HOLDS

HOLDS is a randomised and double blinded multi-centre study. 

The participants will be randomised in a 1:1 ratio to standard dose or a higher dose of oxytocin. 

To provide robust evidence of clinical effectiveness of a high dose compared to the current standard dose regimen of oxytocin in reducing the need for Caesarean section (CS) for nulliparous women with confirmed delay in the first stage of labour.

Suitable participants will be identified in delivery suites at secondary and tertiary level hospitals across the UK.

Sample size of 1500 nulliparous women with confirmed delay in labour in the first stage for a singleton pregnancy where oxytocin has been prescribed. 

Exclusion criteria: nulliparous women who have reached full dilation, undergoing induction, existing cardiac disease, bleeding disorders, previous uterine surgery, or significant antepartum haemorrhage. Those under 16 years of age or with a known contra-indication to oxytocin therapy. 

High dose regimen (4mU/min increasing every 30 minutes to a maximum of 64mU/min) 

Standard dose regimen (2mU/min increasing every 30 minutes to a maximum 32mU/min)

Primary Outcome: Caesarean Section Rate (CSR)

Secondary Outcomes: Maternal clinical and process outcomes data and neonatal outcomes data

The HOLDS trial is funded by a NIHR Health Technology Assessment (HTA)  programme grant.

Birmingham Clinical Trials Unit

Public Health Building
University of Birmingham
Birmingham
B15 2TT

Email: HOLDS@trials.bham.ac.uk

Fax: 0121 415 9135

• Chief Investigator 

 Professor Sara Kenyon: S.Kenyon@bham.ac.uk 

 

 Professor Kenyon is the Chief Investigator for the HOLDS and iHOLDS trials, both of which are funded by the NIHR HTA. Professor Kenyon is a midwife by background and a maternity researcher and policy maker.  She currently leads a varied programme of applied health research.

This includes leading the maternity component of the Maternity and Child Health Theme for the CLAHRC West Midlands where there is involvement in service change at every level, from evaluating services in existence to developing and evaluating new services and translating evidence into practice.   Methodologies employed ensure the most robust possible design and are tailored to the topic concerned and the timelines required. 

Professor Kenyon’s national roles include being part of the MBRRACE collaboration investigating maternal deaths, stillbirths and infant deaths, including the Confidential Enquiry into Maternal Perinatal Deaths.  She is also a member of the Wellbeing of Women Advisory Committee and of the HTA Topic Identification, Development and Evaluation (TIDE) panel for Maternal, Neonatal and Child Health.   She regularly speaks at conferences and has published widely.  She is a NIHR Midwifery Advocate for Career Development and usually has two midwives undertaking their MRes dissertations under her supervision, as well as a PhD student who is developing a patient reported outcome measure for pregnancy and childbirth.

Professor Kenyon is an Honorary Research Fellow at the Murdoch Children’s Research Institute (MCRI), University of Melbourne.  She is currently leading a Global Alignment of Immunisation safety Assessment in pregnancy (GAIA) consensus group for the Brighton Collaboration which is the world’s largest network of vaccine safety professionals agreeing the definition of dysfunctional labour.

• Lead Midwife:

Kate Siddall - k.siddall@bham.ac.uk 

• Senior Trial Manager:

Dee Wherton - d.wherton@bham.ac.uk 

• Trial Manager:

Afreen Khan - a.khan.10@bham.ac.uk

• Senior Data Manager:

Jack Toland - j.toland@bham.ac.uk

• Data Manager:

Scott Phillips - s.k.phillips@bham.ac.uk