跳至主要内容
临床试验/ISRCTN26523605
ISRCTN26523605进行中(未招募)未知

OASI2: a hybrid effectiveness implementation RCT to inform scale up of care bundle to reduce obstetric anal sphincter injury (OASI) caused during childbirth

Croydon Health Services NHS Trust0 个研究点目标入组 11,107 人开始时间: 2021年1月27日最近更新:

试验速览

阶段
未知
状态
进行中(未招募)
入组人数
11,107

研究概览

简要总结

2020 Abstract results in https://doi.org/10.1186/s13012-020-01062-3 study design presented at the 3rd UK Implementation Science Research Conference (16-17 July ): (added 27/01/2021) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34022926/ (added 24/05/2021)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • There are two groups of participants in this study: midwifery and obstetric clinicians from participating units, who will be asked to incorporate the care bundle into their routine practice, and women giving birth in participating units who may receive the care bundle if eligible.
  • All midwives and obstetricians working at participating units are considered participants in the study. Two clinicians (one midwife and one obstetrician) will be selected by their unit leadership for the role of OASI QI Lead. All clinicians (including OASI QI Leads) will be invited to complete surveys at two points in the implementation period to share their experiences and thoughts about the care bundle and its implementation in their units.
  • Women who attend their antenatal care appointment at participating units are eligible to receive information about OASI and the OASI Care Bundle (discussing the care bundle with women during antenatal care is the first element of the care bundle). Women who subsequently have a singleton, live, term, cephalic, vaginal birth are eligible to receive the care bundle if they are in a birthing position that allows for it and if they provide verbal consent to the elements as they are communicated by the attending clinician, as per routine practice.
  • Eligible women will be recruited to participate in a postnatal survey about their birth experience as it relates to perineal protection/OASI prevention. To be eligible to participate in the survey, women must have had a singleton, live, term, cephalic, vaginal birth in any participating maternity unit.

排除标准

  • 1. Clinicians (OASI QI Leads and midwifery/obstetric staff) not employed by one of the 30 participating maternity units
  • 2. Women will not be invited to participate in the postnatal survey if they had a caesarean section or multiple or preterm or breech or stillbirth

研究者

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