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Improving How We Define and Detect Postpartum Bleeding

Validation and Field Testing of a New WHO Definition for Postpartum Haemorrhage - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085740
Enrollment
18000
Registered
2025-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O720- Third-stage hemorrhage

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL Control Intervention2: NIL: NIL

Sponsors

World Health Organization (WHO)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Skilled health workers (including doctors or midwives) involved in intrapartum care in delivery wards and operational theatres Eligible healthcare providers are: -Employed by the participating facility -Staff members (trainee obstetricians or registrars are eligible) -Currently managing deliveries in participating facilities and -Trained on objective blood loss measurement and the WHO first-response bundle

Exclusion criteria

Exclusion criteria: Medical, midwifery or nursing students

Design outcomes

Primary

MeasureTime frame
1.Facility-level adherence to the PPH diagnostic tests: number of women with objective blood loss measurement and clinical signs assessments conducted in line with current recommendations among all women giving birth. 2.Detection rate of postpartum hemorrhage based on revised definition: number of women with a diagnosis of postpartum hemorrhage recorded by the birth attendants, out of the total number of women who had postpartum hemorrhage based on new definition (using objective blood-collection methods and clinical assessment for vaginal births or routine method of blood loos collection for caesarean section). 3.Treatment response: adherence to the MOTIVE first response-bundle, out of the total number of women who had a postpartum hemorrhage based on new definition (using objective blood-collection methods and clinical assessment for vaginal births or routine method of blood loos collection for caesarean section).Timepoint: Up to discharge

Secondary

MeasureTime frame
Secondary exploratory clinical outcomes 1.Postpartum hemorrhage based on current definition of 500 ml or more of objectively measured blood loss among all vaginal births at 1 hour and, if there was continued bleeding, for up to 2 hours post partum 2.Postpartum hemorrhage based on current definition of 1000 ml or more of objectively measured blood loss among all caesarean sections at 1 hour and, if there was continued bleeding, for up to 2 hours post partum; 3.Postpartum hemorrhage based on revised definition among all births at 1 hour and, if there was continued bleeding, for up to 2 hours post partum; 4.Severe postpartum hemorrhage, defined as blood loss of at least 1000 ml after birth at 1 hour and, if there was continued bleeding, for up to 2 hours post partumTimepoint: Up to discharge;Secondary exploratory clinical outcomes 1.Maternal death from any cause 2.Blood transfusion for any cause 3.Blood transfusion for postpartum hemorrhage 4.Volume of blood loss as a continuous variable 5.Uterine tamponade use 6.Intensive care unit (ICU) admission or higher-level hospital transfer 7.Laparotomy or any surgical intervention during postpartum admissionTimepoint: Up to discharge;Other quantitative and qualitative implementation outcomes 1.Objective blood loss measurement: number of women who had their blood loss measured through calibrated drapes, trays or gravimetric methods among all births and by delivery mode (Vaginal or Cesarean section) 2.Clinical signs assessment: number of women with routine measures of pulse, systolic and diastolic blood pressure, and shock index among all deliveries.Timepoint: Up to discharge;Other quantitative and qualitative implementation outcomes 3.Acceptability of the refined definition among healthcare providers, and health facility administrators. 4.Fidelity and Dose: To what extent was the implementation of the new definition delivered and engaged with as planned? 5.Adaptation: what modifications were made to adapt the de

Countries

Colombia, India, Kenya, Nigeria, Tanzania, Thailand

Contacts

Public ContactDr Shivaprasad S Goudar

J N Medical College, KLE Academy of Higher Education and Research Belagavi

sgoudar@jnmc.edu9448126371

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026