Tadalafil for fetus with early-onset growth restriction (TADAFER IIb)

Phase 2

Recruiting

Conditions: Fetal growth restriction
Fetal growth restriction, PDE5 inhibitor

Registration Number: JPRN-jRCTs041190065

Lead Sponsor: Maki Shintaro

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 180

Inclusion Criteria

1)Age 20 - 44
2)Estimated fetal weight (EFW) less than 1.5 standard deviations of the mean EFW for gestational age.
3)Gestational age between 20 + 0 and 31 + 6 weeks.
4)The expected date of confinement is determined using the criteria of the guidelines for obstetrical practice in Japan (2017).
5)Singleton pregnancy
6)Written informed consent.

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

Primary Outcome Measures

Name	Time	Method
Prolongation of gestational age at birth (days)<br>Comparison of group A (placebo) and group B (tadalafil 20 mg/day) , and comparison of group A (placebo) and group C (tadalafil 40 mg/day)

Secondary Outcome Measures