Evidence map›Paper›PMID 21177352›Full record

Trial reportBMJ (Clinical research ed.)2010

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

K E Boers, S M C Vijgen, D Bijlenga, J A M van der Post, D J Bekedam, A Kwee, P C M van der Salm, M G van Pampus, M E A Spaanderman, K de Boer and 16 more

2 registry-linked trialsOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ (Clinical research ed.), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 92 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 9 pooled it
26.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02229630 nacompletednot on this mapstarted 2015, after this paper: background citation

Prognostic Value of Diffusion-weighted Cerebral MRI in Prenatal Evaluation of Foetuses With Intra Uterine Growth Restriction.

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2015 to 2019Enrolled82ConditionsPregnant Women With Foetuses Presenting With Intra-uterine Growth RestrictionArmsPregnant women with intra-uterine growth restricted Foetuses
NCT03625518 early_phase1unknown statusnot on this mapstarted 2018, after this paper: background citation

Mode of Induction in Fetal Growth Restriction and Its Affects on Fetal and Maternal Outcomes

TypeinterventionalSponsorTel-Aviv Sourasky Medical CenterRan2018 to 2021Enrolled280ConditionsFetal Growth Retardation, Induction of Labor Affected Fetus / NewbornArmsprostaglandins E2, intracervical balloon catheter combined with pitocin
3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 9 syntheses or guidelines pooled it, 526 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Early psychosocial development of small for gestational age and intrauterine growth-restricted children: a systematic review.Journal of perinatology : official journal of the California Perinatal Association · 2019
    Pooled it
  6. Delivery or expectant management for prevention of adverse maternal and neonatal outcomes in hypertensive disorders of pregnancy: an individual participant data meta-analysis.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2019
    Pooled it
  7. Prognostic accuracy of cerebroplacental ratio and middle cerebral artery Doppler for adverse perinatal outcome: systematic review and meta-analysis.Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology · 2018
    Pooled it
  8. Pooled it
  9. Use of labour induction and risk of cesarean delivery: a systematic review and meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2014
    Pooled it
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

32 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 16 institutions in 3 countries.

K E BoersLeiden University Medical Centre, Leiden, Netherlands. k.e.boers@lumc.nl
S M C Vijgen
D Bijlenga
J A M van der Post
D J Bekedam
A Kwee
P C M van der Salm
M G van Pampus
M E A Spaanderman
K de Boer
J J Duvekot
H A Bremer
T H M Hasaart
F M C Delemarre
K W M Bloemenkamp
C A van Meir
C Willekes
E J Wijnen
M Rijken
S le Cessie
F J M E Roumen
J G Thornton
J M M van Lith
B W J Mol
S A Scherjon
DIGITAT study group
Leiden University Medical Center · NLAcademic Medical Center · NLOLVG · NLAtrium Medisch Centrum Parkstad · NLElkerliek Ziekenhuis · NLErasmus MC · NLGroene Hart Ziekenhuis · NLMaastricht University · NLMeander Medisch Centrum · NLNottingham City Hospital · GBRadboud University Medical Center · NLRadboud University Nijmegen · NLReinier de Graaf Hospital · NLRijnstate Hospital · NLUniversity Medical Center Utrecht · NLVieCuri Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the effect of induction of labour with a policy of expectant monitoring for intrauterine growth restriction near term.

designMulticentre randomised equivalence trial (the Disproportionate Intrauterine Growth Intervention Trial At Term (DIGITAT)).

settingEight academic and 44 non-academic hospitals in the Netherlands between November 2004 and November 2008.

participantsPregnant women who had a singleton pregnancy beyond 36+0 weeks' gestation with suspected intrauterine growth restriction.

interventionsInduction of labour or expectant monitoring.

main outcome measuresThe primary outcome was a composite measure of adverse neonatal outcome, defined as death before hospital discharge, five minute Apgar score of less than 7, umbilical artery pH of less than 7.05, or admission to the intensive care unit. Operative delivery (vaginal instrumental delivery or caesarean section) was a secondary outcome. Analysis was by intention to treat, with confidence intervals calculated for the differences in percentages or means.

results321 pregnant women were randomly allocated to induction and 329 to expectant monitoring. Induction group infants were delivered 10 days earlier (mean difference -9.9 days, 95% CI -11.3 to -8.6) and weighed 130 g less (mean difference -130 g, 95% CI -188 g to -71 g) than babies in the expectant monitoring group. A total of 17 (5.3%) infants in the induction group experienced the composite adverse neonatal outcome, compared with 20 (6.1%) in the expectant monitoring group (difference -0.8%, 95% CI -4.3% to 3.2%). Caesarean sections were performed on 45 (14.0%) mothers in the induction group and 45 (13.7%) in the expectant monitoring group (difference 0.3%, 95% CI -5.0% to 5.6%).

conclusionsIn women with suspected intrauterine growth restriction at term, we found no important differences in adverse outcomes between induction of labour and expectant monitoring. Patients who are keen on non-intervention can safely choose expectant management with intensive maternal and fetal monitoring; however, it is rational to choose induction to prevent possible neonatal morbidity and stillbirth.

trial registrationInternational Standard Randomised Controlled Trial number ISRCTN10363217.

Indexed as

Labor, InducedWatchful WaitingAdultFemaleFetal Growth RetardationGestational AgeHumansLabor OnsetLength of StayPregnancyPregnancy OutcomeYoung Adult

Identifiers

PMID21177352
PMCPMC3005565
OpenAlexW2109985281

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.