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SWEPIS trial (induction at 41 weeks)

A Swedish trial in healthy women with a normal pregnancy near the end of term. It compared inducing labour at 41 weeks with waiting and inducing at 42 weeks if labour had not started. About 2760 women took part in 14 hospitals. The monitoring board advised stopping the trial early because more babies died around birth in the waiting group. The main combined outcome did not differ between the groups.

Also called SWEPIS · SWEdish Post-term Induction Study

  • Study
  • In this atlas

Overview

Design
Multicentre, open label, randomised controlled superiority trial. Randomisation 1:1 and most data collection used the Swedish Pregnancy Register.
Phase
Not reported
Enrolled
  • 2,762 women (randomized count) (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, retrieved )
  • 2,760 women (as printed in the abstract; the full text says two women withdrew consent after randomisation) (randomized count) (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, retrieved )
  • 1,381 women in the induction group (intention-to-treat analysis) (analyzed count) (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, retrieved )
  • 1,379 women in the expectant management group (intention-to-treat analysis) (analyzed count) (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, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • ISRCTN ISRCTN26113652
Started
(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, retrieved )
Primary completion
Not reported
Completion
Not reported
Countries
Sweden (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, retrieved )
Care setting
Fourteen hospitals in Sweden (five university clinics and nine county hospitals) that take part in the Swedish Pregnancy Register. (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, retrieved )
Registry status
Not reported
Stopped early
The trial stopped early, . On this date the independent monitoring board advised the steering committee to end the trial, because deaths around birth were significantly more frequent in the expectant management group. The date is the board's advice: recruitment ran until 13 October 2018. (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, retrieved )

Technical summary

Multicentre, open label, randomised superiority trial (ISRCTN26113652), register-based: randomisation 1:1 through the Swedish Pregnancy Register. 2760 women randomised, 1381 to induction and 1379 to expectant management. Primary outcome: a composite perinatal outcome of stillbirth, neonatal mortality and serious newborn problems (an Apgar score below 7 at 5 minutes, umbilical artery pH or acidosis criteria, mechanical ventilation within 72 hours, obstetric brachial plexus injury, and hypoxic ischaemic encephalopathy, convulsions, intracranial haemorrhage or meconium aspiration syndrome). Analysis was by intention to treat. Recruitment ran between 20 May 2016 and 13 October 2018; on 2 October 2018 the monitoring board advised stopping the trial, and recruitment ended on 13 October 2018. A published erratum (BMJ 2021, PMID 34911689) corrects the neonatal intensive care figures in table 3. Funders are listed in the paper; no organisation record exists in this atlas. The ISRCTN record was not fetched, so no registry status or registry dates are recorded.

Arms

  • Induction of labour at 41 weeks

    Intervention Induction of labour

    Induction of labour at 41 weeks.

  • Expectant management and induction at 42 weeks

    Intervention None named

    Expectant management, with induction of labour at 42 weeks.

Findings

No findings are published for this study.

Record details

Record id
maternal:swepis-trial
Content hash
9a01833fb120c2f1a672bb1e4f4024fb3c64e742cf056c709aeece650a51fc92