A multicenter phase II trial of the efficacy and safety of tadalafil in fetus with early-onset growth restriction.

Phase 2

• Conditions: Fetal growth restriction

• Registration Number: JPRN-UMIN000023778
• Lead Sponsor: Mie university hospital, Department of Obstetrics and Gynecology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-26
• Study Completion: 2018-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified