Prevention for Recurrence Of The preEClampsia with TAdalafil

Not Applicable

• Conditions: Hypertension disorder of pregnancy; Hypertensive disorder of pregnancy, PDE5 inhibitor

• Registration Number: JPRN-jRCTs041180121
• Lead Sponsor: Tanaka Hiroaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1) 20 years of age or older
2) History of severe Hypertensive disorders of Pregnancy that required delivery prior to 34 weeks' gestation.
3) Gestational age between 12 + 0 and 16 + 6 weeks (The expected date of confinement is determined using the criteria of the guidelines for obstetrical practice in Japan 2014.)
4) Singleton pregnancy
5) For the test participation, it has consent is obtained in writing from the patient.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate of Hypertensive Disorders of Pregnancy

Secondary Outcome Measures

Name	Time	Method
1. Completion rate of the treatment regimen. <br>2. Efficacy monitoring. <br>2.1 Estimated fetal weight (g). <br>2.2 Fetal head circumference (cm). <br>2.3 Doppler imaging of umbilical arterial, middle cerebral arterial, uterine arterial blood flow. <br>2.4 Deepest amniotic fluid pocket (cm). <br>2.5 Prolongation of gestational age at birth (days). <br>2.6 Birth weight (g). <br>2.7 Gestational age at birth. <br>2.8 Apgar score. <br>2.9 Umbilical artery pH and base excess values. <br>2.10 Incidence rate of preeclampsia. <br>2.11 Neonatal morbidity. <br>3. Safety monitoring. <br>3.1 Incidence rate of obstetric complications. <br>3.2 Perinatal mortality. <br>3.3 Neonatal mortality.