Induction of labour at 41 weeks versus expectant management until 42 weeks (INDEX): multicentre, randomised non-inferiority trial
| Autor: | Jeroen van Dillen, Aafke Bruinsma, Frank P.H.A. Vandenbussche, Esteriek de Miranda, Judit K. J. Keulen, Ben W.J. Mol, Anton H. van Kaam, Joep C. Kortekaas, Patrick M. M. Bossuyt, Martijn A. Oudijk, Joris A. M. van der Post, Ruben G. Duijnhoven |
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| Přispěvatelé: | Graduate School, Obstetrics and Gynaecology, Amsterdam Reproduction & Development (AR&D), APH - Personalized Medicine, APH - Methodology, Epidemiology and Data Science, Neonatology, ARD - Amsterdam Reproduction and Development |
| Rok vydání: | 2019 |
| Předmět: |
Psychological intervention
law.invention 0302 clinical medicine Randomized controlled trial Interquartile range law Pregnancy Infant Mortality Outcome Assessment Health Care Medicine 030212 general & internal medicine Netherlands education.field_of_study 030219 obstetrics & reproductive medicine Labor Obstetric Obstetrics Incidence (epidemiology) Absolute risk reduction Obstetrics and Gynecology Gestational age General Medicine 3. Good health Meconium Aspiration Syndrome Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10] Apgar score Female Intracranial Hemorrhages Adult Risk medicine.medical_specialty Adolescent Population Gestational Age 03 medical and health sciences Young Adult All institutes and research themes of the Radboud University Medical Center Intensive Care Units Neonatal Humans Brachial Plexus Labor Induced education Watchful Waiting Fetal Death Perinatal Mortality business.industry Cesarean Section Other Research Radboud Institute for Health Sciences [Radboudumc 0] Infant medicine.disease Confidence interval business |
| Zdroj: | BMJ. British Medical Journal (Online), 364 Obstetrical & gynecological survey, 74(7), 381-383. Lippincott Williams and Wilkins BMJ (Clinical research ed.), 364:l344. British Medical Association |
| ISSN: | 1756-1833 0029-7828 0959-8146 |
| Popis: | 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 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 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 Trial registration Netherlands Trial Register NTR3431. |
| Databáze: | OpenAIRE |
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