scholarly journals Bayesian Scepsis About SWEPIS: Quantifying the Evidence That Early Induction of Labour Prevents Perinatal Deaths

2020 ◽  
Author(s):  
Eric-Jan Wagenmakers ◽  
Alexander Ly
Keyword(s):  
Clinical Trial ◽  
Bayesian Analysis ◽  
Randomized Clinical Trial ◽  
Clinical Studies ◽  
Expectant Management ◽  
Induction Of Labour ◽  
Perinatal Deaths ◽  
Management Group ◽  
Induction Group

In a recent randomized clinical trial, Wennerholm and colleagues compared induction of labour at 41 weeks with expectant management and induction at 42 weeks. The trial was stopped early, because six perinatal deaths occurred in the expectant management group, whereas none occurred in the induction group. Our Bayesian reanalysis finds that the SWEPIS data indeed support the hypothesis that induction of labour at 41 weeks of pregnancy is associated with a lower rate of stillbirths. However, the degree of this support is moderate at best, and arguably provides insufficient ground for terminating the study. In general, it seems hazardous to terminate clinical studies on the basis of a single P<0.05 result, without converging support of a Bayesian analysis.

scholarly journals Induction of labour at 41 weeks versus expectant management until 42 weeks (INDEX): multicentre, randomised non-inferiority trial

BMJ ◽  
2019 ◽  
pp. l344 ◽  
Author(s):  
Judit KJ Keulen ◽  
Aafke Bruinsma ◽  
Joep C Kortekaas ◽  
Jeroen van Dillen ◽  
Patrick MM Bossuyt ◽  
...  
Keyword(s):  
Apgar Score ◽  
Perinatal Outcome ◽  
Primary Outcome ◽  
Expectant Management ◽  
Induction Of Labour ◽  
Maternal Outcomes ◽  
Management Group ◽  
Induction Group ◽  
Significant Difference ◽  
Low Risk Women

Abstract Objective To compare induction of labour at 41 weeks with expectant management until 42 weeks in low risk women. Design Open label, randomised controlled non-inferiority trial. Setting 123 primary care midwifery practices and 45 hospitals (secondary care) in the Netherlands, 2012-16. Participants 1801 low risk women with an uncomplicated singleton pregnancy: randomised to induction (n=900) or to expectant management until 42 weeks (n=901). Interventions Induction at 41 weeks or expectant management until 42 weeks with induction if necessary. Primary outcome measures Primary outcome was a composite of perinatal mortality and neonatal morbidity (Apgar score <7 at five minutes, arterial pH <7.05, meconium aspiration syndrome, plexus brachialis injury, intracranial haemorrhage, and admission to a neonatal intensive care unit (NICU). Secondary outcomes included maternal outcomes and mode of delivery. The null hypothesis that expectant management is inferior to induction was tested with a non-inferiority margin of 2%. Results Median gestational age at delivery was 41 weeks+0 days (interquartile range 41 weeks+0 days-41 weeks+1 day) for the induction group and 41 weeks+2 days (41 weeks+0 days-41 weeks+5 days) for the expectant management group. The primary outcome was analysed for both the intention-to-treat population and the per protocol population. In the induction group, 15/900 (1.7%) women had an adverse perinatal outcome versus 28/901 (3.1%) in the expectant management group (absolute risk difference −1.4%, 95% confidence interval −2.9% to 0.0%, P=0.22 for non-inferiority). 11 (1.2%) infants in the induction group and 23 (2.6%) in the expectant management group had an Apgar score <7 at five minutes (relative risk (RR) 0.48, 95% CI 0.23 to 0.98). No infants in the induction group and three (0.3%) in the expectant management group had an Apgar score <4 at five minutes. One fetal death (0.1%) occurred in the induction group and two (0.2%) in the expectant management group. No neonatal deaths occurred. 3 (0.3%) neonates in the induction group versus 8 (0.9%) in the expectant management group were admitted to an NICU (RR 0.38, 95% CI 0.10 to 1.41). No significant difference was found in composite adverse maternal outcomes (induction n=122 (13.6%) v expectant management n=102 (11.3%)) or in caesarean section rate (both groups n=97 (10.8%)). Conclusions This study could not show non-inferiority of expectant management compared with induction of labour in women with uncomplicated pregnancies at 41 weeks; instead a significant difference of 1.4% was found for risk of adverse perinatal outcomes in favour of induction, although the chances of a good perinatal outcome were high with both strategies and the incidence of perinatal mortality, Apgar score <4 at five minutes, and NICU admission low. Trial registration Netherlands Trial Register NTR3431.

scholarly journals Women’s childbirth experiences in the Swedish Post-term Induction Study (SWEPIS): a multicentre, randomised, controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e042340
Author(s):  
Helena Nilvér ◽  
Anna Wessberg ◽  
Anna Dencker ◽  
Henrik Hagberg ◽  
Ulla-Britt Wennerholm ◽  
...  
Keyword(s):  
Expectant Management ◽  
Induction Of Labour ◽  
Childbirth Experience ◽  
Management Group ◽  
Induction Group ◽  
Significant Difference ◽  
Small Effect Size ◽  
Induction Study ◽  
Randomised Controlled ◽  
Childbirth Experiences

ObjectiveTo compare childbirth experiences in women randomly assigned to either induction of labour at 41 weeks or to expectant management until 42 weeks, in the Swedish Post-term Induction Study.DesignA register-based, multicentre, randomised, controlled, superiority trial.SettingWomen were recruited at 14 hospitals in Sweden, 2016–2018.ParticipantsWomen with an uncomplicated singleton pregnancy were recruited at 41 gestational weeks.InterventionsThe women were randomly assigned to induction of labour at 41 weeks (induction group, n=1381) or expectant management until 42 weeks (expectant management group, n=1379).Outcome measuresAs main outcome, women’s childbirth experiences were measured using the Childbirth Experience Questionnaire version 2 (CEQ2), in 656 women, 3 months after the birth at three hospitals. As exploratory outcome, overall childbirth experience was measured in 1457 women using a Visual Analogue Scale (VAS 1–10) within 3 days after delivery at the remaining eleven hospitals.ResultsThe total response rate was 77% (2113/2760). There were no significant differences in childbirth experience measured with CEQ2 between the groups (induction group, n=354; expectant management group, n=302) in the subscales: own capacity (2.8 vs 2.7, p=0.09), perceived safety (3.3 vs 3.2, p=0.06) and professional support (3.6 vs 3.5, p=0.38) or in the total CEQ2 score (3.3 vs 3.2, p=0.07), respectively. Women in the induction group scored higher in the subscale participation (3.6 vs 3.4, p=0.02), although with a small effect size (0.19). No significant difference was observed in overall childbirth experience according to VAS (8.0 (n=735) vs 8.1 (n=735), p=0.22).ConclusionsThere were no differences in childbirth experience, according to CEQ2 or overall childbirth experience assessed with VAS, between women randomly assigned to induction of labour at 41 weeks or expectant management until 42 weeks. Overall, women rated their childbirth experiences high.Trial registration numberISRCTN26113652.

scholarly journals Induction of labour at 41 weeks versus expectant management and induction of labour at 42 weeks (SWEdish Post-term Induction Study, SWEPIS): multicentre, open label, randomised, superiority trial

BMJ ◽  
2019 ◽  
pp. l6131 ◽  
Author(s):  
Ulla-Britt Wennerholm ◽  
Sissel Saltvedt ◽  
Anna Wessberg ◽  
Mårten Alkmark ◽  
Christina Bergh ◽  
...  
Keyword(s):  
Perinatal Mortality ◽  
Perinatal Outcome ◽  
Expectant Management ◽  
Low Risk ◽  
Induction Of Labour ◽  
Maternal Outcomes ◽  
Open Label ◽  
Management Group ◽  
Induction Group ◽  
Superiority Trial

Abstract Objective To evaluate if induction of labour at 41 weeks improves perinatal and maternal outcomes in women with a low risk pregnancy compared with expectant management and induction of labour at 42 weeks. Design Multicentre, open label, randomised controlled superiority trial. Setting 14 hospitals in Sweden, 2016-18. Participants 2760 women with a low risk uncomplicated singleton pregnancy randomised (1:1) by the Swedish Pregnancy Register. 1381 women were assigned to the induction group and 1379 were assigned to the expectant management group. Interventions Induction of labour at 41 weeks and expectant management and induction of labour at 42 weeks. Main outcome measures The primary outcome was a composite perinatal outcome including one or more of stillbirth, neonatal mortality, Apgar score less than 7 at five minutes, pH less than 7.00 or metabolic acidosis (pH <7.05 and base deficit >12 mmol/L) in the umbilical artery, hypoxic ischaemic encephalopathy, intracranial haemorrhage, convulsions, meconium aspiration syndrome, mechanical ventilation within 72 hours, or obstetric brachial plexus injury. Primary analysis was by intention to treat. Results The study was stopped early owing to a significantly higher rate of perinatal mortality in the expectant management group. The composite primary perinatal outcome did not differ between the groups: 2.4% (33/1381) in the induction group and 2.2% (31/1379) in the expectant management group (relative risk 1.06, 95% confidence interval 0.65 to 1.73; P=0.90). No perinatal deaths occurred in the induction group but six (five stillbirths and one early neonatal death) occurred in the expectant management group (P=0.03). The proportion of caesarean delivery, instrumental vaginal delivery, or any major maternal morbidity did not differ between the groups. Conclusions This study comparing induction of labour at 41 weeks with expectant management and induction at 42 weeks does not show any significant difference in the primary composite adverse perinatal outcome. However, a reduction of the secondary outcome perinatal mortality is observed without increasing adverse maternal outcomes. Although these results should be interpreted cautiously, induction of labour ought to be offered to women no later than at 41 weeks and could be one (of few) interventions that reduces the rate of stillbirths. Trial registration Current Controlled Trials ISRCTN26113652 .

scholarly journals A Randomized Clinical Trial of Misoprostol and Oxytocin for Induction of Labour

1970 ◽  
Vol 5 (1) ◽  
pp. 44-48
Author(s):  
OM Loto ◽  
II Ayuba ◽  
IO Adebara ◽  
AA Ikuomola ◽  
U Onwudiegwu
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Induction Of Labour

DOI: http://dx.doi.org/10.3126/njog.v5i1.5061 NJOG 2010 Jul-Aug; 5(1): 44-48

scholarly journals When Research Meets Reality–-Lessons Learned from a Pragmatic Multisite Group-Randomized Clinical Trial on Psychosocial Interventions in the Psychiatric and Addiction Field

2012 ◽  
Vol 6 ◽  
pp. SART.S9245 ◽  
Author(s):  
Linda E. Wüsthoff ◽  
Helge Waal ◽  
Rolf W. Gråwe
Keyword(s):  
Clinical Trial ◽  
Substance Use ◽  
Randomized Clinical Trial ◽  
Substance Use Disorders ◽  
Clinical Studies ◽  
Psychosocial Interventions ◽  
Integrated Treatment ◽  
Lessons Learned ◽  
Future Research ◽  
New Challenges

Research on treatments for patients with co-occurring psychiatric and substance use disorders is of core importance and at the same time highly challenging as it includes patients that are normally excluded from clinical studies. Such research may require methodological adaptations which in turn create new challenges. However, the challenges that arise in such studies are insufficiently discussed in the literature. The aim of this methodology paper is, firstly, to discuss the methodological adaptations that may be required in such research; secondly, to describe how such adaptations created new challenges in a group-randomized clinical trial on Integrated Treatment amongst patients with co-occurring psychiatric and substance use disorders. We also discuss how these challenges might be understood and highlight lessons for future research in this field. Trial registration: NCT00447733.

scholarly journals Elective induction of labour at 39 weeks versus expectant management up to 41 weeks in a tertiary care centre

2020 ◽  
Vol 9 (2) ◽  
pp. 794
Author(s):  
Yogindra M. Kabadi ◽  
Sanjana Kumar
Keyword(s):  
Cesarean Section ◽  
Gestational Age ◽  
Perinatal Outcome ◽  
Tertiary Care ◽  
Expectant Management ◽  
Induction Of Labour ◽  
Labour Induction ◽  
Perinatal Deaths ◽  
Elective Induction ◽  
Singleton Pregnancies

Background: The timing of delivery and effective management of labour at term makes a huge difference in the obstetric and perinatal outcome. There have always been controversies between choosing the elective induction of labour at 39 weeks versus expectant management up to 41/42 weeks which can result in placental ageing, reduced liquor, non-assuring fetal heart tracings, meconium stained amniotic fluid and fetal macrosomia.  our objective was to perform a comparative effectiveness analysis of elective induction of labor at 39 weeks gestational age among nulliparous women with uncomplicated singleton pregnancies as compared to expectant management up to 41 weeks.Methods: 120 primigravidae with singleton pregnancies with fetus in cephalic presentation were recruited into the study and divided into 2 groups of 60 each A: Patients were induced electively using dinoprostone gel (maximum 3 doses 8 hours apart) B: They were managed expectantly up to 41 weeks allowing for spontaneous onset of labour, induction or cesarean section was done for obstetric indications between 39 and 41 weeks and pregnancy was  terminated by induction for those who continued up to 41 weeks. Their obstetric and perinatal outcome were noted.Results: The cesarean section rates were higher in the expectantly managed group (21%) when compared to the electively induced group (16%). The same was with instrumental delivery rates (15% versus 10%). The perinatal outcome was poorer for the expectantly managed group with 20% NICU admissions and 5% perinatal deaths compared to the electively induced group which had 12% NICU admissions and 3.3% perinatal deaths. The expectantly managed group also resulted in respiratory distress in a larger number of fetuses and resulted in problems due to reduced liquor.Conclusions: Elective induction at 39 weeks gestational age was found to be a better option compared to expectant management up to 41 weeks in terms of obstetric and perinatal outcomes.

Citation Analysis of Articles about Hand Surgery Published in Orthopaedic and Hand Surgery Journals

2019 ◽  
Vol 24 (01) ◽  
pp. 36-44 ◽  
Author(s):  
Yuki Fujihara ◽  
Nasa Fujihara ◽  
Michiro Yamamoto ◽  
Hitoshi Hirata
Keyword(s):  
Clinical Trial ◽  
Sample Size ◽  
Randomized Clinical Trial ◽  
Study Design ◽  
Comparative Studies ◽  
Clinical Studies ◽  
Hand Surgery ◽  
The Impact ◽  
Larger Sample ◽  
Surgery Journals

Background: To date, little is known about the characteristics of highly cited studies in hand surgery compared with other orthopaedic subspecialties. We aimed to assess the position of hand surgery within the orthopedic surgery literature. Methods: We conducted a bibliographic analysis using the Web of Science database to review 1,568 articles published between January 2012 and December 2012 in 4 relevant general orthopedic and 2 hand surgery journals. We used the number of citations within 3 years of publication to measure the impact of each paper. To analyze prognostic factors using logistic regression analysis, we extracted data on orthopedic subspecialty, published journal, location of authorship, and type of study for all articles. For clinical studies, we also recorded details on study design and sample size. Results: Of eligible hand surgery articles (n = 307), the majority (62%) were case reports/series. Only 19% were comparative studies, comprising a significantly smaller proportion of comparative studies from other subspecialties in general orthopedic journals. Systematic reviews/meta-analyses generated a significantly higher number of average citations, whereas educational reviews were consistently cited less frequently than other study types (14.9 and 6.1 average citations, respectively). Being published in the Journal of Bone and Joint Surgery, American volume, having authorship in North America or Europe and Australia, focusing on subspecialties like hip & knee, sports, or shoulder, utilizing a comparative or randomized clinical trial study design, and having a larger sample size increased the odds of receiving more citations. Conclusions: Clinical studies related to hand surgery published in general orthopedic journals are most often of lower quality study design. Having a larger sample size or using a comparative study or randomized clinical trial design can improve the quality of study and may ultimately increase the impact factor of hand surgery journals.

scholarly journals A comparative study of feto-maternal outcome in expectant management versus active management in pre-labor rupture of membranes at term

2017 ◽  
Vol 7 (1) ◽  
pp. 146
Author(s):  
Savitha T. S. ◽  
Pruthvi S. ◽  
Sudha C. P. ◽  
Vikram S. Nadig
Keyword(s):  
Caesarean Section ◽  
Maternal Morbidity ◽  
Caesarean Section Rate ◽  
Mode Of Delivery ◽  
Expectant Management ◽  
Neonatal Morbidity ◽  
Neonatal Infection ◽  
Induction Of Labour ◽  
Active Management ◽  
Induction Group

Background: Premature rupture of the membranes at term is spontaneous rupture of the membranes after 37 weeks of gestation and before the onset of the regular painful uterine contractions, complicates 5-10% of pregnancies, 80% of cases of PROM occur at term. It complicates the pregnancy leading to maternal and fetal complications, immediate risks such as cord prolapse, cord compression and placental abruptions, and later risks such as maternal or neonatal infection and the interventions such as caesarean section and instrumental vaginal delivery. These cases are either managed conservatively or by immediate induction of labour. Objective of present study is to compare the efficacy and safety of induction of labor versus expectant management at term PROM, in terms of maternal and fetal outcome.Methods: A randomized control trial of 100 women coming to KIMSH from 01 /04 /2015 to 01 /05 /2016 with PROM at term with duration of leak ≤6 hours and a Bishop score ≤5 were assigned to group A immediate induction group and group B expectant management group with 50 cases in each group.Results: The mean interval from PROM to delivery was significantly shorter in the induction Group 15.62±4.97 as compared with expectant group 17.58±4.78. Incidence of maternal morbidity and neonatal morbidity was comparable in both the groups. Intrapartum complications and mode of delivery were similar in both groups.Conclusions: Immediate induction of labour in cases of PROM at term using oral misoprostol resulted in shorter induction delivery interval and hospital stay. Maternal morbidity and neonatal morbidity was comparable in both groups. It is concluded that immediate induction is better than expectant management. With active management many patients delivered vaginally within 24 hours without increase in the Caesarean section rate and decreased the need for oxytocin augmentation.

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