Multisite management study of menorrhagia with abnormal laboratory haemostasis: a prospective crossover study of intranasal desmopressin and oral tranexamic acid

Abstract

Summary The optimal management of menorrhagia among women with abnormal laboratory haemostasis is uncertain. In a crossover study, 116 women with menorrhagia [pictorial blood assessment chart (PBAC) score >100], negative gynaecological evaluation and abnormal laboratory haemostasis were randomly assigned to either intranasal desmopressin (IN‐DDAVP) or tranexamic acid (TA) therapy for two menstrual cycles. The subjects then crossed over to the second study drug for two additional cycles. Menstrual blood loss (MBL) was measured by PBAC scores at baseline and after each menstrual cycle. Quality of life (QOL) was assessed with four validated instruments. There was a statistically significant decrease in PBAC scores for both treatments. On average, the estimated decrease in the PBAC from baseline was −64·1 [95% confidence interval (CI) = −88·0, −40·3] for IN‐DDAVP and −105·7 (95% CI = −130·5, −81·0) for TA. The decrease in PBAC score was greater for TA than IN‐DDAVP (a difference of 41·6, P‐value = 0·0002, 95% CI = 19·6, 63·6). The test for treatment‐type effect was significant (P < 0·0001) suggesting a greater reduction in PBAC score with TA. Use of both IN‐DDAVP and TA improved QOL by all four instruments. We conclude that both medications reduced MBL and improved QOL among females with menorrhagia and abnormal laboratory haemostasis, but TA proved more effective.

A comparative study of tranexamic acid and ethamsylate in menorrhagia

“…Previous studies had suggested that tranexamic acid improves health-related quality of life in women with heavy menstrual bleeding. [13][14][15][16] In women with menorrhagia, tranexamic acid appears to stabilize the deposition of endometrial vascular wall fibrin that occurs with menstruation, 17 but is unlikely to increase thrombosis. Thrombosis has not been observed in men or women receiving tranexamic acid for the management of bleeding secondary to cardiac or oral surgery, acute upper gastrointestinal bleeding, or ocular trauma, 17 and the use of tranexamic acid is not associated with an increased risk or incidence of thromboembolic events compared with the background rate of thrombotic events in women of childbearing age.…”

Evaluation of a screening tool for bleeding disorders in a US multisite cohort of women with menorrhagia

“…This study was performed as a substudy of a US multisite menorrhagia management study. 9 The study was approved by the institutional review boards of the respective centers and the Centers for Disease Control and Prevention. The study was explained to eligible women, and informed consent was obtained.…”

“…Additionally, platelet aggregation was measured using ristocetin, and adenosine triphosphate release was measured with thrombin (Chrono-Log Corp) as previously described. 5,9 A complete blood cell count and serum ferritin test were also performed on blood samples from all study participants.…”

“…Platelet aggregation with adenosine triphosphate release and platelet function analyzer (PFA)-100 closure times were performed at each site with uniform instrumentation, methods, and agonist concentrations. 9 PFA-100 closure times were determined with the collagen/epinephrine and collagen/adenosine diphosphate cartridges (Dade-Behring, Deerfield, IL). Platelet aggregation and adenosine triphosphate release was assessed in platelet-rich plasma in a lumiaggregometer with collagen, adenosine diphosphate, arachidonic acid, and epinephrine (Chrono-Log Corp, Havertown, PA).…”

“…This study was performed as a substudy of a US multisite menorrhagia management study. 9 The study was approved by the Philipp et alPage 2 Am J Obstet Gynecol. Author manuscript; available in PMC 2015 October 08.…”