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Management of Postpartum Haemorrhage and Effect of Geographic Region

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ClinicalTrials.gov Identifier: NCT03166839
Recruitment Status : Completed
First Posted : May 25, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:

Background: Maternal deaths occur universally and are largely avoidable. Postpartum haemorrhage accounts for a disproportionate amount of maternal deaths. There remains a great need to expeditiously decrease the rate of postpartum haemorrhage to prevent further mortality.

Methods: This study is a cohort analysis of data collected for the pragmatic international multi-centre randomized double blind placebo controlled design WOMAN Trial. It will present a univariate analysis of patient and delivery characteristics (age, type of delivery, placenta fully delivered, primary cause of haemorrhage, severity of haemorrhage), physiologic characteristics (systolic blood pressure, estimated blood loss, clinical signs of haemodynamic instability) and management characteristics (receipt of blood products, uterotonics). Multivariable logistic regression models and likelihood ratio tests will be used to examine the evidence for interaction between death from PPH and region after adjusting for any independent effects of 1) systolic blood pressure 2)age 3) type of delivery 4) receipt of blood products Discussion: This analysis of the WOMAN trial dataset will explore the relationship between geographical location, patient and environment characteristics and outcomes of postpartum haemorrhage. A protocol and statistical analysis plan is presented here.


Condition or disease Intervention/treatment
Postpartum Hemorrhage Other: Experiencing PPH

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 20060 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Postpartum Haemorrhage and Effect of Geographic Region: A Secondary Analysis of the World Maternal Antifibrinolytic (WOMAN) Trial
Actual Study Start Date : March 2009
Actual Primary Completion Date : June 2016
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Region 1: Africa
Women living in and experiencing PPH in countries located in Africa.
Other: Experiencing PPH
No intervention given

Region 2: Asia
Women living in and experiencing PPH in countries located in Africa.
Other: Experiencing PPH
No intervention given

Region 3: Europe, NA, SA, Aus
Women living in and experiencing PPH in countries located in Africa.
Other: Experiencing PPH
No intervention given




Primary Outcome Measures :
  1. Death [ Time Frame: Within 42 days of delivery ]
    Death due to bleeding from PPH



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible adult women with a clinical diagnosis of postpartum haemorrhage following vaginal or caesarean section delivery will be included in this cohort analysis. While the diagnosis was clinical, a definition of postpartum haemorrhage could be based on clinically estimated blood loss of more than 500mL after vaginal birth or 1000mL after caesarean section or any blood loss sufficient to compromise haemodynamic stability.
Criteria

Inclusion Criteria:

  • Women aged 16 years and older
  • Clinical diagnosis of postpartum haemorrhage (PPH) after vaginal delivery or caesarean section
  • "clinical uncertainty" about benefit of tranexamic acid in addition to routine management of PPH

Exclusion Criteria:

- Women aged 16 years and older with a clinical diagnosis of postpartum haemorrhage with clear indication or contra-indication for tranexamic acid


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166839


Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Ian Roberts London School of Hygiene and Tropical Medicine

Publications of Results:
Other Publications:
Gohel, M Efficacy of tranexemic acid in decreasing blood loss during and after cesarean section: A randomised case controlled prospective study. J Obstet Gynecol India. 2007;57(3):227-30.

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03166839     History of Changes
Other Study ID Numbers: 12049
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by London School of Hygiene and Tropical Medicine:
maternal health
statistical analysis plan

Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage