Feasibility and design of a trial to determine the optimal mode of delivery in women presenting in preterm labour or with planned preterm delivery: CASSAVA

ISRCTN	ISRCTN12295730
DOI	https://doi.org/10.1186/ISRCTN12295730
Secondary identifying numbers	39568

Submission date: 15/10/2018
Registration date: 26/10/2018
Last edited: 10/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
This study is a commissioned call from the Health Technology Assessment (HTA) because the National Institute for Clinical Excellence (NICE) guideline development group on preterm labour and birth were unable to find evidence about the optimal method of delivery for preterm babies. Addressing this clinical uncertainty could improve the rates of stillbirth, neonatal and long-term mortality and morbidity, which are higher in the 50,000 preterm babies born in the UK each year compared with term babies. It is possible that planned delivery by caesarean section (CS) could reduce either death or disability in preterm babies.
However, birth by caesarean section is also associated with higher costs and greater complications for the mother, and there is conflicting evidence of the benefit for preterm babies. Due to the lack of evidence and uncertainty in the national guidance, clinicians and pregnant women are unclear about the best mode of delivery for preterm pregnant women and babies, nor whether they would wish to participate in any future randomised trial. Randomised trials have been performed to address optimal mode of delivery for women with breech presentation and women with twin pregnancy and these trials have reduced uncertainty. However, there are very few randomised trials to compare planned caesarean section with a planned vaginal delivery for women at term, and none for preterm gestations.
The aim of this study is to identify the clinical uncertainties among staff and the public, any additional information possible (e.g. from new publications), and to find out whether women and staff (and if so, under what clinical circumstances) would be willing to participate in a randomised trial.

Who can participate?
Members of the public (men and women aged over 16) and clinical staff working in hospitals with a Neonatal Intensive Care Unit

What does the study involve?
Participants will be asked to answer a short survey and take part in interactive workshops, along with interviews and focus groups.

What are the possible benefits and risks of participating?
There are no known benefits or risks to participants taking part in this study.

Where is the study run from?
This study is run from the University of Edinburgh and the study centres will be NHS Lothian, University College Hospital Foundation Trust and North Bristol NHS Trust (UK)

When is the study starting and how long is it expected to run for?
November 2018 to November 2020

Who is funding the study?
NIHR Health Technology Assessment Programme (UK)

Who is the main contact?
Mrs Sonia Whyte
sonia.whyte@ed.ac.uk

Study website

Contact information

Mrs Sonia Whyte
Public

The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

ORCID ID	0000-0003-0878-4244
Phone	+44 (0)131 242 2693
Email	sonia.whyte@ed.ac.uk

Prof Jane Norman
Scientific

The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

ORCID ID	0000-0001-6031-6953
Phone	+44 (0)131 242 2694
Email	jane.norman@ed.ac.uk

Study information

Study design	Observational; Design type: Qualitative
Primary study design	Observational
Secondary study design	Survey results, working group report and consensus statement, protocol for randomised trial, and reports from qualitative studies
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Feasibility and design of a trial to determine the optimal mode of delivery in women presenting in preterm labour or with planned preterm delivery: CASSAVA
Study acronym	CASSAVA
Study objectives	This research aims to find out the groups of women and babies in preterm labour or with planned preterm delivery in whom is there clinical uncertainty about the optimal planned mode of birth, and whether women and clinical staff would be willing to participate in a future randomised trial.
Ethics approval(s)	London - City & East Research Ethics Committee , 17/09/2018, ref: 18/LO/1616
Health condition(s) or problem(s) studied	Preterm delivery
Intervention	This research will use a series of surveys (public and stuff), a Delphi consensus workshop, interviews and focus groups with clinical staff and the public to find out the groups of women and babies in preterm labour or with planned preterm delivery in whom is there clinical uncertainty about the optimal planned mode of birth, groups and whether women and clinical staff would be willing to participate in a future randomised trial. Phase 1 of this study will involve 200 members of the public and 200 clinicians completing a short 10 minute online survey. Phase 2 is a Delphi consensus workshop of 3 rounds: 1. A web-based questionnaire 2. Rescoring preferences to achieve consensus 3. Final consensus meeting This will include around 20-40 participants. Phase 3 involves interviews with clinical staff, lasting for up to 1 hour, and 6-8 focus groups of 5-8 members of the public each.
Intervention type	Other
Primary outcome measure	Phase 1: Current practice and opinions, assessed using surveys conducted during months 0-4 informing the Delphi consensus Phase 2: Clinical uncertainties, assessed using a Delhi consensus conducted during months 5-9 informing the development of a randomised control trial protocol to be used in phase 3 Phase 3: 1. Willingness to recruit to a randomised controlled trial, assessed through interviews with clinical staff during months 10-22 2. Willingness to participate in a randomised controlled trial, assessed through focus groups during months 10-22
Secondary outcome measures	N/A
Overall study start date	01/03/2018
Completion date	31/10/2020

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 525; UK Sample Size: 525
Key inclusion criteria	Phase 1 Clinicians who work in hospitals with neonatal intensive care units (any of the following): 1. Consultant obestricians 2. Neonatologists 3. Midwives Members of the public: 1. Interested in supporting and commenting on research projects Phase 2 Clinicians with 5 years or more experience of providing clinical care to women at risk of preterm labour or preterm infants born (any of the following): 1. Obstetricians 2. Anaesthetists 3. Midwives 4. Nurses 5. Neonatologists 6. Midwives Women and their partners who fulfill the following criteria: 1. Aged 16 years or older 2. Willing to consent 3. Previous experience of any of the following: 3.1. Previous preterm labour or delivery 3.2. At risk of future preterm labour or delivery Phase 3 Clinicians with 5 years or more experience of providing clinical care to women at risk of preterm labour or preterm infants born (any of the following) who have taken part in phases 1 and 2: 1. Obstetricians 2. Anaesthetists 3. Midwives 4. Nurses 5. Neonatologists 6. Midwives Women who fulfill the following criteria: 1. Aged 16 years or older 2. Willing to consent 3. Previous experience of any of the following: 3.1. Previous preterm labour or delivery 3.2. At risk of future preterm labour or delivery
Key exclusion criteria	Phase 2 and 3 Women and their partners who have experienced adverse events as a result of the issues above (e.g. neonatal death, stillbirth) will not be actively excluded from the consensus workshops or focus groups, but we will be mindful of the need to manage this sensitively. The members of the research team have significant experience of conducting mixed-methods research with parents who have experienced adverse events, including perinatal death.
Date of first enrolment	01/11/2018
Date of final enrolment	31/08/2020

Locations

Countries of recruitment

England
Scotland
United Kingdom

Study participating centres

NHS Lothian Royal Infirmary of Edinburgh

Site 47
Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

University College Hospital Foundation Trust

Elizabeth Garrett Anderson Wing
25 Grafton Way
London
WC1E 6DB
United Kingdom

Sponsor information

The University of Edinburgh and/or Lothian Health Board
Hospital/treatment centre

ACCORD
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Phone	+44 (0)131 242 3330
Email	researchgovernance@ed.ac.uk
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Government

National Institute for Health Research (NIHR); Grant Codes: 2018/0248
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	31/10/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The results of this study will form a report to HTA to allow them to decide whether to commission a future trial. However, we anticipate that the findings of this trial will also be suitable for journal publications. We will also disseminate the results through our charity partners (Tommy’s and BLISS).
IPD sharing plan	Anonymized data will be shared (if requested) with other researchers within the European Union as per the funders data sharing policy. The protocol has been uploaded as an additional file (not peer reviewed) (added 10/12/2019)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version v2	15/10/2018	10/12/2019	No	No
Results article		01/11/2021	10/11/2021	Yes	No
HRA research summary			26/07/2023	No	No

Additional files

ISRCTN12295730_Protocol_v2_15Oct18.pdf: uploaded 10/12/2019

Editorial Notes

10/11/2021: Publication reference added.
10/12/2019: Uploaded protocol (not peer reviewed)
04/11/2019: North Bristol NHS Trust Southmead Hospital has been removed from the trial participating centres.
25/03/2019: The condition has been changed from "Specialty: Reproductive Health and Childbirth, Primary sub-specialty: Reproductive and Sexual Medicine; Health Category: Reproductive health and childbirth; Disease/Condition: Complications of labour and delivery" to "Preterm delivery" following a request from the NIHR.
02/11/2018: Internal review.