Condition category
Pregnancy and Childbirth
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
14/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr James G Thornton

ORCID ID

Contact details

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. Results

    A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation., BJOG, 2003, 110, 1, 27-32.

  2. 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.

Additional files

Editorial Notes