fetal growth restriction
Conditions
Interventions
The administration period: until delivery (after 34 weeks the judgment of the physician, up to 37 weeks) Dose and method: 3 cases cohort Cohort 1: tadalafil once a day, once 10 mg <
Zalutia(5 mg) 2 tablets>
daily administration
The administration period: until delivery (after 34 weeks the judgment of the physician, up to 37 weeks) Dose and method: 3 cases cohort Cohort 2: tadalafil once a day,
daily administration
The administration period: until delivery (after 34 weeks the judgment of the physician, up to 37 weeks) Dose and method: 3 cases cohort Cohort 3: tadalafil once a day, once 4
Sponsors
Department of Obstetrics & Gynecology Mie University Faculty of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Fetal growth restriction (less than -1.5SD) 2) Healthy pregnancy 22 weeks after less than 34 weeks 3) Single pregnancy 4) 20 years of age or older 5) For the test participation, it has consent is obtained in writing from the patient.
Exclusion criteria
Exclusion criteria: 1) Patients with allergic to tadalafil 2) Patients are taking the drug, which is contraindicated to tadalafil 3) Patients are undergoing kidney dialysis, with severe renal impairment(creatinine clearance<30mL / min) 4) Patients with severe liver failure [AST (GOT) or ALT (GPT)>100 IU / L] 5) Patients with uncontrolled arrhythmias, hypotension (blood pressure <90 / 50mmHg), or uncontrolled high blood pressure (blood pressure> 170 / 100mmHg) 6) Fetus with chromosomal abnormality can be considered from ultrasonography 7) Retinitis pigmentosa patients 8) Patients with bleeding disorders or peptic ulcer 9) Patients with pulmonary venous occlusive disease 10) Patient is determined to be unsuitable as a study subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation time: until after the end of the study four weeks from the start of study Safety of maternal and fetal (Maternal: biochemistry, urinalysis, electrocardiogram, concentration in the drug blood Fetus: chest abdominal X-ray, heart ultrasound examination, head ultrasound, blood drug concentration) | — |
Secondary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose, the optimal dose, fetal abdominal circumference, estimated fetal weight, neonatal death, perinatal death, obstetric complications (gestational hypertension, preterm labor, placental abruption), birth weight, birth weeks, Apgar score, umbilical artery blood gas, fetal arterial blood flow test, fetal venous blood flow test, uterine artery blood flow test | — |
Countries
Japan
Contacts
Public ContactMichiko Kubo
Mie University Faculty of Medicine Department of Obstetrics & Gynecology
Outcome results
None listed