TADAFL

JRCT ID: jRCTs041210073

Registered date:22/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pregnancy Singlton
• Date of first enrollment: 08/10/2021
• Target sample size: 12
• Study type: Interventional

Intervention(s)

Cohort I:
Start taking tadalafil 10 mg (Zartia Coupling Tablets 5 mg, 2 tablets) from the beginning of labor, and take the same amount every 12 hours.
Cohort II:
Start oral administration of tadalafil 20 mg (Zartia coupling tablets 5 mg, 4 tablets) from the start of labor, and take the same amount every 12 hours.

Outcome(s)

• Primary Outcome: Maternal Safty

Secondary Outcome

Pharmacokinetic parameters: AUC0 12, Cmax
Comparison of placental PlGF and prepartum PlGF in cesarean section and transvaginal delivery by fetal adaptation, adverse events in newborns

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Female

Include criteria

20 years old and under 45 years old
It is predicted that the baby will be delivered after 37 weeks of gestation and less than 42 weeks.
28 weeks or more and less than 41 weeks gestation
The expected delivery date has been determined in accordance with the Obstetrics and Gynecology Practice Guidelines Obstetrics Edition 2020.
Single fetal flow.
A written consent has been obtained from the person mother regardingregarding participation in the test.

Exclude criteria

Pregnant women whose delivery method is defined as cesarean section before the start of labor (previous cesarean section, post myomectomy.
Has a history of hypersensitivity to tadalafil.
Patients who used PDE5 inhibitors containing tadalafil during this pregnancy.
I am taking a drug that is contraindicated in combination with the drug in the package insert of tadalafil.
Patients undergoing renal dialysis or having severe renal dysfunction with measured or estimated creatinine clearance of less than 30 mL / min.
Patients with severe hepatic disorder [patients with AST (GOT) or ALT (GPT) of 100 IU / L or more].
Patients with uncontrolled arrhythmia, hypotension (blood pressure <80/40 mmHg) or uncontrolled hypertension (resting blood pressure> 170/100 mmHg).
When fetal morphological abnormalities including multiple malformations that may be chromosomal abnormalities are observed in the foetation by fetal ultrasonography.
Patients with retinitis pigmentosa, hemorrhagic disease, peptic ulcer, or pulmonary vein obstructive disease.
Patients who are judged by the principal investigator or the investigator to be unsuitable for the study.

Related Information

• Primary Sponsor: Tanaka Hiroaki
• Source(s) of Monetary Support: Japan Research Foundation for Clinical Pharmacology