World Maternal Antifibrinolytic Trial_2
Paraules clau
Resum
Descripció
Anaemia is a cause and consequence of PPH. A cohort study in Assam, India found that women with moderate or severe anaemia had a greatly increased risk of PPH. Women with moderate anaemia had a 50% increased risk, whereas those with severe anaemia had a ten-fold increased risk of PPH. Anaemic women may be more susceptible to uterine atony due to impaired oxygen transport to the uterus. Anaemic women experience worse outcomes after PPH. An international survey of 275,000 women found that severe maternal outcomes after PPH were nearly three times more common in anaemic than in non-anaemic women. Even moderate bleeding can be life threatening in anaemic women. Excessive bleeding after childbirth worsens maternal anaemia, resulting in a vicious circle of bleeding and adverse outcomes. Fatigue due to anaemia severely limits a mothers' wellbeing and her ability to care for her children. Despite efforts to prevent anaemia, many women labour with perilously low haemoglobin levels
Tranexamic acid (TXA) inhibits fibrinolysis by blocking the lysine binding sites on plasminogen. TXA reduces surgical bleeding and death due to bleeding in trauma patients. The WOMAN trial assessed the effects of TXA in 20,060 women with PPH. When given within three hours of birth, TXA reduced death due to bleeding by nearly one-third (RR=0.69, 95% CI 0.52 to 0.91, p=0.008). However, for many women, treatment is too late to prevent death from PPH. Most PPH deaths occur in the first hours after giving birth and women with anaemia are at greatly increased risk. Whilst there have been some trials of TXA for the prevention of PPH, most have serious flaws and none collected data on maternal health and wellbeing. There is currently no reliable evidence about the effectiveness and safety of TXA for preventing PPH.
The WOMAN-2 trial will determine reliably the effects of TXA in anaemic women who give birth vaginally.
Dates
| Darrera verificació: | 01/31/2020 |
| Primer enviat: | 02/22/2018 |
| Inscripció estimada enviada: | 03/15/2018 |
| Publicat per primera vegada: | 03/22/2018 |
| Última actualització enviada: | 02/13/2020 |
| Publicació de l'última actualització: | 02/17/2020 |
| Data d'inici de l'estudi real: | 08/23/2019 |
| Data estimada de finalització primària: | 05/31/2022 |
| Data estimada de finalització de l’estudi: | 07/31/2022 |
Condició o malaltia
Intervenció / tractament
Drug: Tranexamic acid
Other: Placebo
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Active Comparator: Tranexamic acid One intravenous injection of tranexamic acid. Total dose 1 gram (10mL) | Drug: Tranexamic acid Ampoules and packaging for both arms will be identical in appearance. |
| Placebo Comparator: Placebo One Injection of the placebo which is 10 mL Sodium Chloride (0.9%) | Other: Placebo Ampoules and packaging for both arms will be identical in appearance. |
Criteris d'elegibilitat
| Sexes elegibles per estudiar | Female |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - Women with moderate or severe anaemia (haemoglobin level <100 g/L or packed cell volume <30%) after giving birth vaginally where the responsible clinician is substantially uncertain whether to use TXA Exclusion Criteria: - Women who are not legally adult (<18 years) and not accompanied by a guardian - Women with a known allergy to tranexamic acid or its excipients. |
Resultat
Mesures de resultats primaris
1. Postpartum Haemorrhage (cause will be described) [24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier]
Mesures de resultats secundaris
1. Postpartum blood loss [24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier]
2. Haemaglobin [24 hours after administration of the trial medication or at discharge from hospital, whichever is earlier]
3. Haemodynamic instability [24 hours after administration of trial treatment or discharge from hospital, whichever is earlier]
4. Shock index [24 hours after administration of trial treatment or discharge from hospital, whichever is earlier]
5. Quality of Life (maternal) [Day 42 or discharge from hospital, whichever is earlier]
6. Expected side effects of trial medication [Day 42 or discharge from hospital, whichever is earlier]
7. Exercise tolerance [Day 42 or discharge from hospital, whichever is earlier]
8. Interventions to control primary postpartum haemorrhage (medical and surgical) [Day 42 or discharge from hospital, whichever is earlier]
9. Receipt of blood product transfusion [Day 42 or discharge of mother from hospital, whichever is earlier]
10. Vascular occlusive events [Day 42 or discharge from hospital, whichever is earlier]
11. Symptoms of anaemia [Day 42 or discharge of mother from hospital, whichever is earlier]
12. Organ disfunction [Day 42 or discharge from hospital, whichever is earlier]
13. Sepsis [Day 42 or discharge from hospital, whichever is earlier]
14. In hospital death [Day 42]
15. Length of hospital stay. [Day 42 or discharge from hospital, whichever is earlier]
16. Admission to and time spent in higher level facility [Day 42 or discharge from hospital, whichever is earlier]
17. Status of baby/ies [Day 42 or discharge of mother from hospital, whichever is earlier]
18. Thromboembolic events in breastfed babies [Day 42 or discharge of mother from hospital, whichever is earlier]
19. Adverse events [Day 42]
