A study on Prevention of Hypertensive Disorders of Pregnancy who have a history of severe hypertensive disorders of pregnancy -Pre-test for multi center trial-

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027270

Enrollment

Registered

2017-05-15

Start date

2017-05-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertensive Disorders of Pregnancy

Interventions

Arm A: The conventional management of prenatal checkup following [The guideline of Maternity care](Edited by Japan Society of Obstetrics and Gynecology, Japan Association of Obstetrics and Gynecology)

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Recurrence rate of Hypertensive Disorders of Pregnancy	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026