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THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage

ConditionPostpartum Hemorrhage
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Quality improvement program

    Other intervention

    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.

Treatment groups

2,400 Participants
are divided into 2 treatment groups
Group A: Control phaseNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Patient assessed as high-risk for postpartum haemorrhage

To evaluate the effect of the trial intervention on identification of high-risk patients

Time frame
6 months
2

Administration of uterotonics intra- or postoperatively

To evaluate the effect of the trial intervention on administration of uterotonics

Time frame
6 months
3

Administration of tranexamic acid intra- or postoperatively

To evaluate the effect of the trial intervention on administration of tranexamic acid

Time frame
6 months
4

Uterine massage intra- or postoperatively after delivery of the baby

To evaluate the effect of the trial intervention on uterine massage

Time frame
6 months

Secondary outcomes

1

Diagnosis of postpartum haemorrhage

To evaluate the effect of the trial intervention on a diagnosis of postpartum haemorrhage

Time frame
6 months
2

30 day in-hospital mortality

To evaluate the effect of the trial intervention on 30 day in-hospital mortality

Time frame
6 months
3

Repeat laparotomy for suspected haemorrhage

To evaluate the effect of the trial intervention on repeat laparotomy for suspected haemorrhage

Time frame
6 months
4

Duration of hospital stay

To evaluate the effect of the trial intervention on duration of hospital stay

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bruce Biccard

Lead sponsor

University of Cape Town

Sponsor institution

Source ClinicalTrials.gov
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