Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12295730
Enrollment
525
Registered
2018-10-26
Start date
2018-11-01
Completion date
Unknown
Last updated
2021-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm delivery Pregnancy and Childbirth Complications of labour and delivery

Interventions

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

Sponsors

The University of Edinburgh and/or Lothian Health Board
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

England, Scotland, United Kingdom

Contacts

Public ContactSonia Whyte
sonia.whyte@ed.ac.uk+44 (0)131 242 2693

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026