RESUMO
BACKGROUND: Gonorrhoea is a sexually transmitted infection that is caused by Neisseria gonorrhoeae, and is a major public health challenge today. N gonorrhoeae can be transmitted from the mother's genital tract to the newborn during birth, and can cause gonococcal ophthalmia neonatorum as well as systemic neonatal infections. It can also cause endometritis and pelvic sepsis in the mother. This review updates and replaces an earlier Cochrane Review on antibiotics for treating this infectious condition. OBJECTIVES: To assess the clinical effectiveness and harms of antibiotics for treating gonorrhoea in pregnant women. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2017), LILACS database (1982 to April 5, 2017), the WHO International Clinical Trials Registry Platform (ICTRP; April 5, 2017), ClinicalTrials.gov (April 5, 2017), the ISRCTN Registry (April 5, 2017), and Epistemonikos (April 5, 2017). We also searched reference lists of all retrieved articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing the use of antibiotics for treating gonorrhoea in pregnancy. The antibiotics could have been used alone or in combination, were administered parenterally, orally, or both, and were compared with another antibiotic.We included RCTs regardless of their publication status (published, unpublished, published as an article, an abstract, or a letter), language, or country. We applied no limits on the length of follow-up.We excluded RCTs using a cluster- or cross-over design, or quasi-RCTs. DATA COLLECTION AND ANALYSIS: Three review authors independently assessed trials for inclusion and risk of bias, extracted data, and checked them for accuracy. MAIN RESULTS: We included two RCTs, that randomised 514 pregnant women (347 women analysed) at a mean gestational age of 22 weeks. Both trials were conducted in the outpatient department of the same two hospitals in the USA between 1993 and 2001, and had a follow-up of 14 days. One of the trials was sponsored by a drug company. We considered both trials to be at a high risk of bias.One trial compared ceftriaxone (125 mg, intramuscular) with cefixime (400 mg, oral); the other trial had three arms, and assessed ceftriaxone (250 mg, intramuscular) versus either amoxicillin (3 g, oral) plus probenecid (1 g, oral) or spectinomycin (2 g, intramuscular). We did not include the spectinomycin data because this medication is no longer produced. We were unable to conduct meta-analysis because the trials compared different medications.We found inconclusive evidence that there were clear differences in the cure of gonococcal infections (genital, extragenital, or both) between intramuscular ceftriaxone versus oral amoxicillin plus oral probenecid (risk ratio (RR) 1.07, 95% confidence interval (CI) 0.98 to 1.16; one RCT; 168 women; very low-quality evidence) or intramuscular ceftriaxone versus oral cefixime (RR 0.99, 95% CI 0.91 to 1.08; one RCT; 95 women; very low-quality evidence).Neither of the trials reported on two of this review's primary maternal outcomes: incidence of obstetric complications (miscarriage, premature rupture of membranes, preterm delivery, or fetal death), or disseminated gonococcal infection, or on the incidence of neonatorum ophthalmia in the neonates.One trial reported one case of vomiting in the oral amoxacillin plus probenecid group. Trials reported pain at the injection sites, but did not quantify it. Hyperberbilurrubinemia was more frequent in neonates whose mothers were exposed to ceftriaxone. There were no clear differences between groups for neonatal malformation. AUTHORS' CONCLUSIONS: This Cochrane Review found high levels of cure of gonococcal infections in pregnancy with the given antibiotic regimens. However, the evidence in this review is inconclusive as it does not support one particular regimen over another. This conclusion was based on very low-quality evidence (downgraded for poor trial design, imprecision) from two trials (involving 514 women), which we assessed to be at a high risk of bias for a number of domains. The harm profiles of the antibiotic regimes featured in this review remain unknown.High-quality RCTs are needed, with sufficient power to assess the clinical effectiveness and potential harms of antibiotics in pregnant women with gonorrhoea. These should be planned according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT),conducted following CONSORT recommendations, and based on Patient-Centered Outcomes Research Institute (PCORI) outcomes.
Assuntos
Antibacterianos/uso terapêutico , Gonorreia/tratamento farmacológico , Complicações Infecciosas na Gravidez/tratamento farmacológico , Amoxicilina/administração & dosagem , Amoxicilina/uso terapêutico , Antibacterianos/administração & dosagem , Cefixima/administração & dosagem , Cefixima/uso terapêutico , Ceftriaxona/administração & dosagem , Ceftriaxona/uso terapêutico , Feminino , Humanos , Gravidez , Probenecid/administração & dosagem , Probenecid/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Espectinomicina/administração & dosagem , Espectinomicina/uso terapêuticoRESUMO
BACKGROUND: Disseminated intravascular coagulation (DIC) is an acquired syndrome characterised by systemic intravascular activation of coagulation. There are several obstetric causes of DIC during pregnancy and postpartum. OBJECTIVES: To assess the clinical effectiveness and safety of haematological interventions such as heparins (low molecular weight heparin (LMWH) and unfractionated heparin (UFH), danaparoid sodium, synthetic protease inhibitor, antithrombin, human recombinant activated protein C, recombinant human soluble thrombomodulin, recombinant tissue factor pathway inhibitor, recombinant activated factor VIIa and any other types of haematological interventions (except transfusions) for treating DIC during pregnancy and postpartum. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 July 2010), LILACS (1982 to 22 July 2010), ongoing trials registries via the World Health Organization International Clinical Trials Platform Search Portal (22 July 2010), and other relevant websites (22 July 2010). SELECTION CRITERIA: Randomised controlled trials (RCTs) on any haematological interventions for treating DIC during pregnancy and postpartum. DATA COLLECTION AND ANALYSIS: There were no included studies. MAIN RESULTS: We could not find any RCTs on haematological interventions (heparins (LMWH and UFH), danaparoid sodium, synthetic protease inhibitor, antithrombin, human recombinant activated protein C, recombinant human soluble thrombomodulin, recombinant tissue factor pathway inhibitor, recombinant activated factor VIIa and any other types of haematological interventions) for treating DIC during pregnancy and postpartum. AUTHORS' CONCLUSIONS: This review found no RCTs on the safety and efficacy of haematological interventions for treating DIC during pregnancy and postpartum. Such interventions need to be tested in RCTs assessing outcomes such as maternal death, perinatal death and safety.
Assuntos
Coagulação Intravascular Disseminada/tratamento farmacológico , Complicações Hematológicas na Gravidez/tratamento farmacológico , Feminino , Humanos , Período Pós-Parto , GravidezRESUMO
BACKGROUND: Anemia is common in persons with HIV infection and is associated with poor prognosis. There is a need to assess the effects of anemia treatments, and to determine whether these interventions are beneficial. OBJECTIVES: To determine the efficacy and safety of treatments for anemia in people with HIV infection and AIDS. SEARCH STRATEGY: The Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 10, 2010), MEDLINE (1980-November 25, 2010), EMBASE (1980-November 25, 2010), LlLACS (1982 to November 25, 2010), Africa Index Medicus (up to November 9, 2010), ISI Web of Knowledge (2005 to October 9, 2010), Scirus (October 9, 2010) reference lists of relevant articles. We asked the Cochrane HIV/AIDS and Pregnancy and Childbirth Groups to check their Specialised Registers. We also checked the reference lists of all trials identified by the above methods. SELECTION CRITERIA: Randomized trials assessing the effects of treatments for anemia in people diagnosed with HIV infection. There were no age restrictions. DATA COLLECTION AND ANALYSIS: Two authors independently assessed relevant studies for inclusion. Data extraction and quality assessment of relevant studies was performed by two authors and checked by the other two authors. MAIN RESULTS: Six trials with a high risk of bias, including 537 patients, met the inclusion criteria. These trials only covered recombinant Human erythropoietin alfa (rHuEPO). Two of them including adult and paediatric participants (84 participants and 4 events) comparing rHuEPO to placebo did not reduce the risk of mortality with a follow up to 12 weeks (pooled RR 0.56, 95% confidence interval (CI) 0.08 to 4.05, I(2) = 0%). Any trials that compared rHuEPO to placebo did not show any benefit on hematological values response, number of patients transfused, or number of packed red cell transfused. Two trial compared the effects of two rHuEPO dosing regimens on hemoglobin value and quality of life, but the effects are unclear. Three RCT reported high risk of attrition bias; therefore, were not included in a meta-analysis. AUTHORS' CONCLUSIONS: This updated Cochrane review provides evidence that rHuEPO compared with placebo does not reduce mortality, does not reduce transfusion requirements, did not increase hemoglobin levels, and did not improve quality of life in HIV-infected patients with anemia. The results are based on six RCTs with high risk of bias. Therefore prescription of this intervention for treating anemia in patients with AIDS is not justified, unless new evidence from a large high quality trial alters this conclusion.
Assuntos
Síndrome da Imunodeficiência Adquirida/complicações , Anemia/terapia , Eritropoetina/uso terapêutico , Hematínicos/uso terapêutico , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas RecombinantesRESUMO
BACKGROUND: Idiopathic thrombocytopenic purpura (ITP) is a common hematologic disorder caused by immune-mediated thrombocytopenia. The magnitude of the maternal-fetal risk of ITP during pregnancy is controversial. Labour management of pregnant women with ITP remains controversial. Management of ITP during pregnancy is complex because of the disparity between maternal and fetal platelet counts. OBJECTIVES: To assess the effectiveness and safety of corticosteroids, intravenous immunoglobulin, vinca alkaloids, danazol, dapsone, and any other types of pharmacological treatments for the treatment of idiopathic thrombocytopenic purpura during pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (February 2009), LILACS (1982 to 8 February 2009), ClinicalTrials.gov (8 February 2009), Current Controlled Trials (16 February 2009), Google Scholar (16 February 2009) and ongoing and unpublished trials cited in the reference lists of relevant articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) on any medical treatments for idiopathic thrombocytopenia purpura during pregnancy. DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated methodological quality and extracted trial data. Any disagreement was resolved by discussion or by consulting a third review author. MAIN RESULTS: This review included one RCT in which 38 women (41 pregnancies) were randomised, with only 26 women (28 pregnancies) being analysed.This RCT comparing the effect of betamethasone (1.5 mg/day) with no medication found no statistically significant difference in neonatal thrombocytopenia (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.62 to 2.05) and neonatal bleeding (RR 1.00, 95% CI 0.24 to 4.13). Review authors conducted an intention-to-treat analysis which showed similar findings: RR 1.18, 95% CI 0.57 to 2.45 and RR 1.05, 95% CI 0.24 to 4.61, respectively. Maternal death, perinatal mortality, postpartum haemorrhage and neonatal intracranial haemorrhage were not studied by this RCT. AUTHORS' CONCLUSIONS: Current evidence indicates that compared to no medication, betamethasone did not reduce the risk of neonatal thrombocytopenia and neonatal bleeding in ITP during pregnancy. There is insufficient evidence to support the use of betamethasone for treating ITP. This Cohrane review does not provide evidence about other medical treatments for ITP during pregnancy. This systematic review also identifies the need for well-designed, adequately powered randomised clinical trials for this medical condition during pregnancy. Unless randomised clinical trials provide evidence of a treatment effect and the trade off between potential benefits and harms are established, policy-makers, clinicians, and academics should not use betamethasone for ITP in pregnant women. Any future trials on medical treatments for treating ITP during pregnancy should test a variety of important maternal, neonatal or both outcome measures, including maternal death, perinatal mortality, postpartum haemorrhage and neonatal intracranial haemorrhage.
Assuntos
Betametasona/uso terapêutico , Complicações Hematológicas na Gravidez/tratamento farmacológico , Púrpura Trombocitopênica Idiopática/tratamento farmacológico , Feminino , Humanos , Recém-Nascido , Gravidez , Trombocitopenia Neonatal Aloimune/prevenção & controleRESUMO
BACKGROUND: Sickle cell disease is a group of genetic haemoglobin disorders. All over the world, about 300,000 children with these disorders are born each year. Acute sickle cell pain episodes are the most common cause of hospitalisation. Pregnancy in women with sickle cell disease is associated with an increased incidence of maternal and fetal morbidity and mortality. The painful crisis is a severe complication of this illness, and it requires several interventions: packed red cell transfusion, fluid replacement therapy, analgesic drugs, oxygen therapy and steroids; but the approach is not standardised. OBJECTIVES: To assess the effectiveness and safety of different regimens of packed red cell transfusion, oxygen therapy, fluid replacement therapy, analgesic drugs, and steroids for the treatment of painful sickle cell crisis during pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (December 2007), the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Register (October 2007), LILACS database (1982 to December 2007) and the following web sites: ClinicalTrials.gov (http://www.clinicaltrials.gov) (December 5, 2007); Current Controlled Trials (http://controlled-trials.com/) (December 5, 2007), and Sistema de Información Esencial en Terapéutica y Salud (http://www.icf.uab.es/informacion/Papyrus/sietes.asp) (December 1, 2007). We also handsearched the European Haematology Association conference (June 2007), the American Society of Hematology conference (December 2007) and reference lists of all retrieved articles. SELECTION CRITERIA: We intended to include randomised clinical trials. DATA COLLECTION AND ANALYSIS: We intended to summarise data by standard Cochrane Collaboration methodologies. MAIN RESULTS: We could not find any randomised clinical trials on interventions (packed red cell transfusion, oxygen therapy, fluid replacement therapy, analgesic drugs, and steroids) for the treatment of painful sickle cell crisis during pregnancy. AUTHORS' CONCLUSIONS: This review found no randomised clinical trials on the safety and efficacy of interventions for treating painful sickle cell crisis during pregnancy. The effects of interventions need to be tested in randomised clinical trials.
Assuntos
Anemia Falciforme/terapia , Manejo da Dor , Complicações Hematológicas na Gravidez/terapia , Feminino , Humanos , GravidezRESUMO
The purpose of this study was to determine the association and its magnitude between prematurity and folate deficiency in women in their third trimester of pregnancy, and at labor. An incident case-control study was conducted using 2 controls per case. Data was obtained in a tertiary hospital in Valencia, Venezuela. A total of 543 women who delivered between May and December 1996 entered into the study. Women having a preterm delivery (< 37 weeks of gestation at delivery) were defined as cases (n = 181). Anemia was defined according to WHO as Hb less than 11 g/dL, when a pregnant woman had a folate serum level < 3 microg/ml was considered a folate deficiency. Logistic regression was used to analyze the data and likelihood ratio test was done for model comparison. Folate deficiency was found to be significantly associated with prematurity (Odds Ratio: 1.97; 95%CI = 1.06 to 3.68 P = .032), after adjusting for prior preterm labor, prenatal care visits, prior abortion, prior fetal death, placental abruption, and premature rupture oval membranes. In conclusion, maternal folate deficiency at the end of the third trimester of pregnancy, at labor, was associated with an increased risk of prematurity.