JPRN-UMIN000023778
Completed
Phase 2
A multicenter phase II trial of the efficacy and safety of tadalafil in fetus with early-onset growth restriction. - Tadalafil for fetus with early-onset growth restriction (TADAFER 2)
Mie university hospital, Department of Obstetrics and Gynecology0 sites140 target enrollmentAugust 26, 2016
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mie university hospital, Department of Obstetrics and Gynecology
- Enrollment
- 140
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\)A result from antepartum fetal tests consisted of ultrasonography including Doppler imaging and fetal heart rate monitoring at eligibility indicates that delivery should be attempted. 2\)A history of allergy to tadalafil 3\)Concurrent medications that interact adversely with tadalafil 4\)Relative contraindication of tadalafil treatment due to renal disease. 5\)Relative contraindication of tadalafil treatment due to liver disease. 6\)Relative contraindication of tadalafil treatment due to uncontrolled arrhythmia, hypertension (BP \>170/110 mmHg), and hypotension (BP \<80/40 mmHg). 7\)Fetus with suspected chromosomal disorder and/or multiple congenital anomalies. 8\) Relative contraindication of tadalafil treatment due to retinitis pigmentosa, coagulation defect, active gastric and/or intestinal ulcer, and venous obstructive disease. 9\)Attending physician decides to entry inappropriate.
Outcomes
Primary Outcomes
Not specified
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