot project was to test a new method of study called EviSIP (Evidence from SIP), a method of generating information on maternal near miss and abortion for the region. We describe the implementation of this initiative in reproductive healthcare facilities using SIP. Junior researchers/clinicians from these countries were included, along with expert researchers in reproductive health from across the world. Articles were produced with data on maternal near miss and abortion gathered from the SIP of each participating sentinel center; and recommendations from experts. EviSIP was the first joint workspace to discuss patient outcomes after treatment of abortion or near miss cases, with data analysis of each Sentinel Center; discuss and analyze data among centers, at a country and regional level; discuss the main outcomes and their impact on changing procedures and policies; strengthen the operational research capacity of the centers; develop and encourage the publication of scientific articles. The EviSIP initiative also promoted training of healthcare professionals in research. EviSIP provided a unique opportunity to train for research and mentorship and was pivotal to the production of scientific knowledge of reproductive health in the region.

8.
BMJ ; 370: m3320, 2020 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-32873575

RESUMO

OBJECTIVE: To determine the clinical manifestations, risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed coronavirus disease 2019 (covid-19). DESIGN: Living systematic review and meta-analysis. DATA SOURCES: Medline, Embase, Cochrane database, WHO COVID-19 database, China National Knowledge Infrastructure (CNKI), and Wanfang databases from 1 December 2019 to 26 June 2020, along with preprint servers, social media, and reference lists. STUDY SELECTION: Cohort studies reporting the rates, clinical manifestations (symptoms, laboratory and radiological findings), risk factors, and maternal and perinatal outcomes in pregnant and recently pregnant women with suspected or confirmed covid-19. DATA EXTRACTION: At least two researchers independently extracted the data and assessed study quality. Random effects meta-analysis was performed, with estimates pooled as odds ratios and proportions with 95% confidence intervals. All analyses will be updated regularly. RESULTS: 77 studies were included. Overall, 10% (95% confidence interval 7% to14%; 28 studies, 11 432 women) of pregnant and recently pregnant women attending or admitted to hospital for any reason were diagnosed as having suspected or confirmed covid-19. The most common clinical manifestations of covid-19 in pregnancy were fever (40%) and cough (39%). Compared with non-pregnant women of reproductive age, pregnant and recently pregnant women with covid-19 were less likely to report symptoms of fever (odds ratio 0.43, 95% confidence interval 0.22 to 0.85; I2=74%; 5 studies; 80 521 women) and myalgia (0.48, 0.45 to 0.51; I2=0%; 3 studies; 80 409 women) and were more likely to need admission to an intensive care unit (1.62, 1.33 to 1.96; I2=0%) and invasive ventilation (1.88, 1.36 to 2.60; I2=0%; 4 studies, 91 606 women). 73 pregnant women (0.1%, 26 studies, 11 580 women) with confirmed covid-19 died from any cause. Increased maternal age (1.78, 1.25 to 2.55; I2=9%; 4 studies; 1058 women), high body mass index (2.38, 1.67 to 3.39; I2=0%; 3 studies; 877 women), chronic hypertension (2.0, 1.14 to 3.48; I2=0%; 2 studies; 858 women), and pre-existing diabetes (2.51, 1.31 to 4.80; I2=12%; 2 studies; 858 women) were associated with severe covid-19 in pregnancy. Pre-existing maternal comorbidity was a risk factor for admission to an intensive care unit (4.21, 1.06 to 16.72; I2=0%; 2 studies; 320 women) and invasive ventilation (4.48, 1.40 to 14.37; I2=0%; 2 studies; 313 women). Spontaneous preterm birth rate was 6% (95% confidence interval 3% to 9%; I2=55%; 10 studies; 870 women) in women with covid-19. The odds of any preterm birth (3.01, 95% confidence interval 1.16 to 7.85; I2=1%; 2 studies; 339 women) was high in pregnant women with covid-19 compared with those without the disease. A quarter of all neonates born to mothers with covid-19 were admitted to the neonatal unit (25%) and were at increased risk of admission (odds ratio 3.13, 95% confidence interval 2.05 to 4.78, I2=not estimable; 1 study, 1121 neonates) than those born to mothers without covid-19. CONCLUSION: Pregnant and recently pregnant women are less likely to manifest covid-19 related symptoms of fever and myalgia than non-pregnant women of reproductive age and are potentially more likely to need intensive care treatment for covid-19. Pre-existing comorbidities, high maternal age, and high body mass index seem to be risk factors for severe covid-19. Preterm birth rates are high in pregnant women with covid-19 than in pregnant women without the disease. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020178076. READERS' NOTE: This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication.


Assuntos
Betacoronavirus , Infecções por Coronavirus , Pandemias , Pneumonia Viral , Complicações Infecciosas na Gravidez , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/etiologia , Infecções por Coronavirus/terapia , Feminino , Saúde Global/estatística & dados numéricos , Humanos , Recém-Nascido , Terapia Intensiva Neonatal/estatística & dados numéricos , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/etiologia , Pneumonia Viral/terapia , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Complicações Infecciosas na Gravidez/etiologia , Complicações Infecciosas na Gravidez/terapia , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/virologia , Prognóstico , Fatores de Risco
9.
BMC Womens Health ; 20(1): 142, 2020 07 07.
Artigo em Inglês | MEDLINE | ID: mdl-32635921

RESUMO

BACKGROUND: A wide range of drugs have been studied for first trimester medical abortion. Studies evaluating different regimens, including combination mifepristone and misoprostol and misoprostol alone regimens, show varying results related to safety, efficacy and other outcomes. Thus, the objectives of this systematic review were to compare the safety, effectiveness and acceptability of medical abortion and to compare medical with surgical methods of abortion ≤63 days of gestation. METHODS: Pubmed and EMBASE were systematically searched from database inception through January 2019 using a combination of MeSH, keywords and text words. Randomized controlled trials on induced abortion at ≤63 days that compared different regimens of medical abortion using mifepristone and/or misoprostol and trials that compared medical with surgical methods of abortion were included. We extracted data into a pre-designed form, calculated effect estimates, and performed meta-analyses where possible. The primary outcomes were ongoing pregnancy and successful abortion. RESULTS: Thirty-three studies composed of 22,275 participants were included in this review. Combined regimens using mifepristone and misoprostol had lower rates of ongoing pregnancy, higher rates of successful abortion and satisfaction compared to misoprostol only regimens. In combined regimens, misoprostol 800 µg was more effective than 400 µg. There was no significant difference in dosing intervals between mifepristone and misoprostol and routes of misoprostol administration in combination or misoprostol alone regimens. The rate of serious adverse events was generally low. CONCLUSION: In this systematic review, we find that medical methods of abortion utilizing combination mifepristone and misoprostol or misoprostol alone are effective, safe and acceptable. More robust studies evaluating both the different combination and misoprostol alone regimens are needed to strengthen existing evidence as well as assess patient perspectives towards a particular regimen.


Assuntos
Abortivos não Esteroides/uso terapêutico , Abortivos Esteroides/uso terapêutico , Aborto Induzido/métodos , Mifepristona/uso terapêutico , Misoprostol/uso terapêutico , Feminino , Humanos , Gravidez , Primeiro Trimestre da Gravidez
10.
11.
Reprod Health ; 17(1): 59, 2020 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-32326943

RESUMO

The novel coronavirus disease (COVID-19) outbreak was first declared in China in December 2019, and WHO declared the pandemic on 11 March 2020. A fast-rising number of confirmed cases has been observed in all continents, with Europe at the epicentre of the outbreak at this moment.Sexual and reproductive health (SRH) and rights is a significant public health issue during the epidemics. The novel coronavirus (SARS-CoV-2) is new to humans, and only limited scientific evidence is available to identify the impact of the disease COVID-19 on SRH, including clinical presentation and outcomes of the infection during pregnancy, or for persons with STI/HIV-related immunosuppression. Beyond the clinical scope of SRH, we should not neglect the impacts at the health system level and disruptions or interruptions in regular provision of SRH services, such as pre- and postnatal checks, safe abortion, contraception, HIV/AIDS and sexually transmitted infections. Furthermore, other aspects merit attention such as the potential increase of gender-based violence and domestic abuse, and effects of stigma and discrimination associated with COVID-19 and their effects on SRH clients and health care providers. Therefore, there is an urgent need for the scientific community to generate sound clinical, epidemiological, and psycho-social behavioral links between COVID-19 and SRH and rights outcomes.


Assuntos
Infecções por Coronavirus/prevenção & controle , Surtos de Doenças/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Saúde Reprodutiva , Saúde Sexual , Infecções por Coronavirus/epidemiologia , Humanos , Pneumonia Viral/epidemiologia , Direitos Sexuais e Reprodutivos
12.
Cochrane Database Syst Rev ; 3: CD013181, 2020 Mar 09.
Artigo em Inglês | MEDLINE | ID: mdl-32150279

RESUMO

BACKGROUND: The advent of medical abortion has improved access to safe abortion procedures. Medical abortion procedures involve either administering mifepristone followed by misoprostol or a misoprostol-only regimen. The drugs are commonly administered in the presence of clinicians, which is known as provider-administered medical abortion. In self-administered medical abortion, drugs are administered by the woman herself without the supervision of a healthcare provider during at least one stage of the drug protocol. Self-administration of medical abortion has the potential to provide women with control over the abortion process. In settings where there is a shortage of healthcare providers, self-administration may reduce the burden on the health system. However, it remains unclear whether self-administration of medical abortion is effective and safe. It is important to understand whether women can safely and effectively terminate their own pregnancies when having access to accurate and adequate information, high-quality drugs, and facility-based care in case of complications. OBJECTIVES: To compare the effectiveness, safety, and acceptability of self-administered versus provider-administered medical abortion in any setting. SEARCH METHODS: We searched Cochrane Central Register of Controlled Trials, MEDLINE in process and other non-indexed citations, Embase, CINAHL, POPLINE, LILACS, ClinicalTrials.gov, WHO ICTRP, and Google Scholar from inception to 10 July 2019. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and prospective cohort studies with a concurrent comparison group, using study designs that compared medical abortion by self-administered versus provider-administered methods. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted the data, and we performed a meta-analysis where appropriate using Review Manager 5. Our primary outcome was successful abortion (effectiveness), defined as complete uterine evacuation without the need for surgical intervention. Ongoing pregnancy (the presence of an intact gestational sac) was our secondary outcome measuring success or effectiveness. We assessed statistical heterogeneity with Chi2 tests and I2 statistics using a cut-off point of P < 0.10 to indicate statistical heterogeneity. Quality assessment of the data used the GRADE approach. We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We identified 18 studies (two RCTs and 16 non-randomized studies (NRSs)) comprising 11,043 women undergoing early medical abortion (≤ 9 weeks gestation) in 10 countries. Sixteen studies took place in low-to-middle income resource settings and two studies were in high-resource settings. One NRS study received analgesics from a pharmaceutical company. Five NRSs and one RCT did not report on funding; nine NRSs received all or partial funding from an anonymous donor. Five NRSs and one RCT received funding from government agencies, private foundations, or non-profit bodies. The intervention in the evidence is predominantly from women taking mifepristone in the presence of a healthcare provider, and subsequently taking misoprostol without healthcare provider supervision (e.g. at home). There is no evidence of a difference in rates of successful abortions between self-administered and provider-administered groups: for two RCTs, risk ratio (RR) 0.99, 95% confidence interval (CI) 0.97 to 1.01; 919 participants; moderate certainty of evidence. There is very low certainty of evidence from 16 NRSs: RR 0.99, 95% CI 0.97 to 1.01; 10,124 participants. For the outcome of ongoing pregnancy there may be little or no difference between the two groups: for one RCT: RR 1.69, 95% CI 0.41 to 7.02; 735 participants; low certainty of evidence; and very low certainty evidence for 11 NRSs: RR 1.28, 95% CI 0.65 to 2.49; 6691 participants. We are uncertain whether there are any differences in complications requiring surgical intervention, since we found no RCTs and evidence from three NRSs was of very low certainty: for three NRSs: RR 2.14, 95% CI 0.80 to 5.71; 2452 participants. AUTHORS' CONCLUSIONS: This review shows that self-administering the second stage of early medical abortion procedures is as effective as provider-administered procedures for the outcome of abortion success. There may be no difference for the outcome of ongoing pregnancy, although the evidence for this is uncertain for this outcome. There is very low-certainty evidence for the risk of complications requiring surgical intervention. Data are limited by the scarcity of high-quality research study designs and the presence of risks of bias. This review provides insufficient evidence to determine the safety of self-administration when compared with administering medication in the presence of healthcare provider supervision. Future research should investigate the effectiveness and safety of self-administered medical abortion in the absence of healthcare provider supervision through the entirety of the medical abortion protocol (e.g. during administration of mifepristone or as part of a misoprostol-only regimen) and at later gestational ages (i.e. more than nine weeks). In the absence of any supervision from medical personnel, research is needed to understand how best to inform and support women who choose to self-administer, including when to seek clinical care.


Assuntos
Abortivos/administração & dosagem , Aborto Induzido/métodos , Segurança do Paciente , Feminino , Humanos , Mifepristona/administração & dosagem , Misoprostol/administração & dosagem , Gravidez , Primeiro Trimestre da Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto
13.
Artigo em Inglês | MEDLINE | ID: mdl-31937493

RESUMO

Globally, many women undergo unsafe abortion, although abortion is extremely safe when done in accordance with recommended guidelines. Hence, many women suffer from abortion-related complications, and unsafe abortion remains a major cause of maternal mortality. The high percentage of unsafe abortion is attributed to the inability of women to access safe abortion services. A critical barrier to access is the lack of trained providers. To address this problem, task sharing and the expansion of health worker roles in abortion care have become a public health strategy to mitigate health worker shortages and reduce unsafe abortion. This chapter provides an overview of the WHO guidance on task sharing in safe abortion care, discusses the special role of physicians, and highlights the complexity of implementing task sharing by analyzing the findings from six country case studies.


Assuntos
Aborto Induzido , Papel do Médico , Médicos , Aborto Induzido/efeitos adversos , Aborto Induzido/métodos , Feminino , Acesso aos Serviços de Saúde , Humanos , Mortalidade Materna , Guias de Prática Clínica como Assunto , Gravidez , Saúde da Mulher , Organização Mundial da Saúde
14.
BMJ Open ; 9(6): e026092, 2019 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-31217315

RESUMO

INTRODUCTION: Zika virus (ZIKV) infection during pregnancy is a known cause of microcephaly and other congenital and developmental anomalies. In the absence of a ZIKV vaccine or prophylactics, principal investigators (PIs) and international leaders in ZIKV research have formed the ZIKV Individual Participant Data (IPD) Consortium to identify, collect and synthesise IPD from longitudinal studies of pregnant women that measure ZIKV infection during pregnancy and fetal, infant or child outcomes. METHODS AND ANALYSIS: We will identify eligible studies through the ZIKV IPD Consortium membership and a systematic review and invite study PIs to participate in the IPD meta-analysis (IPD-MA). We will use the combined dataset to estimate the relative and absolute risk of congenital Zika syndrome (CZS), including microcephaly and late symptomatic congenital infections; identify and explore sources of heterogeneity in those estimates and develop and validate a risk prediction model to identify the pregnancies at the highest risk of CZS or adverse developmental outcomes. The variable accuracy of diagnostic assays and differences in exposure and outcome definitions means that included studies will have a higher level of systematic variability, a component of measurement error, than an IPD-MA of studies of an established pathogen. We will use expert testimony, existing internal and external diagnostic accuracy validation studies and laboratory external quality assessments to inform the distribution of measurement error in our models. We will apply both Bayesian and frequentist methods to directly account for these and other sources of uncertainty. ETHICS AND DISSEMINATION: The IPD-MA was deemed exempt from ethical review. We will convene a group of patient advocates to evaluate the ethical implications and utility of the risk stratification tool. Findings from these analyses will be shared via national and international conferences and through publication in open access, peer-reviewed journals. TRIAL REGISTRATION NUMBER: PROSPERO International prospective register of systematic reviews (CRD42017068915).


Assuntos
Microcefalia/complicações , Complicações Infecciosas na Gravidez/epidemiologia , Infecção por Zika virus/epidemiologia , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Metanálise como Assunto , Microcefalia/epidemiologia , Microcefalia/virologia , Gravidez , Complicações Infecciosas na Gravidez/virologia , Cuidado Pré-Natal , Projetos de Pesquisa , Revisões Sistemáticas como Assunto , Zika virus , Infecção por Zika virus/transmissão
15.
PLoS Med ; 15(7): e1002611, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-30040845

RESUMO

BACKGROUND: Health authorities in the United States and Europe reported an increasing number of travel-associated episodes of sexual transmission of Zika virus (ZIKV) following the 2015-2017 ZIKV outbreak. This, and other scientific evidence, suggests that ZIKV is sexually transmissible in addition to having its primary mosquito-borne route. The objective of this systematic review and evidence synthesis was to clarify the epidemiology of sexually transmitted ZIKV. METHODS AND FINDINGS: We performed a living (i.e., continually updated) systematic review of evidence published up to 15 April 2018 about sexual transmission of ZIKV and other arthropod-borne flaviviruses in humans and other animals. We defined 7 key elements of ZIKV sexual transmission for which we extracted data: (1) rectal and vaginal susceptibility to infection, (2) incubation period following sexual transmission, (3) serial interval between the onset of symptoms in a primary and secondary infected individuals, (4) duration of infectiousness, (5) reproduction number, (6) probability of transmission per sex act, and (7) transmission rate. We identified 1,227 unique publications and included 128, of which 77 presented data on humans and 51 presented data on animals. Laboratory experiments confirm that rectal and vaginal mucosae are susceptible to infection with ZIKV and that the testis serves as a reservoir for the virus in animal models. Sexual transmission was reported in 36 human couples: 34/36 of these involved male-to-female sexual transmission. The median serial symptom onset interval in 15 couples was 12 days (interquartile range: 10-14.5); the maximum was 44 days. We found evidence from 2 prospective cohorts that ZIKV RNA is present in human semen with a median duration of 34 days (95% CI: 28-41 days) and 35 days (no CI given) (low certainty of evidence, according to GRADE). Aggregated data about detection of ZIKV RNA from 37 case reports and case series indicate a median duration of detection of ZIKV of 40 days (95% CI: 30-49 days) and maximum duration of 370 days in semen. In human vaginal fluid, median duration was 14 days (95% CI: 7-20 days) and maximum duration was 37 days (very low certainty). Infectious virus in human semen was detected for a median duration of 12 days (95% CI: 1-21 days) and maximum of 69 days. Modelling studies indicate that the reproduction number is below 1 (very low certainty). Evidence was lacking to estimate the incubation period or the transmission rate. Evidence on sexual transmission of other flaviviruses was scarce. The certainty of the evidence is limited because of uncontrolled residual bias. CONCLUSIONS: The living systematic review and sexual transmission framework allowed us to assess evidence about the risk of sexual transmission of ZIKV. ZIKV is more likely transmitted from men to women than from women to men. For other flaviviruses, evidence of sexual transmissibility is still absent. Taking into account all available data about the duration of detection of ZIKV in culture and from the serial interval, our findings suggest that the infectious period for sexual transmission of ZIKV is shorter than estimates from the earliest post-outbreak studies, which were based on reverse transcription PCR alone.


Assuntos
Coito , Período de Incubação de Doenças Infecciosas , Doenças Sexualmente Transmissíveis/epidemiologia , Doenças Sexualmente Transmissíveis/transmissão , Infecção por Zika virus/epidemiologia , Infecção por Zika virus/transmissão , Zika virus/patogenicidade , Animais , Feminino , Homossexualidade Masculina , Interações Hospedeiro-Patógeno , Humanos , Masculino , Medição de Risco , Fatores de Risco , Sêmen/virologia , Comportamento Sexual Animal , Doenças Sexualmente Transmissíveis/diagnóstico , Doenças Sexualmente Transmissíveis/virologia , Fatores de Tempo , Viagem , Vagina/virologia , Zika virus/isolamento & purificação , Infecção por Zika virus/diagnóstico , Infecção por Zika virus/virologia
19.
Cochrane Database Syst Rev ; 1: CD007223, 2017 01 31.
Artigo em Inglês | MEDLINE | ID: mdl-28138973

RESUMO

BACKGROUND: Miscarriage occurs in 10% to 15% of pregnancies. The traditional treatment, after miscarriage, has been to perform surgery to remove any remaining placental tissues in the uterus ('evacuation of uterus'). However, medical treatments, or expectant care (no treatment), may also be effective, safe, and acceptable. OBJECTIVES: To assess the effectiveness, safety, and acceptability of any medical treatment for incomplete miscarriage (before 24 weeks). SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (13 May 2016) and reference lists of retrieved papers. SELECTION CRITERIA: We included randomised controlled trials comparing medical treatment with expectant care or surgery, or alternative methods of medical treatment. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias, and carried out data extraction. Data entry was checked. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included 24 studies (5577 women). There were no trials specifically of miscarriage treatment after 13 weeks' gestation.Three trials involving 335 women compared misoprostol treatment (all vaginally administered) with expectant care. There was no difference in complete miscarriage (average risk ratio (RR) 1.23, 95% confidence interval (CI) 0.72 to 2.10; 2 studies, 150 women, random-effects; very low-quality evidence), or in the need for surgical evacuation (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. For unplanned surgical intervention, we did not identify any difference between misoprostol and expectant care (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence).Sixteen trials involving 4044 women addressed the comparison of misoprostol (7 studies used oral administration, 6 studies used vaginal, 2 studies sublingual, 1 study combined vaginal + oral) with surgical evacuation. There was a slightly lower incidence of complete miscarriage with misoprostol (average RR 0.96, 95% CI 0.94 to 0.98; 15 studies, 3862 women, random-effects; very low-quality evidence) but with success rate high for both methods. Overall, there were fewer surgical evacuations with misoprostol (average RR 0.05, 95% CI 0.02 to 0.11; 13 studies, 3070 women, random-effects; very low-quality evidence) but more unplanned procedures (average RR 5.03, 95% CI 2.71 to 9.35; 11 studies, 2690 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. Nausea was more common with misoprostol (average RR 2.50, 95% CI 1.53 to 4.09; 11 studies, 3015 women, random-effects; low-quality evidence). We did not identify any difference in women's satisfaction between misoprostol and surgery (average RR 1.00, 95% CI 0.99 to 1.00; 9 studies, 3349 women, random-effects; moderate-quality evidence). More women had vomiting and diarrhoea with misoprostol compared with surgery (vomiting: average RR 1.97, 95% CI 1.36 to 2.85; 10 studies, 2977 women, random-effects; moderate-quality evidence; diarrhoea: average RR 4.82, 95% CI 1.09 to 21.32; 4 studies, 757 women, random-effects; moderate-quality evidence).Five trials compared different routes of administration, or doses, or both, of misoprostol. There was no clear evidence of one regimen being superior to another. Limited evidence suggests that women generally seem satisfied with their care. Long-term follow-up from one included study identified no difference in subsequent fertility between the three approaches. AUTHORS' CONCLUSIONS: The available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Further studies, including long-term follow-up, are clearly needed to confirm these findings. There is an urgent need for studies on women who miscarry at more than 13 weeks' gestation.


Assuntos
Abortivos não Esteroides/administração & dosagem , Aborto Incompleto/terapia , Extração Obstétrica/métodos , Misoprostol/administração & dosagem , Conduta Expectante , Abortivos não Esteroides/efeitos adversos , Administração Intravaginal , Administração Oral , Diarreia/induzido quimicamente , Feminino , Idade Gestacional , Humanos , Misoprostol/efeitos adversos , Náusea/induzido quimicamente , Gravidez , Primeiro Trimestre da Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Vômito/induzido quimicamente
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