Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery
TRAAP
1 other identifier
interventional
4,079
1 country
1
Brief Summary
The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 27, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedSeptember 6, 2017
September 1, 2017
1.9 years
November 17, 2014
September 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of PPH
Incidence of PPH defined by blood loss ≥ 500 ml, measured with a graduated collector bag
24 hours after birth
Secondary Outcomes (12)
Mean blood loss at 15 minutes after birth
15 minutes after birth
Mean total blood loss
Up to 24 hours after birth
Incidence of severe PPH
24 hours after birth
Need for supplementary uterotonic treatment
24 hours after birth
Postpartum transfusion
Duration of postpartum hospital stay, an expected average of 3 days
- +7 more secondary outcomes
Other Outcomes (2)
Women's satisfaction
Day 2 postpartum
Psychological status
2 months postpartum
Study Arms (2)
TXA
EXPERIMENTALIntravenous administration of 1g of tranexamic acid within 2 minutes after birth and prophylactic oxytocin administration
Placebo
PLACEBO COMPARATORIntravenous administration of placebo within 2 minutes after birth and prophylactic oxytocin administration
Interventions
Intravenous administration of a 10 mL solution containing 1g of tranexamic acid within 2 minutes of birth and routine prophylactic IV injection of oxytocin
Intravenous administration of 10 mL of 0.9% sodium chloride solution within 2 minutes of birth and routine prophylactic IV injection of oxytocin
Eligibility Criteria
You may qualify if:
- Age≥ 18 years
- Planned vaginal delivery
- Term ≥ 35 weeks of gestation
- Singleton pregnancy
- Informed consent form signed
You may not qualify if:
- History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombosis.
- History of epilepsy or seizure
- Any known cardiovascular, renal, liver disorders
- Auto-immune disease
- Sickle cell disease
- Severe hemorrhagic disease
- Placenta previa
- Abnormally invasive placenta (placenta accreta/increta/percreta)
- Abruptio placentae
- Eclampsia; hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
- Multiple pregnancy
- In utero foetal death
- Administration of Low-Molecular-Weight Heparin or antiplatelet agents seven days before delivery
- Poor understanding of the French language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Angers University Hospital
Angers, 49933, France
Related Publications (5)
Novikova N, Hofmeyr GJ. Tranexamic acid for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007872. doi: 10.1002/14651858.CD007872.pub2.
PMID: 20614466BACKGROUNDPeitsidis P, Kadir RA. Antifibrinolytic therapy with tranexamic acid in pregnancy and postpartum. Expert Opin Pharmacother. 2011 Mar;12(4):503-16. doi: 10.1517/14656566.2011.545818. Epub 2011 Feb 4.
PMID: 21294602BACKGROUNDSentilhes L, Daniel V, Darsonval A, Deruelle P, Vardon D, Perrotin F, Le Ray C, Senat MV, Winer N, Maillard F, Deneux-Tharaux C. Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial. BMC Pregnancy Childbirth. 2015 Jun 14;15:135. doi: 10.1186/s12884-015-0573-5.
PMID: 26071040BACKGROUNDSentilhes L, Lasocki S, Ducloy-Bouthors AS, Deruelle P, Dreyfus M, Perrotin F, Goffinet F, Deneux-Tharaux C. Tranexamic acid for the prevention and treatment of postpartum haemorrhage. Br J Anaesth. 2015 Apr;114(4):576-87. doi: 10.1093/bja/aeu448. Epub 2015 Jan 8.
PMID: 25571934BACKGROUNDSentilhes L, Winer N, Azria E, Senat MV, Le Ray C, Vardon D, Perrotin F, Desbriere R, Fuchs F, Kayem G, Ducarme G, Doret-Dion M, Huissoud C, Bohec C, Deruelle P, Darsonval A, Chretien JM, Seco A, Daniel V, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Vaginal Delivery. N Engl J Med. 2018 Aug 23;379(8):731-742. doi: 10.1056/NEJMoa1800942.
PMID: 30134136DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Loic SENTILHES, MD PhD
Department of Obstetrics, Angers University Hospital Center
- STUDY DIRECTOR
Catherine DENEUX-THARAUX, MD PhD
Institut National de la Santé Et de la Recherche Médicale, France
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 27, 2014
Study Start
February 1, 2015
Primary Completion
January 1, 2017
Study Completion
April 1, 2017
Last Updated
September 6, 2017
Record last verified: 2017-09