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1.
Artigo em Inglês | MEDLINE | ID: mdl-38780492

RESUMO

BACKGROUND: Excess intravenous fluid for women requiring an induction of labour may adversely affect the duration of labour and maternal/neonatal outcomes. AIMS: This study aimed to determine the difference in duration of labour and outcomes with a low background infusion rate, compared to liberal background intravenous fluid management. MATERIALS AND METHODS: A double blind randomised controlled pilot study was performed on 200 women who underwent induction of labour at a single institution. Women were randomised to an intravenous rate of 40 mL/h versus 250 mL/h of Hartmann's solution. Fluid boluses were strictly controlled to limit bias. This trial was registered with the Australian clinical trial registry: ACTRN12621001298808. RESULTS: Analysis of the total amount of fluid received showed good separation with Group 1 (40 mL/h) receiving 1,736 mL less than Group 2 (250 mL/h), median (interquartile range) 841 mL (458, 1691) versus 2,577 mL (1620, 4326) (P < 0.001). Median duration of labour was shorter in Group 1 by 24 min (P = ns). Subset analysis of nulliparous women showed that duration of labour was shorter in Group 1 by 83.5 min (P = ns). CONCLUSION: As this was a pilot study, a significant difference in duration of labour or secondary outcomes was not seen. Given the increasing numbers of nulliparous women having an induction of labour, potential for adverse maternal and neonatal outcomes and the associated higher rate of operative birth, this study guides power calculations and supports proof of concept for future research into optimum fluid management during induction of labour for these women.

2.
Birth ; 2024 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-38173333

RESUMO

OBJECTIVE: To evaluate whether induction of labor (IOL) is associated with cesarean birth (CB) and perinatal mortality in uncomplicated first births at term compared with expectant management outside the confines of a randomized controlled trial. METHODS: Population-based retrospective cohort study of all births in Victoria, Australia, from 2010 to 2018 (n = 640,191). Preliminary analysis compared IOL at 37 weeks with expectant management at that gestational age and beyond for uncomplicated pregnancies. Similar comparisons were made for IOL at 38, 39, 40, and 41 weeks of gestation and expectant management. The primary analysis repeated these comparisons, limiting the population to nulliparous women with uncomplicated pregnancies and excluding those with a medical indication for IOL. We compared perinatal mortality between groups using Chi-square tests and multivariable logistic regression for all other comparisons. Adjusted odds ratios and 99% confidence intervals were reported. p < 0.01 denoted statistical significance. RESULTS: Among nulliparous, uncomplicated pregnancies at ≥37 weeks of gestation in Victoria, IOL increased from 24.6% in 2010 to 30.0% in 2018 (p < 0.001). In contrast to the preliminary analysis, the primary analysis showed that IOL in lower-risk nulliparous women was associated with increased odds of CB when performed at 38 (aOR 1.23(1.13-1.32)), 39 (aOR 1.31(1.23-1.40)), 40 (aOR 1.42(1.35-1.50)), and 41 weeks of gestation (aOR 1.43(1.35-1.51)). Perinatal mortality was rare in both groups and non-significantly lower in the induced group at most gestations. DISCUSSION: For lower-risk nulliparous women, the odds of CB increased with IOL from 38 weeks of gestation, along with decreased odds of perinatal mortality at 41 weeks only.

3.
J Paediatr Child Health ; 59(9): 1028-1034, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37294278

RESUMO

AIM: To explore the association between induction of labour at full-term gestations in low-risk nulliparous women and childhood school outcomes. METHODS: A retrospective whole-of-population cohort study linking perinatal data to educational test scores at grades 3, 5 and 7 in Victoria, Australia. Low-risk nulliparous women with singleton pregnancies induced at 39 and 40 weeks without a medical indication were compared to those expectantly managed from that week of gestation. Multivariable logistic regressions were used as well as generalised estimating equations on longitudinal data. RESULTS: At 39 weeks, there were 3687 and 103 164 infants in the induction and expectant arms, respectively. At 40 weeks' gestation, there were 7914 and 70 280 infants, respectively. Infants born to nulliparous women induced at 39 weeks' gestation had significantly poorer educational outcomes at grade 3 (adjusted odds ratio (aOR) = 1.39, 95% confidence interval (CI): 1.13-1.70) but not grades 5 (aOR = 1.05, 95% CI: 0.84-1.33) and 7 (aOR = 1.07, 95% CI: 0.81-1.40) compared to those expectantly managed. Infants born to nulliparous women induced at 40 weeks had comparable educational outcomes at grade 3 (aOR = 1.06, 95% CI: 0.90-1.25) but poorer educational outcomes at grades 5 (aOR = 1.23, 95% CI: 1.05-1.43) and 7 (aOR = 1.23, 95% CI: 1.03-1.47) compared to those expectantly managed. CONCLUSIONS: There were inconsistent associations between elective induction of labour at full-term gestations in low-risk nulliparous women and impaired childhood school outcomes.


Assuntos
Cesárea , Trabalho de Parto Induzido , Gravidez , Lactente , Criança , Feminino , Humanos , Estudos de Coortes , Estudos Retrospectivos , Modelos Logísticos , Instituições Acadêmicas , Vitória
4.
Eur Respir J ; 60(5)2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-35777773

RESUMO

INTRODUCTION: Asthma exacerbations in pregnancy are associated with adverse perinatal outcomes. We aimed to determine whether fractional exhaled nitric oxide (F ENO)-based asthma management improves perinatal outcomes compared to usual care. METHODS: The Breathing for Life Trial was a multicentre, parallel-group, randomised controlled trial conducted in six hospital antenatal clinics, which compared asthma management guided by F ENO (adjustment of asthma treatment according to exhaled nitric oxide and symptoms each 6-12 weeks) to usual care (no treatment adjustment as part of the trial). The primary outcome was a composite of adverse perinatal events (preterm birth, small for gestational age (SGA), perinatal mortality or neonatal hospitalisation) assessed using hospital records. Secondary outcomes included maternal asthma exacerbations. Concealed random allocation, stratified by study site and self-reported smoking status was used, with blinded outcome assessment and statistical analysis (intention to treat). RESULTS: Pregnant women with current asthma were recruited; 599 to the control group (608 infants) and 601 to the intervention (615 infants). There were no significant group differences for the primary composite perinatal outcome (152 (25.6%) out of 594 control, 177 (29.4%) out of 603 intervention; OR 1.21, 95% CI 0.94-1.56; p=0.15), preterm birth (OR 1.14, 95% CI 0.78-1.68), SGA (OR 1.06, 95% CI 0.78-1.68), perinatal mortality (OR 3.62, 95% CI 0.80-16.5), neonatal hospitalisation (OR 1.24, 95% CI 0.89-1.72) or maternal asthma exacerbations requiring hospital admission or emergency department presentation (OR 1.19, 95% CI 0.69-2.05). CONCLUSION: F ENO-guided asthma pharmacotherapy delivered by a nurse or midwife in the antenatal clinic setting did not improve perinatal outcomes.


Assuntos
Asma , Nascimento Prematuro , Lactente , Feminino , Recém-Nascido , Gravidez , Humanos , Óxido Nítrico , Expiração , Asma/tratamento farmacológico , Respiração
5.
Pilot Feasibility Stud ; 7(1): 214, 2021 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-34876233

RESUMO

BACKGROUND: A new wireless and beltless monitoring device utilising fetal and maternal electrocardiography (ECG) and uterine electromyography, known as 'non-invasive fetal ECG' (NIFECG) was registered for clinical use in Australia in 2018. The safety and reliability of NIFECG has been demonstrated in controlled settings for short periods during labour. As far as we are aware, at the time our study commenced, this was globally the first trial of such a device in an authentic clinical setting for the entire duration of a woman's labour. METHODS: This study aimed to assess the feasibility of using NIFECG fetal monitoring for women undergoing continuous electronic fetal monitoring during labour and birth. Women were eligible to participate in the study if they were at 36 weeks gestation or greater with a singleton pregnancy, planning to give birth vaginally and with obstetric indications as per local protocol (NSW Health Fetal Heart Rate Monitoring Guideline GL2018_025. 2018) for continuous intrapartum fetal monitoring. Written informed consent was received from participating women in antenatal clinic prior to the onset of labour. This single site clinical feasibility study took place between January and July 2020 at the Royal Hospital for Women in Sydney, Australia. Quantitative and qualitative data were collected to inform the analysis of results using the NASSS (Non-adoption, Abandonment, Scale up, Spread and Sustainability) framework, a validated tool for analysing the implementation of new health technologies into clinical settings. RESULTS: Women responded positively about the comfort and freedom of movement afforded by the NIFECG. Midwives reported that when no loss of contact occurred, the device enabled them to focus less on the technology and more on supporting women's physical and emotional needs during labour. Midwives and obstetricians noticed the benefits for women but expressed a need for greater certainty about the reliability of the signal. CONCLUSION: The NIFECG device enables freedom of movement and positioning for labouring women and was well received by women and the majority of clinicians. Whilst measurement of the uterine activity was reliable, there was uncertainty for clinicians in relation to loss of contact of the fetal heart rate. If this can be ameliorated the device shows potential to be used as routinely as cardiotocography (CTG) for fetal monitoring. This is the first time the NASSS framework has been used to synthesise the implementation needs of a health technology in the care of women during labour and birth. Our findings contribute new knowledge about the determinants for implementation of a complex technology in a maternity care setting. TRIAL REGISTRATION: The Universal Trial Number is reU1111-1228-9845 and the Australian and New Zealand Clinical Trial Registration Number is 12619000293167p. Trial registration occurred on the 20 February, 2019. The trial protocol may be viewed at http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377027.

6.
BMJ Open ; 11(6): e047040, 2021 05 31.
Artigo em Inglês | MEDLINE | ID: mdl-34059509

RESUMO

OBJECTIVES: We compared intrapartum interventions and outcomes for mothers, neonates and children up to 16 years, for induction of labour (IOL) versus spontaneous labour onset in uncomplicated term pregnancies with live births. DESIGN: We used population linked data from New South Wales, Australia (2001-2016) for healthy women giving birth at 37+0 to 41+6 weeks. Descriptive statistics and logistic regression were performed for intrapartum interventions, postnatal maternal and neonatal outcomes, and long-term child outcomes adjusted for maternal age, country of birth, socioeconomic status, parity and gestational age. RESULTS: Of 474 652 included births, 69 397 (15%) had an IOL for non-medical reasons. Primiparous women with IOL versus spontaneous onset differed significantly for: spontaneous vaginal birth (42.7% vs 62.3%), instrumental birth (28.0% vs 23.9%%), intrapartum caesarean section (29.3% vs 13.8%), epidural (71.0% vs 41.3%), episiotomy (41.2% vs 30.5%) and postpartum haemorrhage (2.4% vs 1.5%). There was a similar trend in outcomes for multiparous women, except for caesarean section which was lower (5.3% vs 6.2%). For both groups, third and fourth degree perineal tears were lower overall in the IOL group: primiparous women (4.2% vs 4.9%), multiparous women (0.7% vs 1.2%), though overall vaginal repair was higher (89.3% vs 84.3%). Following induction, incidences of neonatal birth trauma, resuscitation and respiratory disorders were higher, as were admissions to hospital for infections (ear, nose, throat, respiratory and sepsis) up to 16 years. There was no difference in hospitalisation for asthma or eczema, or for neonatal death (0.06% vs 0.08%), or in total deaths up to 16 years. CONCLUSION: IOL for non-medical reasons was associated with higher birth interventions, particularly in primiparous women, and more adverse maternal, neonatal and child outcomes for most variables assessed. The size of effect varied by parity and gestational age, making these important considerations when informing women about the risks and benefits of IOL.


Assuntos
Cesárea , Web Semântica , Austrália , Criança , Feminino , Humanos , Recém-Nascido , Trabalho de Parto Induzido , New South Wales/epidemiologia , Parto , Gravidez
7.
Am J Obstet Gynecol MFM ; 3(2): 100306, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33418103

RESUMO

BACKGROUND: Persistent occiput posterior position in labor is associated with adverse maternal and perinatal outcomes. Prophylactic manual rotation from the occiput posterior position to the occiput anterior position in the second stage of labor is considered a safe and easy to perform procedure that in observational studies has shown promise as a method for preventing operative deliveries. OBJECTIVE: This study aimed to determine the efficacy of prophylactic manual rotation in the management of occiput posterior position for preventing operative delivery. The hypothesis was that among women who are at least 37 weeks pregnant and whose baby is in the occiput posterior position early in the second stage of labor, manual rotation will reduce the rate of operative delivery compared with the "sham" rotation. STUDY DESIGN: A double-blinded, parallel, superiority, multicenter, randomized controlled clinical trial in 4 tertiary hospitals was conducted in Australia. A total of 254 nulliparous and parous women with a term pregnancy and a baby in the occiput posterior position in the second stage of labor were randomly assigned to receive either a prophylactic manual rotation (n=127) or a sham rotation (n=127). The primary outcome was operative delivery (cesarean, forceps, or vacuum delivery). Secondary outcomes were cesarean delivery, combined maternal mortality and serious morbidity, and combined perinatal mortality and serious morbidity. Analysis was by intention to treat. Proportions were compared using chi-square tests adjusted for stratification variables using the Mantel-Haenszel method or the Fisher exact test. Planned subgroup analyses by operator experience and by manual rotation technique (digital or whole-hand rotation) were performed. RESULTS: Operative delivery occurred in 79 of 127 women (62%) assigned to prophylactic manual rotation and 90 of 127 women (71%) assigned to sham rotation (common risk difference, 12; 95% confidence interval, -1.7 to 26; P=.09). Among more experienced operators or investigators, operative delivery occurred in 46 of 74 women (62%) assigned to manual rotation and 52 of 71 women (73%) assigned to a sham rotation (common risk difference, 18; 95% confidence interval, -0.5 to 36; P=.07). Cesarean delivery occurred in 22 of 127 women (17%) in both groups. Instrumental delivery (forceps or vacuum) occurred in 57 of 127 women (45%) assigned to prophylactic manual rotation and 68 of 127 women (54%) assigned to sham rotation (common risk difference, 10; 95% confidence interval, -3.1 to 22; P=.14). There was no significant difference in the combined maternal and perinatal outcomes. CONCLUSION: Prophylactic manual rotation did not result in a reduction in the rate of operative delivery. Given manual rotation was associated with a nonsignificant reduction in operative delivery, more randomized trials are needed, as our trial might have been underpowered. In addition, further research is required to further explore the potential impact of operator or investigator experience.


Assuntos
Apresentação no Trabalho de Parto , Complicações do Trabalho de Parto , Austrália , Feminino , Humanos , Gravidez , Rotação , Ultrassonografia Pré-Natal
8.
BMC Pregnancy Childbirth ; 20(1): 245, 2020 Apr 25.
Artigo em Inglês | MEDLINE | ID: mdl-32334562

RESUMO

BACKGROUND: Bimanual clot evacuation (BCE) is a simple clinical manoeuvre that may reduce need for surgical intervention in the management of severe postpartum haemorrhage (PPH). We sought to determine whether performing BCE in cases of severe PPH after vaginal birth reduces the need for surgical intervention. METHODS: A retrospective chart review of women who delivered vaginally with a severe PPH between January 1, 2011 and December 31, 2014 in a single tertiary women's hospital in Sydney, Australia was conducted. Severe PPH was classified as a blood loss ≥1000mls. The need for surgical management (including operating theatre uterine exploration or evacuation, intrauterine balloon tamponade, repair of significant trauma, uterine or internal iliac artery ligation, B-Lynch suture insertion or hysterectomy) was the primary outcome measure, as expressed by need for operating theatre utilisation. RESULTS: From a cohort of 438, 149 women (34.0%) had BCE, of whom 29 (19.5%) required surgical management compared to 103 of 289 women with no BCE (35.6%); an odds ratio (OR) of 0.38 for BCE (confidence interval 0.20-0.72; p = 0.003). Early BCE (< 1 h of delivery) was associated with a further reduction in surgery (OR 0.24; confidence interval 0.08-0.70; p = 0.009) compared to late BCE (> 1 h of delivery). There was no reduction in estimated blood loss (p = 0.86) or blood transfusion (p = 0.71) with BCE. CONCLUSION: Our study suggests BCE reduces theatre utilisation in the context of severe PPH following vaginal delivery. Prospective trials are needed to determine whether BCE should be endorsed as a treatment modality for PPH post-vaginal delivery.


Assuntos
Parto Obstétrico/efeitos adversos , Trombólise Mecânica/métodos , Hemorragia Pós-Parto/terapia , Adulto , Austrália/epidemiologia , Transfusão de Sangue/estatística & dados numéricos , Feminino , Humanos , Procedimentos Cirúrgicos Obstétricos/estatística & dados numéricos , Gravidez , Estudos Retrospectivos
11.
BMC Pregnancy Childbirth ; 17(1): 236, 2017 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-28728552

RESUMO

BACKGROUND: Studies examining psychosocial and depression assessment programs in maternity settings have not adequately considered the context in which psychosocial assessment occurs or how broader components of integrated care, including clinician decision-making aids, may optimise program delivery and its cost-effectiveness. There is also limited evidence relating to the diagnostic accuracy of symptom-based screening measures used in this context. The Perinatal Integrated Psychosocial Assessment (PIPA) Project was developed to address these knowledge gaps. The primary aims of the PIPA Project are to examine the clinical- and cost-effectiveness of two alternative models of integrated psychosocial care during pregnancy: 'care as usual' (the SAFE START model) and an alternative model (the PIPA model). The acceptability and perceived benefit of each model of care from the perspective of both pregnant women and their healthcare providers will also be assessed. Our secondary aim is to examine the psychometric properties of a number of symptom-based screening tools for depression and anxiety when used in pregnancy. METHODS: This is a comparative-effectiveness study comparing 'care as usual' to an alternative model sequentially over two 12-month periods. Data will be collected from women at Time 1 (initial antenatal psychosocial assessment), Time 2 (2-weeks after Time 1) and from clinicians at Time 3 for each condition. Primary aims will be evaluated using a between-groups design, and the secondary aim using a within group design. DISCUSSION: The PIPA Project will provide evidence relating to the clinical- and cost- effectiveness of psychosocial assessment integrated with electronic clinician decision making prompts, and referral options that are tailored to the woman's psychosocial risk, in the maternity care setting. It will also address research recommendations from the Australian (2011) and NICE (2015) Clinical Practice Guidelines. TRIAL REGISTRATION: ACTRN12617000932369.


Assuntos
Ansiedade/diagnóstico , Depressão/diagnóstico , Assistência Perinatal/métodos , Complicações na Gravidez/diagnóstico , Avaliação de Sintomas/métodos , Protocolos Clínicos , Pesquisa Comparativa da Efetividade , Análise Custo-Benefício , Sistemas de Apoio a Decisões Clínicas/economia , Feminino , Humanos , Assistência Perinatal/economia , Gravidez , Complicações na Gravidez/psicologia , Psicometria , Avaliação de Sintomas/economia
13.
Midwifery ; 44: 41-47, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27889682

RESUMO

OBJECTIVE: the outcomes of the Term Breech Trial had a profound impact on women's options for breech birth, with caesarean section now seen as the default method for managing breech birth by many clinicians. Despite this, the demand for planned vaginal breech birth from women does exist. This study aimed to examine the experiences of women who sought a vaginal breech birth to increase understanding as to how to care for women seeking this birth option. DESIGN: an electronic survey was distributed to women online via social media. The survey consisted of qualitative and quantitative questions, with the qualitative data being the focus of this paper. Open ended questions sought information on the ways in which woman sourced a clinician skilled in vaginal breech birth and the level of support and quality of information provided from clinicians regarding vaginal breech birth. Thematic analysis was used to analyse and code the qualitative data into major themes. FINDINGS: in total, 204 women from over seven countries responded to the survey. Written responses to the open ended questions were categorised into seven themes: Seeking the chance to try for a VBB; Encountering coercion and fear; Putting the birth before the baby?; Dealing with emotional wounds; Searching for information and support; Traveling across boundaries; Overcoming obstacles in the system. KEY CONCLUSIONS: for women seeking vaginal breech birth, limited system and clinical support can impede access to balanced information and options for care. Recognition of existing evidence on the safety of vaginal breech birth, as well as the presence of clinical guidelines that support it, may assist in promoting vaginal breech birth as a legitimate option that should be available to women.


Assuntos
Apresentação Pélvica/psicologia , Acontecimentos que Mudam a Vida , Mães/psicologia , Adulto , Cesárea/psicologia , Tomada de Decisões , Medo/psicologia , Feminino , Humanos , Gravidez , Complicações na Gravidez/psicologia , Pesquisa Qualitativa , Estresse Psicológico/etiologia , Estresse Psicológico/psicologia , Inquéritos e Questionários
15.
Birth ; 43(4): 353-357, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27549572

RESUMO

OBJECTIVE: The aim of this study was to explore the experiences of women who planned a vaginal breech birth. METHOD: An online survey was developed consisting of questions regarding women's experiences surrounding planned vaginal breech birth. The survey was distributed between April 2014 and January 2015 to closed membership Facebook groups that had a consumer focus on vaginal breech birth. RESULTS: In total, 204 unique responses to the survey were obtained from women who had sought the option of a vaginal breech birth in a previous pregnancy. Most women (80.8%) stated that they were happy with the birth choices they made, and a significant proportion (89.4%) would attempt a vaginal breech birth in subsequent pregnancies. Less than half of women were formally referred to a clinician skilled in vaginal breech birth when their baby was diagnosed breech (41.8%), while the remainder sourced a clinician themselves. Half of the women felt supported by their care provider (56.7%) and less than half (42.3%) felt supported by family and friends. CONCLUSION: The women who responded to this international survey sought the option of a vaginal breech birth, were subsequently happy with this decision, and would attempt a vaginal breech birth in their next pregnancy. Access to vaginal breech birth is important for some women; however, this choice may be challenging to achieve. Consistent information and support from clinicians is important to assist decision-making.


Assuntos
Apresentação Pélvica/psicologia , Cesárea/psicologia , Parto/psicologia , Adulto , Tomada de Decisões , Família/psicologia , Feminino , Humanos , Gravidez , Relações Profissional-Paciente , Pesquisa Qualitativa , Mídias Sociais , Inquéritos e Questionários
18.
BMC Pregnancy Childbirth ; 16: 111, 2016 05 17.
Artigo em Inglês | MEDLINE | ID: mdl-27189595

RESUMO

BACKGROUND: Asthma exacerbations are common during pregnancy and associated with an increased risk of adverse perinatal outcomes. Adjusting asthma treatment based on airway inflammation rather than symptoms reduces the exacerbation rate by 50 %. The Breathing for Life Trial (BLT) will test whether this approach also improves perinatal outcomes. METHODS/DESIGN: BLT is a multicentre, parallel group, randomised controlled trial of asthma management guided by fractional exhaled nitric oxide (FENO, a marker of eosinophilic airway inflammation) compared to usual care, with prospective infant follow-up. Women with physician-diagnosed asthma, asthma symptoms and/or medication use in the previous 12 months, who are 12-22 weeks gestation, will be eligible for inclusion. Women randomised to the control group will have one clinical assessment of their asthma, including self-management education. Any treatment changes will be made by their general practitioner. Women randomised to the intervention group will have clinical assessments every 3-6 weeks during pregnancy, and asthma treatments will be adjusted every second visit based on an algorithm which uses FENO to adjust inhaled corticosteroid (ICS) dose (increase in dose when FENO >29 parts per billion (ppb), decrease in dose when FENO <19 ppb, and no change when FENO is between 19 and 29 ppb). A long acting beta agonist (LABA) will be added when symptoms remain uncontrolled. Both the control and intervention groups will report on exacerbations at a postpartum phone interview. The primary outcome is adverse perinatal outcome (a composite measure including preterm birth, intrauterine growth restriction, neonatal hospitalisation at birth or perinatal mortality), assessed from hospital records. Secondary outcomes will be each component of the primary outcome, maternal exacerbations requiring medical intervention during pregnancy (both smokers and non-smokers), and hospitalisation and emergency department presentation for wheeze, bronchiolitis or croup in the first 12 months of infancy. Outcome assessment and statistical analysis of the primary outcome will be blinded. To detect a reduction in adverse perinatal outcomes from 35 % to 26 %, 600 pregnant women with asthma per group are required. DISCUSSION: This trial will provide evidence for the effectiveness of a FENO-based management strategy in improving perinatal outcomes in pregnant women with asthma. If successful, this would improve the management of pregnant women with asthma worldwide. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12613000202763 .


Assuntos
Corticosteroides/administração & dosagem , Asma/tratamento farmacológico , Expiração/fisiologia , Óxido Nítrico/metabolismo , Complicações na Gravidez/tratamento farmacológico , Terapia Respiratória/métodos , Administração por Inalação , Adulto , Asma/fisiopatologia , Testes Respiratórios , Protocolos Clínicos , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Exposição Materna/efeitos adversos , Óxido Nítrico/análise , Gravidez , Complicações na Gravidez/fisiopatologia , Resultado da Gravidez , Efeitos Tardios da Exposição Pré-Natal/induzido quimicamente , Resultado do Tratamento , Adulto Jovem
19.
Trials ; 16: 362, 2015 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-26282668

RESUMO

BACKGROUND: Fetal occiput transverse position in the form of deep transverse arrest has long been associated with caesarean section and instrumental vaginal delivery. Occiput transverse position incidentally found in the second stage of labour is also associated with operative delivery in high risk cohorts. There is evidence from cohort studies that prophylactic manual rotation reduces the caesarean section rate. This is a protocol for a double blind, multicentre, randomised, controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate. METHODS/DESIGN: Eligible participants will be ≥37 weeks pregnant, with a singleton pregnancy, and a cephalic presentation in the occiput transverse position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 49%, for a reduction to 35%, an alpha value of 0.05 and a beta value of 0.2, 416 participants will need to be enrolled. Participants will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery. Secondary outcomes will be caesarean section, significant maternal mortality and morbidity, and significant perinatal mortality and morbidity. Analysis will be on an intention-to-treat basis. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, (protocol number: X110410). DISCUSSION: This trial addresses an important clinical question concerning a commonly used procedure which has the potential to reduce operative delivery and its associated complications. Some issues discussed in the protocol include methods of assessing risk of bias due to inadequate masking of a procedural interventions, variations in intervention efficacy due to operator experience and the recruitment difficulties associated with intrapartum studies. TRIAL REGISTRATION: This trial was registered with the Australian New Zealand Clinical Trials Registry (identifier: ACTRN12613000005752 ) on 4 January 2013.


Assuntos
Complicações do Trabalho de Parto/terapia , Versão Fetal/métodos , Adolescente , Adulto , Cesárea , Distribuição de Qui-Quadrado , Protocolos Clínicos , Método Duplo-Cego , Extração Obstétrica/instrumentação , Feminino , Idade Gestacional , Mortalidade Hospitalar , Humanos , Lactente , Mortalidade Infantil , Análise de Intenção de Tratamento , Segunda Fase do Trabalho de Parto , Modelos Logísticos , Mortalidade Materna , New South Wales , Complicações do Trabalho de Parto/diagnóstico , Complicações do Trabalho de Parto/mortalidade , Complicações do Trabalho de Parto/fisiopatologia , Gravidez , Projetos de Pesquisa , Fatores de Risco , Rotação , Austrália do Sul , Resultado do Tratamento , Ultrassonografia Pré-Natal , Versão Fetal/efeitos adversos , Versão Fetal/mortalidade , Adulto Jovem
20.
BMC Pregnancy Childbirth ; 15: 89, 2015 Apr 11.
Artigo em Inglês | MEDLINE | ID: mdl-25885035

RESUMO

BACKGROUND: In many countries, planned vaginal breech birth (VBB) is a rare event. After the Term Breech Trial in 2000, VBB reduced and caesarean section for breech presentation increased. Despite this, women still request VBB. The objective of this study was to explore the experiences and decision-making processes of women who had sought a VBB. METHODS: A qualitative study using descriptive exploratory design was undertaken. Twenty-two (n = 22) women who planned a VBB, regardless of eventual mode of birth were recruited. The women had given birth at one of two maternity hospitals in Australia that supported VBB. In-depth, semi-structured interviews using an interview guide were conducted. Interviews were analysed thematically. RESULTS: Twenty two women were interviewed; three quarters were primiparous (n = 16; 73%). Nine (41%) were already attending a hospital that supported VBB with the remaining women moving hospitals. All women actively sought a vaginal breech birth because the baby remained breech after an external cephalic version - 12 had a vaginal birth (55%) and 10 (45%) a caesarean section after labour commenced. There were four main themes: Reacting to a loss of choice and control, Wanting information that was trustworthy, Fighting the system and seeking support for VBB and The importance of 'having a go' at VBB. CONCLUSIONS: Women seeking a VBB value clear, consistent and relevant information in deciding about mode of birth. Women desire autonomy to choose vaginal breech birth and to be supported in their choice with high quality care.


Assuntos
Apresentação Pélvica , Cesárea , Tomada de Decisões , Letramento em Saúde , Parto/psicologia , Versão Fetal , Adulto , Austrália , Apresentação Pélvica/psicologia , Apresentação Pélvica/cirurgia , Apresentação Pélvica/terapia , Cesárea/métodos , Cesárea/psicologia , Feminino , Humanos , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Relações Médico-Paciente , Gravidez , Pesquisa Qualitativa , Versão Fetal/métodos , Versão Fetal/psicologia
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