Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 1.234
Filtrar
1.
BMC Res Notes ; 14(1): 355, 2021 Sep 10.
Artigo em Inglês | MEDLINE | ID: mdl-34507611

RESUMO

OBJECTIVES: Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013-15. DATA DESCRIPTION: This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare.


Assuntos
Hipertensão , Misoprostol , Ocitócicos , Cateteres , Maturidade Cervical , Feminino , Humanos , Índia , Recém-Nascido , Trabalho de Parto Induzido , Gravidez
2.
Front Public Health ; 9: 689115, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34222185

RESUMO

Objective: Out-of-hospital (outpatient) cervical ripening prior to induction of labor (IOL) is discussed for its potential to decrease the burden on hospital resources. We assessed the cost and clinical outcomes of adopting an outpatient strategy with a synthetic hygroscopic cervical dilator, which is indicated for use in preinduction cervical ripening. Methods: We developed a cost-consequence model from the hospital perspective with a time period from IOL to post-delivery discharge. A hypothetical cohort of women to undergo IOL at term with an unfavorable cervix (all risk levels) were assessed. As the standard of care (referred to as IP-only) all women were ripened as inpatients using the vaginal PGE2 insert or the single-balloon catheter. In the comparison (OP-select), 50.9% of low-risk women (41.4% of the study population) received outpatient cervical ripening using a synthetic hygroscopic cervical dilator and the remaining women were ripened as inpatients as in the standard of care. Model inputs were sourced from a structured literature review of peer-reviewed articles in PubMed. Testing of 2,000 feasible scenarios (probabilistic multivariate sensitivity analysis) ascertained the robustness of results. Outcomes are reported as the average over all women assessed, comparing OP-select to IP-only. Results: Implementing OP-select resulted in hospital savings of US$689 per delivery, with women spending 1.48 h less time in the labor and delivery unit and 0.91 h less in the postpartum recovery unit. The cesarean-section rate was decreased by 3.78 percentage points (23.28% decreased to 19.50%). In sensitivity testing, hospital costs and cesarean-section rate were reduced in 91% of all instances. Conclusion: Our model analysis projects that outpatient cervical ripening has the potential to reduce hospital costs, hospital stay, and the cesarean section rate. It may potentially allow for better infection-prevention control during the ongoing COVID-19 pandemic and to free up resources such that more women might be offered elective IOL at 39 weeks.


Assuntos
COVID-19 , Maturidade Cervical , Colo do Útero , Cesárea , Feminino , Custos Hospitalares , Hospitais , Humanos , Trabalho de Parto Induzido , Pandemias , Gravidez , SARS-CoV-2 , Estados Unidos
3.
Eur J Obstet Gynecol Reprod Biol ; 263: 148-152, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34214801

RESUMO

OBJECTIVE: The aims of this study are to assess (changes in) local procedures for inpatient cervical priming as part of induction of labor and to identify the implementation of outpatient cervical priming in the Netherlands. METHODS: This survey study was conducted from October 2019 until January 2020; obstetricians of all 72 hospitals with a maternity unit in the Netherlands received a questionnaire. The questionnaire consisted of three parts: basic hospital data, local protocol on methods of inpatient induction of labor (IPI), local protocol for outpatient induction of labor (OPI). RESULTS: A response was received from 66/72 hospitals, giving a response rate of 92%. For IPI the most preferred method was a Foley catheter (87.9%), 27.6% protocols switched to prostaglandins after day 1 if the cervix was not ripe yet. A prostaglandin gel or pessary was not the preferred method on day 1 but only used after 24 h in 5 hospitals (7.6%). OPI was offered in 53% (35/66 hospitals), all using a Foley catheter. CONCLUSION: In the Netherlands, local protocols for IPI have shifted towards the use of a Foley catheter. More than half of the hospitals offer OPI. As safety and efficacy data of OPI are lacking, research on this topic is urgently warranted.


Assuntos
Maturidade Cervical , Pacientes Ambulatoriais , Feminino , Humanos , Pacientes Internados , Trabalho de Parto Induzido , Países Baixos , Gravidez , Inquéritos e Questionários
4.
J Obstet Gynaecol Res ; 47(9): 3171-3178, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34162016

RESUMO

AIM: To compare the efficacy and safety of dinoprostone vaginal insert (DVI) alone versus DVI with adjunctive sweeping of membranes (ASM) for induction of labor (IOL). METHODS: Single-center, prospective, randomized controlled trial; women with singleton term pregnancies, cervical dilation ≥1 and <3 cm, intact membranes allocated to either DVI or DVI with ASM. The primary outcome was vaginal delivery within 24 h of insertion. Secondary outcomes included mean time from insertion to delivery, tachysystole, operative delivery for non-reassuring fetal status (NRFS), tocolytics, fetal outcomes, pain information, and subject satisfaction. RESULTS: One hundred and four received DVI (Group 1) alone and 104 DVI with ASM (Group 2). The rate of vaginal delivery within 24 h was 53% versus 56%, cesarean rate 8.7% versus 10.6% in Groups 1 and 2 respectively. Although the duration of labor was similar in both groups, about 6% of women required additional ripening with dinoprostone vaginal tablets in Group 2 compared to 11.5% in Group 1 (p-value = 0.2). The frequency of hyperstimulation syndrome, failed induction, analgesic requirements, and fetal outcomes were comparable. The majority (83%-86%) in either cohort were satisfied with their labor experience. Multivariate logistic regression demonstrated a slightly better chance for vaginal delivery within 24 h (odds ratio [OR] 1.22 [95% confidence interval, CI 0.65-2.29]; p-value 0.53] for DVI with ASM, although statistically insignificant. Younger maternal age and multiparity (OR 10.36 [95% CI 4.88-23.67]; p-value <0.0001) contributed to successful IOL. CONCLUSION: DVI with ASM is at least as efficacious as DVI for cervical ripening with no increase in morbidity. Although DVI with ASM group less often needed additional dinoprostone tablets to complete the process of IOL (p-value = 0.2), adjunctive sweeping has not been shown to have a significant impact on the duration of labor or mode of delivery.


Assuntos
Misoprostol , Ocitócicos , Administração Intravaginal , Maturidade Cervical , Dinoprostona , Feminino , Humanos , Trabalho de Parto Induzido , Gravidez , Estudos Prospectivos
5.
J Midwifery Womens Health ; 66(4): 459-469, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33984171

RESUMO

Induction of labor is increasingly a common component of the intrapartum care. Knowledge of the current evidence on methods of labor induction is an essential component of shared decision-making to determine which induction method meets an individual's health needs and personal preferences. This article provides a review of the current research evidence on labor induction methods, including cervical ripening techniques, and contraction stimulation techniques. Current evidence about expected duration of labor following induction, use of the Bishop score to guide induction, and guidance on the use of combination methods for labor induction are reviewed.


Assuntos
Trabalho de Parto Induzido , Ocitócicos , Maturidade Cervical , Feminino , Humanos , Ocitocina , Gravidez
6.
BMJ Open ; 11(5): e050452, 2021 05 04.
Artigo em Inglês | MEDLINE | ID: mdl-33947741

RESUMO

INTRODUCTION: The aim of the cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study is to compare home versus in-hospital cervical ripening to determine whether home cervical ripening is safe (for the primary outcome of neonatal unit (NNU) admission), acceptable to women and cost-effective from the perspective of both women and the National Health Service (NHS). METHODS AND ANALYSIS: We will perform a prospective multicentre observational cohort study with an internal pilot phase. We will obtain data from electronic health records from at least 14 maternity units offering only in-hospital cervical ripening and 12 offering dinoprostone home cervical ripening. We will also conduct a cost-effectiveness analysis and a mixed methods study to evaluate processes and women/partner experiences. Our primary sample size is 8533 women with singleton pregnancies undergoing induction of labour (IOL) at 39+0 weeks' gestation or more. To achieve this and contextualise our findings, we will collect data relating to a cohort of approximately 41 000 women undergoing IOL after 37 weeks. We will use mixed effects logistic regression for the non-inferiority comparison of NNU admission and propensity score matched adjustment to control for treatment indication bias. The economic analysis will be undertaken from the perspective of the NHS and Personal Social Services (PSS) and the pregnant woman. It will include a within-study cost-effectiveness analysis and a lifetime cost-utility analysis to account for any long-term impacts of the cervical ripening strategies. Outcomes will be reported as incremental cost per NNU admission avoided and incremental cost per quality adjusted life year gained. RESEARCH ETHICS APPROVAL AND DISSEMINATION: CHOICE has been funded and approved by the National Institute of Healthcare Research Health Technology and Assessment, and the results will be disseminated via publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN32652461.


Assuntos
Maturidade Cervical , Medicina Estatal , Estudos de Coortes , Feminino , Hospitais , Humanos , Recém-Nascido , Estudos Observacionais como Assunto , Gravidez , Estudos Prospectivos
7.
BMC Pregnancy Childbirth ; 21(1): 310, 2021 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-33874913

RESUMO

BACKGROUND: Induction of labour (IOL) is one of the most commonly performed interventions in maternity care, with outpatient cervical ripening increasingly offered as an option for women undergoing IOL. The COVID-19 pandemic has changed the context of practice and the option of returning home for cervical ripening may now assume greater significance. This work aimed to examine whether and how the COVID-19 pandemic has changed practice around IOL in the UK. METHOD: We used an online questionnaire to survey senior obstetricians and midwives at all 156 UK NHS Trusts and Boards that currently offer maternity services. Responses were analysed to produce descriptive statistics, with free text responses analysed using a conventional content analysis approach. FINDINGS: Responses were received from 92 of 156 UK Trusts and Boards, a 59% response rate. Many Trusts and Boards reported no change to their IOL practice, however 23% reported change in methods used for cervical ripening; 28% a change in criteria for home cervical ripening; 28% stated that more women were returning home during cervical ripening; and 24% noted changes to women's response to recommendations for IOL. Much of the change was reported as happening in response to attempts to minimise hospital attendance and restrictions on birth partners accompanying women. CONCLUSIONS: The pandemic has changed practice around induction of labour, although this varied significantly between NHS Trusts and Boards. There is a lack of formal evidence to support decision-making around outpatient cervical ripening: the basis on which changes were implemented and what evidence was used to inform decisions is not clear.


Assuntos
Atitude do Pessoal de Saúde , COVID-19 , Maturidade Cervical , Procedimentos Clínicos , Trabalho de Parto Induzido , Adulto , Assistência Ambulatorial/métodos , COVID-19/epidemiologia , COVID-19/prevenção & controle , Tomada de Decisão Clínica , Procedimentos Clínicos/organização & administração , Procedimentos Clínicos/tendências , Feminino , Humanos , Controle de Infecções/métodos , Trabalho de Parto Induzido/métodos , Trabalho de Parto Induzido/tendências , Serviços de Saúde Materna/tendências , Inovação Organizacional , Formulação de Políticas , Gravidez , Inquéritos e Questionários , Reino Unido
8.
Am J Obstet Gynecol MFM ; 3(4): 100343, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33652160

RESUMO

BACKGROUND: Pregnancies complicated by hypertensive disease of pregnancy often require labor induction. Rates of cesarean delivery range from 15% to 60% in this population. Nitric oxide deficiency has been shown to underlay the pathophysiology of preeclampsia, and nitric oxide promotes cervical ripening. OBJECTIVE: We hypothesized that addition of vaginal isosorbide mononitrate for labor induction could decrease the rate of cesarean delivery in pregnancies with hypertensive disease of pregnancy. STUDY DESIGN: This study was a double-blind, placebo-controlled, randomized trial of patients with singleton pregnancy at ≥24 weeks' gestation undergoing labor induction for hypertensive diseases of pregnancy between November 2017 and February 2020. Participants were eligible if their Bishop score was <6 and if their cervical dilation was ≤2 cm. In addition, participants received up to 3 doses of 40 mg isosorbide mononitrate in addition to misoprostol for labor induction. Labor management was per healthcare provider preference. The primary outcome was rate of cesarean delivery. Secondary outcomes included the length of labor and frequency of intrapartum adverse events, including the use of intrapartum antihypertensive agents. RESULTS: 89 women were randomized to the isosorbide mononitrate group, and 87 women were randomized to the placebo group. Cesarean delivery rates were similar in both groups (32.6% vs 25.3%; relative risk, 1.29; 95% confidence interval, 0.81-2.06; P=.39). Maternal headache was increased in patients exposed to isosorbide mononitrate (42.7% vs 31%; relative risk, 1.52; 95% confidence interval, 1.04-2.23; P=.04). Clinical chorioamnionitis was increased in the placebo group (0% vs 8%; P=.02). Secondary outcomes were similar between groups. CONCLUSION: The addition of vaginal isosorbide mononitrate for labor induction in pregnancies complicated by hypertensive disease of pregnancy did not result in fewer cesarean deliveries.


Assuntos
Hipertensão , Doadores de Óxido Nítrico , Maturidade Cervical , Feminino , Humanos , Hipertensão/tratamento farmacológico , Dinitrato de Isossorbida/análogos & derivados , Trabalho de Parto Induzido , Doadores de Óxido Nítrico/uso terapêutico , Gravidez
9.
Am J Obstet Gynecol MFM ; 3(4): 100350, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-33757937

RESUMO

BACKGROUND: The combination method for cervical ripening with a Foley catheter and concurrent oxytocin administration has been shown to reduce the total time from induction to delivery when compared with a Foley catheter only in patients with an unfavorable cervix (Bishop score of <6). It is unclear if this is still effective for patients with a less favorable cervix as indicated by a Bishop score of ≤3. OBJECTIVE: This study aimed to determine if inducing labor with a Foley catheter and concurrent oxytocin administration reduced the total time from induction to delivery in subjects with a Bishop score of ≤3 compared with those who only received a Foley catheter without oxytocin for cervical ripening. STUDY DESIGN: This was a secondary analysis of a randomized, multicenter trial of patients with a live singleton pregnancy at ≥24 weeks' gestation undergoing labor induction with a Foley catheter and a Bishop score of <6. This analysis included patients with a Bishop score of ≤3. Exclusions included >1 cesarean delivery, unexplained bleeding, nonreassuring fetal tracing, major fetal anomalies, or other contraindications for vaginal delivery. The subjects were randomized to receive an intracervical Foley catheter only or with concurrent oxytocin infusion. The primary outcome for this analysis was the time from induction to delivery. Secondary outcomes included delivery at ≤12 hours, time to delivery ≤24 hours, cesarean delivery, total time of oxytocin infusion, need for additional ripening agents, postpartum hemorrhage, chorioamnionitis, and neonatal intensive care unit admission. RESULTS: A total of 322 patients were enrolled in the primary trial; 151 subjects had an initial Bishop score of ≤3 and were included in the secondary analysis (n=77 for Foley catheter with oxytocin and n=74 for the Foley catheter only). The demographics were similar in both groups. Those with a Bishop score of ≤3 who received a Foley catheter with concurrent oxytocin administration had a shorter time from induction to delivery than those patients who received a Foley catheter only for cervical ripening (21.3 vs 27 hours; P=.005). The group with a Foley catheter and oxytocin administered concurrently also had a shorter time from induction to delivery after adjusting for body mass index, parity status, and first Bishop score (21.5 vs 26.7 hours; P=.007). They also were more likely to deliver within 24 hours (74% vs 46%; P=.001) and not to require additional ripening agents (4% vs 15%; P=.04). Patients with the Foley catheter only method were more likely to receive additional ripening agents, but had fewer hours of oxytocin infusion (19.1 vs 12.4 hours; P<.001). There was no difference in the rate of delivery at ≤12 hours, cesarean delivery, postpartum hemorrhage, chorioamnionitis, and neonatal intensive care unit admission. CONCLUSION: Concurrent Foley catheter and oxytocin infusion significantly reduced the time from induction to delivery in patients with a Bishop score of ≤3 when compared with a Foley catheter only, particularly in multiparous patients.


Assuntos
Ocitócicos , Ocitocina , Cateteres , Maturidade Cervical , Feminino , Humanos , Recém-Nascido , Trabalho de Parto Induzido , Gravidez , Cateterismo Urinário
10.
Acta Obstet Gynecol Scand ; 100(8): 1463-1477, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33768520

RESUMO

INTRODUCTION: Induction of labor is increasing. A common indication for induction of labor is late term and postterm pregnancy at 41 weeks or more. We aimed to evaluate if there are any differences regarding efficacy, safety, and women's childbirth experience between oral misoprostol and transvaginal balloon catheter for cervical ripening in women with a low-risk singleton pregnancy and induction of labor at 41+0 to 42+0 to 1 weeks of gestation. MATERIAL AND METHODS: In this observational study, based on data from the Swedish Postterm Induction Study (SWEPIS), a multicenter randomized controlled trial, a total of 1213 women with a low-risk singleton pregnancy at 41 to 42 weeks of gestation were induced with oral misoprostol (n = 744) or transvaginal balloon catheter (n = 469) at 15 Swedish delivery hospitals. The primary efficacy outcome was vaginal delivery within 24 h and primary safety outcomes were neonatal and maternal composite adverse outcomes. Secondary outcomes included time to vaginal delivery and mode of delivery. Women's childbirth experience was assessed with the Childbirth Experience Questionnaire (CEQ 2.0) and visual analog scale. We present crude and adjusted mean differences and relative risks (RR) with 95% CI. Adjustment was performed for a propensity score based on delivery hospital and baseline characteristics including Bishop score. RESULTS: Vaginal delivery within 24 h was significantly lower in the misoprostol group compared with the balloon catheter group (46.5% [346/744] vs 62.7% [294/469]; adjusted RR 0.76 95% CI 0.640.89]). Primary neonatal and maternal safety outcomes did not differ between groups (neonatal composite 3.5% [36/744] vs 3.2% [15/469]; adjusted RR 0.77 [95% CI 0.31-1.89]; maternal composite 2.3% [17/744] vs 1.9% [9/469]; adjusted RR 1.70 [95% CI 0.58-4.97]). Adjusted mean time to vaginal delivery was increased by 3.8 h (95% CI 1.3-6.2 h) in the misoprostol group. Non-operative vaginal delivery and cesarean delivery rates did not differ. Women's childbirth experience was positive overall and similar in both groups. CONCLUSIONS: Induction of labor with oral misoprostol compared with a transvaginal balloon catheter was associated with a lower probability of vaginal delivery within 24 h and a longer time to vaginal delivery. However, primary safety outcomes, non-operative vaginal delivery, and women's childbirth experience were similar in both groups. Therefore, both methods can be recommended in women with low-risk postdate pregnancies.


Assuntos
Maturidade Cervical , Trabalho de Parto Induzido , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Cuidado Pré-Natal , Adulto , Cateteres/efeitos adversos , Feminino , Idade Gestacional , Humanos , Gravidez , Resultado da Gravidez , Inquéritos e Questionários , Suécia
13.
Obstet Gynecol ; 137(6): 1091-1101, 2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-33752219

RESUMO

OBJECTIVE: To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening in the outpatient setting alone. DATA SOURCES: Searches for articles in English included MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and reference lists (up to August 2020). METHODS OF STUDY SELECTION: Using predefined criteria and DistillerSR software, 10,853 citations were dual-reviewed for randomized controlled trials (RCTs) and cohort studies of outpatient cervical ripening using prostaglandins and mechanical methods in pregnant women at or beyond 37 weeks of gestation. TABULATION, INTEGRATION, AND RESULTS: Using prespecified criteria, study data abstraction and risk of bias assessment were conducted by two reviewers, random-effects meta-analyses were conducted and strength of evidence was assessed. We included 30 RCTs and 10 cohort studies (N=9,618) most generalizable to women aged 25-30 years with low-risk pregnancies. All findings were low or insufficient strength of evidence and not statistically significant. Incidence of cesarean delivery was not different for any comparison of inpatient and outpatient settings, or comparisons of different methods in the outpatient setting (most evidence available for single-balloon catheters and dinoprostone). Harms were inconsistently reported or inadequately defined. Differences were not found for neonatal infection (eg, sepsis) with outpatient compared with inpatient dinoprostone, birth trauma (eg, cephalohematoma) with outpatient compared with inpatient single-balloon catheter, shoulder dystocia with outpatient dinoprostone compared with placebo, maternal infection (eg, chorioamnionitis) with outpatient compared with inpatient single-balloon catheters or outpatient prostaglandins compared with placebo, and postpartum hemorrhage with outpatient catheter compared with inpatient dinoprostone. Evidence on misoprostol, hygroscopic dilators, and other outcomes (eg, perinatal mortality and time to vaginal birth) was insufficient. CONCLUSION: In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD42020167406.


Assuntos
Assistência Ambulatorial , Trabalho de Parto Induzido/métodos , Trabalho de Parto Induzido/estatística & dados numéricos , Complicações do Trabalho de Parto/etiologia , Cateteres , Maturidade Cervical , Cesárea/estatística & dados numéricos , Dilatação/efeitos adversos , Dinoprostona/uso terapêutico , Feminino , Hospitalização , Humanos , Trabalho de Parto Induzido/efeitos adversos , Ocitócicos/uso terapêutico , Gravidez
14.
Am J Obstet Gynecol ; 224(6): 611.e1-611.e8, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33771496

RESUMO

BACKGROUND: Induction of labor is common in the United States. Multiple previous studies have tried to outline a faster time to delivery to improve maternal and fetal outcomes. OBJECTIVE: This study aimed to evaluate whether women who undergo induction of labor with a single-balloon catheter and oxytocin have a shorter time to delivery with planned removal of the catheter at 6 vs 12 hours. STUDY DESIGN: In this randomized controlled trial, induction of labor was performed using a combination of single-balloon catheter and oxytocin. Term women, both nulliparous and multiparous, aged 18 to 50 years old with cephalic singletons were included if they were undergoing induction of labor with a Bishop score of <6 and cervical dilation of <2 cm. Women were randomized to planned removal of the single-balloon catheter at 6 hours vs 12 hours. The primary outcome was time from catheter insertion to delivery. We were powered to show a 4-hour time difference with a sample size of 89 women per group (n=178). Planned sensitivity analyses were performed to account for cesarean delivery in labor. RESULTS: From February 2019 to June 2020, 237 women were screened, 178 women were randomized, and 177 women were included in the final analysis (89 women in the 6-hour group and 88 women in the 12-hour group). Insertion to delivery time was significantly shorter in the 6-hour group (19.2 vs 24.3 hours; P=.04), and the proportion of women delivered by 24 hours was significantly greater in the 6-hour group (67.4% vs 47.4%; P<.01). There was no difference in the Bishop score at removal of the catheter or secondary maternal or neonatal outcomes. In a Cox proportional-hazards model censoring for cesarean delivery, the 6-hour group had a significantly shorter insertion to delivery time (hazard ratio, 0.67; P=.02). CONCLUSION: Induction of labor with a single-balloon catheter and oxytocin with planned removal of the catheter at 6 hours rather than 12 hours results in a shorter time from insertion to delivery without increasing the rate of cesarean delivery. Decreasing the length of time a single-balloon catheter is in place should be considered in clinical protocols.


Assuntos
Cateterismo/métodos , Trabalho de Parto Induzido/métodos , Ocitócicos/uso terapêutico , Ocitocina/uso terapêutico , Adolescente , Adulto , Cateterismo/instrumentação , Cateteres , Maturidade Cervical , Cesárea/estatística & dados numéricos , Terapia Combinada , Feminino , Humanos , Trabalho de Parto Induzido/instrumentação , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Gravidez , Modelos de Riscos Proporcionais , Estudos Prospectivos , Fatores de Tempo , Adulto Jovem
15.
Nurs Open ; 8(5): 2892-2900, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-33689238

RESUMO

AIM: To develop and validate the nomogram for risk estimation of Caesarean delivery and to compare the effect of cervical ripening balloon, evening primrose oil (EPO) and misoprostol on Bishop Score and duration of the first stage of labour. DESIGN: The first phase is a prospective study, and the second phase is a randomized controlled trial. METHODS: In the first phase, the nomogram will be developed and validated over 300 participants, and in the second phase, the 90 participants will be allocated to three groups: vaginal 25mcg misoprostol, vaginal 4000mg EPO and double-balloon catheter, through block randomization method. The Bishop score will be evaluated every 4 hr, and if required the same dose will be repeated. Maximum waiting time for balloon is 12 hr if not effective, the catheter will be removed, and other interventions will be done according to guidelines. DISCUSSION: The nomogram will help informed decision-making for women undergoing an induction with an unfavourable cervix and introducing effective low-complication methods of labour induction can improve the pregnancy outcomes.


Assuntos
Misoprostol , Ocitócicos , Maturidade Cervical , Cesárea , Feminino , Humanos , Trabalho de Parto Induzido , Ácidos Linoleicos , Nomogramas , Ocitócicos/uso terapêutico , Óleos Vegetais , Gravidez , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Ácido gama-Linolênico
16.
Eur J Obstet Gynecol Reprod Biol ; 260: 124-130, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33770629

RESUMO

OBJECTIVE: The aim of this work was to assess the cost-effectiveness of induction of labor with outpatient balloon catheter cervical priming versus inpatient prostaglandin vaginal gel or tape. STUDY DESIGN: Economic evaluation alongside a multi-centre, randomized controlled trial at eight Australian maternity hospitals. The trial reported on 448 women with live singleton term pregnancies, undergoing induction of labor for low-risk indications between September 2015 and October 2018. An economic decision tree model was designed from a health services perspective from time of induction of labor to hospital discharge. Sensitivity and subgroup analyses were performed to test the robustness of model outcomes. We estimated resource use, collected data on health outcomes (using EQ-5D-3 L questionnaire) and reported cost (Australian Dollars) per quality-adjusted life year gained, incremental cost-effect ratio and net monetary benefit. RESULTS: Deterministic analysis showed lower mean costs ($7294 versus $7585) in the outpatient-balloon (n = 205) compared to the inpatient-prostaglandin group (n = 243), with similar health outcomes (0.75 vs 0.74 quality-adjusted life years gained) and overall higher net monetary benefit ($30,054 vs $29,338). In probabilistic analyses outpatient-balloon induction of labor was cost-effective in 55.3 % of all simulations and 59.1 % for women with favourable cervix (modified Bishop score >3) and 64.5 % for nulliparous women. CONCLUSIONS: Outpatient-balloon induction of labor may be cost-saving compared to inpatient induction of labor with prostaglandin and is most likely to be cost-effective for nulliparous women, but more research is warranted in other settings to explore the generalisability of results.


Assuntos
Análise Custo-Benefício , Trabalho de Parto Induzido , Ocitócicos , Austrália , Maturidade Cervical , Feminino , Humanos , Pacientes Ambulatoriais , Gravidez , Prostaglandinas
17.
PLoS Med ; 18(2): e1003448, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33571294

RESUMO

BACKGROUND: Prolonged pregnancies are a frequent indication for induction of labour. When the cervix is unfavourable, cervical ripening before oxytocin administration is recommended to increase the likelihood of vaginal delivery, but no particular method is currently recommended for cervical ripening of prolonged pregnancies. This trial evaluates whether the use of mechanical cervical ripening with a silicone double balloon catheter for induction of labour in prolonged pregnancies reduces the cesarean section rate for nonreassuring fetal status compared with pharmacological cervical ripening by a vaginal pessary for the slow release of dinoprostone (prostaglandin E2). METHODS AND FINDINGS: This is a multicentre, superiority, open-label, parallel-group, randomised controlled trial conducted in 15 French maternity units. Women with singleton pregnancies, a vertex presentation, ≥41+0 and ≤42+0 weeks' gestation, a Bishop score <6, intact membranes, and no history of cesarean delivery for whom induction of labour was decided were randomised to either mechanical cervical ripening with a Cook Cervical Ripening Balloon or pharmacological cervical ripening by a Propess vaginal pessary serving as a prostaglandin E2 slow-release system. The primary outcome was the rate of cesarean for nonreassuring fetal status, with an independent endpoint adjudication committee determining whether the fetal heart rate was nonreassuring. Secondary outcomes included delivery (time from cervical ripening to delivery, number of patients requiring analgesics), maternal and neonatal outcomes. Between January 2017 and December 2018, 1,220 women were randomised in a 1:1 ratio, 610 allocated to a silicone double balloon catheter, and 610 to the Propess vaginal pessary for the slow release of dinoprostone. The mean age of women was 31 years old, and 80% of them were of white ethnicity. The cesarean rates for nonreassuring fetal status were 5.8% (35/607) in the mechanical ripening group and 5.3% (32/609) in the pharmacological ripening group (proportion difference: 0.5%; 95% confidence interval (CI) -2.1% to 3.1%, p = 0.70). Time from cervical ripening to delivery was shorter in the pharmacological ripening group (23 hours versus 32 hours, median difference 6.5 95% CI 5.0 to 7.9, p < 0.001), and fewer women required analgesics in the mechanical ripening group (27.5% versus 35.4%, difference in proportion -7.9%, 95% CI -13.2% to -2.7%, p = 0.003). There were no statistically significant differences between the 2 groups for other delivery, maternal, and neonatal outcomes. A limitation was a low observed rate of cesarean section. CONCLUSIONS: In this study, we observed no difference in the rates of cesarean deliveries for nonreassuring fetal status between mechanical ripening with a silicone double balloon catheter and pharmacological cervical ripening with a pessary for the slow release of dinoprostone. TRIAL REGISTRATION: ClinicalTrials.gov NCT02907060.


Assuntos
Maturidade Cervical/efeitos dos fármacos , Dinoprostona/farmacologia , Ocitócicos/farmacologia , Silicones/farmacologia , Adulto , Maturidade Cervical/fisiologia , Cesárea/métodos , Parto Obstétrico/métodos , Dinoprostona/administração & dosagem , Feminino , Humanos , Trabalho de Parto Induzido/métodos , Ocitócicos/administração & dosagem , Pessários , Gravidez , Gravidez Prolongada/tratamento farmacológico
18.
Am J Obstet Gynecol ; 224(5): 524.e1-524.e8, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33617796

RESUMO

BACKGROUND: Combining pharmacologic agents with mechanical ripening achieves the shortest time to labor; however, there is no clear evidence on route of drug administration. Buccal administration of misoprostol has shown greater patient acceptance but remains understudied. OBJECTIVE: This study aimed to evaluate the difference in time to delivery between buccal and vaginal administration of misoprostol along with a Foley catheter for induction of labor. STUDY DESIGN: The BEGIN trial (buccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term) was an institutional review board-approved, randomized clinical trial conducted from June 2019 to January 2020 comparing identical doses (25 µg) of buccal misoprostol and vaginal misoprostol along with a Foley catheter for induction of labor. Randomization was stratified by parity. Labor management was standardized among participants. Individuals undergoing induction of labor at ≥37 weeks with a singleton gestation and needing cervical ripening were included. Our primary outcome was time to delivery. Kruskal-Wallis, Pearson chi-squared, and Cox survival analyses with intent-to-treat principles were performed. A sample size of 216 was planned to detect a 4-hour reduction in delivery time. RESULTS: A total of 215 women (108 in the buccal drug administration group and 107 in the vaginal drug administration group) were randomized. The vaginal route of drug administration achieved a faster median time to delivery than the buccal route of drug administration (19.7 hours in the vaginal route vs 24.1 hours in the buccal route; P<.001). A greater percentage of women in the vaginal drug administration group delivered within 24 hours compared with the buccal drug administration group (65% vs 49%; P=.02). There was no difference in the cesarean delivery rate between the 2 groups (17% in the vaginal drug administration group vs 21% in the buccal drug administration group; P=.6). Individuals who received vaginal misoprostol with Foley catheter delivered 2 times faster than women who received buccal misoprostol with Foley catheter after censoring for cesarean delivery and adjusting for parity (hazard ratio, 2.13; 95% confidence interval, 1.44-3.17). There was no significant difference in maternal and neonatal outcomes. CONCLUSION: We found that vaginal administration of misoprostol was superior to buccal administration of misoprostol along with a Foley catheter for induction of labor. Furthermore, vaginal administration of misoprostol resulted in twice the chance of delivering earlier compared with buccal administration of misoprostol with no difference in cesarean delivery rates. Therefore, the vaginal route of administration of misoprostol should be preferred among individuals undergoing a combined pharmacologic and mechanical induction.


Assuntos
Maturidade Cervical , Trabalho de Parto Induzido/métodos , Misoprostol/administração & dosagem , Ocitócicos/administração & dosagem , Cateterismo Urinário , Administração Bucal , Administração Intravaginal , Adulto , Terapia Combinada , Feminino , Humanos , Parto , Gravidez , Fatores de Tempo , Adulto Jovem
19.
Eur J Obstet Gynecol Reprod Biol ; 259: 90-94, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33610830

RESUMO

OBJECTIVE: To compare the success of the double-balloon catheter (DBC) versus prostaglandin gel (PGE2) for induction of labour in women with one previous caesarean section. DESIGN: Retrospective cohort study using routinely collected maternity data in a Tertiary NHS hospital, North West England, UK. Women with a live singleton cephalic pregnancy induced using DBC or PGE2 after one previous birth by caesarean section from 1st April 2017 to 1st July 2019 were included. The core outcomes assessed were the inability to perform artificial rupture of membranes, requirement of oxytocin, vaginal birth and uterine rupture. RESULTS: 208 women met the inclusion criteria, 127 were induced using the DBC and 81 using PGE2. The two groups were well matched for demographics and characteristics. Women induced for prolonged ruptured membranes with PGE2 were excluded from the study leaving 127 managed with DBC and 69 with PGE2. There were no significant differences observed between the two groups. Vaginal birth rates were 52.7% for the DBC and 66.6% for the PGE2 (relative risk 0.79 (confidence interval 0.63-1.00); P = 0.05). A single uterine rupture was reported following DBC usage. CONCLUSIONS: The DBC and PGE2 appear to be equally effective for induction of labour in women with one previous caesarean section.


Assuntos
Ocitócicos , Nascimento Vaginal Após Cesárea , Maturidade Cervical , Cesárea , Dinoprostona , Inglaterra , Feminino , Humanos , Trabalho de Parto Induzido , Gravidez , Prostaglandinas , Estudos Retrospectivos
20.
Am J Obstet Gynecol MFM ; 3(1): 100294, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33451623

RESUMO

BACKGROUND: Labor induction accounts for over 1 in 5 births in the United States. There is large variability in practices of induction of labor. Standardizing aspects of induction of labor has been shown to have beneficial maternal and fetal effects. OBJECTIVE: This study aimed to investigate the impact of the implementation of an evidence-based labor induction protocol on maternal and neonatal outcomes. STUDY DESIGN: In February 2018, a contemporary labor induction protocol composed of standardized cervical ripening and early amniotomy was implemented in the labor and delivery unit at a large academic center along with comprehensive training of staff. Maternal and fetal outcomes were compared between patients undergoing induction over a 9 month period following the implementation of the protocol and those undergoing induction 9 months earlier, excluding a 2 week washout period while training occurred. RESULTS: We studied 887 patients who underwent induction of labor of a live singleton at >24 weeks' gestation during our study period (387 patients before the implementation of the protocol and 500 patients after the implementation of the protocol). Baseline characteristics of maternal age, previous vaginal deliveries, and birthweight were similar in patients before and after the implementation of the protocol. There was a significant increase in the number of elective inductions occurring after the implementation of the protocol. There was a significant decrease in time from start of induction to rupture of membranes in all women under the protocol (13.3 hours before the implementation of the protocol vs 10.4 hours after the implementation of the protocol; P≤.001) and decrease in time from start of induction to delivery (21.2 hours before the implementation of the protocol vs 19.7 hours after the implementation of the protocol; P=.04). When the analysis was stratified by elective and nonelective inductions of labor, we found that time from induction of labor initiation to vaginal delivery was shortened after the implementation of the protocol for those undergoing elective induction (18.5 hours vs 14.6 hours; P=.03). There was no difference in cesarean delivery rate (P=.7), chorioamnionitis (P=.3), postpartum hemorrhage (P=.7), or newborn intensive care unit admission (P=.3). CONCLUSION: The implementation of an evidence-based labor induction protocol was associated with decreased time to delivery, primarily driven by decreased time to vaginal delivery among those undergoing elective inductions of labor, without compromise of maternal or neonatal outcomes.


Assuntos
Trabalho de Parto Induzido , Hemorragia Pós-Parto , Maturidade Cervical , Cesárea , Parto Obstétrico , Feminino , Humanos , Recém-Nascido , Gravidez , Estados Unidos
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...