Multicentre Trial of Calcium Channel Blocker versus Calcium Channel Blocker Plus Cox2 Inhibitor in Preterm Labour

早产是我们社会的一个主要问题，对父母和孩子都有巨大的影响。它还对稀缺的财政资源产生重大影响。当妇女出现早产时，目前的治疗方法在停止宫缩和推迟分娩方面的成功率有限。它们没有被证明可以降低与早产有关的严重新生儿问题的发生率。该项目将在西北部的纽卡斯尔协调，并将涉及澳大利亚各地的主要围产期中心，以及沿着的海外中心。它将测试一种新的药物组合是否有能力推迟早产妇女的分娩。据推测，药物的组合将比现有的疗法更有效。试验中使用的药物是硝苯地平和罗非昔布。早产儿的并发症包括新生儿死亡、脑瘫、视力和听力障碍以及慢性肺病。这些并发症在极早产儿中最为严重，特别是那些分娩时妊娠期不足28周的婴儿。因此，本研究将仅侧重于28周以下分娩的妇女。停止分娩的能力很重要，但任何早产治疗的主要目的都是降低新生儿死亡率和残疾率。入组本研究的女性所生婴儿将在出生后随访一年，以评估其结局。我们的假设是，罗非昔布和硝苯地平的组合将导致婴儿死亡率和残疾率低于硝苯地平单药。此外，我们还将研究接受治疗的女性的副作用发生率。目前使用的疗法，包括静脉注射万托林，有很高的产妇副作用率。硝苯地平和罗非昔布都被证明有产妇副作用的发生率低。

Preterm birth is a major problem in our society, and has enormous consequences for parents and children. It also has a major impact on scarce financial resources. When women present in preterm labor, current therapies have only limited success in stopping contractions and postponing birth. They have not been shown to reduce the rates of the serious neonatal problems associated with prematurity. This project will be coordinated in Newcastle, N.S.W., and will involve major perinatal centres throughout Australia, along with overseas centres. It will test a new combination of drugs for their ability to postpone delivery in women presenting with preterm labour. It is postulated that the combination of drugs will be more effective than existing therapies. The drugs used in the trial are Nifedipine and Rofecoxib. Complications of prematurity include neonatal death, cerebral palsy, visual and hearing impairment, and chronic lung disease. These complications are most significant in extremely premature infants - in particular, those under 28 weeks gestation at the time of their delivery. For this reason, the study will focus only on women presenting in labour below 28 weeks. The ability to stop labour is important, but the main aim of any treatment for preterm labour is to reduce the rates of neonatal death and handicap. Babies born to women enrolled in this study will be followed for a period of one year after birth to assess their outcomes. It is our hypothesis that the combination of Rofecoxib and Nifedipine will result in lower rates of death and handicap in babies than Nifedipine alone. In addition, we will examine the rates of side effects in women receiving therapy. Currently used therapies, including intravenous ventolin, have high rates of maternal side effects. Nifedipine and Rofecoxib have both been shown to have low rates of maternal side effects.