THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorBruce Biccard

About this trial

The quality improvement project evaluating the delivery of a perioperative care complex intervention to improve haemorrhage-related outcomes in patients undergoing caesarean section. The objectives of the current study will be:

1. To evaluate whether implementation of the 'Rule of THUMB' perioperative complex intervention increases risk assessment, diagnosis and compliance with proven interventions for haemorrhage during and after caesarean section. 2. To understand the influence of contextual and socio-dynamic factors on how the trial results were achieved and how the intervention mechanisms did, or did not, work in practice (the process evaluation). The findings from this study will be used subsequently to modify and improve the quality improvement intervention, so that it can be delivered at scale across Africa and assess its impact on haemorrhage during and after caesarean section in the future.

Eligibility criteria

Qualifiers

Any patient who requires a caesarean section in participating countries with hospitals that routinely perform caesarean section.

Disqualifiers

Patients who opt out of the trial will be excluded.

Trial design

Treatments tested in this trial

  • Quality improvement program

Treatment groups

2,400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Bruce Biccard

Lead sponsor

University of Cape Town

Sponsor institution