Growth Restriction Intervention Trial

ISRCTN	ISRCTN41358726
DOI	https://doi.org/10.1186/ISRCTN41358726
Secondary identifying numbers	G9533539

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr James G Thornton
Scientific

Centre for Reproduction, Growth and Development
University of Leeds
34 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	GRIT
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Development Quotient at two years of age, with deaths included and scored as zero.
Secondary outcome measures	Not provided at time of registration
Overall study start date	09/01/1994
Completion date	31/01/1996

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	510 (233 UK; 277 non-UK)
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	09/01/1994
Date of final enrolment	31/01/1996

Centre for Reproduction, Growth and Development

Leeds
LS2 9LN
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2003		Yes	No
Results article	results	01/08/2004		Yes	No