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Obstetric Bleeding Study UK (OBS UK): protocol for a stepped wedge cluster randomised trial investigating the clinical and cost-effectiveness of a maternity quality improvement programme to reduce excess bleeding and need for transfusion after childbirth

Por: Kotecha · S. J. · Potter · C. · Hope-Bell · J. · Riddell · N. S. · Munnery · K. · Onyimadu · O. · Liberty · C. · Taylor · H. · Dop · C. · De Lloyd · L. · Parry-Smith · W. · Townson · J. · Pallmann · P. · Moody · G. · Moriarty · Y. · Deere · R. · Barlow · C. · Dhadda · A. · Elsmore · A. · Wil
Introduction

Bleeding during and after childbirth (postpartum haemorrhage, PPH) is the leading cause of severe maternal morbidity in the UK. Between 2017 and 2018, a PPH care bundle termed the Obstetric Bleeding Strategy (OBS) was implemented as a quality improvement project across all Welsh maternity units and improvements in maternal outcomes were observed. The OBS PPH care bundle incorporates assessment of bleeding risk, real-time cumulative quantification of blood loss, escalation of multiprofessional care including more senior staff at defined volumes of blood loss and point-of-care testing of coagulation at 1 L blood loss (or earlier if clinical concern) with targeted blood product transfusion in cases of haemostatic impairment. The Obstetric Bleeding Study UK (OBS UK) will evaluate this intervention in a larger number of maternity units across the UK.

Methods and analysis

OBS UK is a stepped wedge cluster randomised trial designed to test the effectiveness of the OBS intervention compared with usual care on clinical and psychological PPH outcomes after childbirth, evaluate its cost-effectiveness and perform a process evaluation. The study will be capturing data from over 270 000 women and birthing people giving birth in the care of 36 participating maternity units during the 30-month study period. All maternity units will undertake a control period (lasting 3–18 months) during which usual PPH care will be provided, followed by a 9-month implementation period during which the OBS PPH care bundle will be introduced using quality improvement methods and then an OBS UK intervention period (lasting 3–18 months) during which OBS PPH care will be delivered.

The primary outcome is the number of women receiving allogeneic red blood cell transfusion for PPH per 1000 maternities. Secondary outcomes are informed by the core PPH outcome set, psychological and cost-effectiveness measures for women and their partners and a mixed methods process evaluation exploring how the intervention was deployed and possible improvements to inform wider implementation.

Ethics and dissemination

OBS UK will establish whether (and how) the OBS UK PPH care bundle improves outcomes and experiences of women and their partners. Published results will provide evidence to inform PPH maternity care across the UK and internationally. Dissemination of the findings will be made available to members of the public and participants.

Trial registration number

ISRCTN17679951.

What should be discussed when considering an induction of labour? A UK-wide, multi-centre Delphi study to develop a core information set for induction of labour

Por: Bunni · E. · Kingdon · C. · Bradley · V. · Hunt · A. · Mahdi · A. · Axcell · T. · Jagadish · R. · Fox · S. · ODair · M. · Simms · C. · Munn · Y. T. · Bonnett · L. · Greenfield · B. · Cunningham · C. · Holt · S. · Burden · C. · Ficquet · J. · Otero-Romero · E. · Parry-Smith · W. · Black · M.
Objective

To develop a core information set for induction of labour. Rates of induction of labour for childbirth are rising in many high-income countries. In England, a third of women have their labours induced. National guidelines recommend women receive information to make informed decisions about induction.

Design

Two-stage consensus study using modified Delphi.

Setting

UK.

Participants

Pregnant people, parents and professionals.

Outcomes

Stage 1: A long list of information points was identified through a systematic review of reviews, reviewing patient leaflets, qualitative interviews and a stakeholder survey, with ongoing patient, public and professional involvement. Stage 2: Think-aloud interviews were undertaken to refine the Delphi survey before a two-round modified Delphi process where participants voted on the importance of the information items. Pre-specified criteria were used to select items taken forward to a consensus meeting.

Results

199 information points were identified through systematic review (110), patient information leaflets (162), qualitative interviews (58) and a survey (93). 46 unique information items entered the first Delphi round after four think-aloud interviews, 2 items were added following round 2. 368 people (310 parents/58 professionals) participated in round 1 and 177 people (154 parents/23 professionals) in round 2. 44 items met inclusion criteria; one item excluded, and three items were carried forward for consensus meeting discussion where 12 overarching information points were agreed on.

Conclusions

This study has established a consensus-based core information set for induction of labour from a sample of the birthing population and staff providing their care. The resultant set has been populated with evidence in line with national guidelines. It can be used by women and clinicians as a standardised starting point from which to personalise discussions about birth.

Trial registration number

COMET Initiative registration 2600: Developing a core information set for induction of labour.

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