Immediate Postpartum Hemorrhage Clinical Trial
— TRAAPOfficial title:
Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial
Verified date | September 2017 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4079 |
Est. completion date | April 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age= 18 years - Planned vaginal delivery - Term = 35 weeks of gestation - Singleton pregnancy - Informed consent form signed Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Angers University Hospital | Angers |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers | Institut National de la Santé Et de la Recherche Médicale, France |
France,
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. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD007872. — View Citation
Peitsidis 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. Review. — View Citation
Sentilhes 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. — View Citation
Sentilhes 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Women's satisfaction | self-questionnaire | Day 2 postpartum | |
Other | Psychological status | self questionnaire | 2 months postpartum | |
Primary | Incidence of PPH | Incidence of PPH defined by blood loss = 500 ml, measured with a graduated collector bag | 24 hours after birth | |
Secondary | Mean blood loss at 15 minutes after birth | Measured with a collector bag left in place at least 15 minutes to have one measure of blood loss at the same time point in all women | 15 minutes after birth | |
Secondary | Mean total blood loss | Measured at collector bag removal | Up to 24 hours after birth | |
Secondary | Incidence of severe PPH | Incidence of PPH defined by blood loss = 1000 ml, measured with a graduated collector bag | 24 hours after birth | |
Secondary | Need for supplementary uterotonic treatment | Proportion of women requiring supplementary uterotonic treatment including sulprostone | 24 hours after birth | |
Secondary | Postpartum transfusion | Proportion of women transfused in postpartum | Duration of postpartum hospital stay, an expected average of 3 days | |
Secondary | Need for invasive second-line procedures for PPH | Any of the following: arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy | Duration of postpartum hospital stay, an expected average of 3 days | |
Secondary | Hemoglobin peripartum delta | Mean difference between the hemoglobin values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells. | 2 days postpartum | |
Secondary | Hematocrit peripartum delta | Mean difference between the hematocrit values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells | 2 days postpartum | |
Secondary | Hemodynamic tolerance | Heart rate, blood pressure | 15, 30, 45, 60 and 120 minutes after delivery | |
Secondary | Mild adverse effects | Nausea, vomiting, phosphenes, dizziness | Stay in labor ward, an expected average of 2 hours | |
Secondary | Tolerance lab tests | Urea, creatinemia, prothrombin time, active prothrombin time, fibrinogenemia, aspartate and alanine transaminase, total bilirubin | Day 2 postpartum | |
Secondary | Severe adverse effects | Deep venous thrombosis, pulmonary embolism, myocardial infarction, renal failure needing dialysis | Up to 12 weeks after delivery |
Status | Clinical Trial | Phase | |
---|---|---|---|
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