Tadalafil treatment for Fetus with Early onset growth Restrictio
- Conditions
- fetal growth restriction
- Registration Number
- JPRN-UMIN000020044
- Lead Sponsor
- Department of Obstetrics & Gynecology Mie University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 12
Not provided
1) Patients with allergic to tadalafil 2) Patients are taking the drug, which is contraindicated to tadalafil 3) Patients are undergoing kidney dialysis, with severe renal impairment(creatinine clearance<30mL / min) 4) Patients with severe liver failure [AST (GOT) or ALT (GPT)>100 IU / L] 5) Patients with uncontrolled arrhythmias, hypotension (blood pressure <90 / 50mmHg), or uncontrolled high blood pressure (blood pressure> 170 / 100mmHg) 6) Fetus with chromosomal abnormality can be considered from ultrasonography 7) Retinitis pigmentosa patients 8) Patients with bleeding disorders or peptic ulcer 9) Patients with pulmonary venous occlusive disease 10) Patient is determined to be unsuitable as a study subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation time: until after the end of the study four weeks from the start of study Safety of maternal and fetal (Maternal: biochemistry, urinalysis, electrocardiogram, concentration in the drug blood Fetus: chest abdominal X-ray, heart ultrasound examination, head ultrasound, blood drug concentration)
- Secondary Outcome Measures
Name Time Method The maximum tolerated dose, the optimal dose, fetal abdominal circumference, estimated fetal weight, neonatal death, perinatal death, obstetric complications (gestational hypertension, preterm labor, placental abruption), birth weight, birth weeks, Apgar score, umbilical artery blood gas, fetal arterial blood flow test, fetal venous blood flow test, uterine artery blood flow test