TRUFFLE 2
Research type
Research Study
Full title
Perinatal and 2 year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 Randomised Trial
IRAS ID
266400
Contact name
Christoph Lees
Contact email
ISRCTN Number
ISRCTN76016200
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
In the last months of pregnancy, babies who are smaller or who grow more slowly than expected are at higher risk of dying in the mother's womb. Some of these smaller babies who survive may have developmental problems later in infancy. Doctors have many ways to monitor such babies in the womb, but the only treatment available is to deliver the baby.
If pregnancy has reached its full term, induction of labour is the usual option. If the baby is preterm (before 37 weeks) the right course of action is less clear. Delivering the baby early will minimise any damage due to lack of oxygen in the womb, but the baby may suffer harm as a result of being born prematurely. This study is looking at the balance of risks linked with continuing the pregnancy a little longer or delivering the baby early.
The study has 11 UK and 24 non-UK sites confirmed (Oct 2019). Pregnant women whose babies are either smaller or growing more slowly than expected between 32 and 36 weeks of pregnancy, will be invited to participate in the study. Their babies will be closely monitored with ultrasound scans, Doppler tests for blood flow and computerised heart rate tests. All these tests are regularly used in normal maternity care and are safe. If the Doppler test shows changes in the blood flow to the baby’s brain, mothers will be randomly assigned to one of two groups: in one group the babies will be delivered immediately. In the other group the babies will continue to be monitored closely. Babies in the second group will be delivered if the baby’s heart rate shows signs of deteriorating health. The health of all the babies will be recorded at birth, and ongoing health and development follow ups.
This study is funded by the NIHR.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0031
Date of REC Opinion
16 Jan 2020
REC opinion
Favourable Opinion