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

Not Applicable

Completed

• Conditions: Preterm delivery; Pregnancy and Childbirth; Complications of labour and delivery

• Registration Number: ISRCTN12295730
• Lead Sponsor: The University of Edinburgh and/or Lothian Health Board

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34751645/ (added 10/11/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-26
• Study Completion: 2020-10-31
• Last Update Posted: 22 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 525

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified