A multicenter phase II trial of the efficacy and safety of tadalafil with pre-eclampsia.

Phase 2

• Conditions: pregnancy induced hypertension

• Registration Number: JPRN-UMIN000024042
• 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: 2016-09-15
• Study Completion: 2018-04-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

1)uncontrolled hypertension 2)Delivery should be attempted because of severe preeclampsia 3) 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. 4) A history of allergy to tadalafil 5) Concurrent medications that interact adversely with tadalafil 6) Relative contraindication of tadalafil treatment due to renal disease. 7) Relative contraindication of tadalafil treatment due to liver disease. 8) Relative contraindication of tadalafil treatment due to uncontrolled arrhythmia, hypertension (BP >170/110 mmHg), and hypotension (BP <80/40 mmHg). 9) Fetus with suspected chromosomal disorder and/or multiple congenital anomalies. 10) Relative contraindication of tadalafil treatment due to retinitis pigmentosa, coagulation defect, active gastric and/or intestinal ulcer, and venous obstructive disease. 11) Attending physician decides to entry inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Enrollment-to-delivery interval (days)

Secondary Outcome Measures

Name	Time	Method
1. Completion rate of the treatment regimen. 2. Efficacy monitoring. 2.1 Incidence rate of severe preeclampsia 2.2 Incidence rate of liver dysfunction 2.3 Incidence rate of Eclampsia 2.4 Incidence rate of pulmonary edema 2.5 Incidence rate of FGR 2.6 Birth weight (g). 2.7 Gestational age at birth. 2.8 Apgar score. 2.9 Umbilical artery pH and base excess values. 2.10 Neonatal morbidity. 2.11 Offspring outcome until 1.5 years of age. 3. Safety monitoring. 3.1 Incidence rate of obstetric complications. 3.2 Perinatal mortality. 3.3 Neonatal mortality.