CASSAVA
Research type
Research Study
Full 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
IRAS ID
251310
Contact name
Jane E. Norman
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Preterm birth (birth before 37 weeks) is the major cause of neonatal mortality and morbidity in the United Kingdom (UK). Around 7% of UK babies are born preterm. The earlier a babies is born the worse the outcome. Importantly, although survival rates have increased with time, rates of disability remain unchanged.
Currently there is uncertainty about the ideal method of delivery for preterm babies. Addressing this clinical uncertainty could improve the Rates of intrapartum 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 plausible that planned delivery by caesarean Section (CS) could reduce either death or disability in preterm babies. Conversely, CS is associated with higher National Health Service (NHS) costs and greater complications for the mother and there is conflicting evidence of benefit for preterm babies.
Despite the lack of evidence and uncertainty in the national guidance, it is not clear whether clinicians and pregnant women think about the best mode of delivery for preterm pregnant women and babies, nor whether they would wish to participate in any future randomised trial.
This research will use a series of surveys, a Delphi consensus, interviews and focus aims 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.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1616
Date of REC Opinion
17 Sep 2018
REC opinion
Favourable Opinion