Clinical trial NCT07005349: THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 2400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: The study involves a complex intervention to improve maternal outcomes for patients undergoing caesarean section based on early diagnosis of haemorrhage during and after surgery coupled to early treatment through first-responder protocolised treatment using a care bundle of five elements called the rule of THUMB. The intervention is essentially a quality improvement programme aimed at delivering better care, care that is already known to be effective in delivering better patient outcomes. The intervention comprises two mandatory risk assessments (preoperatively in theatre and postoperatively prior to discharge from the recovery area) which are linked to hospital-specific responses. Assessments for bleeding will occur intraoperatively (through direct vision, haemodynamic changes and/or measurement of blood loss) and postoperatively (with the use of the rapid assessment tool). If bleeding is diagnosed at any point, the THUMB checklist will be used to activate bundled care. On discharge from recovery, high-risk patients will be scheduled to receive a postoperative ward visit within four hours, when a further assessment for bleeding will occur. Staff at each hospital will collect data for the two-week usual care (control) phase describing usual perioperative care. This will be followed by a period of co-design and training (2-6 weeks, as required), and then implementation of the intervention phase for a further two weeks at each hospital. The initial intervention will be modified in accordance with data collected during the usual care phase, in conjunction with local stakeholders. Further intervention refinement will occur after each period of data recruitment and analysis. Two intervention cycles will occur. The intervention is essentially a quality improvement programme aimed at delivering better care, care that is already known to be effective in delivering better patient outcomes. The intervention aims to improve compliance with recommended care for prevention and treatment of haemorrhage during and after caesarean section by creating a bundle of care that is delivered simultaneously (not sequentially) by first responders. It includes two mandated risk assessments before and after surgery, and implementation of the THUMB care bundle either in response to bleeding intraoperatively or in recovery or the ward through the rapid assessment tool.

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.

Primary outcomes:
measure: Patient assessed as high-risk for postpartum haemorrhage
timeFrame: 6 months
measure: Administration of uterotonics intra- or postoperatively
timeFrame: 6 months
measure: Administration of tranexamic acid intra- or postoperatively
timeFrame: 6 months
measure: Uterine massage intra- or postoperatively after delivery of the baby
timeFrame: 6 months
measure: A postoperative clinician visit within four hours of discharge to the ward
timeFrame: 6 months
Secondary outcomes:
measure: Diagnosis of postpartum haemorrhage
timeFrame: 6 months
measure: 30 day in-hospital mortality
timeFrame: 6 months
measure: Repeat laparotomy for suspected haemorrhage
timeFrame: 6 months
measure: Duration of hospital stay
timeFrame: 6 months
measure: Referral to higher level of care for further management of bleeding/resuscitation
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Cape Town
name: BRUCE BICCARD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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