ISRCTN39133303
Completed
Phase 3
A randomised controlled trial of sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction
iverpool Women's NHS Foundation Trust (UK)0 sites112 target enrollmentJuly 31, 2014
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- iverpool Women's NHS Foundation Trust (UK)
- Enrollment
- 112
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
- 2014 protocol in https://www.ncbi.nlm.nih.gov/pubmed/24618418 2. 2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/29282009 3. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30169244
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •1\. Multiple pregnancy
- •2\. Known or suspected structural or chromosomal fetal abnormality
- •3\. Maternal illness (e.g., pre\-eclampsia) that is 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, e.g., known maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil
Outcomes
Primary Outcomes
Not specified
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