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ARRIVE trial (induction at 39 weeks in low-risk first births)

A large trial in the United States that asked whether offering induction at 39 weeks to healthy first-time mothers leads to better results than waiting for labour to start on its own. About 6100 women took part. Induction did not clearly lower the main outcome, a mix of baby deaths and serious newborn problems, but it did lower the caesarean rate. The registry lists no masking.

Also called ARRIVE · A Randomized Trial of Induction Versus Expectant Management

  • Study
  • In this atlas

Overview

Design
Allocation: randomised. Intervention model: parallel. Masking: none listed. Primary purpose: prevention. Women were randomly assigned to induction of labour at 39 weeks 0 days to 39 weeks 4 days or to expectant management (registry values, paraphrased).
Phase
Not applicable
Enrolled
  • 6,106 women (registry enrollment, type ACTUAL) (enrolled count) (A Randomized Trial of Induction Versus Expectant Management, retrieved )
  • 3,062 women assigned to labour induction (randomized count) (Labor Induction versus Expectant Management in Low-Risk Nulliparous Women, retrieved )
  • 3,044 women assigned to expectant management (randomized count) (Labor Induction versus Expectant Management in Low-Risk Nulliparous Women, retrieved )
Sponsor
Not recorded
Registry
  • NCT NCT01990612
Started
(A Randomized Trial of Induction Versus Expectant Management, retrieved )
Primary completion
(actual) (A Randomized Trial of Induction Versus Expectant Management, retrieved )
Completion
(actual) (A Randomized Trial of Induction Versus Expectant Management, retrieved )
Results first posted
(actual) (A Randomized Trial of Induction Versus Expectant Management, retrieved )
Countries
United States (A Randomized Trial of Induction Versus Expectant Management, retrieved )
Care setting
Multicentre trial in the United States. The abstract does not say what kind of site took part. (Labor Induction versus Expectant Management in Low-Risk Nulliparous Women, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Randomised, parallel-group trial (NCT01990612; phase not applicable). The registry enrolled count is 6106 (actual); the abstract gives 3062 women assigned to induction at 39 weeks 0 days to 39 weeks 4 days and 3044 assigned to expectant management, women randomised at 38 weeks 0 days to 38 weeks 6 days. Primary outcome: a composite of perinatal death or severe neonatal complications. Principal secondary outcome: caesarean delivery. The registry induction arm used oxytocin, with cervical ripening first (method left to the physician) when the cervix was unfavourable. Registry lead sponsor: The George Washington University Biostatistics Center (no organisation record in this atlas), with NICHD as collaborator; the abstract says the trial was funded by NICHD. The funded_by link to NICHD rests on the abstract's funding statement, not on the registry collaborator line. The registry start date has no type; results were first posted 2019-01-25 and were not read.

Arms

  • Elective induction of labour at 39 weeks 0 days to 39 weeks 4 days

    Intervention Induction of labour

    Induction of labour between 39 weeks 0 days and 39 weeks 4 days in women with no medical indication; the registry says induction was by oxytocin, after cervical ripening when the cervix was unfavourable.

  • Expectant management

    Intervention None named

    Expectant management, unless a medical indication arose, until at least 40 weeks 5 days (registry arm description).

Findings

No findings are published for this study.

Record details

Record id
maternal:arrive-trial
Content hash
91a8b9eca967e437cb687bc892fe3a8cd68f30157889eed43d0ffb5b924a5e7e