Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9533539
Study information
Scientific title
Acronym
GRIT
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).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Obstetrics and gynaecology
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Development Quotient at two years of age, with deaths included and scored as zero.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
09/01/1994
Overall trial end date
31/01/1996
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
510 (233 UK; 277 non-UK)
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
09/01/1994
Recruitment end date
31/01/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Reproduction, Growth and Development
Leeds
LS2 9LN
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2003 results in: http://www.ncbi.nlm.nih.gov/pubmed/12504932
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15302194
Publication citations
-
Results
A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation., BJOG, 2003, 110, 1, 27-32.
-
Results
Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M, , Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial., Lancet, 364, 9433, 513-520, doi: 10.1016/S0140-6736(04)16809-8.