首页    期刊浏览 2024年12月06日 星期五
登录注册

文章基本信息

  • 标题:Transverse occiput position: Using manual Rotation to aid Normal birth and improve delivery OUTcomes (TURN-OUT): A study protocol for a randomised controlled trial
  • 本地全文:下载
  • 作者:Bradley de Vries ; Hala Phipps ; Sabrina Kuah
  • 期刊名称:Trials
  • 印刷版ISSN:1745-6215
  • 电子版ISSN:1745-6215
  • 出版年度:2015
  • 卷号:16
  • 期号:1
  • 页码:362
  • DOI:10.1186/s13063-015-0854-3
  • 语种:English
  • 出版社:BioMed Central
  • 摘要:

    Background

    Fetal occiput transverse position in the form of deep transverse arrest has long been associated with caesarean section and instrumental vaginal delivery. Occiput transverse position incidentally found in the second stage of labour is also associated with operative delivery in high risk cohorts. There is evidence from cohort studies that prophylactic manual rotation reduces the caesarean section rate. This is a protocol for a double blind, multicentre, randomised, controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate.

    Methods/Design

    Eligible participants will be ≥37 weeks pregnant, with a singleton pregnancy, and a cephalic presentation in the occiput transverse position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 49%, for a reduction to 35%, an alpha value of 0.05 and a beta value of 0.2, 416 participants will need to be enrolled. Participants will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery. Secondary outcomes will be caesarean section, significant maternal mortality and morbidity, and significant perinatal mortality and morbidity.

    Analysis will be on an intention-to-treat basis. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, (protocol number: X110410).

    Discussion

    This trial addresses an important clinical question concerning a commonly used procedure which has the potential to reduce operative delivery and its associated complications. Some issues discussed in the protocol include methods of assessing risk of bias due to inadequate masking of a procedural interventions, variations in intervention efficacy due to operator experience and the recruitment difficulties associated with intrapartum studies.

    Trial registration

    This trial was registered with the Australian New Zealand Clinical Trials Registry (identifier: ACTRN12613000005752 ) on 4 January 2013.

  • 关键词:Transverse position; Caesarean section; Fetal malposition; Anterior position; Operative delivery; Instrumental delivery; Abdominal ultrasound; Manual rotation; Digital rotation; Second stage of labour
国家哲学社会科学文献中心版权所有