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)

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)  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): 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)

Patient characteristics associated with COVID-19 positivity and fatality in Nigeria: retrospective cohort study

Objective: Despite the increasing disease burden, there is a dearth of context-specific evidence on the risk factors for COVID-19 positivity and subsequent death in Nigeria. Thus, the study objective was to identify context-specific factors associated with testing positive for COVID-19 and fatality in Nigeria. Design Retrospective cohort study. Setting: COVID-19 surveillance and laboratory centres in 36 states and the Federal Capital Territory reporting data to the Nigeria Centre for Disease Control. Participants: Individuals who were investigated for SARSCoV-2 using real-time PCR testing during the study period 27 February–8 June 2020. Methods: COVID-19 positivity and subsequent mortality. Multivariable logistic regression analyses were performed to identify factors independently associated with both outcome variables, and findings are presented as adjusted ORs (aORs) and 95% CIs. Results: A total of 36 496 patients were tested for COVID-19, with 10 517 confirmed cases. Of 3215 confirmed cases with available clinical outcomes, 295 died. Factors independently associated with COVID-19 positivity were older age (p value for trend<0.0001), male sex (aOR 1.11, 95%CI 1.04 to 1.18) and the following presenting symptoms: cough (aOR 1.23, 95% CI 1.13 to 1.32), fever (aOR 1.45, 95% CI 1.45 to 1.71), loss of smell (aOR 7.78, 95% CI 5.19 to 11.66) and loss of taste (aOR 2.50, 95% CI 1.60 to 3.90). An increased risk of mortality following COVID-19 was observed in those aged ≥51 years, patients in farming occupation (aOR 7.56, 95% CI 1.70 to 33.53) and those presenting with cough (aOR 2.06, 95% CI 1.41 to 3.01), breathing difficulties (aOR 5.68, 95% CI 3.77 to 8.58) and vomiting (aOR 2.54, 95% CI 1.33 to 4.84). Conclusion: The significant risk factors associated with COVID-19 positivity and subsequent mortality in the Nigerian population are similar to those reported in studies from other countries and should guide clinical decisions for COVID-19 testing and specialist care referrals

Factors Influencing the Knowledge and Practice of Emergency Contraception among Nigerian Male Undergraduates

Background: Unwanted pregnancies among young women is a growing&nbsp; reproductive health concern. Correct and consistent use of contraception will stop this ugly trend while emergency contraception (EC) can also be viewed as a 'second chance method' in preventing unwanted pregnancies and unsafe abortions. The aim of this study is to assess the knowledge and practice of emergency contraception among Nigerian male undergraduates as they are known to have risky sexual behaviours.Methodology: This was a cross sectional study involving three hundred and thirty male undergraduates from three Tertiary institutions in Ibadan. A Multi-staged random sampling technique was used to recruit participants.Results: Knowledge about EC was poor among majority (74.5%) of male undergraduates. About 55.2% of the participants were sexually active and out of which 33.9% are currently using EC. The commonly (67.5%) used EC by their partners was levonorgestrel only pill (Postinor). Participants with higher levels of education, awareness of EC, previous use or having a partner who had previouslyused EC, participants who had sex within the past 6 months and those who were willing to recommend EC to others had a better knowledge of EC, which were all statistically significant.Conclusion: Providing accurate information to improve knowledge of EC among young men could lead to an increase in the uptake of EC

Breast examination as a cost-effective screening tool in a clinical practice setting in Ibadan, Nigeria

Background: Breast cancer is a disease of public health importance. It results in high morbidity and mortality in women worldwide. The high morbidity and mortality from breast cancer can be decreased by measures targeted at early detection such as screening. Breast examination as a screening tool for breast cancer in developing countries is advocated in view of its costeffectiveness. Method: The article selection method was obtained from primary and secondary literature sources which included original research articles, case control studies, review articles, proceedings, transactions and textbooks. The authors cited a clinical audit and articles published between 1988 and 2011. The search strategy included the use of internet search engines. This review was part of a larger research and the study protocol was approved by the University of Ibadan/University College Hospital, Ibadan Institutional Review Board (UI/UCH IRB). Clinical trial registration number-NHREC/05/01/2008a. Results: Breast self-examination (BSE) and clinical breast examination (CBE) as screening tools for breast cancer were analysed in detail. Conclusion: Breast examination is a screening tool that is cost-effective and reliable and should be encouraged in resource-constrained countries. Given the high cost and expertise required for mammography, current efforts at screening for breast cancer in developing countries should rely more on a combination of BSE and CBE

Determinants of cervical cancer knowledge and the utilisation of screening among a Nigerian female population

Background: Cervical cancer remains a leading cause of death among females in the developing world, with poor prognosis attributed to lack of awareness about the disease and its prevention. Objective: The study was aimed at providing useful information on socio-demographic factors determining the awareness of cervical cancer, pap smear and its utilisation among market women, a unique population of women from diverse socio-cultural backgrounds. Methodology: This cross-sectional descriptive survey was carried out among 483 randomly selected market women at Aleshinloye market in November 2003using a questionnaire probing into basic demographic characteristics, knowledge of cervical cancer and screening with Papanicolaou's smear as well as utilisation of the test. Variations of these parameters with socio-demographic factors were studied. Results: The majority (79.5%) of the women were sexually active, 38.5% had early sexual debut and 33.7% had multiple sexual partners. Only 40.8% were aware of cervical cancer while 19.7% were aware of screening with pap smear. However, only 5.2% had had previous Pap smear. Identified determinants of awareness of cervical cancer and pap smear were age, marital status and level of education while utilisation of the screening test depended on the first two factors. Conclusion: There is need for more intensive awareness campaign among market women and the general population, especially among the identified categories of the women who are less likely to have knowledge of cervical cancer and screening. Keywords: determinants, screening, cervical cancer, Nigeria Tropical Journal of Obstetrics and Gynaecology Vol. 22(1) 2005: 21-2