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The OASI Care Bundle: a quality improvement project to reduce rates of severe perineal tears that occur during childbirth

The OASI Care Bundle: a multi-centre quality improvement project to reduce the incidence of obstetric anal sphincter injuries sustained in women who give birth vaginally in sixteen UK maternity units

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12143325
Enrollment
20000
Registered
2017-10-03
Start date
2017-01-16
Completion date
Unknown
Last updated
2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstetric anal sphincter injuries Pregnancy and Childbirth

Interventions

Great Britain (England, Wales and Scotland but not Northern Ireland) was divided into four geographical blocks. Within each region, four maternity units of different type and size were selected to obt

Sponsors

Royal College of Obstetricians and Gynaecologists (RCOG)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All vaginal births are eligible for the intervention when the attending clinician (midwife or obstetrician) has been trained to use the OASI Care Bundle

Exclusion criteria

Exclusion criteria: Women are excluded if they are in a birthing position (e.g. water birth) that makes it impossible to implement all aspects of the OASI Care Bundle

Design outcomes

Primary

MeasureTime frame
Rate of obstetric anal sphincter injuries (OASI), assessed via routinely collected patient-level data, captured through each unit’s maternity information system (MIS) over an 18-month period

Secondary

MeasureTime frame
1. Acceptability (satisfaction with the intervention) will be measured using: 1.1. The Organisational Readiness for Implementing Change (ORIC) scale will assess the unit’s commitment to change. This questionnaire will be completed by all champions prior to roll-out (January 2017, April 2017, July 2017 and September 2017) 1.2. Focus groups with clinicians at the maternity units will explore individual attitudes towards the care bundle, training and the awareness campaign. These discussions will be held six weeks after the start of roll-out in each unit (March 2017, June 2017, August 2017 and December 2017) 1.3. Focus groups with the champions from each maternity unit will explore the attitudes of staff within the unit towards the care bundle and what drove this reaction. These discussions will be held at the end of the three month ‘transition’ phase (April 2017, July 2017, September 2017 and January 2018) 1.4. Interviews with women who have experienced the care bundle will explore appropriateness and views of the intervention. These will be conducted six months after the start of roll out within each unit (July 2017, October 2017, January 2018 and March 2018) 2. Feasibility (extent to which intervention can be applied) will be measured using: 2.1. The Organisational Readiness for Implementing Change (ORIC) scale will assess collective commitment to change. This questionnaire will be completed by all clinicians at the maternity units who participate in the focus group discussions (March 2017, June 2017, August 2017 and December 2017) 2.2. Focus groups with clinicians at the maternity units will explore individual views on the ‘train the trainer’ approach, main issues with the care bundle and perceived women’s attitudes towards it. These discussions will be held six weeks after the start of roll-out in each unit (March 2017, June 2017, August 2017 and Decemb

Countries

United Kingdom

Contacts

Public ContactAlexandra Hellyer
ahellyer@rcog.org.uk+44 (0)20 7772 6200

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026