None listed
Conditions
Interventions
Group 1 Type of group
A dose of 1 gram tranexamic acid will be administered by intravenous injection as soon as the random assignment has been made. If after 30 minutes the bleeding continues, or if it stops and starts again within 24 hours after the first dose, a second dose may be administered.
Group name:Group 2 Type of group
A placebo dose (0.9% sodium chloride) will be administered as soon as the randomisation has been made. If after 30 minutes the bleeding continues, or if it stops and starts again within 24 hours after the first dose, a second dose may be administered.
Sponsors
LONDON SCHOOL OF HYGIENE & TROPICAL MEDICINE,
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: • All legally adult women with a medical diagnosis of postpartum hemorrhage after a vaginal or cesarean delivery; the women have been able to give birth in the participating hospital or outside it, and have been admitted after childbirth • The medical diagnosis of PPH may be based on the following: estimated blood loss after vaginal delivery> 500 ml, loss of> 1,000 ml after cesarean delivery, estimated estimated blood loss to endanger the hemodynamic state of the woman
Exclusion criteria
Exclusion criteria: • Women for whom the responsible physician considers that there is a clear indication for the use of ATX should not participate in the assignment. • Women for whom the responsible physician considers that there is a clear contraindication for the use of ATX should not participate in the assignment (for example, having suffered a thromboembolic event during pregnancy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Number of women who die or undergo a hysterectomy. The leading cause of death will be described. Measure:Proportion of women who die or undergo a hysterectomy Timepoints:42 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:hysterectomy, compression suture (B-Lynch / Cho), selective arterial embolization, laparotomy for other reasons, manual removal of the placenta, Intrauterine tamponade (plugging or filling the uterine cavity with gauze, condom catheter or any other method of uterine tamponade ), uterine artery ligation, to achieve hemostasis. Measure:Proportion of surgical interventions Timepoints:42 days ; Outcome name:number of units of blood or blood components transfused Measure:Proportion of blood transfusions Timepoints:42 days ; Outcome name:Will be measured using the approximate EQ-SD version when the patient is discharged from the participating hospital or in the hospital 42 days after (upon randomization. The EQSD questionnaire includes single-item measures for mobility, personal care, daily activities, pain / discomfort and anxiety / depression Each element is coded using 3 levels {1 = no problems; 2 = some problem; 3 = several problems). The instrument includes an overall global health score using an analog visual scale (VAS) that ranges from O (lousy) to 100 (optimal). The EQ-SD is a generic measure of health status that provides a simple descriptive profile and a single indicative value that can be used in the clinical and economic evaluation of health care. Measure:The health-related quality of life Timepoints:42 days ; Outcome name:Occurrence of myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis. Measure:Proportion of thromboembolic events Timepoints:42 days | — |
Countries
Nigeria, Peru
Contacts
Public ContactJuan Jaime Miranda
DR. JAIME MIRANDA MONTERO
Outcome results
None listed