World Maternal Antifibrinolytic Trial (WOMAN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by London School of Hygiene and Tropical Medicine
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00872469
First received: March 30, 2009
Last updated: October 3, 2012
Last verified: October 2012
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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: October 3, 2012
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 July 26, 2014