Evidence map›Paper›PMID 23046499›Full record

Trial reportBMC pregnancy and childbirth2012

The IDEAL study: investigation of dietary advice and lifestyle for women with borderline gestational diabetes: a randomised controlled trial - study protocol.

Caroline A Crowther, William M Hague, Philippa F Middleton, Peter A Baghurst, Andrew J McPhee, Thach S Tran, Lisa N Yelland, Pat Ashwood, Shan Han, Jodie M Dodd and 2 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Caroline A CrowtherAustralian Research Centre for Health of Women and Babies (ARCH), The Robinson Institute, Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia. caroline.crowther@adelaide.edu.au
William M Hague
Philippa F Middleton
Peter A Baghurst
Andrew J McPhee
Thach S Tran
Lisa N Yelland
Pat Ashwood
Shan Han
Jodie M Dodd
Jeffrey S Robinson
IDEAL Study Group
The University of Adelaide · AUWomen's and Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) showed that treatment of pregnant women with mild gestational diabetes mellitus is beneficial for both women and their infants. It is still uncertain whether there are benefits of similar treatment for women with borderline gestational diabetes.This trial aims to assess whether dietary and lifestyle advice and treatment given to pregnant women who screen for borderline gestational diabetes reduces neonatal complications and maternal morbidities. METHODS/

design

designMulticentre, randomised controlled trial. INCLUSION CRITERIA: Women between 240 and 346 weeks gestation with a singleton pregnancy, a positive oral glucose challenge test (venous plasma glucose ≥7.8 mmol/L) and a normal oral 75 gram glucose tolerance test (fasting venous plasma glucose <5.5 mmol/L and a 2 hour glucose <7.8 mmol/L) with written, informed consent.Trial entry and randomisation: Women with an abnormal oral glucose tolerance test (fasting venous plasma glucose ≥5.5 mmol/L or 2 hour glucose ≥7.8 mmol/L) will not be eligible and will be offered treatment for gestational diabetes, consistent with recommendations based on results of the ACHOIS trial. Eligible women will be randomised into either the 'Routine Care Group' or the 'Intervention Group'.Study groups: Women in the 'Routine Care Group' will receive routine obstetric care reflecting current clinical practice in Australian hospitals. Women in the 'Intervention Group' will receive obstetric care, which will include dietary and lifestyle advice, monitoring of blood glucose and further medical treatment for hyperglycaemia as appropriate.Primary study outcome: Incidence of large for gestational age infants. SAMPLE SIZE: A sample size of 682 women will be sufficient to show a 50% reduction in the risk of large for gestational age infants (alpha 0.05 two-tailed, 80% power, 4% loss to follow up) from 14% to 7% with dietary and lifestyle advice and treatment. DISCUSSION: A conclusive trial outcome will provide reliable evidence of relevance for the care of women with borderline glucose intolerance in pregnancy and their infants.

trial registrationAustralian New Zealand Clinical Trials Registry - ACTRN12607000174482.

Indexed as

DietLife StyleAdultDiabetes, GestationalFemaleFetal MacrosomiaGlucose Tolerance TestHumansInfant, NewbornPatient Education as TopicPregnancy

Identifiers

PMID23046499
PMCPMC3506505
OpenAlexW2150385862

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.