World Maternal Antifibrinolytic Trial - Full Text View

Sponsor:	London School of Hygiene and Tropical Medicine
Collaborator:	Indian Council of Medical Research
Information provided by:	London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00872469

Purpose

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. 15,000 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
Postpartum Haemorrhage	Drug: Tranexamic acid Drug: Placebo [Saline]	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Tranexamic Acid for the Treatment of Postpartum Haemorrhage: An International Randomised, Double Blind, Placebo Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy Postpartum Care

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:

The primary outcome is the proportion of women who die or undergo hysterectomy. The primary cause of death will be described. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Surgical Interventions including hysterectomy; brace suture; selective arterial embolisation; laparotomy for other reasons; manual removal of placenta; intrauterine tamponade; artery ligation, to achieve haemostasis. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]
Need for blood transfusion - blood or blood component units transfused. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]
Health Status measured using the EQ-5D. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: No ]
Thromboembolic events (myocardial infarction, strokes, pulmonary embolism, DVT). [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]
Other relevant medical events [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: Yes ]
Length of stay at hospital/time spent at an intensive care unit [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: No ]
Need for mechanical ventilation. [ Time Frame: up to 42 days after randomisation ] [ Designated as safety issue: No ]
Status of baby/ies [ Time Frame: up to 42 weeks after randomisation of mother ] [ Designated as safety issue: Yes ]
Cost-effectiveness analysis [ Designated as safety issue: No ]

Estimated Enrollment:	15000
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
Active Comparator: Tranexamic acid	Drug: Tranexamic acid 1-2 grams by intravenous injection
Placebo Comparator: placebo	Drug: Placebo [Saline] Matched to active comparator

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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:

Blood loss after vaginal delivery > 500 mL OR
> 1,000 mL after caesarean section OR blood loss sufficient to compromise the haemodynamic status of the woman The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular woman with postpartum haemorrhage.
Women for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised.
Women for whom there is considered to be a clear contraindication to antifibrinolytic therapy should not be randomised.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00872469

Contacts

Contact: Haleema Shakur, MSc, RN

++44 (0)20-7958-8113

thewomantrial@lshtm.ac.uk

Locations

Nigeria
University College Hospital	Recruiting
Ibadan, Nigeria
Principal Investigator: Oladapo Olayemi, MD

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine

Indian Council of Medical Research

Investigators

Study Director:

Ian G Roberts, MD

London School of Hygiene and Tropical Medicine

More Information

Additional Information:

Trial website This link exits the ClinicalTrials.gov site

Sponsor

Publications:

Shakur H, Elbourne D, Gülmezoglu M, Alfirevic Z, Ronsmans C, Allen E, Roberts I. The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial. Trials. 2010 Apr 16;11:40.

Responsible Party:	Professor Ian Roberts, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:	NCT00872469 History of Changes
Other Study ID Numbers:	ISRCTN76912190
Study First Received:	March 30, 2009
Last Updated:	June 29, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; India: Drugs Controller General of India; India: Indian Council of Medical Research; Nigeria: The National Agency for Food and Drug Administration and Control

Keywords provided by London School of Hygiene and Tropical Medicine:

Postpartum haemorrhage
randomised controlled trial
tranexamic acid
antifibrinolytic

Additional relevant MeSH terms:

Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Antifibrinolytic Agents

Tranexamic Acid
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012