A randomised controlled trial of sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction - STRIDER version 2.0

iverpool Women's NHSFT0 sites112 target enrollmentFebruary 9, 2015

Overview

No summary available.

Registry

who.int

Start Date

February 9, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

iverpool Women's NHSFT

•1\) Women with singleton pregnancy and fetus diagnosed with severe, early onset intrauterine growth restriction (IUGR) between 22\+0 and 29\+6 weeks of gestation and clinical decision to manage pregnancy expectantly.
•2\) IUGR is defined as estimated fetal weight or abdominal circumference \<10th centile and absent or reversed end diastolic velocity Doppler in the umbilical artery.
•3\) 16 years of age or older
•4\) Consent to take part in the trial
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range 112
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range 0

•1\) Multiple pregnancy
•2\) Known or suspected structural or chromosomal fetal abnormality
•3\) Maternal illness (eg pre\-eclampsia) thatis expected to require delivery for maternal reasons within the next 72 hours
•4\) Maternal wish not to have active management of the pregnancy, or to have pregnancy termination weeks
•5\) Inability to give informed consent
•6\) Cocaine use
•7\) Contraindication to sildenafil therapy, eg known maternal cardiac disease, left ventricular outflow tract obstruction, concommitant treatment with nitrates or previous allergy to sildenafil