Haemostasis and Tranexamic Acid in Caesarean Delivery (NCT03742947) | Clinical Trial Compass
CompletedNot Applicable
Haemostasis and Tranexamic Acid in Caesarean Delivery
France34 participantsStarted 2019-01-10
Plain-language summary
The aim of the study is to evaluate haemostasis and fibrinolysis in peripartum of caesarean delivery and the effect of tranexamic acid (TXA) given in prevention of post-partum haemorrhage (PPH).
Who can participate
Age range18 Years – 65 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patient randomized into TRAAP2 study (NCT03431805):
* adult women admitted for a planned caesarean delivery,
* at term ≥ 34 weeks,
* haemoglobin level at the last blood sample \>9g/dl,
* blood Formula numbering within 7 days before caesarean delivery, informed signed consent)
* informed signed consent for BIO-TRAAP
Exclusion Criteria:
* patient not included into TRAAP2 study:
* previous thrombotic event or pre-existing pro-thrombotic disease,
* epileptic state or history of seizures,
* presence of any chronic or active cardiovascular disease outside hypertension,
* any chronic or active renal disease including renal, chronic or acute insufficiency (glomerular flow \<90mL / min), and chronic or active liver disease at risk thrombotic or haemorrhagic,
* autoimmune disease,
* sickle cell disease,
* placenta praevia,
* placenta accreta/increta/percreta,
* abruption placentae,
* eclampsia,
* HELLP syndrome,
* in utero fetal death,
* administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
* general anaesthesia,
* hypersensitivity to tranexamic acid or concentrated hydrochloric acid, instrumental extraction failure,
* multiple pregnancy with genital delivery of the first twin and caesarean delivery for the second or at third trimester,
* poor understanding of the French language
What they're measuring
1
Clot lysis time
Timeframe: Baseline (defined as the time of insertion of the peripheric venous line)