THUMB care package to reduce bleeding during and after caesarean section

Rule of THUMB: A Multi-centre Cluster Trial Evaluating the Implementation of a Perioperative Care Complex Intervention to Improve Outcomes From Haemorrhage During and After Caesarean Section in African Hospitals

This project tests a perioperative care package called the 'Rule of THUMB' to reduce bleeding in people having a caesarean section.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2400 (estimated)
• Sex: Female
• Sponsor: University of Cape Town (Academic / other)
• Locations: 1 site (Cape Town)
• Trial ID: NCT07005349 on ClinicalTrials.gov

What this trial studies

This is a cluster quality-improvement project that introduces a five-element bundled response (the Rule of THUMB) and linked risk assessments to improve early diagnosis and treatment of haemorrhage during and after caesarean section. Each participating hospital will collect two weeks of baseline usual-care data, then complete a co-design and training period (2–6 weeks) before implementing the intervention for two weeks. The intervention mandates preoperative and postoperative risk assessments, intraoperative and rapid postoperative bleeding checks, activation of a THUMB checklist when bleeding is identified, and scheduled early ward review for high-risk patients. The study also includes a process evaluation to understand contextual and socio-dynamic factors that influence how the intervention works in practice and to inform future scale-up across African settings.

Who should consider this trial

Good fit: Any person undergoing a caesarean section at a participating hospital who does not opt out is eligible to take part.

Not a fit: Patients who opt out, whose bleeding occurs outside the perioperative monitoring window, or whose hospitals cannot implement the THUMB protocol reliably are unlikely to benefit from the intervention.

Why it matters

Potential benefit: If successful, the intervention could reduce severe bleeding after caesarean section, lower transfusion rates, and improve maternal recovery.

How similar studies have performed: Similar protocolized care bundles and rapid-response checklists for obstetric haemorrhage have improved outcomes in other settings, though implementation and evaluation in African perioperative caesarean settings remain more limited.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* Patients who opt out of the trial will be excluded.

Where this trial is running

Cape Town

• Mowbray Maternity Hospital — Cape Town, South Africa (Recruiting)

Study contacts

• Principal investigator: BRUCE BICCARD, PhD — University of Cape Town
• Study coordinator: MARGOT FLINT, PhD

Conditions Postpartum Hemorrhage