STRIDER - Sildenafil therapy for treatment of intrauterine growth restrictio
- Conditions
- Early onset intrauterine growth restrictionMedDRA version: 17.1Level: LLTClassification code 10022819Term: Intrauterine growth retardationSystem Organ Class: 100000004868Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2013-005398-32-GB
- Lead Sponsor
- iverpool Women's NHSFT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 112
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method