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Improving how we measure and recognize heavy bleeding during caesarean birth

Diagnosis of post partum haemorrhage at Caesarean section: a multi-country diagnostic and prognostic accuracy study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/0105872
Enrollment
1245
Registered
2026-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: O72- Postpartum hemorrhage

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Women aged 18 or over 2.Women undergoing birth by caesarean section it can be elective or semi-emergency that is category 2 or 3 during the study period. Multiple pregnancies will be eligible. 3.Written informed consent from participants.

Exclusion criteria

Exclusion criteria: 1.Women undergoing a category 1, the immediate threat to life caesarean section. 2.Women participating in another PPH study.

Design outcomes

Primary

MeasureTime frame
1. Agreement between the colorimetric sponge and canister system and the gravimetric/volumetric method with the haemoglobin mass reference standard for blood loss estimation 2. Diagnostic accuracy of the two methods for detecting blood loss greater than or equal to 500 mL 3. Prognostic accuracy of the two methods for predicting adverse maternal outcomes (blood transfusion, severe anaemia, hysterectomy, re-laparotomy, ICU admission, maternal death, and other PPH-related interventions) 4. Feasibility, usability, and acceptability of the two blood loss measurement methods among healthcare providers by a mixed studyTimepoint: 1. Intraoperative period (knife-to-skin to completion of caesarean section, results recorded within one hour) 2. maternal outcomes assessed within 24 hours post-surgery 3. Mixed study done after enrolment of 250 participants.

Secondary

MeasureTime frame
NilTimepoint:

Countries

India, Kenya, Nigeria, Pakistan, Rwanda

Contacts

Public ContactDr Anne George Cherian

Christian Medical College, Vellore

annegc@cmcvellore.ac.in9487760904

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026