دورية أكاديمية
Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial.
| العنوان: | Prophylactic tranexamic acid for reducing intraoperative blood loss during cesarean section in women at high risk of postpartum hemorrhage: A double-blind placebo randomized controlled trial. |
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| المؤلفون: | Ortuanya KE; Department of Obstetrics & Gynaecology, Enugu State University of Science and Technology Teaching Hospital Parklane, Enugu, Nigeria., Eleje GU; Department of Obstetrics & Gynaecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria., Ezugwu FO; Department of Obstetrics & Gynaecology, Enugu State University of Science and Technology Teaching Hospital Parklane, Enugu, Nigeria., Odugu BU; Department of Obstetrics & Gynaecology, Enugu State University of Science and Technology Teaching Hospital Parklane, Enugu, Nigeria., Ikechebelu JI; Department of Obstetrics & Gynaecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria., Ugwu EO; Department of Obstetrics and Gynaecology, College of Medicine, University of Nigeria Teaching Hospital, Enugu, Nigeria., Eke AC; Division of Maternal-Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Awkadigwe FI; Department of Obstetrics & Gynaecology, Enugu State University of Science and Technology Teaching Hospital Parklane, Enugu, Nigeria., Ezenwaeze MN; Department of Obstetrics & Gynaecology, Enugu State University of Science and Technology Teaching Hospital Parklane, Enugu, Nigeria., Ofor IJ; Department of Obstetrics & Gynaecology, Enugu State University of Science and Technology Teaching Hospital Parklane, Enugu, Nigeria., Okafor CC; Department of Psychiatry, Leicestershire Partnership NHS Trust, Leicester, UK., Okafor CG; Department of Obstetrics & Gynaecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria. |
| المصدر: | Women's health (London, England) [Womens Health (Lond)] 2024 Jan-Dec; Vol. 20, pp. 17455057231225311. |
| نوع المنشور: | Randomized Controlled Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: SAGE Publishing Country of Publication: United States NLM ID: 101271249 Publication Model: Print Cited Medium: Internet ISSN: 1745-5065 (Electronic) Linking ISSN: 17455057 NLM ISO Abbreviation: Womens Health (Lond) Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: July 2016- : Thousand Oaks, CA : SAGE Publishing Original Publication: London, UK : Future Medicine Ltd. |
| مواضيع طبية MeSH: | Postpartum Hemorrhage*/prevention & control , Postpartum Hemorrhage*/drug therapy , Postpartum Hemorrhage*/etiology , Tranexamic Acid*/therapeutic use , Antifibrinolytic Agents*/therapeutic use, Infant, Newborn ; Female ; Pregnancy ; Humans ; Cesarean Section/adverse effects ; Blood Loss, Surgical/prevention & control ; Nigeria ; Double-Blind Method ; Hemoglobins |
| مستخلص: | Background: Postpartum hemorrhage remains a leading cause of maternal mortality especially in developing countries. The majority of previous trials on the effectiveness of tranexamic acid in reducing blood loss were performed in low-risk women for postpartum hemorrhage. A recent Cochrane Systematic Review recommended that further research was needed to determine the effects of prophylactic tranexamic acid for preventing intraoperative blood loss in women at high risk of postpartum hemorrhage. Objective: This study aimed to evaluate the effectiveness and safety of tranexamic acid in reducing intraoperative blood loss when given prior to cesarean delivery in women at high risk of postpartum hemorrhage. Study Design: The study is a double-blind randomized controlled trial. Methods: The study consisted of 200 term pregnant women and high-risk preterm pregnancies scheduled for lower-segment cesarean delivery at Enugu State University of Science and Technology, Teaching Hospital, Parklane, Enugu, Nigeria. The participants were randomized into two arms (intravenous 1 g of tranexamic acid or placebo) in a ratio of 1:1. The participants received either 1 g of tranexamic acid or placebo (20 mL of normal saline) intravenously at least 10 min prior to commencement of the surgery. The primary outcome measures were the mean intraoperative blood loss and hematocrit change 48 h postoperatively. Results: The baseline sociodemographic characteristics were similar in both groups. The tranexamic acid group when compared to the placebo group showed significantly lower mean blood loss (442.94 ± 200.97 versus 801.28 ± 258.68 mL; p = 0.001), higher mean postoperative hemoglobin (10.39 + 0.96 versus 9.67 ± 0.86 g/dL; p = 0.001), lower incidence of postpartum hemorrhage (1.0% versus 19.0%; p = 0.001), and lower need for use of additional uterotonic agents after routine management of the third stage of labor (39.0% versus 68.0%; p = 0.001), respectively. However, there was no significant difference in the mean preoperative hemoglobin (11.24 ± 0.88 versus 11.15 ± 0.90 g/dL; p = 0.457), need for other surgical intervention for postpartum hemorrhage (p > 0.05), and reported side effect, respectively, between the two groups. Conclusion: Prophylactic administration of tranexamic acid significantly decreases postpartum blood loss, improves postpartum hemoglobin, decreases the need for additional uterotonics, and prevents postpartum hemorrhage following cesarean section in pregnant women at high risk of postpartum hemorrhage. Its routine use during cesarean section in high-risk women may be encouraged.The trial was registered in the Pan-African Clinical Trial Registry with approval number PACTR202107872851363 . |
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| فهرسة مساهمة: | Keywords: blood loss; cesarean section; high risk; postpartum hemorrhage; prophylaxis; tranexamic acid |
| المشرفين على المادة: | 6T84R30KC1 (Tranexamic Acid) 0 (Antifibrinolytic Agents) 0 (Hemoglobins) |
| تواريخ الأحداث: | Date Created: 20240127 Date Completed: 20240129 Latest Revision: 20240606 |
| رمز التحديث: | 20240606 |
| مُعرف محوري في PubMed: | PMC10822094 |
| DOI: | 10.1177/17455057231225311 |
| PMID: | 38279808 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1745-5065 |
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| DOI: | 10.1177/17455057231225311 |