Fetal growth restriction
Conditions
Interventions
The administration period: from enrollment to delivery (Tadalafil treatment was continued after 34 weeks of gestation depending on the physician'
s decision.) Dose and method: 3 cases cohort Cohort 1: tadalafil once a day, once 20 mg <
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, once 40
Sponsors
Department of Obstetrics & Gynecology Mie University Faculty of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) One or both fetuses with fetal growth restriction (less than -1.8SD) in twin pregnancy. 2) Healthy pregnancy between 20 weeks and 34 weeks 3) DD twin or MD twin pregnancy 4) 20 years of age or older 5) Written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients with allergy 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 11) MD twin with hydramnion(amniotic fluid depth by ultrasound greater than 8 cm)and oligoamnion(amniotic fluid depth less than 2 cm)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of tadalafil treatment for both fetus and mother until four weeks after the end of the study. (Mother: 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 ContactShoichi Magawa
Mie University Faculty of Medicine Department of Obstetrics & Gynecology
Outcome results
None listed