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Sponsored by: |
London School of Hygiene and Tropical Medicine |
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Information provided by: | London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00872469 |
This trial is a large pragmatic randomised double-blind, placebo controlled trial to quantify the effects of the early administration of tranexamic acid on death, hysterectomy and other relevant outcomes. 12,000 adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent.
Condition | Intervention | Phase |
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Postpartum Haemorrhage |
Drug: Tranexamic acid Drug: Placebo [Saline] |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial |
Estimated Enrollment: | 12000 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | February 2015 |
Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Tranexamic acid: Active Comparator |
Drug: Tranexamic acid
1-2 grams by intravenous injection
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placebo: Placebo Comparator |
Drug: Placebo [Saline]
Matched to active comparator
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Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
All legally adult women with postpartum haemorrhage following vaginal or caesarean section delivery who have a clinical diagnosis of postpartum haemorrhage. The clinical diagnosis of PPH may be based on any of the following:
Where the responsible clinician is substantially uncertain as to whether or not to use an antifibrinolytic, all these women are eligible for randomisation and should be considered for the trial. There are no other pre-specified exclusion criteria.
Contact: Haleema Shakur, MSc, RN | ++44 (0)20-7958-8113 | thewomantrial@lshtm.ac.uk |
Responsible Party: | London School of Hygiene and Tropical Medicine ( Professor Ian Roberts ) |
Study ID Numbers: | ISRCTN76912190 |
Study First Received: | March 30, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00872469 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; India: Drugs Controller General of India; India: Indian Council of Medical Research |
Postpartum haemorrhage randomised controlled trial tranexamic acid antifibrinolytic |
Postpartum Hemorrhage Serine Proteinase Inhibitors Pregnancy Complications Uterine Hemorrhage Obstetric Labor Complications Tranexamic Acid Hemorrhage |
Hemostatics Protease Inhibitors Antiplasmin Fibrin Modulating Agents Antifibrinolytic Agents Puerperal Disorders |
Serine Proteinase Inhibitors Postpartum Hemorrhage Pregnancy Complications Coagulants Uterine Hemorrhage Molecular Mechanisms of Pharmacological Action Hematologic Agents Obstetric Labor Complications Enzyme Inhibitors Tranexamic Acid |
Hemorrhage Hemostatics Pharmacologic Actions Protease Inhibitors Antiplasmin Fibrin Modulating Agents Pathologic Processes Antifibrinolytic Agents Puerperal Disorders Therapeutic Uses |