Pharmacy and Poisons Board
Protocol No: ECCT/26/03/02 Date of Protocol: 28-07-2025
Study Title:

Diagnosis of postpartum haemorrhage at caesarean section: a multi-country diagnostic and prognostic accuracy study (E-MASTER: PHASE 1)
Study Objectives:

Broad Obective

The primary aim of this study is to estimate the diagnostic and prognostic accuracy of a colorimetric sponge and canister system (Triton System, Stryker Inc.) and a gravimetric and volumetric method for the intraoperative measurement of blood loss at caesarean birth, as well as evaluate their implementation in low-and middle-income settings.

 

Specific Objectives

  1. Evaluate the agreement of 1) the colorimetric sponge and canister system, and 2) the gravimetric and volumetric blood loss measurement method against the reference standard of haemoglobin (Hb) mass method from surgical sponges and suction canister. We will also explore the diagnostic test accuracy of 1) the colorimetric sponge and canister system, and 2) the gravimetric and volumetric blood loss measurement method against the reference standard of Hb mass method from surgical sponges and suction canister for the outcome of blood loss ≥ 500mL.
  2. Evaluate the diagnostic test accuracy of the colorimetric sponge and canister system, against the reference standard of gravimetric and volumetric blood loss measurement method for the outcome of blood loss ≥ 500mL. 
  3. Evaluate the prognostic accuracy of the colorimetric sponge and canister system and the gravimetric and volumetric blood loss measurement method on the composite clinical outcome of blood transfusion, Hb <6g/dL or a difference of 4g/dL from baseline, as well as PPH-related hysterectomy, re-laparotomy, maternal ICU admission, or maternal mortality. Prognostic accuracy analysis will also be conducted for the individual components of the composite outcome separately, and in addition, for shock, uterine tamponade, compression sutures, uterine tourniquet, uterine or iliac artery ligation, organ failure and other key outcomes from the PPH core outcome set.
  4. Evaluate the implementation of the colorimetric sponge and canister system and the gravimetric and volumetric blood loss measurement method.
Laymans Summary:

The E-MASTER Phase I study is taking place in five countries to find better ways to measure blood loss during caesarean sections. It compares two methods—a new color-based system and a traditional weighing method—to see which more accurately detects dangerous bleeding (postpartum haemorrhage). The study also looks at how well these tools can predict serious health risks for mothers and whether they can be used effectively in real hospital settings in low- and middle-income countries.
Abstract of Study:

The E-MASTER Phase I study is a prospective, multi-country diagnostic and prognostic accuracy study evaluating methods for measuring blood loss during caesarean sections (CS), with a focus on improving postpartum haemorrhage (PPH) diagnosis in low- and middle-income countries (LMICs). Conducted in Kenya, Nigeria, Rwanda, India, and Pakistan, the study aims to assess the diagnostic and prognostic accuracy of a colorimetric sponge and canister system (Triton, Stryker Inc.) and a gravimetric and volumetric method, as well as evaluate their implementation in real-world clinical settings.

The diagnostic test agreement component will compare both methods against a haemoglobin mass reference method using a sample of 250 women (50 per country). The goal is to assess bias, agreement, and accuracy with 97.5% confidence that differences remain within 250mL.

For diagnostic accuracy, the colorimetric system is the index test, compared against the gravimetric/volumetric method as the reference. A sample size of 1,245 women (including a 5% buffer) will determine sensitivity, specificity, and predictive values, targeting a minimum PPH detection sensitivity and specificity of 80%.

In the prognostic accuracy study, both measurement methods will be evaluated against a composite clinical outcome that includes blood transfusion, severe haemoglobin drop, hysterectomy, ICU admission, or maternal death. A total of 1,245 participants will be recruited to ensure sufficient power to detect an area under the curve (AUC) of ≥0.60.

An embedded mixed methods implementation evaluation, guided by RE-AIM and CFIR frameworks, will assess feasibility, acceptability, and sustainability. Data from 110–210 healthcare workers across 10 facilities will be collected through surveys and qualitative interviews to explore implementation outcomes, contextual influences, and staff perceptions.

This study aims to provide robust evidence on the accuracy and practicality of intraoperative blood loss measurement tools for better management of PPH in LMICs.