Condition category
Pregnancy and Childbirth
Date applied
15/10/2018
Date assigned
26/10/2018
Last edited
02/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

https://www.ed.ac.uk/centre-reproductive-health/cassava

Contact information

Type

Public

Primary contact

Mrs Sonia Whyte

ORCID ID

http://orcid.org/0000-0003-0878-4244

Contact details

The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 2693
sonia.whyte@ed.ac.uk

Type

Scientific

Additional contact

Prof Jane Norman

ORCID ID

http://orcid.org/0000-0001-6031-6953

Contact details

The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 2694
jane.norman@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39568

Study information

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

Acronym

CASSAVA

Study hypothesis

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

London - City & East Research Ethics Committee , 17/09/2018, ref: 18/LO/1616

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

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

Phase

Drug names

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 trial start date

01/03/2018

Overall trial end date

31/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 525; UK Sample Size: 525

Participant 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.

Recruitment start date

01/11/2018

Recruitment end date

31/08/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Lothian Royal Infirmary of Edinburgh
Site 47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Trial participating centre

North Bristol NHS Trust
Southmead Hospital North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom

Trial participating centre

University College Hospital Foundation Trust
Elizabeth Garrett Anderson Wing 25 Grafton Way
London
WC1E 6DB
United Kingdom

Sponsor information

Organisation

The University of Edinburgh and/or Lothian Health Board

Sponsor details

ACCORD
The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 3330
researchgovernance@ed.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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 statement:
Anonymized data will be shared (if requested) with other researchers within the European Union as per the funders data sharing policy.

Intention to publish date

31/10/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/11/2018: Internal review.