THE EARLY EXTERNAL CEPHALIC VERSION 2 TRIAL (EEVC2)

早期外部头颅版本 2 试验 (EEVC2)

• 批准号: 7377079
• 负责人: JANET Isabel ANDREWS
• 金额: $ 0.08万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377079
• 关键词: EARLY; EXTERNAL; CEPHALIC; VERSION; TRIAL

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The goals of this study are to confirm findings of a pilot study that demonstrated a 9.5% reduction in the rate of non-cephalic (breech) presentation at birth following early external cephalic version (ECV) and to determine that beginning ECV early (34-35 vs 37 weeks gestation) will decrease the rate of Cesarean section (CS) without an increase in the rate of pre-term births or serious fetal complications. Three to four percent of all term pregnancies will be breech. Research has indicated that the safest method of delivery of breech presentation is CS. CS is complicated by maternal mortality and morbidity. A technique called external cephalic version (ECV) beginning at 37 weeks gestation can lower the CS rate but the success rate has been 30% for nulliparous women in American and European experience. This research study seeks to evaluate the success rate of early ECV beginning at 34-35 weeks and compare in a randomized controlled trial design to that of delayed ECV at 37 weeks gestation (standard of care).

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是证实一项初步研究的结果，该研究表明早期体外头位妊娠（ECV）后出生时非头位（臀位）出现率降低9.5%，并确定早期（妊娠34-35周vs 37周）开始体外头位妊娠（ECV）将降低剖宫产（CS）的发生率，而不会增加早产或严重胎儿并发症的发生率。足月妊娠中有3%到4%是臀位妊娠。研究表明，最安全的臀后展示方式是CS。CS因产妇死亡率和发病率而复杂化。在妊娠37周开始的一种称为头外版本（ECV）的技术可以降低CS率，但在美国和欧洲的经验中，无产妇女的成功率为30%。本研究旨在评估34-35周早期ECV的成功率，并在随机对照试验设计中与妊娠37周延迟ECV（标准护理）的成功率进行比较。