Haematological and fibrinolytic status of Nigerian women with post-partum haemorrhage.

BACKGROUND: Early treatment with tranexamic acid reduces deaths due to bleeding after post-partum haemorrhage. We report the prevalence of haematological, coagulation and fibrinolytic abnormalities in Nigerian women with postpartum haemorrhage. METHODS: We performed a secondary analysis of the WOMAN trial to assess laboratory data and rotational thromboelastometry (ROTEM) parameters in 167 women with postpartum haemorrhage treated at University College Hospital, Ibadan, Nigeria. We defined hyper-fibrinolysis as EXTEM maximum lysis (ML) > 15% on ROTEM. We defined coagulopathy as EXTEM clot amplitude at 5 min (A5) < 40 mm or prothrombin ratio > 1.5. RESULTS: Among the study cohort, 53 (40%) women had severe anaemia (haemoglobin< 70 g/L) and 17 (13%) women had severe thrombocytopenia (platelet count < 50 × 109/L). Thirty-five women (23%) had ROTEM evidence of hyper-fibrinolysis. Based on prothrombin ratio criteria, 16 (12%) had coagulopathy. Based on EXTEM A5 criteria, 49 (34%) had coagulopathy. CONCLUSION: Our findings suggest that, based on a convenience sample of women from a large teaching hospital in Nigeria, hyper-fibrinolysis may commonly occur in postpartum haemorrhage. Further mechanistic studies are needed to examine hyper-fibrinolysis associated with postpartum haemorrhage. Findings from such studies may optimize treatment approaches for postpartum haemorrhage. TRIAL REGISTRATION: The Woman trial was registered: NCT00872469; ISRCTN76912190 (Registration date: 22/03/2012).

Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial.

Background: Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial) is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants. Methods. Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo.  Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM). Secondary outcomes are international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria. Discussion:  This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding. Trial registration: The trial was registered: ClinicalTrials.gov, Identifier NCT00872469 https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier ISRCTN76912190 http://www.isrctn.com/ISRCTN76912190 (Registration date: 22/03/2012).

Microalbuminuria in pregnancy as a predictor of preeclampsia and eclampsia.

INTRODUCTION: Hypertensive disorders of pregnancy are common major complications of pregnancy and are responsible for significant morbidity and mortality in the fetus, the newborn infant and the mother. OBJECTIVES: To access if a single estimation of urinary microalbumin at booking would be of value in the prediction of subsequent development of preeclampsia or eclampsia METHODS: We studied at booking urinary microalbumin excretion in one hundred healthy normotensive Nigerian pregnant women attending the antenatal clinic and followed them till delivery. The women were grouped into 3 i.e. those with normal, micro and macro albumin excretion during analysis. RESULTS: Ninety-three of these patients delivered at UCII, 2 had spontaneous abortions and five delivered elsewhere. At booking, 57 patients (61.3%) had normal albumin excretion and 22 (23.7%) and 14(15%) had microalbuminuria and gross albuminuria respectively. The men urinary albumin excretions for the normal, micro and gross albuminuria groups were 10.2 +/- 8.4, 67.0 +/- 55.2 and 321.4 +/- 14.0 mg/24 hours respectively. There was increased incidence of preeclampsia with an increase in albumin excretion and this was statistically significant (P value < 0.05). No patient developed eclampsia. With single urinary microalbumin excretion estimation at booking, the sensitivity, specificity, positive and negative predictive values of albuminuria were 88.9%, 67.9%, 22.2% and 98.3% respectively. CONCLUSION: Urinary microalbumin excretion when used as a single test at booking appeared to predict preeclampsia with a high sensitivity but a low positive predictive value.