Can intrapartum Sildenafil Citrate safely avert the risks of contraction-induced hypoxia in labour? iSEARCH – a pragmatic multicentre Phase III randomised controlled trial.

The University of Sydney0 个研究点目标入组 3,200 人开始时间: 2021年3月4日最近更新: 2024年1月29日

适应症

试验速览

暂无简介。

•1.Women with singleton or dichorionic twin pregnancies planning in-hospital vaginal birth at term (>37 weeks gestation).
•2.Age 18 years and older.
•3.Willing and able to comply with all study requirements.
•4.Signed, written informed consent.

•1.A woman should not be entered if the responsible clinician or the woman are, for any medical or nonmedical reasons, reasonably certain that SC would be inappropriate for her in comparison with no treatment or some other treatment that could be offered in or outside the trial.
•2.Triplets or higher order multiple births, which are generally delivered electively before term.
•3.Contraindications to the investigational product SC
•4.Participants who are taking any type of nitrate drug therapy or who utilize short-acting nitrate-containing medications during labour [such as sodium nitroprusside, bosentan, fosamprenavir and ritonavir combination, hepatic enzyme inhibitors CYP3A4 (including itraconazole, ketoconazole, ritonavir, cimetidine, erythromycin, saquinavir, darunavir), or hepatic enzyme substrates (CYP3A4), medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors like riociguat], due to the risk of potentially life-threatening hypotension.
•5.Severe hepatic or renal impairment.

发起方