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

A multicenter phase II trial of the efficacy and safety of tadalafil with pre-eclampsia. - Medication in Pre-Eclampsia Trial (MIE)II

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024042

Enrollment

160

Registered

2016-09-15

Start date

2016-10-17

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

pregnancy induced hypertension

Interventions

Arm A: The conventional management of FGR consisted of evaluation of fetal well-being by ultrasonography including Doppler imaging and fetal heart rate monitoring to evaluate possible pregnancy termin

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Age>=20 2) sBP>=140 or dBP>=90 or proteinuria>=300mg/day 3) Gestational age between 20 + 0 and 33 + 6 weeks. 4) Singleton pregnancy 5) Written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Enrollment-to-delivery interval (days)	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactMichiko Kubo, Hiroaki Tanaka, Takashi Umekawa

Mie University Faculty of Medicine Department of Obstetrics & Gynecology

tadafer.study@gmail.com059-232-1111

Outcome results

None listed

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