Utama Debby P, Crowther Caroline A
Department of Obstetrics and Gynaecology, Frankston Hospital, Frankston, Victoria, Australia.
Cochrane Database Syst Rev. 2018 Jun 14;6(6):CD008981. doi: 10.1002/14651858.CD008981.pub3.
Despite major advances in medical technology, the incidence of preterm birth remains high. The use of antenatal corticosteroid administered transplacentally, by intramuscular injection to women at risk of preterm birth, has reduced the incidence of respiratory distress syndrome and increased the survival rates of preterm infants. However, this intervention also comes with its own risks and side effects. Animal studies and early studies in pregnant women at risk of preterm birth have reported the use of an alternative route of administration, by direct intramuscular injection of corticosteroid into the fetus under ultrasound guidance, in an attempt to minimise the side-effect profile. Direct fetal corticosteroid administration may have benefits over maternal administration in terms of safety and efficacy.
To assess if different routes of corticosteroid administration (maternal versus direct fetal) have effects on health outcomes for women and their babies.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (25 October 2017), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 October 2017) and reference lists of retrieved studies.
Randomised controlled trials comparing maternal with direct fetal routes of antenatal corticosteroid administration in women at risk of preterm birth.
The two review authors independently assessed study eligibility. In future updates of this review, at least two review authors will extract data and assess the risks of bias in included studies. We will also assess the quality of the evidence using the GRADE approach.
We did not identify any eligible randomised controlled trials to include in this review.
AUTHORS' CONCLUSIONS: The available clinical studies carried out so far on animals and human have shown that direct intramuscular injection of corticosteroid into the fetus under ultrasound guidance is feasible, but data on health outcomes are lacking. Uncertainty therefore persists as to which method could provide better efficacy and safety. Randomised controlled trials are required focusing on the benefits and harms of transplacental versus direct fetal corticosteroid treatment. Until the uncertainties have been addressed, it is advisable to stay with the current standard of antenatal transplacental maternally-administered corticosteroid treatment.
尽管医学技术取得了重大进展,但早产的发生率仍然很高。对有早产风险的妇女经胎盘或通过肌肉注射给予产前皮质类固醇,已降低了呼吸窘迫综合征的发生率并提高了早产婴儿的存活率。然而,这种干预也有其自身的风险和副作用。动物研究以及对有早产风险的孕妇的早期研究报告了一种替代给药途径,即在超声引导下将皮质类固醇直接肌肉注射到胎儿体内,以尽量减少副作用。就安全性和有效性而言,直接给胎儿注射皮质类固醇可能比给母体注射更有益。
评估不同的皮质类固醇给药途径(母体给药与直接胎儿给药)对妇女及其婴儿健康结局的影响。
我们检索了Cochrane妊娠与分娩组试验注册库(2017年10月25日)、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台(ICTRP)(2017年10月25日)以及检索到的研究的参考文献列表。
比较有早产风险的妇女中母体给药与直接胎儿给药这两种产前皮质类固醇给药途径的随机对照试验。
两位综述作者独立评估研究的合格性。在本综述的未来更新中,至少两位综述作者将提取数据并评估纳入研究的偏倚风险。我们还将使用GRADE方法评估证据质量。
我们未找到任何符合纳入本综述标准的随机对照试验。
目前在动物和人体上进行的现有临床研究表明,在超声引导下将皮质类固醇直接肌肉注射到胎儿体内是可行的,但缺乏关于健康结局的数据。因此,关于哪种方法能提供更好的疗效和安全性仍存在不确定性。需要开展聚焦于经胎盘给药与直接胎儿给药的皮质类固醇治疗的利弊的随机对照试验。在这些不确定性得到解决之前,建议继续采用目前经胎盘母体给药的产前皮质类固醇治疗标准。