OASI2: Evaluation of strategies for sustainable implementation of the OASI Care Bundle in maternity units

Plain English Summary

Background and study aims
Obstetric anal sphincter injury (OASI) refers to severe tearing of the perineum (the area between the vagina and anus) which may be sustained during childbirth. OASI may result in complications such as anal incontinence (difficulty or inability to control bowels and the passing of wind) with significant psychosocial consequences to women and long-term financial consequences for health systems. The OASI Care Bundle was developed in response to the tripling in rates of detected OASI identified in primiparous women (first-time mothers) in England between 2000-2012 by a group of national experts following the review of literature and pre-existing guidelines to standardise practice and address inconsistencies in training and skills.
In 2016-2018, the OASI Care Bundle was rolled out in 16 maternity units across England, Scotland and Wales in a study referred to as ‘OASI1’ (ISRCTN12143325). Implementation of the care bundle in these OASI1 units was led by clinical and implementation experts from the OASI1 project team. Findings from the OASI1 study demonstrated that the care bundle is associated with a 20% reduction in women’s risk of OASI (after adjusting for case-mix factors) with no change in caesarean section or episiotomy rates. The study also confirmed the care bundle’s acceptability to clinicians and women as well as the feasibility of its implementation in maternity units.
OASI2 is a follow-on study with two aims: to study the care bundle’s sustainability in ten of the original OASI1 units, and to evaluate two methods of care bundle implementation that are more scalable and do not rely on continuous expert support. The two methods will be evaluated and compared to determine the minimum requirements for successful implementation and to inform the development of a final implementation blueprint that will operationalise study findings and guide wider scale-up of the OASI Care Bundle, nationally and beyond.

Who can participate?
Thirty NHS maternity units in England, Scotland, and Wales will participate in one of the three arms of OASI2. Within these participating units, there are two groups of study participants: clinicians (midwives and obstetricians) and women.
Two OASI Quality Improvement (QI) Leads (one midwife and one obstetrician) per participating unit will be designated to lead the local implementation of the OASI Care Bundle, including training of midwifery and obstetric staff at their unit. All midwifery and obstetric staff at the participating units will be invited to participate in a survey at two points in the study period.
This study will evaluate the level of compliance with the care bundle by staff across study units, which will be measured in terms of how many women of those eligible actually receive all four elements of the care bundle. Women receiving antenatal care and having a live, term, cephalic vaginal birth at a participating unit receive the care bundle if their birthing position allows the application of all care bundle elements and if they provide consent to the care bundle elements as they are communicated during and after birth, as per local routine practice. The estimated average number of care bundle-eligible births over a 12-month period is 2,374. Therefore, an estimated total of 71,220 women will be potentially eligible to receive the care bundle across all OASI2 participating units during the study period. All women who are eligible to receive the care bundle will also be invited to participate in a postnatal survey.

What does the study involve?
OASI2 involves testing different scale-up strategies of the OASI Care Bundle, a set of four evidence-based practices that when used together, have demonstrated effectiveness in reducing women’s risk of severe perineal tearing during childbirth.

The four elements of the OASI Care Bundle are:
1. In the antenatal period, the midwife or doctor will discuss OASI with the woman and what can be done to reduce the risk of it occurring.
2. At the time of birth and with the woman’s consent, the midwife or doctor will use their hands to support both the perineum and the baby’s head (known as manual perineal protection, or MPP) while communicating with the woman to encourage a slow and guided birth.
3. If clinically indicated and with the woman’s consent, an episiotomy (a cut made through the vaginal wall and perineum) should be performed at an angle of 60 degrees from the midline at crowning.
4. Following all vaginal births, a systematic examination of the perineum (including the vaginal and anus), should be systematically offered to all women even if the perineum appears intact. This is to ensure that any tears are identified immediately and that treatment options are discussed and implemented as necessary.
While the first three components of the care bundle contribute to the primary prevention of OASI, the fourth element aims to improve detection rates and therefore is a secondary prevention measure.

All 30 participating maternity units will designate two OASI QI Leads (one midwife and one obstetrician) who are responsible for care bundle implementation and will receive an implementation toolkit to guide and support their efforts.

There are three study arms with ten maternity units each: the ‘sustainability’ arm, the ‘peer support’ arm, and the ‘lean implementation’ arm.
Ten of the 16 maternity units that implemented the care bundle in OASI1 study are invited to take part in the sustainability arm of OASI2. Twenty other maternity units in England, Scotland and Wales that have expressed interest will be randomised into the peer support or lean implementation arms.
OASI QI Leads in all three arms will lead and support care bundle implementation over a 13-month period that includes a 1-month transition period (from study set up to interventions and data collection initiation). The three study arms are described in the Intervention section.

What are the possible benefits and risks of participating?
Midwives and obstetricians from participating units will have the opportunity to undergo additional training in the prevention of perineal trauma during childbirth.

Where is the study run from?
The study is managed by the Royal College of Obstetricians and Gynaecologists, in collaboration with the Royal College of Midwives, Croydon Health Services NHS Trust, and the London School of Hygiene and Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
July 2019 to December 2022

Who is funding the study?
The Health Foundation (UK)

Who is the main contact?
Miss Magdalena Jurczuk (OASI2 research fellow)
mjurczuk@rcog.org.uk
Mr Dorian Martinez (OASI2 project manager)
dmartinez@rcog.org.uk

Study website

Contact information

Mr Dorian Martinez
Scientific

10-18, Union St
London
SE1 1SZ
United Kingdom

Phone	+44 (0)20 7772 6285
Email	dmartinez@rcog.org.uk

Ms Magdalena Jurczuk
Scientific

10-18, Union St
London
SE1 1SZ
United Kingdom

ORCID ID	0000-0001-6915-767X
Phone	+44 (0)7340 551833
Email	mjurczuk@rcog.org.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

Croydon Health Services NHS Trust
Hospital/treatment centre

Croydon University Hospital
530 London Road
Thornton Heath
CR7 7YE
England
United Kingdom

Phone	+44 (0)20 8655 5520
Email	ranee.thakar@nhs.net
Website	https://www.croydonhealthservices.nhs.uk/
"ROR"	https://ror.org/00sh7p618

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

17/02/2022: The target number of participants was changed from 'Planned Sample Size: 30; UK Sample Size: 30' (i.e. study sites) to '11,107' (i.e., participants).
15/02/2022: The following changes were made to the trial record:
1. IPD sharing statement added.
2. The recruitment start date was changed from 01/04/2021 to 27/11/2021.
3. The recruitment end date was changed from 28/02/2022 to 31/10/2022.
4. The overall end date was changed from 31/08/2022 to 31/12/2022.
5. NHS Fife was removed as a trial participating centre.
24/05/2021: Publication reference added.
16/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2021 to 28/02/2022.
2. The overall end date was changed from 30/04/2022 to 31/08/2022.
3. The recruitment start date was changed from 01/03/2021 to 01/04/2021.
4. The plain English summary was updated to reflect these changes.
5. The trial participating centre Bedford Hospital has been replaced by Milton Keynes University Hospital
08/02/2021: The sponsor email and telephone number were updated.
25/01/2021: Trial's existence confirmed by the NIHR.