STRIDER (NZAus): A randomised placebo-controlled trial of a new therapy (sildenafil) to help growth in severely growth restricted fetuses at very early gestations.
Phase 2
Completed
- Conditions
- Severe early onset fetal growth restrictionReproductive Health and Childbirth - Fetal medicine and complications of pregnancy
- Registration Number
- ACTRN12612000584831
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 122
Inclusion Criteria
1. Singleton pregnancy.
2a. At 22+0 weeks to 27+6 weeks: AC measure less than or equal to 3 percentile for gestational age; OR
2b. At 28+0 weeks to 29+6 weeks ultrasound estimate of fetal weight (EFW) <700grams.
Exclusion Criteria
1. Known major fetal anomaly/syndrome/congenital infection deemed to be the likely cause of IUGR.
2. Known fetal aneuploidy.
3. Already made plan for termination of pregnancy.
4. Maternal disease (e.g. pre-eclampsia) where it is expected that delivery is necessary within 48 hours.
5. Any contraindication to sildenafil therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method