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BACKGROUND: Current guidelines regarding oxytocin stimulation are not tailored to individuals as they are based on randomised controlled trials. The objective of the study was to develop an artificial intelligence (AI) model for individual prediction of the risk of caesarean delivery (CD) in women with a cervical dilatation of 6 cm after oxytocin stimulation for induced labour. The model included not only variables known when labour induction was initiated but also variables describing the course of the labour induction. METHODS: Secondary analysis of data from the CONDISOX randomised controlled trial of discontinued vs. continued oxytocin infusion in the active phase of induced labour. Extreme gradient boosting (XGBoost) software was used to build the prediction model. To explain the impact of the predictors, we calculated Shapley additive explanation (SHAP) values and present a summary SHAP plot. A force plot was used to explain specifics about an individual's predictors that result in a change of the individual's risk output value from the population-based risk. RESULTS: Among 1060 included women, 160 (15.1%) were delivered by CD. The XGBoost model found women who delivered vaginally were more likely to be parous, taller, to have a lower estimated birth weight, and to be stimulated with a lower amount of oxytocin. In 108 women (10% of 1060) the model favoured either continuation or discontinuation of oxytocin. For the remaining 90% of the women, the model found that continuation or discontinuation of oxytocin stimulation affected the risk difference of CD by less than 5% points. CONCLUSION: In women undergoing labour induction, this AI model based on a secondary analysis of data from the CONDISOX trial may help predict the risk of CD and assist the mother and clinician in individual tailored management of oxytocin stimulation after reaching 6 cm of cervical dilation.
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Trabalho de Parto , Ocitócicos , Gravidez , Feminino , Humanos , Ocitocina , Inteligência Artificial , Trabalho de Parto InduzidoAssuntos
Ocitócicos , Ocitocina , Recém-Nascido , Humanos , Feminino , Gravidez , Trabalho de Parto Induzido , MorbidadeRESUMO
INTRODUCTION: Therapeutic rest refers to the usage of medication to relieve pain in women in the latent phase of labor. Very few data are available to evaluate the safety and effect of its use. The objectives of this study were to compare perinatal and labor outcomes in women who were seeking hospital care during the latent phase of labor and who were treated either with or without therapeutic rest. MATERIAL AND METHODS: Retrospective cohort study with inclusion of nulliparous singleton pregnant women in the latent phase of labor presenting at the labor ward at Aarhus University Hospital, Denmark from May 13, 2018 to June 1, 2021. We identified two groups: women who were treated with therapeutic rest and women who were not. The primary outcomes were neonatal admission and neonatal resuscitation. Secondary outcomes included use of cardiotocography during labor, nonreactive fetal heart rate, meconium-stained amniotic fluid, pediatric delivery room assistance, umbilical cord arterial pH and standard base excess, Apgar score at 5 minutes, interventions during labor and mode of delivery. RESULTS: In our sample of 800 women in the latent phase of labor, 414 women (52%) were treated with therapeutic rest and 386 women (48%) were not. The most frequently used (n = 206) medication for therapeutic rest was a combination of paracetamol, triazolam and codeine. We found no significant difference in neonatal admission (9.2% vs 6.5%, adjusted odds ratio [aOR] 1.2, 95% confidence interval [CI] 0.4-3.1) or neonatal resuscitation (2.4% vs 3.1%, aOR 0.7, 95% CI 0.1-4.0) between women treated with or without therapeutic rest. There were no differences between the two groups in other perinatal adverse outcomes, interventions during labor or mode of delivery. CONCLUSIONS: This study found no significant association between therapeutic rest and neonatal admission or resuscitation. Our findings indicate that therapeutic rest is a safe method for managing the latent phase of labor concerning neonatal health and does not increase the risk of labor complications.
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Trabalho de Parto , Ressuscitação , Criança , Gravidez , Feminino , Recém-Nascido , Humanos , Estudos de Coortes , Estudos Retrospectivos , PartoAssuntos
Trabalho de Parto , Gravidez , Feminino , Humanos , Cesárea , Trabalho de Parto Induzido , Idade GestacionalRESUMO
OBJECTIVE: This study aimed to review the literature comparing full-term induction of labor with expectant management in women with obesity on the risk of cesarean delivery and other adverse outcomes. DATA SOURCES: A literature search was performed on PubMed, EMBASE, Scopus, ClinicalTrials.gov, and the Cochrane Library. This study had no time, language, or geographic restriction. STUDY ELIGIBILITY CRITERIA: Studies were eligible if (1) they were cohort or randomized controlled trials, (2) they compared induction of labor at early or late term with expectant management, and (3) they included women with a body mass index of ≥30 kg/m2. Studies restricted to women with multiple pregnancy, premature rupture of membranes, or noncephalic presentation were excluded. The primary outcome was cesarean delivery. The secondary outcomes included maternal and neonatal mortality and morbidities and were evaluated. METHODS: The risk of bias was assessed by 2 authors using the Risk of Bias In Non-Randomized Studies of Interventions tool. Only studies assessed with low or moderate risk of bias contributed to the meta-analysis. Data were combined to pooled relative risks and 95% confidence intervals using random effects models. The quality of evidence was assessed for selected outcomes. RESULTS: Of the 232 studies identified, 13 were aligned with the inclusion criteria, and 4 cohort studies, including 216,318 women with induction of labor and 1,122,769 women managed expectantly, were included in the meta-analysis for the primary outcome. In women with obesity, full-term induction of labor was associated with a lower risk of cesarean delivery than expectant management (19.7% vs 24.5%; relative risk, 0.71; 95% confidence interval, 0.63-0.81). Moreover, this study found the same direction of the association for other selected outcomes: severe perineal lacerations (relative risk, 0.65; 95% confidence interval, 0.48-0.89), maternal infection (relative risk, 0.42; 95% confidence interval, 0.21-0.84), perinatal mortality (relative risk, 0.41; 95% confidence interval, 0.18-0.90), low Apgar score (relative risk, 0.48; 95% confidence interval, 0.26-0.91), meconium aspiration syndrome (relative risk, 0.40; 95% confidence interval, 0.28-0.56), and macrosomia (relative risk, 0.57; 95% confidence interval, 0.43-0.75). Conversely, induction of labor was associated with an increased risk of instrumental vaginal delivery (relative risk, 1.12; 95% confidence interval, 1.02-1.22). The quality of evidence ranged from low to very low. CONCLUSION: Full-term induction of labor in women with obesity may reduce the risk of cesarean delivery compared with expectant management, but the quality of the evidence is low.
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Síndrome de Aspiração de Mecônio , Conduta Expectante , Gravidez , Humanos , Feminino , Recém-Nascido , Trabalho de Parto Induzido/efeitos adversos , Síndrome de Aspiração de Mecônio/etiologia , Cesárea/efeitos adversos , Obesidade/complicações , Obesidade/diagnóstico , Obesidade/epidemiologiaRESUMO
OBJECTIVE: To examine the factors associated with unexpectedly high rates of conversion to open label oxytocin in the CONDISOX trial of continuation versus discontinuation of oxytocin infusion during induced labour. DESIGN: Secondary retrospective analysis of data from a prospective randomised controlled trial. SETTING: Nine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020. POPULATION OR SAMPLE: 1200 women having labour induced. METHODS: Analysis of outcomes by actual management. MAIN OUTCOME MEASURES: Mode of delivery and associated variables. RESULTS: Switching to open label oxytocin (42.4% overall) was associated with nulliparity, an unripe cervix, larger babies and higher rates of delivery by caesarean section. CONCLUSIONS: In the CONDISOX trial, slow labour was associated with features suggesting a higher 'resistance to progress', often prompting the use of open-label oxytocin infusion rather than study medication.
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Ocitócicos , Ocitocina , Feminino , Gravidez , Humanos , Cesárea , Estudos Prospectivos , Estudos Retrospectivos , Trabalho de Parto InduzidoRESUMO
INTRODUCTION: Worldwide, the estimated prevalence of urinary incontinence is 8.7%. Urinary incontinence is more frequent in women than in men. Posing the right questions is crucial, when diagnosing urinary incontinence, but also to evaluate the need of treatment and treatment effect. Therefore, reliable and validated questionnaires within this area are needed. Even though the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) has been used on a daily basis in the Danish Urogynaecological Database since 2006, it has not yet been validated in a Danish population of both men and women. OBJECTIVE: To test the reliability and validity of the Danish version of the ICIQ-UI SF in a Danish speaking population of men and women among municipal employees. METHODS: Content validity was evaluated with semi-structured interviews. A quantitative field test was performed, in which the questionnaire was distributed electronically to municipal workers by E-mail. Statistical methods included item characteristics (missings, kurtosis and skewness), internal consistency (Chronbach's alfa), test-retest (ICC), construct validity (known group validation), and floor and ceiling effect. RESULTS: A number of 1814 Danish municipal workers completed the questionnaire. Of the total number of responders, 426 were invited to complete the questionnaire twice (for test-retest) and 215 (50.5%) of these completed the questions again two weeks later. Statistical analyses of the ICIQ-UI SF demonstrated no floor and ceiling effects, skewness was zero and kurtosis 0.00-0.49. Cronbach's alfa was 0.87 and intraclass correlation coefficient 0.73. Two out of three hypotheses were accepted in the known-groups validation. CONCLUSION: This study offers an adaptation of the ICIQ-UI SF to a Danish setting. The Danish ICIQ-UI SF demonstrated acceptable reliability and validity. However, clinicians should consider the relatively high measurement error.
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Qualidade de Vida , Incontinência Urinária , Dinamarca/epidemiologia , Feminino , Humanos , Masculino , Encaminhamento e Consulta , Reprodutibilidade dos Testes , Inquéritos e Questionários , Incontinência Urinária/diagnóstico , Incontinência Urinária/epidemiologiaRESUMO
INTRODUCTION: Obesity is associated with many pregnancy complications, including both fetal macrosomia and prolonged labour. As a result, there is often also an increased risk of caesarean section. In other settings, labour induction near to term reduces adverse outcomes such as stillbirth and birth injury, without causing more caesarean deliveries. It has been suggested that induction will reduce adverse events in this setting too, but there have been no trials and the effect on caesarean section is unknown. The objective of this study is to compare induction of labour in gestational week 39 with expectant management on the risk of caesarean section in women with body mass index ≥30 kg/m2. METHODS AND ANALYSIS: An open label randomised controlled multicentre trial are conducted at Danish delivery departments with an in-house neonatal intensive care unit. Recruitment started October 2020. A total of 1900 women with a prepregnancy body mass index ≥30 kg/m2 are randomised in a 1:1 ratio to either labour induction at 39 weeks and 0 to 3 days of gestation or to expectant management; that is, waiting for spontaneous labour onset or induction if medically indicated. The primary outcome is caesarean section. Data will be analysed according to intention-to-treat. ETHICS AND DISSEMINATION: The Central Denmark Region Committee on Biomedical Research Ethics approved the study. The study is conducted in accordance with the ethical principles outlined in the latest version of the 'Declaration of Helsinki' and the 'Guideline for Good Clinical Practice' related to experiments on humans. The trial findings will be disseminated to participants, clinicians, commissioning groups and via peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04603859.
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Cesárea , Conduta Expectante , Feminino , Humanos , Recém-Nascido , Trabalho de Parto Induzido/métodos , Masculino , Estudos Multicêntricos como Assunto , Obesidade/complicações , Obesidade/terapia , Gravidez , Resultado da Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Conduta Expectante/métodosRESUMO
INTRODUCTION: Little is known about the optimal simulation-based team training in obstetric emergencies. We aimed to review how simulation-based team training affects patient outcomes in obstetric emergencies. MATERIAL AND METHODS: Search Strategy: MEDLINE, Embase, Cochrane Library, and Cochrane Central Register of Controlled Trials were searched up to and including May 15, 2021. SELECTION CRITERIA: randomized controlled trials (RCTs) and cohort studies on obstetric teams in high-resource settings comparing the effect of simulation-based obstetric emergency team training with no training on the risk of Apgar scores less than 7 at 5 min, neonatal hypoxic ischemic encephalopathy, severe postpartum hemorrhage, blood transfusion of four or more units, and delay of emergency cesarean section by more than 30 min. DATA COLLECTION AND ANALYSIS: The included studies were assessed using PRISMA, EPCO, and GRADE. RESULTS: We found 21 studies, four RCTs and 17 cohort studies, evaluating patient outcomes after obstetric team training compared with no training. Annual obstetric emergency team training may reduce brachial plexus injury (six cohort studies: odds ratio [OR] 0.47, 95% CI 0.33-0.68; one RCT: OR 1.30, 95 CI% 0.39-4.33, low certainty evidence) and suggest a positive effect; but it was not significant on Apgar score below 7 at 5 min (three cohort studies: OR 0.77, 95% CI 0.51-1.19; two RCT: OR 0.87, 95% CI 0.72-1.05, moderate certainty evidence). The effect was unclear for hypoxic ischemic encephalopathy, umbilical prolapse, decision to birth interval in emergency cesarean section, and for severe postpartum hemorrhage. Studies with in situ multi-professional simulation-based training demonstrated the best effect. CONCLUSIONS: Emerging evidence suggests an effect of obstetric team training on obstetric outcomes, but conflicting results call for controlled trials targeted to identify the optimal methodology for effective team training.
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Serviço Hospitalar de Emergência , Avaliação de Resultados em Cuidados de Saúde , Equipe de Assistência ao Paciente , Hemorragia Pós-Parto/terapia , Cuidado Pré-Natal , Treinamento por Simulação , Feminino , Humanos , Recém-Nascido , Gravidez , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To determine whether discontinuing oxytocin stimulation in the active phase of induced labour is associated with lower caesarean section rates. DESIGN: International multicentre, double blind, randomised controlled trial. SETTING: Nine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020. PARTICIPANTS: 1200 women stimulated with intravenous oxytocin infusion during the latent phase of induced labour. INTERVENTION: Women were randomly assigned to have their oxytocin stimulation discontinued or continued in the active phase of labour. MAIN OUTCOME MEASURE: Delivery by caesarean section. RESULTS: A total of 607 women were assigned to discontinuation and 593 to continuation of the oxytocin infusion. The rates of caesarean section were 16.6% (n=101) in the discontinued group and 14.2% (n=84) in the continued group (relative risk 1.17, 95% confidence interval 0.90 to 1.53). In 94 parous women with no previous caesarean section, the caesarean section rate was 7.5% (11/147) in the discontinued group and 0.6% (1/155)in the continued group (relative risk 11.6, 1.15 to 88.7). Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups. CONCLUSIONS: In a setting where monitoring of the fetal condition and the uterine contractions can be guaranteed, routine discontinuation of oxytocin stimulation may lead to a small increase in caesarean section rate but a significantly reduced risk of uterine hyperstimulation and abnormal fetal heart rate patterns. TRIAL REGISTRATION: ClinicalTrials.gov NCT02553226.
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Cesárea/estatística & dados numéricos , Primeira Fase do Trabalho de Parto , Segunda Fase do Trabalho de Parto , Ocitócicos/administração & dosagem , Ocitocina/administração & dosagem , Adulto , Método Duplo-Cego , Feminino , Frequência Cardíaca Fetal/efeitos dos fármacos , Humanos , Ocitócicos/efeitos adversos , Ocitocina/efeitos adversos , Paridade , Gravidez , Fatores de TempoRESUMO
INTRODUCTION: It is common practice after a pelvic exam to ask a woman to put her pants on, before she is given verbal information. We aimed to compare short-term memory in undressed versus dressed women. METHODS: Thirty-six female Ob/Gyn doctors were randomised to receive verbal information while undressed and still in a lithotomy position, or once dressed again. The primary outcome was the proportion of items recalled from a 20-item list. RESULTS: We found no significant difference in recall; 58% in dressed women versus 62% in undressed women (p = 0.26). CONCLUSION: The memory of women is not affected by, whether or not they are dressed. FUNDING: none. TRIAL REGISTRATION: none.
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Memória , Rememoração Mental , Feminino , HumanosRESUMO
BACKGROUND: Acute fatty liver of pregnancy is a rare but serious complication in the last trimester of pregnancy or postpartum period. Data on the recurrence risk are largely unavailable, as only case reports or very small case series exist in which only 1 woman had recurrent acute fatty liver of pregnancy. OBJECTIVE: We aimed to estimate the risk of acute fatty liver of pregnancy recurrence and to compare disease severity and gestational age between primary and recurrent disease using patient-provided data from an acute fatty liver of pregnancy social media patient group. MATERIALS AND METHODS: We developed and distributed an electronic questionnaire through an international Facebook group called "Acute Fatty Liver of Pregnancy." The data collection took place from June 11, 2018, to August 17, 2018, using REDCap. Our main outcome measures were recurrence of acute fatty liver of pregnancy, severity with recurrence, and gestational age at delivery. RESULTS: A total of 69 women with previous acute fatty liver of pregnancy completed the questionnaire; 24 women had a subsequent delivery, of whom 5 women were diagnosed with acute fatty liver of pregnancy again. In 4 of 5 of these women (80%), acute fatty liver of pregnancy took a milder course, whereas in 1 woman it worsened in the next pregnancy. Women with acute fatty liver of pregnancy recurrence delivered at a median gestational age at 265 days (interquartile range, 242-287 days) in their first pregnancy with acute fatty liver of pregnancy as compared to delivery by a prelabor cesarean delivery at 245 days (interquartile range, 235-261 days) in their second pregnancy with acute fatty liver of pregnancy. Male fetal sex was not associated with an increased risk of recurrent acute fatty liver of pregnancy. CONCLUSION: One in 5 women reported having had recurrent acute fatty liver of pregnancy, with most cases being milder, possibly because of an earlier gestational age at delivery.
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Fígado Gorduroso , Complicações na Gravidez , Mídias Sociais , Fígado Gorduroso/epidemiologia , Feminino , Humanos , Masculino , Gravidez , Complicações na Gravidez/epidemiologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: When determining optimal treatment regimens, patient reported outcomes including satisfaction are increasingly appreciated. It is well established that the birth experience may affect the postnatal attachment to the newborn and the management of subsequent pregnancies and deliveries. As we have no robust validated Danish tool to evaluate the childbirth experience exists, we aimed to perform a transcultural adaptation of the Childbirth Experience Questionnaire (CEQ) to a Danish context. METHODS: In accordance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), we translated the Swedish-CEQ to Danish. The Danish-CEQ was tested for content validity among 10 new mothers. In a population of women who have had their labour induced, we then assessed the electronic questionnaire for validity and reliability using factor analytical design, hypothesis testing, and internal consistency. Based on these data, we determined criterion and construct responsiveness in addition to floor and ceiling effects. RESULTS: The content validation resulted in minor adjustments in two items. This improved the comprehensibility. The electronic questionnaire was completed by 377 of 495 women (76.2%). The original Swedish-CEQ was four-dimensional, however an exploratory factor analysis revealed a three-dimensional structure in our Danish population (Own capacity, Participation, and Professional support). Parous women, women who delivered vaginally, and women with a labour duration <12 hours had a higher score in each domain. The internal consistency (Cronbach's alpha) ranged between 0.75 and 0.89 and the ICC between 0.68-0.93. We found ceiling effects of 57.6% in the domain Professional support and of 25.5% in the domain Participation. CONCLUSION: This study offers transcultural adaptation of the Swedish-CEQ to a Danish context. The 3-dimensional Danish-CEQ demonstrates construct validity and reliability. Our results revealed significant ceiling effect especially in the domain Professional support, which needs to be acknowledged when considering implementing the Danish-CEQ into trials and clinical practice.
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Trabalho de Parto/efeitos dos fármacos , Ocitocina/farmacologia , Parto/fisiologia , Inquéritos e Questionários , Adulto , Dinamarca , Análise Fatorial , Feminino , Humanos , Gravidez , Reprodutibilidade dos Testes , TraduçõesRESUMO
BACKGROUND: Oxytocin is an effective drug for induction of labour, but is associated with serious adverse effects of which uterine tachysystole, fetal distress and the need of immediate delivery are the most common. Discontinuation of oxytocin once the active phase of labour is established could reduce the adverse effects. The objective is to investigate how the caesarean section rate is affected when oxytocin stimulation is discontinued in the active phase of labour compared to labours where oxytocin is continued. METHODS: CONDISOX is a double-blind multicentre randomised controlled trial conducted at Danish and Dutch Departments of Obstetrics and Gynaecology. The first participant was recruited on April 8 2016. Based on a clinically relevant relative reduction in caesarean section rate of 7%, an alpha of 0.05, a beta of 80%, we aim for 1200 participating women (600 in each arm). The CONDISOX trial includes women at a gestational age of 37-42 complete weeks of pregnancy, who have uterine activity stimulated with oxytocin infusion for the induction of labour. Women are randomised when the active phase of labour becomes established, to study medication containing either oxytocin (continuous group) or placebo (discontinued group) infusion. Women are stratified by birth site, indication for oxytocin stimulation (induction of labour, prelabour rupture of membranes) and parity (nulliparous, parous +/- previous caesarean section). We will compare the primary outcome, caesarean section rate, in the two groups using a chi-square test with a p-value of 0.05. If superiority is not demonstrated, we have a pre-defined post hoc non-inferiority boundary (margin, delta) at 1.09. Secondary outcomes include duration of the active phase of labour, incidence of uterine tachysystole, postpartum haemorrhage, admission to the neonatal intensive care unit, Apgar score, umbilical arterial blood pH, and birth experience. DISCUSSION: The high frequency of oxytocin use and the potential risks of both maternal and fetal adverse effects of oxytocin emphasise the need to determine the optimal oxytocin regime for induction of labour. TRIAL REGISTRATION: NCT02553226 (registered September 17, 2015). Eudra-CT number: 2015-002942-30.
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Trabalho de Parto Induzido/métodos , Ocitócicos , Ocitocina , Hemorragia Pós-Parto/epidemiologia , Índice de Apgar , Cesárea/estatística & dados numéricos , Desprescrições , Método Duplo-Cego , Feminino , Sangue Fetal/química , Humanos , Concentração de Íons de Hidrogênio , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Complicações do Trabalho de Parto/epidemiologia , Gravidez , Contração UterinaRESUMO
BACKGROUND: In most Western countries, obstetricians and midwives induce labour in about 25% of pregnant women. Oxytocin is an effective drug for this purpose, but associated with serious adverse effects of which uterine tachysystole, fetal distress and the need for immediate delivery are the most common. Various administration regimens such as reduced or pulsatile dosing have been suggested to minimise these. Discontinuation in the active phase of labour, i.e. when contractions are well-established and the cervix is dilated at least 5 cm is another method which may reduce adverse effects. OBJECTIVES: To assess whether birth outcomes can be improved by discontinuation of intravenous (IV) oxytocin, initiated in the latent phase of induced labour, once active phase of labour is established. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2018), Scopus, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) (23 January 2018) together with reference checking, citation searching, and contact with study authors to identify additional studies. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing discontinued IV with continuous IV oxytocin in the active phase of induced labour.No exclusion criteria were applied in terms of parity, maternal age, ethnicity, co-morbidity status, labour setting, gestational age, and prior caesarean delivery.Studies comparing different dosage regimens are outside the scope of this review. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. MAIN RESULTS: We found 10 completed RCTs involving 1888 women. One additional trial is ongoing. The included trials were conducted in hospital settings between February 1998 and January 2016, two in Europe (Denmark, and Greece), two in Turkey, and one each in Israel, Iran, USA, Bangladesh, India, and Thailand. Most trials included full-term singleton pregnancies with a fetus in vertex presentation. Some excluded women with cervical priming prior to induction and some excluded women with a history of prior caesarean delivery. When reported, the average age of the women ranged from 22 to 31 years, nulliparity from 45% to 68%, and pre-pregnancy body mass index from 22 to 32.Many of the included trials had design limitations and were judged to be at either high or unclear risk of bias across a number of 'Risk of bias' domains.Four trials included a Consort flow diagram. In three, this gave details of participants delivered before the active phase of labour, and treatment compliance for those who reached that stage. One Consort diagram only provided the latter information. The data in many of the trials without such a flow diagram were implausibly compliant with treatment allocation, suggesting that there had been silent post randomisation exclusions of women delivered before the active phase of labour. We therefore conducted a secondary analysis (not in our protocol) of caesarean section among women who reached the active phase of labour and were therefore eligible for the intervention.Our analysis by 'intention-to-treat' found that, compared with continuation of IV oxytocin stimulation, discontinuation of IV oxytocin may reduce the caesarean delivery rate, risk ratio (RR) 0.69, 95% confidence interval (CI) 0.56 to 0.86, 9 trials, 1784 women, low-level certainty. However, restricting our analysis to women who reached the active phase of labour (using 'reached active phase' as our denominator) suggests there is probably little or no difference between groups (RR 0.92, 95% CI 0.65 to 1.29, 4 trials, 787 women, moderate-certainty evidence).Discontinuation of IV oxytocin probably reduces the risk ofuterine tachysystole combined with abnormal fetal heart rate (FHR) compared with continued IV oxytocin (RR 0.15, 95% CI 0.05 to 0.46, 3 trials, 486 women, moderate-level certainty). We are uncertain about whether or not discontinuation increases the risk of chorioamnionitis (average RR 2.32, 95% CI 0.99 to 5.45, 1 trial, 252 women, very low-level certainty). Discontinuation of IV oxytocin may have little or no impact on the use of analgesia and epidural during labour compared to the use of continued IV oxytocin (RR 1.04 95% CI 0.95 to 1.14, 3 trials, 556 women, low-level certainty). Intrapartum cardiotocography (CTG) abnormalities (suspicious/pathological CTGs) are probably reduced by discontinuing IV oxytocin (RR 0.65, 95% CI 0.51 to 0.83, 7 trials, 1390 women, moderate-level certainty). Compared to continuing IV oxytocin, discontinuing IV oxytocin probably has little or no impact on the incidence of Apgar < 7 at five minutes (RR 0.78, 95% CI 0.27 to 2.21, 4 trials, 893 women, low-level certainty), or and acidotic cord gasses at birth (arterial umbilical pH < 7.10), (RR 1.03, 95% CI 0.50 to 2.13, 4 trials, 873 women, low-level certainty).Many of this review's maternal and infant secondary outcomes (including maternal and neonatal mortality) were not reported in the included trials. AUTHORS' CONCLUSIONS: Discontinuing IV oxytocin stimulation after the active phase of labour has been established may reduce caesarean delivery but the evidence for this was low certainty. When restricting our analysis to those trials that separately reported participants who reached the active phase of labour, our results showed there is probably little or no difference between groups. Discontinuing IV oxytocin may reduce uterine tachysystole combined with abnormal FHR.Most of the trials had 'Risk of bias' concerns which means that these results should be interpreted with caution. Our GRADE assessments ranged from very low certainty to moderate certainty. Downgrading decisions were based on study limitations, imprecision and indirectness.Future research could account for all women randomised and, in particular, note those who delivered before the point at which they would be eligible for the intervention (i.e. those who had caesareans in the latent phase), or because labour was so rapid that the infusion could not be stopped in time.Future trials could adopt the outcomes listed in this review including maternal and neonatal mortality, maternal satisfaction, and breastfeeding.
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Trabalho de Parto Induzido , Ocitócicos/administração & dosagem , Ocitocina/administração & dosagem , Suspensão de Tratamento , Administração Intravenosa , Adulto , Cardiotocografia , Cesárea/estatística & dados numéricos , Corioamnionite/etiologia , Feminino , Sofrimento Fetal/prevenção & controle , Humanos , Análise de Intenção de Tratamento , Terceira Fase do Trabalho de Parto/fisiologia , Ocitócicos/efeitos adversos , Ocitocina/efeitos adversos , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto JovemRESUMO
Puerperal infection with Group A streptococcus (GAS) can present with few symptoms and rapidly progress to a life-threatening condition. Often, the infection can be treated with antibiotics. Delay in diagnosis increases risk of sepsis, multiorgan failure, and death. GAS infection is a differential diagnose for all postpartum women with unexplained symptoms.
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OBJECTIVE: The aim of this study was to investigate whether low-intensity extracorporeal shockwave therapy (LI-ESWT) can be used as a treatment for men with erectile dysfunction of organic origin. MATERIALS AND METHODS: This prospective, randomized, blinded, placebo-controlled study included 112 men unable to have intercourse either with or without medication. Erectile dysfunction was assessed at screening and 5, 12 and 24 weeks after treatment. Assessment was performed by interview and using the Erection Hardness Scale (EHS) and the International Index of Erectile Function (IIEF-15) questionnaire. The men were randomly assigned either to LI-ESWT (n = 51, active group) or placebo (n = 54, placebo group). They received five treatments over 5 weeks. Both the participants and the doctors were blinded to the treatment. After 10 weeks, the placebo group received active treatment (active placebo group). RESULTS: Twenty-nine men (57%, active group) were able to obtain an erection after treatment and to have sexual intercourse without the use of medication. In the placebo group, only five men (9%) showed similar results (p = 0.0001). The EHS after 5 weeks showed that men in the active group experienced a significant improvement in their erectile dysfunction, but no significant result was found with the use of the IIEF - Erectile Function domain. CONCLUSIONS: This placebo-controlled study over 5 weeks shows that 57% of the men who suffered from erectile dysfunction had an effect from LI-ESWT. After 24 weeks, seven (19%, active group) and nine (23%, active placebo group) men were still able to have intercourse without medication. This study shows a possible cure in some patients, but more research, longer follow-up in the placebo group and an international multicentre randomized study are needed.