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DIGITAT trial (induction or monitoring for growth restriction at term)

A Dutch trial in women near term whose babies were thought to be growing poorly. Half were offered induction of labour and half were watched closely and left to go into labour on their own. The authors found no important differences in the babies' outcomes between the two approaches.

  • Study
  • In this atlas

Overview

Design
Multicentre randomised equivalence trial. Pregnant women with a singleton pregnancy beyond 36+0 weeks and suspected intrauterine growth restriction were randomly allocated to induction of labour or expectant monitoring. Analysis was by intention to treat.
Phase
Not reported
Enrolled
  • 321 women (randomly allocated to induction of labour) (randomized count) (Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT), retrieved )
  • 329 women (randomly allocated to expectant monitoring) (randomized count) (Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT), retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • ISRCTN ISRCTN10363217
Started
Not reported
Primary completion
Not reported
Completion
Not reported
Countries
Netherlands (Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT), retrieved )
Care setting
Not reported
Registry status
Not reported

Technical summary

Multicentre randomised equivalence trial in 8 academic and 44 non-academic hospitals in the Netherlands, November 2004 to November 2008 (BMJ 2010; ISRCTN 10363217). 321 women were allocated to induction and 329 to expectant monitoring. Primary outcome: a composite adverse neonatal outcome (5.3% against 6.1%). The authors found no important differences between induction and expectant monitoring, and say both choices are reasonable. The study is filed under induction of labour as well as fetal growth restriction. The PMC copy is licensed non-commercial, so only the abstract was read.

Arms

  • Induction of labour

    Intervention Induction of labour

    Induction of labour for suspected intrauterine growth restriction beyond 36+0 weeks.

  • Expectant monitoring

    Intervention None named

    Expectant monitoring for suspected intrauterine growth restriction beyond 36+0 weeks.

Findings

No findings are published for this study.

Claims and evidence

Context Infants born near term after suspected intrauterine growth restriction, induced or monitored (DIGITAT)

Recipient
Newborn
Population
Infants of women with a singleton pregnancy beyond 36+0 weeks and suspected intrauterine growth restriction (321 women allocated to induction and 329 to expectant monitoring). Outcomes in this context are counted in infants.
Care setting
8 academic and 44 non-academic hospitals
Geography
The Netherlands
Life stage
Birth at or after 36+0 weeks of gestation; outcomes up to hospital discharge
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Death before hospital discharge, five minute Apgar score, umbilical artery pH and intensive care admission
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Singleton pregnancy beyond 36+0 weeks of gestation with suspected intrauterine growth restriction
Excluded
  • Not stated in the parts of the source that were read.

  • Effect Interventional Certainty not assessed

    DIGITAT randomly allocated 321 women with a singleton pregnancy beyond 36+0 weeks and suspected intrauterine growth restriction to induction of labour and 329 to expectant monitoring, in 8 academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008. A composite adverse neonatal outcome (death before hospital discharge, five-minute Apgar score below 7, umbilical artery pH below 7.05, or admission to intensive care) occurred in 17 infants (5.3%) after induction and 20 (6.1%) after expectant monitoring (difference -0.8%, 95% CI -4.3% to 3.2%). Induction group infants were born 10 days earlier (mean difference -9.9 days) and weighed 130 g less. The authors found no important differences in adverse outcomes between the two policies.

    Applies to Newborn
    • Infants of women with a singleton pregnancy beyond 36+0 weeks and suspected intrauterine growth restriction (321 women allocated to induction and 329 to expectant monitoring). Outcomes in this context are counted in infants.
    • 8 academic and 44 non-academic hospitals
    • The Netherlands
    • Birth at or after 36+0 weeks of gestation; outcomes up to hospital discharge
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Death before hospital discharge, five minute Apgar score, umbilical artery pH and intensive care admission
    Certainty method
    Not assessed
    Limitations
    The trial tested equivalence, and its confidence interval for the composite (-4.3% to 3.2%) does not rule out differences of a few percentage points either way. It enrolled women in the Netherlands in 2004 to 2008. The authors add that women who prefer no intervention can safely choose expectant management with intensive maternal and fetal monitoring, and that it is rational to choose induction to prevent possible neonatal morbidity and stillbirth. Only the abstract was read; the PMC copy is licensed non-commercial and was not used.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (14)

    1. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, DESIGN, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, SETTING, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, PARTICIPANTS, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    4. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, INTERVENTIONS, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    5. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, MAIN OUTCOME MEASURES, sentence 1, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    6. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, MAIN OUTCOME MEASURES, sentence 1, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    7. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, RESULTS, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    8. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, RESULTS, sentence 2, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    9. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, RESULTS, sentence 2, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    10. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, RESULTS, sentence 3, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    11. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, RESULTS, sentence 3, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    12. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    13. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, CONCLUSIONS, sentence 2, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    14. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, CONCLUSIONS, sentence 2, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Context Women with suspected intrauterine growth restriction near term, induced or monitored (DIGITAT)

Recipient
Maternal
Population
Women with a singleton pregnancy beyond 36+0 weeks and suspected intrauterine growth restriction: 321 allocated to induction of labour and 329 to expectant monitoring. Outcomes in this context are counted in mothers.
Care setting
8 academic and 44 non-academic hospitals
Geography
The Netherlands
Life stage
Pregnancy beyond 36+0 weeks of gestation, labour and birth
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Mode of delivery
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Singleton pregnancy beyond 36+0 weeks of gestation with suspected intrauterine growth restriction
Excluded
  • Not stated in the parts of the source that were read.

  • Effect Interventional Certainty not assessed

    In DIGITAT, caesarean sections were performed on 45 mothers (14.0%) in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%). Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome.

    Applies to Maternal
    • Women with a singleton pregnancy beyond 36+0 weeks and suspected intrauterine growth restriction: 321 allocated to induction of labour and 329 to expectant monitoring. Outcomes in this context are counted in mothers.
    • 8 academic and 44 non-academic hospitals
    • The Netherlands
    • Pregnancy beyond 36+0 weeks of gestation, labour and birth
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Mode of delivery
    Certainty method
    Not assessed
    Limitations
    These are secondary outcomes counted in mothers. The confidence interval spans about five percentage points either way. Only the abstract was read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (4)

    1. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, MAIN OUTCOME MEASURES, sentence 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, RESULTS, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, RESULTS, sentence 4, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    4. Supports Induction versus expectant monitoring for intrauterine growth restriction at term: randomised equivalence trial (DIGITAT)

      Publication · BMJ (Clinical research ed.) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2010-12-21 · DOI: 10.1136/bmj.c7087 · PMID: 21177352

      Locator
      Abstract, RESULTS, sentence 4, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      ae35719dd4adb2c4e098c6a481adf7d72f63e84b56691c1e7daeb13a56c5ec85
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Record details

Record id
maternal:digitat-trial
Content hash
06ac6ff850d8c1dcbdaf59eac8e1a4010517af79192c40d54be14f23bf2a03f6