Obstetrics. & Gynecology

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    Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): a single-centre, randomised, double-blind, placebo-controlled trial
    (The Wellcome Trust, 2018) Shakur-Still, H.; Roberts, I.; Fawole, B.; Kuti, M.; Olayemi, O. O.; Bello, A.; Huque, S.; Ogunbode, O.; Kotila, T.|; Aimakhu, C.; Okunade, O. A.; Olutogun, T.; Adetayo, C. O.; Dallaku, K.; Mansmann, U.; Hunt, B. J.; Pepple, T.; Balogun, E.
    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.
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    Intravenous tranexamic acid for reducing blood loss during caesarean delivery: a randomized, double-blind, placebo-controlled trial
    (2023) Halifa, I. S.; Oluwasola, T. A. O.; Fawole, B.; Oladokun, A.
    Background: Urinary tract infections (UTIs) is a common medical problem that affects all age groups but with significant morbidity in females because of the nature of their anatomy and physiology. This study was aimed to identify the common causative organisms of UTI and their antimicrobial susceptibility pattern among female students in Babcock University. Methods: A cross sectional study, in which 200 female participants with symptoms of UTI were recruited. Mid stream urine was collected from them and processed using the standard microbiological procedures. Antimicrobial susceptibility testing was performed on isolates from the samples with significant bacteriuria. Socio-demographic and risk factors were obtained using standard questionnaires, and statistical analysis was performed using SPSS version 23.0. Results: UTIs were confirmed in 14.5% (29/200) participants. Of the pathogens isolated, Escherichia coli was predominant 30.6% (11/36). Most of the pathogens isolated were susceptible to ofloxacin and gentamicin, while ceftriaxone had the least susceptibility (18.2%). The majority of the participants, 165 (82.5%) though symptomatic, did not have bacteriuria. The participants aged 15–20 years were mostly infected [24 (13.4%)]. No significant association was found between the socio-demographic factors and UTI. Conclusion: The prevalence of UTI from this study was 14.5%. E. coli was the predominant bacteria pathogen isolated, and of loxacin and gentamycin were the most active antibiotics on susceptibility pattern. The majority of the patients though symptomatic, had no pathogens isolated from their urine. Therefore, caution should be applied on the use of antibiotics when managing UTI based on symptoms alone, to prevent antibiotic resistance.
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    Haematological and fibrinolytic status of Nigerian women with post-partum haemorrhage
    (BioMed Central(BMC), 2018) Roberts, I.; Shakur, H.; Fawole, B.; Kuti, M.; Olayemi, O.; Bello, A.; Ogunbode, O.; Kotila, T..; Aimakhu, C. O.; Olutogun, T.; Hunt, B. J.; Huque, S
    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.
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    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
    (Wellcome Trust., 2016) Shakur, H.; Fawole, B.; Kuti, M.; Olayemi, O.; Bello, A.; Ogunbode, O.; Kotila, T.; Aimakhu, S. H.; Gregg, M.; Roberts, I.
    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 oftranexamic 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.
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    Sublingual misoprostol versus standard surgical care for treatment of incomplete abortion in five sub-Saharan African countries
    (BioMed Central (BMC), 2012) Shochet, T.; Diop, A.; Gaye, A.; Nayama, M.; Sall, A. B.; Fawole, B.; Blandie, T.; Okunlola, M. A; Dao, B.; Ogunbode, O. O.; Winkoff, B.
    Background: In low-resource settings, where abortion is highly restricted and self-induced abortions are common, access to post-abortion care (PAC) services, especially treatment of incomplete terminations, is a priority. Standard post-abortion care has involved surgical intervention but can be hard to access in these areas. Misoprostol provides an alternative to surgical intervention that could increase access to abortion care. We sought to gather additional evidence regarding the efficacy of 400 mcg of sublingual misoprostol vs. standard surgical care for treatment of incomplete abortion in the environments where need for economical non-surgical treatments may be most useful. Methods: A total of 860 women received either sublingual misoprostol or standard surgical care for treatment of incomplete abortion in a multi-site randomized trial. Women with confirmed incomplete abortion, defined as past or present history of vaginal bleeding during pregnancy and an open cervical os. were eligible to participate. Participants returned for follow-up one week later to confirm clinical status. If abortion was incomplete at that time, women were offered an additional follow-up visit or immediate surgical evacuation. Results: Both misoprostol and surgical evacuation are highly effective treatments for incomplete abortion (misoprostol: 94.4%, surgical: 100.0%). Misoprostol treatment resulted in a somewhat lower chance of success than standard surgical practice (RR = 0.90; 95% Cl: 0.89-0.92). Both tolerability of side effects and women's satisfaction were similar in the two study arms. Conclusion: Misoprostol, much easier to provide than surgery in low-resource environments, can be used safely, successfully, and satisfactorily for treatment of incomplete abortion. Focus should shift to program implementation, including task-shifting the provision of post-abortion care to mid- and low- level providers, training and assurance of drug availability.