Reducing operative birth for fetal distress in women with small or suboptimally grown infants - The RidStress 2 Randomised Controlled Trial

Mater Misericordiae Ltd0 个研究点目标入组 660 人开始时间: 2021年3月29日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•1. Singleton pregnancy
•2. Planning a vaginal birth at term (>37 weeks gestation)
•3. Aged >18 years and able to give informed consent
•4. Pregnancy complicated by suspected small for gestational age (SGA) infant or late fetal growth restriction (FGR) (see below definitions)
•SGA is defined as Estimated Fetal Weight (EFW) or Abdominal Circumference (AC) <10th centile for gestation based on ultrasound assessment.
•FGR is defined as EFW or AC <3rd centile or two out of three of the following:
•1. EFW or AC <10th centile.
•2. AC or EFW crossing centiles by >two quartiles on growth charts.
•3. Cerebroplacental ratio (CPR) <5th centile or Umbilical Artery Pulsatility Index (UA PI) >95th centile for gestation.

•1.Two or more previous CS births
•2.Previous classical CS
•3.Major fetal anomaly in this pregnancy
•4.Non-cephalic presentation
•5.Severe hepatic or renal impairment
•6.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.

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