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

Abstract

ObjectiveTo 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. DesignMulticentre, 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. interventiOnsInduction of labour at 41 weeks and expectant management and induction of labour at 42 weeks. Main OutcOMe MeasuresThe 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. resultsThe 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. cOnclusiOnsThis 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 registratiOnCurrent Controlled Trials ISRCTN26113652.

Reference values for pulsatility index of fetal anterior and posterior cerebral arteries in prolonged pregnancy

“…This study reports Doppler reference values for the PI in both anatomical segments of the anterior and posterior cerebral arteries from 40 + 0 to 41 + 6 weeks. Since prolonged pregnancies have been shown to present a higher incidence of placental insufficiency and adverse neonatal outcomes, 4,36,37 the possibility of vascular examination in different fetal brain regions represents an interesting tool for the clinicians to eventually choose the correct management for these pregnancies.…”

“…However, the pathophysiology of fetal and neonatal complications related to prolonged pregnancies is yet to be elucidated and needs more evidence to be clarified. Thus prolonged pregnancy constitutes a clinical dilemma in terms of choice between an active management and a “wait and see” policy in order to avoid unnecessary labor inductions 3,4 …”

Accuracy of postpartum hemorrhage coding in the Swedish Pregnancy Register

“…Population‐based registers containing routinely collected health data are valuable resources from both an epidemiological and a public health point of view. Validated birth and pregnancy registers allow quality improvement in perinatal care and facilitate retrospective studies and registry‐based randomized controlled trials 20 . In the era of Big Data, medical researchers and health authorities have become increasingly dependent on the ICD‐coding system for tracking patterns in obstetric‐related morbidities.…”

“…registry-based randomized controlled trials 20. In the era of Big Data, medical researchers and health authorities have become increasingly dependent on the ICD-coding system for tracking patterns in obstetric-related morbidities.…”

SWEPIS-Studie (SWEdish Post-term Induction Study): Geburtseinleitung in SSW 41 versus in SSW 42 bei risikoarmen Schwangerschaften

“…Ziel der 16 Forscherinnen und Forscher, mehrheitlich aus dem Karolinska Institut in Stockholm, Schweden, war es, die bislang in Schweden übliche Routine bei Terminüberschreitung (Einleitung 14-15 Tage nach errechnetem Termin) mit einer etwas früheren Einleitung (7-8 Tage nach errechnetem Termin) zu vergleichen und dabei sowohl kindliches als auch mütterliches Outcome zu berücksichtigen [1].…”