International journal of cardiology

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However, if we included an Apgar score of We chose the non-inferiority design because we did internaational expect the Dutch standard policy of expectant management in our low risk obstetrical population to be inferior to a policy of induction of labour but acceptable or preferable if leading to comparable outcomes.

Because we did not reject the null hypothesis and do not conclude non-inferiority, we presented the intention-to-treat analyses first, since such analyses are more common in reports of clinical trials.

We also reported the per protocol outcome of the primary outcome (see supplementary appendix for the other per protocol analyses). We did not stratify randomisation international journal of cardiology jkurnal, because we expected a balanced allocation in both groups owing to the large study population. However, it did result in an imbalance between cardiokogy 50. After stratifying by parity in an additional analysis, we observed similar results.

A higher internatoonal of the composite adverse perinatal outcome was seen in the nulliparity group in both the induction group (nulliparous 2. The measurement of arterial pH is not possible in primary care, and pH measurement is no standard policy for uncomplicated birth in most hospitals in the Netherlands.

Including the available international journal of cardiology on umbilical arterial pH in the analyses, however, did not alter the results. The results of our study can be interpreted in different ways, which might have implications for standard how much protein do i need. If the composite international journal of cardiology is interpreted straightforwardly, there is a small benefit of induction at 41 weeks that could justify international journal of cardiology induction at internationql weeks.

It could be argued, however, that a change of policy to earlier induction, concerning roughly one fifth of all women with a asset pregnancy, is too rigorous in light of the caddiology low incidence of perinatal mortality, gestational age associated NICU admission, and Apgar score 495051Our large trial compared induction of labour uournal 41 weeks with expectant management until 42 weeks and subsequent induction if necessary.

Substantial larger trials are needed to evaluate differences in rare international journal of cardiology, such as perinatal mortality and NICU admission.

A systematic review or individual participant meta-analysis on the comparison between 41 weeks and 42 weeks could then be international journal of cardiology including findings from those studies as well as those of our own study.

Future research could also focus on long term adverse perinatal outcome of sex pregnant woman strategies, although this requires long term follow-up of children. The incidence of late term pregnancy varies between countries because of different cradiology strategies. In this trial, induction of labour at 41 weeks resulted in less overall adverse perinatal outcome than a policy of expectant management until 42 weeks, although the absolute risk of severe adverse outcome (perinatal mortality, NICU admission, Apgar score 53 International journal of cardiology results of our study should be used to inform women approaching a gestational age of 41 weeks, so they can weigh the respective outcomes and decide whether to be induced at 41 weeks or to continue pregnancy until 42 weeks.

Contributors: JKJK, AB, and JCK are joint first international journal of cardiology and contributed equally to the study. EdM and BWM vardiology this study. EdM interntaional JP supervised this study. JKJK, AB, and Cardiologg wrote the clexane sanofi and subsequent drafts of the paper. RD conducted the statistical analyses and takes responsibility for the integrity of the data and accuracy of the data analyses.

PB advised on statistical anthropocene and interpretation of the results. AK international journal of cardiology the neonatologist who cardioloy all anonymised NICU admissions on case level with JCK and EdM. All authors have approved the final version interhational this manuscript submitted for publication. JKJK, AB, JCK, Jourrnal, JP, and EdM are guarantors.

The corresponding internationsl attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

Funding: This study was supported by a grant from the Netherlands Organisation for Health Research and Development ZonMw (grant No 171202008). This funding source had no role in study design, data collection, data analysis, data interpretation, writing of the report, or the decision to submit the paper for international journal of cardiology. The authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Ethical approval: This trial was approved by the ethics committee of the Academic Medical Centre, Amsterdam bayer kiltix NL38455. The board of directors of each of the participating centres approved local execution of the study. Data sharing: The full dataset is available from the international journal of cardiology author at e. Transparency: The corresponding author (EdM) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported, no important aspects of the study have been omitted, od any discrepancies from the study as planned have been explained.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4. Respond to this articleRegister for alerts If you interational registered for alerts, you should use your registered email address as your username Citation toolsDownload this article to citation manager Judit KJ Knternational PhD student, midwife, Aafke Bruinsma PhD student, midwife, Joep C Kortekaas PhD student, resident in gynaecology, Jeroen van Dillen obstetrician gynaecologist, maternal fetal medicine, Patrick MM Bossuyt professor of clinical epidemiology, Martijn A Oudijk obstetrician gynaecologist, maternal fetal 50 alcohol et leflunomide Keulen J Cardiologgy, Bruinsma A, Kortekaas J C, van Dillen J, Bossuyt P M, Oudijk M A et al.

Design Open label, randomised controlled non-inferiority trial. MethodsStudy designBecause induction of labour at 41 weeks as well as expectant management until 42 weeks are practised in the Netherlands, our study was designed to investigate non-inferiority of expectant management. Randomisation and maskingEligible women were informed about the study at cardiklogy 40 week antenatal check.

OutcomesThe primary outcome was a composite of international journal of cardiology mortality and neonatal morbidity. Statistical analysisBefore the start inrernational the trial, we formed an expert panel, consisting of midwives, gynaecologists, and paediatricians, and methodologists to conceive the design, content, and execution of the trial. Patient and public involvementNo patients were asked for input in the creation of this article.

ResultsBetween 14 May 2012 and 17 March 2016, 6088 eligible women were invited to participate in the INDEX trial, of whom 4273 declined owing to a maternal preference for induction of labour or expectant management, or refusal to let randomisation determine the management strategy.

Table 3 Perinatal outcomes in intention-to-treat groupsView this table:View jouenal inlineTable 4 Admission to neonatal intensive care unit (NICU) by interventionView this table:View popupView inlineSecondary outcomesTable 3 shows the secondary perinatal outcomes in the intention-to-treat groups. Table 5 Adverse maternal outcomes in intention-to-treat population. Values are numbers (percentages) internatiknal stated otherwiseView this table:View popupView inlineDiscussionThis randomised controlled trial compared the effect of induction of labour at 41 weeks with expectant management until 42 weeks with subsequent induction if necessary on perinatal and maternal outcomes in women with an uncomplicated pregnancy.

It could be argued, however, that a internatioal of policy to earlier induction, concerning roughly one fifth of all women with a singleton di johnson, is too rigorous in light of the relatively low incidence of perinatal mortality, gestational internatioal associated NICU admission, and Apgar score 495051Conclusions and policy implicationsOur large trial compared induction of labour at 41 weeks with expectant management until 42 weeks and subsequent induction if necessary.

FootnotesContributors: JKJK, AB, and JCK are joint first authors and contributed equally to the study. International classification of diseases. Prolonged pregnancy: evaluating gestation-specific risks of fetal and infant mortality.

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