About the CASSAVA study

Summary.

This research is looking at of babies and women who are in premature labour and for whom it is not known which way is the best for them to give birth: whether it is better (safer) by caesarean section (CS) or better (safer) to try and have a vaginal delivery. The first part of this research is to find out where doctors and women feel that more research on this topic is needed.

The “more research” is likely to be a randomised trial, where women who are willing to take part are allocated either to a CS or to a vaginal delivery “at random” (normally by a computer programme). We can then look at the benefits and any complications in those who have a CS and compare them with those who tried to have a vaginal delivery. Individual women and clinicians in the future can then use this information to decide which is best for them. The “at random” part is important to prevent bias, but it might reduce women’s (and clinician’s) willingness to take part in the research. Therefore, the second part of this research is to find out whether women and clinicians would be willing to take part.

Aims

We want to find out if women and their caregivers would be willing to take part in a potential future study to address this question. At the end of this research, we anticipate one of four outcomes:

  1. We will know the best way for women to give birth when in premature labour. 
  2. We will have questions about the best way for some groups of women to give birth prematurely, and we have found that women (and their caregivers) would be happy to take part in a study to find the answers. 
  3. We will have questions about the best way for some groups of women to give birth prematurely, and we have found that women (and their caregivers) would happy to take part in a study to find some but not all of the answers.
  4. We will have questions about the best way for some groups of women to give birth prematurely, but we have found that women (and their caregivers) would not happy to take part in a study to find the answers.

Who is involved?

Doctors, Social Scientists, Midwives, Patient, public representatives groups (BLISS and TOMMY’S), and individual women who have experienced preterm birth have designed this project.

Designs and methods

  1. Survey health professionals and patients to find out what current practice is; And what the questions for research are. 
  2. Design a study to answer these questions.
  3. Ask women who have or may experience premature birth and health professionals what they think about the study we have designed and whether they think, people would take part.
  4. Finalise the design (including size and cost) of a study to answer the questions we have found. 
  5. Look at any existing research. 

What will happen to the results?

We will write a report, which the funder will use to decide if they want to fund the study we designed. Bliss and Tommy’s will also share the results, so families and health professionals can read what we found.

Funding

The Study is funded by the NIHR Health Technology Assessment Programme (project number 17/22/02). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the HTA.

 

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