Fetal growth restriction
Conditions
Sponsors
Mie university hospital, Department of Obstetrics and Gynecology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Age>=20 2) Estimated fetal weight (EFW) less than 1.5 standard deviations of the mean EFW for gestational age. 3) Gestational age between 20 + 0 and 33 + 6 weeks. 4) The expected date of confinement is determined using the criteria of the guidelines for obstetrical practice in Japan (2014). 5) Singleton pregnancy 6) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) 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. 2) A history of allergy to tadalafil 3) Concurrent medications that interact adversely with tadalafil 4) Relative contraindication of tadalafil treatment due to renal disease. 5) Relative contraindication of tadalafil treatment due to liver disease. 6) Relative contraindication of tadalafil treatment due to uncontrolled arrhythmia, hypertension (BP >170/110 mmHg), and hypotension (BP <80/40 mmHg). 7) Fetus with suspected chromosomal disorder and/or multiple congenital anomalies. 8) Relative contraindication of tadalafil treatment due to retinitis pigmentosa, coagulation defect, active gastric and/or intestinal ulcer, and venous obstructive disease. 9) Attending physician decides to entry inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fetal growth velocity (g/day) from enrollment to birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Completion rate of the treatment regimen. 2. Efficacy monitoring. 2.1 Estimated fetal weight (g). 2.2 Fetal growth velocity (g/day) during two weeks from enrollment and one week after enrollment (g/day). 2.3 Fetal growth rate. 2.4 Fetal head circumference (cm). 2.5 Doppler imaging of umbilical arterial blood flow. 2.6 Deepest amniotic fluid pocket (cm). 2.7 Prolongation of gestational age at birth (days). 2.8 Birth weight (g). 2.9 Gestational age at birth. 2.10 Apgar score. 2.11 Umbilical artery pH and base excess values. 2.12 Incidence rate of preeclampsia. 2.13 Neonatal morbidity. 2.14 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. | — |
Countries
Japan
Contacts
Public ContactShintaro Maki, Michiko Kubo, Takashi Umekawa
Mie university hospital Department of Obstetrics and Gynecology
Outcome results
None listed