Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial.

Background: Postpartum haemorrhage (PPH) is a leading cause of maternal death. The WOMAN trial showed that tranexamic acid (TXA) reduces death due to bleeding in women with PPH. We evaluated the effect of TXA on fibrinolysis and coagulation in a sample of WOMAN trial participants. Methods: Adult women with a clinical diagnosis of PPH were randomised to receive 1 g TXA or matching placebo in the WOMAN trial. Participants in the WOMAN trial at University College Hospital (Ibadan, Nigeria) also had venous blood taken just before administration of the first dose of trial treatment and again 30 (±15) min after the first dose (the ETAC study).  We aimed to determine the effects of TXA on fibrinolysis (D-dimer and rotational thromboelastometry maximum clot lysis (ML)) and coagulation (international normalized ratio and clot amplitude at 5 min). We compared outcomes in women receiving TXA and placebo using linear regression, adjusting for baseline measurements. Results: Women (n=167) were randomised to receive TXA (n=83) or matching placebo (n=84). Due to missing data, seven women were excluded from analysis. The mean (SD) D-dimer concentration was 7.1 (7.0) mg/l in TXA-treated women and 9.6 (8.6) mg/l in placebo-treated women (p=0.09). After adjusting for baseline, the D-dimer concentration was 2.16 mg/l lower in TXA-treated women (-2.16, 95% CI -4.31 to 0.00, p=0.05). There was no significant difference in ML between TXA- and placebo-treated women (12.3% (18.4) and 10.7% (12.6), respectively; p=0.52) and no significant difference after adjusting for baseline ML (1.02, 95% CI -3.72 to 5.77, p=0.67).  There were no significant effects of TXA on any other parameters. Conclusion: TXA treatment was associated with reduced D-dimer levels but had no apparent effects on thromboelastometry parameters or coagulation tests. Registration: ISRCTN76912190 (initially registered 10/12/2008, WOMAN-ETAC included on 22/03/2012) and NCT00872469 (initially registered 31/03/2009, WOMAN-ETAC included on 22/03/2012).

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).

Predictors of quality of life in patients with diabetes mellitus in two tertiary health institutions in Ghana and Nigeria.

BACKGROUND: Patients with chronic diseases such as Type 2 diabetes mellitus (DM) usually have a relatively poor quality of life (QoL), because the cost of care (living expenses and health) or diet restrictions are heavily felt by these patients, and this is of a public health concern. However, limited data on DM QoL exist in Ghana and Nigeria. This makes it imperative for data to be collated in that regard. MATERIALS AND METHODS: We adopted the Strengthening The reporting of observational studies in epidemiology (STROBE) consensus checklist to survey the patients with DM seen at the diabetic clinic at the Department of Medicine of the Korle-Bu Teaching Hospital and University College Hospital, Ibadan, Nigeria. Patients with Type 2 DM aged 40 years and older were recruited by using systematic random sampling method. The World Health Organization Quality of Life-BREF, diabetes empowerment scale, and DM knowledge scale were used to assess QoL, patient empowerment, and knowledge of DM, respectively. The predictors of QoL were determined using multiple linear regression analyses. RESULTS: A total of 198 patients in Ghana and 203 patients in Nigeria completed the survey, with female-to-male ratio being 3:1 and 2:1, respectively. The overall QoL in both countries was relatively low: 56.19 ± 8.23 in Ghana and 64.34 ± 7.34 in Nigeria. In Ghana, significant correlates of higher scores on the QoL scale were medication adherence (P = 0.02) and employment status (P = 0.02). Among patients in Nigeria, employment status (P = 0.02) and DM empowerment (0.03) were significant predictors of QoL in patients with DM. CONCLUSION: Our study revealed an association between a number of psychosocial factors and QoL among patients with DM in Ghana and Nigeria.

Understanding the Influence of Socioeconomic Environment on Paediatric Antiretroviral Treatment Coverage: Towards Closing Treatment Gaps in Sub-Saharan Africa.

OBJECTIVE: Many sub-Saharan African countries have massively scaled-up their antiretroviral treatment (ART) programmes, but many national programmes still show large gaps in paediatric ART coverage making it challenging to reduce AIDS-related deaths among HIV-infected children. We sought to identify enablers of paediatric ART coverage in Africa by examining the relationship between paediatric ART coverage and socioeconomic parameters measured at the population level so as to accelerate reaching the 90-90-90 targets. METHODS: Ecological analyses of paediatric ART coverage and socioeconomic indicators were performed. The data were obtained from the United Nations agencies and Forum for a new World Governance reports for the 21 Global Plan priority countries in Africa with highest burden of mother-to-child HIV transmission. Spearman's correlation and median regression were utilized to explore possible enablers of paediatric ART coverage. RESULTS: Factors associated with paediatric ART coverage included adult literacy (r=0.6, p=0.004), effective governance (r=0.6, p=0.003), virology testing by 2 months of age (r=0.9, p=0.001), density of healthcare workers per 10,000 population (r=0.6, p=0.007), and government expenditure on health (r=0.5, p=0.046). The paediatric ART coverage had a significant inverse relationship with the national mother-to-child transmission (MTCT) rate (r=-0.9, p<0.001) and gender inequality index (r=-0.6, p=0.006). Paediatric ART coverage had no relationship with poverty and HIV stigma indices. CONCLUSIONS: Low paediatric ART coverage continues to hamper progress towards eliminating AIDS-related deaths in HIV-infected children. Achieving this requires full commitment to a broad range of socioeconomic development goals.

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).

Urinary pathogens and drug susceptibility patterns of urinary tract infections among antenatal clinic attendees in Ibadan, Nigeria.

AIM: To determine the bacterial agents involved in urinary tract infections in pregnant women and their antibiotic susceptibility patterns in Ibadan, Nigeria. METHODS: All consenting subjects who attended antenatal clinics of the University College Hospital and Adeoyo Maternity Hospital, Ibadan, Nigeria, from 1 April 2007 and 30 March 2009 were interviewed to obtain demographic and pregnancy health data. Mid-stream urine samples obtained were processed by standard methods. Confirmed bacterial isolates were tested against seven antibiotics using the Kirby-Bauer disc diffusion technique. RESULTS: Of the 473 specimens processed, 136 (28.8%) were positive for microscopy, 118 (25.0%) were culture positive, while 18 (3.8%) were microscopy positive but negative for culture. More than 90% of the bacterial isolates were Gram-negative bacilli, of which approximately 80% were members of the family Enterobacteriaceae. Klebsiella oxytoca accounted for 45 (38.1%) of the causative agents identified, followed by Escherichia coli (31.3%), Pseudomonas aeruginosa (9.3%) and Proteus mirabilis (6.8%). Candida albicans accounted for three (2.6%) of the isolates. Ten isolates (22.2%) of K. oxytoca were resistant to cefuroxime while three (6.7%) were resistant to ofloxacin. The only Gram-positive bacterium isolated, Staphylococcus saprophyticus, accounted for four (4.3%) of all pathogens, of which three (75.0%) were susceptible to nitrofurantoin, ofloxacin, cefuroxime and the amoxicillin-clavulanic acid combination. CONCLUSIONS: In conclusion, the incidence of culture-positive urinary tract infection in pregnancy is common in Ibadan. More studies are needed to evaluate the susceptibility profile of uropathogens to commonly used antibiotics in our environment.

Outcome of adolescent pregnancies in southwestern Nigeria: a case-control study.

BACKGROUND: The most important health problems among adolescents in the developing countries are increased incidence of preterm labour and delivery, hypertensive disease, anaemia, more severe forms of malaria, obstructed labour, poor maternal nutrition and poor breastfeeding, low birth weight and increased neonatal mortality and morbidity. OBJECTIVES: To evaluate the risk factors of adolescent pregnancy, assess and explore the occurrence of specific complications and compare pregnancy complications among adolescent parturients to older controls in a tertiary health centre in order to design appropriate policies and interventions. METHOD: A retrospective study was conducted in a population of adolescents (age <18 years) delivered at the University College Hospital, Ibadan, Nigeria from January 2007 to November 2008. The birth register for the study-period was reviewed and socio-demographic data and labour records were extracted for both cases and controls. RESULTS: The proportion of adolescent pregnancy between January 2007 and November, 2008 is between 1.5% and 2.2%. Overall, considering all the complications considered in the study 44.44% of adolescent pregnancies had one form of complication or the other. The corresponding figure among the control was 22.22%. The p-value = 0.002 showing that adolescents had statistically more significant complication rates in pregnancy. Concerning the individual complications, the incidence of eclampsia and pre-eclampsia among adolescent was 20% which was only 3.33% among the controls. The p-value when this was compared was 0.001 showing statistical significance. CONCLUSION: Psychological, nutritional and social work services should be an integral part of obstetrical care in adolescent pregnancy especially in low resource country like Nigeria.

Contraceptive knowledge and practice: a survey of under graduates in Ibadan, Nigeria.

UNLABELLED: Despite the mounting reproductive health problems among adolescents in Nigeria, very little has been done at governmental level to address the problem, hence presenting a major health concern and a leading cause of morbidity and mortality. OBJECTIVE: To determine the knowledge, attitude of the undergraduates to contraception and their practice of the various contraceptive options. METHODS: A descriptive cross-sectional study was done among the undergraduates of the Polytechnic of Ibadan and University of Ibadan, Nigeria. Interviewer-administered questionnaires were given to 600 consenting undergraduates. The data were analyzed using SPSS version 11 software. Chi2 and Fisher exact tests were used for categorical variables as appropriate. RESULTS: A large percent (65.1%) of the undergraduates were sexually experienced. Approximately, 90.2% of the respondents who had sex did so before the age of 19 years, 31.8% had more than one sexual partner, and 21.8% had clandestine abortions. All respondents were quite knowledgeable about HIV/AIDS but few (30.2%) of the sexually active took precautions to prevent HIV transmission. The majority (65.4%) were not knowledgeable about contraception, and 10.5% heard about contraception from parents. About 52.3% of the latter cited pharmacy shops as their source of contraceptives. CONCLUSION: The attitudes of the students were below expectations. Specially designated centers for the provision of appropriate contraceptive services to students by trained personnel are needed in the institutions to tackle their reproductive health problems.

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.