THUMB care package to reduce bleeding during and after caesarean section
Official title: 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
Run by University of Cape Town · NCT07005349 · Data updated 2026-11-12
This project tests a perioperative care package called the 'Rule of THUMB' to reduce bleeding in people having a caesarean section.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 2400 (estimated) |
| Sponsor | University of Cape Town Academic / other |
| Locations | 1 site (Cape Town) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07005349 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Any person undergoing a caesarean section at a participating hospital who does not opt out is eligible to take part.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Mowbray Maternity Hospital
Cape Town, South Africa Recruiting
Study contacts
- Principal investigator: BRUCE BICCARD, PhD — University of Cape Town
- Study coordinator: MARGOT FLINT, PhD
- Email: margot.flint@uct.ac.za
- Phone: 00274045001
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.