Trials and tribulations of trials in Obstetrics, evaluation of the randomised controlled trials of C-STICH, PREPS and C-STICH2

Hodgetts Morton, Victoria Ann ORCID: 0000-0001-9817-4313 (2020). Trials and tribulations of trials in Obstetrics, evaluation of the randomised controlled trials of C-STICH, PREPS and C-STICH2. University of Birmingham. Ph.D.

HodgettsMorton2020PhD.pdf
Text - Accepted Version
Restricted to Repository staff only until 31 October 2027.
Available under License All rights reserved.
Download (7MB)

Abstract

Introduction:
An evaluation of trials in obstetrics.
PREPS - Vaginal Preparation with chlorhexidine at Caesarean Section (CS) to Reduce Endometritis and Prevent Sepsis: feasibility RCT.
C-STICH- Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes.
C-STICH2- RCT of emergency cervical cerclage vs expectant management in women with bulging membranes.
Methods:
PREPS –there were uncertainties regarding the ability to recruit (screen, consent and randomise) women undergoing emergency CS. Process were developed to overcome these challenges and tested within a feasibility RCT.
C-STICH – an evaluation of the challenges of recruiting women undergoing a rare surgical procedure and managing a lower than anticipated control group event rate.
C-STICH2 – to access the feasibility of recruitment when prognosis poor. Accessed via an RCT with internal pilot and embedded qualitative evaluation.
Results:
PREPS demonstrated it is feasible to perform an RCT of vaginal cleansing at CS to reduce SSI, using bespoke verbal consent and telephone randomisation.
C-STICH demonstrated that by establishing a large clinical network you can recruit women undergoing a rare procedure.
C-STICH 2 demonstrated the importance of including a mixed methods evaluation in trials when recruitment is challenging.
Conclusion:
New processes allow consent, randomisation and follow up in difficult trials.