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 |
| Protocol serial number | 39568 |
| Sponsor | The University of Edinburgh and/or Lothian Health Board |
| Funder | National Institute for Health Research (NIHR); Grant Codes: 2018/0248 |
- 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
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
Contact information
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 |
| sonia.whyte@ed.ac.uk |
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 |
| jane.norman@ed.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational; Design type: Qualitative |
| Secondary study design | Survey results, working group report and consensus statement, protocol for randomised trial, and reports from qualitative studies |
| Study type | Participant 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(s) |
Phase 1: |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 31/10/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
- Scotland
Study participating centres
Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
25 Grafton Way
London
WC1E 6DB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| Results article | 01/11/2021 | 10/11/2021 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version v2 | 15/10/2018 | 10/12/2019 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
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.
