STRIDER
Research type
Research Study
Full title
A randomised controlled trial of sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction
IRAS ID
138347
Contact name
Zarko Alfirevic
Contact email
Eudract number
2013-005398-32
ISRCTN Number
N/A
Research summary
The STRIDER trial aims to determine whether maternal treatment of oral sildenafil citrate improves perinatal outcomes in pregnancies complicated by severe early-onset IUGR without increasing risk to mother.
Failure to thrive before birth (intrauterine growth restriction (IUGR)) can occur due to a variety of causes such as fetal chromosomal or structural abnormalities. However, the main management issues occur when fetal growth slows down, or stops altogether, because of poorly functioning placenta.
In a healthy pregnancy, placental cells invade the lining of the maternal uterine blood vessels. Women whose unborn children are failing to thrive due to poor blood supply to the placenta will be invited to participate. The trial will be conducted in large maternity units across England.
During a 24 month period, all women carrying a fetus diagnosed with severe IUGR before 30+0 weeks of pregnancy will be invited to participate. It is anticipated that around 50% of eligible women will agree to participate and 112 women will be given either oral sildenafil or matching placebo tablets until delivery, or 32+0 weeks of pregnancy, whichever comes first.
It is expected that babies exposed to sildenafil will be delivered one week later compared to those exposed to placebo. This one week increase in maturity is clinically very important.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/0011
Date of REC Opinion
20 Mar 2014
REC opinion
Further Information Favourable Opinion