Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial

Sentilhes, Loïc; Daniel, Valérie; Darsonval, Astrid; Deruelle, Philippe; Vardon, Delphine; Perrotin, Franck; Le Ray, Camille; Senat, Marie-Victoire; Winer, Norbert; Maillard, Françoise; Deneux-Tharaux, Catherine

doi:10.1186/s12884-015-0573-5

Table 1 Characteristics of the randomized trials that have assessed tranexamic acid for preventing postpartum hemorrhage after cesarean delivery

From: Study protocol. TRAAP - TRAnexamic Acid for Preventing postpartum hemorrhage after vaginal delivery: a multicenter randomized, double-blind, placebo-controlled trial

Study [réf]	Country	Study design	Sample size	Study groups	Intervention	TXA Dosage/route	Primary outcome	Result	P value	Adverse effects
Gai et al. al, (2004) [30]	China	Multicenter, prospective, randomized controlled study	N = 180, primiparas	N = 91 (experimental)	Infusion of TXA 10 min before CS	1 g IV for 5 min	Postpartum blood loss not clearly specified	359.3 mL vs 439.3 mL	0.002	No thromboembolic or other side effects reported
Gai et al. al, (2004) [30]	China	Multicenter, prospective, randomized controlled study	N = 180, primiparas	N = 89 (no placebo)	Infusion of TXA 10 min before CS	1 g IV for 5 min	Postpartum blood loss not clearly specified	359.3 mL vs 439.3 mL	0.002	No thromboembolic or other side effects reported
Gohel et al., (2007) [31]	India	Prospective, randomized controlled study	N = 100, primiparas and multiparas	N = 50 (experimental)	Infusion of TXA 20 min before CS	1 g IV for 5 min	Postpartum blood loss not clearly specified	374.9 mL vs 472.8 mL	0.003	No thromboembolic or other side effects reported
Gohel et al., (2007) [31]	India	Prospective, randomized controlled study	N = 100, primiparas and multiparas	N = 50 (no placebo)	Infusion of TXA 20 min before CS	1 g IV for 5 min	Postpartum blood loss not clearly specified	374.9 mL vs 472.8 mL	0.003	No thromboembolic or other side effects reported
Sekhavat et al., (2009) [32]	Iran	Prospective, randomized, placebo-controlled study	N = 90, primiparas	N = 45 (experimental)	Infusion of TXA 10 min before CS	1 g IV for 5 min	Postpartum blood loss not clearly specific	28.0 mL vs 37.1 mL	0.001	No thromboembolic or other side effects reported
Sekhavat et al., (2009) [32]	Iran	Prospective, randomized, placebo-controlled study	N = 90, primiparas	N = 45 (placebo)	Infusion of TXA 10 min before CS	1 g IV for 5 min	Postpartum blood loss not clearly specific	28.0 mL vs 37.1 mL	0.001	No thromboembolic or other side effects reported
Gungorkuk et al., (2011) [33]	Turkey	Prospective, unicenter, double-blind, randomised controlled study	N = 666, primiparas and multiparas	N = 330 (experimental)	Infusion of TXA 10 min before CS	1 g IV for 5 min	Estimated blood loss during CS.	600.7 mL vs 499.9 mL	<0.001	Gastrointestinal side effects (16.3 %) in the experimental group
				N = 330 (placebo)
										Gastrointestinal side effects not mentioned for the placebo group.
										No thromboembolic events
Movafegh et al., 2011 [34]	Iran	Prospective, unicenter, double-blind, randomized controlled study	N = 100, primiparas and multiparas	N = 50 (experimental)	Infusion of TXA 20 min before CS	10 mg/kg IV for 10 min	Postpartum blood loss not clearly specified	262.5 mL vs 404.7 mL	<0.001	No thromboembolic events
Movafegh et al., 2011 [34]	Iran		N = 100, primiparas and multiparas	N = 50 (placebo)	Infusion of TXA 20 min before CS	10 mg/kg IV for 10 min	Postpartum blood loss not clearly specified	262.5 mL vs 404.7 mL	<0.001	No thromboembolic events
Xu et al., 2013 [35]	China	Randomized, double-blind, placebo-controlled study	N = 174 primiparas	N = 88 (experimental)	Infusion of TXA 10 min before CS	10 mg/kg IV for 5 min	Postpartum blood loss not clearly specified	379 mL vs 441 mL	0.02	2 thromboses occurred in each group.
				N = 88 (experimental)						Gastrointestinal side effects occurred in 10 TXA patients versus one placebo patient
				N = 86 (placebo)
Senturk et al., 2013 [36]	Turkey	Randomized, double-blind, placebo-controlled study	N = 223, primiparas and multiparas	N = 101 (experimental)	Infusion of TXA 10 min before CS	10 mg/kg IV for 5 min	Postpartum blood loss not clearly specified	272 mL vs 347 mL	0.001	No thromboembolic or gastrointestinal side effects
Senturk et al., 2013 [36]	Turkey	Randomized, double-blind, placebo-controlled study	N = 223, primiparas and multiparas	N = 122 (placebo)	Infusion of TXA 10 min before CS	10 mg/kg IV for 5 min	Postpartum blood loss not clearly specified	272 mL vs 347 mL	0.001	No thromboembolic or gastrointestinal side effects
Shahid A et al., 2013 [37]	Pakistan	Randomized double-blind placebo controlled study	N = 74 primiparas and multiparas	N = 38 (experimental)	Infusion of TXA 10 min before CS	1 g IV for 10 min	Postpartum blood loss not clearly specified	356 mL vs 710 mL	<0.001	No thromboembolic side effects
Shahid A et al., 2013 [37]	Pakistan	Randomized double-blind placebo controlled study	N = 74 primiparas and multiparas	N = 36 (placebo)	Infusion of TXA 10 min before CS	1 g IV for 10 min	Postpartum blood loss not clearly specified	356 mL vs 710 mL	<0.001	No thromboembolic side effects
Abdel-Aleem et al., 2013 [38]	Egypt	Randomized, single center, open, controlled study	N = 740 primiparas and multiparas	N = 373 (experimental)	Infusion of TXA 10 min before CS	1 g IV for 10 min	Blood loss two hours after delivery	241.6 mL vs 510.6 mL	<0.001	Gastrointestinal side effects (74.3 % versus 53.1 %; P = 0.0001)
				N = 367 (no placebo)
				N = 367 (no placebo)						No thromboembolic side effects
Goswami et al., 2013 [39]	India	Randomized, single center, double-blinded placebo controlled study	N = 90 primiparas and multiparas	N = 30 (experimental 1)	Infusion of TXA 20 min before CS	Experimental 1: 10 mg/kg	Postpartum blood loss, not clearly specified	376.8 mL vs 261.2 mL vs 527.2 mL	Not reported	No thromboembolic side effects
				N = 30 (experimental 2)		Experimental 1: 10 mg/kg
				N = 30 (experimental 2)		Experimental 2: 15 mg/kg
				N = 30 (placebo)		Experimental 2: 15 mg/kg

TXA Tranexamic acid, IV intravenous

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