A study to measure the efficacy of tranexamic acid to reduce post partum haemorrhage volume

A multi-centre open-label randomised controlled trial measuring the efficacy of tranexamic acid to reduce post partum haemorrhage volume

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN09968140

Enrollment

144

Registered

2011-03-24

Start date

2005-05-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Post-partum haemorrhage Pregnancy and Childbirth Post-partum haemorrhage

Interventions

Immediately after inclusion, patients were randomised to receive either TA (TA group) or no antifibrinolytic treatment (control group). The randomisation sequence was generated by a centralised comput

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients were included in the study when PPH was more than 800 mL

Exclusion criteria

Exclusion criteria: 1. Age < 18 years 2. Asence of informed consent 3. Caesarean section 4. Presence of known haemostatic abnormalities before pregnancy 5. History of previous thrombosis or epilepsy

Design outcomes

Primary

Measure	Time frame
The volume of blood loss between enrollment and 6 hours later	—

Secondary

Measure	Time frame
1. Duration of bleeding and the impact of TA on PPH-related outcome [decrease in haemoglobin concentration, transfusion of packed red blood cells (PRBC) at T4 and at day 42, and the need for invasive procedures (uterine artery embolisation or ligature, hysterectomy), late post-partum curettage or general outcome (intensive care unit stay, use of any vasopressors, dyspnoea, renal and multiple organ failure)]. 2. Severe PPH was defined according to Charbit et al. as exhibiting one of the following criteria: 2.1. Peri-partum decrease of haemoglobin > 4g/dL, with the last haemoglobin value before delivery considered as the reference 2.2. Transfusion of at least four packed red blood cells (PRBC) 2.3. Invasive haemostatic intervention 2.4. Death Evaluation of each endpoint was performed by investigators blinded to treatment allocation. 3. Side effects: Although the study was not powered to address safety issues, side effects that could be related to TA were analysed. Major (thrombotic events, renal failure, seizures) and minor side effects were reported at each time point and at day 42. With respect to venous thrombosis, clinical signs of superficial or deep thrombosis were collected and ultrasonography was performed, as soon as the signs were detected.	—

Measure

Time frame

1. Duration of bleeding and the impact of TA on PPH-related outcome [decrease in haemoglobin concentration, transfusion of packed red blood cells (PRBC) at T4 and at day 42, and the need for invasive procedures (uterine artery embolisation or ligature, hysterectomy), late post-partum curettage or general outcome (intensive care unit stay, use of any vasopressors, dyspnoea, renal and multiple organ failure)]. 2. Severe PPH was defined according to Charbit et al. as exhibiting one of the following criteria: 2.1. Peri-partum decrease of haemoglobin > 4g/dL, with the last haemoglobin value before delivery considered as the reference 2.2. Transfusion of at least four packed red blood cells (PRBC) 2.3. Invasive haemostatic intervention 2.4. Death Evaluation of each endpoint was performed by investigators blinded to treatment allocation. 3. Side effects: Although the study was not powered to address safety issues, side effects that could be related to TA were analysed. Major (thrombotic events, renal failure, seizures) and minor side effects were reported at each time point and at day 42. With respect to venous thrombosis, clinical signs of superficial or deep thrombosis were collected and ultrasonography was performed, as soon as the signs were detected.

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Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026