JPRN-jRCTs041210073已完成1 期
Safety trial of tadalafil administered during labor A phase-1 clinical study - TADAF
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
There were 9 maternal and 5 neonatal adverse events, but no tadalafil-related adverse events were observed in either mothers or neonates. Tadalafil administration during labor and delivery is considered safe for both mother and neonate.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 45age old（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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.
研究者
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