Trial of Umbilical and Foetal Flow in Europe: TRUFFLE study

Completed

• Conditions: Pregnancy/foetal growth restriction; Pregnancy and Childbirth; Maternal care for other known or suspected foetal problems

• Registration Number: ISRCTN56204499
• Lead Sponsor: Addenbrooke's Hospital (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. The pregnancy should be singleton (i.e., not multiple pregnancy)
2. No obvious major structural abnormalities should have been identified on ultrasound
3. Certain menstrual age and/or ultrasound assessment of gestational age
4. The pregnancy should have reached at least 26 weeks gestation, but not yet 32 weeks of gestation by the time of recruitment
5. The ultrasound estimation of foetal weight should be at least 500 g at entry of the study
6. There should be ultrasound evidence of growth restriction, defined as a foetal abdominal circumference measurement under the 10th centile
7. Short term variability of the foetal heart rate after 1 hour recording should be greater than 3.5 beats per minute at 26 - 29 weeks, and greater than 4 beats per minute at 30 - 32 weeks
8. There should be evidence of abnormal umbilical artery bloodflow, manifesting as Umbilical arterial Doppler velocimetry above 95th centile
9. The foetal Ductus Venosus waveform using doppler ultrasound, should be normal defined as a venous pulsatility index under the 95th centile
10. There should be no obvious indication for immediate delivery (such as uncontrolled maternal high blood pressure)
11. The patient must be able to give informed consent to participation

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified