Prevention for Recurrence Of The preEClampsia with TAdalafil

JRCT ID: jRCTs041180121

Registered date:23/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hypertension disorder of pregnancy
• Date of first enrollment: 23/03/2019
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Medicine

Outcome(s)

• Primary Outcome: Recurrence rate of Hypertensive Disorders of Pregnancy

Secondary Outcome

1. Completion rate of the treatment regimen.
2. Efficacy monitoring.
2.1 Estimated fetal weight (g).
2.2 Fetal head circumference (cm).
2.3 Doppler imaging of umbilical arterial, middle cerebral arterial, uterine arterial blood flow.
2.4 Deepest amniotic fluid pocket (cm).
2.5 Prolongation of gestational age at birth (days).
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 Incidence rate of preeclampsia.
2.11 Neonatal morbidity.
3. Safety monitoring.
3.1 Incidence rate of obstetric complications.
3.2 Perinatal mortality.
3.3 Neonatal mortality.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Maki Shintaro
• Secondary ID(s): UMIN000027270