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

BMJ : British Medical Journal
Judit K J KeulenEsteriek de Miranda

Abstract

To compare induction of labour at 41 weeks with expectant management until 42 weeks in low risk women. Open label, randomised controlled non-inferiority trial. 123 primary care midwifery practices and 45 hospitals (secondary care) in the Netherlands, 2012-16. 1801 low risk women with an uncomplicated singleton pregnancy: randomised to induction (n=900) or to expectant management until 42 weeks (n=901). Induction at 41 weeks or expectant management until 42 weeks with induction if necessary. 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%. 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 populatio...Continue Reading

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Citations

Feb 23, 2019·BMJ : British Medical Journal·Sara KenyonTracey Johnston
Nov 22, 2019·BMJ : British Medical Journal·Sara KenyonTracey Johnston
Jan 30, 2020·PloS One·Dominiek CoatesCaroline Homer
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Feb 20, 2020·Acta Obstetricia Et Gynecologica Scandinavica·Joep C KortekaasEsteriek De Miranda
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Dec 7, 2021·Acta Obstetricia Et Gynecologica Scandinavica·Charlotte Brix AnderssonUlrik Schiøler Kesmodel

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