|
ISRCTN
|
ISRCTN41358726
|
|
DOI
|
10.1186/ISRCTN41358726
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Growth Restriction Intervention Trial
|
|
Scientific title
|
|
|
Acronym
|
GRIT
|
|
Serial number at source
|
G9533539
|
|
Study hypothesis
|
The aim of this trial is to compare the effect of immediate or delayed delivery for premature fetuses with good evidence of failure to thrive in utero. Cases will be stratified by gestational age and the degree of abnormality of test results. The sole entry criterion will be obstetrician uncertainty about the best management. The primary outcome measure will be Development Quotient at two years of age, with deaths included and scored as zero. The analysis will be stratified by gestation and the degree of test abnormality.
Please note that, as of 14/02/2007, the target number of participants has been updated from 548 to 510 (233 UK; 277 non-UK).
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom, Europe
|
|
Disease/condition/study domain
|
Obstetrics and gynaecology
|
|
Participants - inclusion criteria
|
1. Gestation between 24 - 36 completed weeks
2. Evidence of pregnancy compromise
3. Clinical uncertainty about the optimum timing of delivery. Entry criteria are flexible since the degree of compromise that would make obstetricians consider delivery vary with gestational age and between clinicians
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
09/01/1994
|
|
Anticipated end date
|
31/01/1996
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
510 (233 UK; 277 non-UK)
|
|
Interventions
|
Immediate delivery or defer delivery until uncertainty no longer exists.
Please note that, as of 14/02/2007, the anticipated start and end dates of this trial have been updated to 01/04/1997 and 27/06/2008, respectively.
|
|
Primary outcome measure(s)
|
Development Quotient at two years of age, with deaths included and scored as zero.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Medical Research Council (UK)
|
|
Trial website
|
|
|
Publications
|
1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12504932
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15302194
|
|
Contact name
|
Dr
James G
Thornton
|
|
Address
|
Centre for Reproduction, Growth and Development
University of Leeds
34 Hyde Terrace
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS2 9LN
|
|
Country
|
United Kingdom
|
|
Email
|
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
25/10/2000
|
|
Last edited
|
31/03/2009
|
|
Date ISRCTN assigned
|
25/10/2000
|
