THUMB: Multi-centre Cluster Trial for Caesarean Section Haemorrhage

April 8, 2026 updated by: Bruce Biccard

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control phase
Control data will be collected at all hospitals over a two-week period (usual care phase). Patients in the control phase will receive the current standard postoperative care.
Active Comparator: Intervention
The intervention (a quality improvement programme) will then be implemented by the unit for all patients, aimed at delivering care that is already known to be effective in delivering better patient outcomes.
Other: Quality improvement program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient assessed as high-risk for postpartum haemorrhage
Time Frame: 6 months
To evaluate the effect of the trial intervention on identification of high-risk patients
6 months
Administration of uterotonics intra- or postoperatively
Time Frame: 6 months
To evaluate the effect of the trial intervention on administration of uterotonics
6 months
Administration of tranexamic acid intra- or postoperatively
Time Frame: 6 months
To evaluate the effect of the trial intervention on administration of tranexamic acid
6 months
Uterine massage intra- or postoperatively after delivery of the baby
Time Frame: 6 months
To evaluate the effect of the trial intervention on uterine massage
6 months
A postoperative clinician visit within four hours of discharge to the ward
Time Frame: 6 months
To evaluate the effect of the trial intervention on clinician ward visit postoperatively
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diagnosis of postpartum haemorrhage
Time Frame: 6 months
To evaluate the effect of the trial intervention on a diagnosis of postpartum haemorrhage
6 months
30 day in-hospital mortality
Time Frame: 6 months
To evaluate the effect of the trial intervention on 30 day in-hospital mortality
6 months
Repeat laparotomy for suspected haemorrhage
Time Frame: 6 months
To evaluate the effect of the trial intervention on repeat laparotomy for suspected haemorrhage
6 months
Duration of hospital stay
Time Frame: 6 months
To evaluate the effect of the trial intervention on duration of hospital stay
6 months
Referral to higher level of care for further management of bleeding/resuscitation
Time Frame: 6 months
To evaluate the effect of the trial intervention on referral to higher level of care for further management of bleeding/resuscitation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bruce Biccard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: BRUCE BICCARD, PhD, University of Cape Town

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • The Rule of THUMB trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared with researchers upon request, including, the supporting information selected below.

IPD Sharing Time Frame

Following publication of the results, IPD will be made available upon request.

IPD Sharing Access Criteria

Any researchers, and clinicians or healthcare workers continuing care of the participants after the study, as well as the participants themselves.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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