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Tytuł:
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Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania.
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Autorzy:
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Ammerdorffer A; Concept Foundation, Geneva, Switzerland.
Rushwan S; Concept Foundation, Geneva, Switzerland.
Timms R; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
Wright P; Drug Delivery Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.
Beeson L; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
Devall AJ; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
Mammoliti KM; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
Alwy Al-Beity FM; Department of Obstetrics and Gynecology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Galadanci H; Africa Center of Excellence for Population Health and Policy, Bayero University, Kano, Kano, Nigeria.
Hofmeyr GJ; Department of Obstetrics and Gynecology, University of Botswana, Gaborone, Botswana.; University of the Witwatersrand, Johannesburg, South Africa.; Walter Sisulu University, South Africa.
Singata-Madliki M; Effective Care Research Unit, Department of Obstetrics and Gynaecology, Universities of the Witwatersrand, East London, South Africa.
Qureshi Z; Department of Obstetrics and Gynecology, School of Medicine, University of Nairobi, Kenyatta National Hospital Campus, Nairobi, Kenya.
Lambert P; Drug Delivery Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.
Gallos ID; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
Coomarasamy A; Institute of Metabolism and Systems Research (IMSR), WHO Collaborating Centre for Global Women's Health, University of Birmingham, Birmingham, UK.
Gülmezoglu AM; Concept Foundation, Geneva, Switzerland.
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Źródło:
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International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics [Int J Gynaecol Obstet] 2022 Jun; Vol. 158 Suppl 1, pp. 46-55.
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Typ publikacji:
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Journal Article
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Język:
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English
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Imprint Name(s):
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Publication: 2017- : Malden, MA : Wiley
Original Publication: [New York, NY] Hoeber Medical Division, Harper & Row, [c1969-
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MeSH Terms:
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Postpartum Hemorrhage*/drug therapy
Postpartum Hemorrhage*/prevention & control
Tranexamic Acid*/therapeutic use
Female ; Humans ; Kenya ; Nigeria ; Oxytocin/therapeutic use ; Pregnancy ; South Africa ; Tanzania
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References:
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Int J Gynaecol Obstet. 2022 Jun;158 Suppl 1:46-55. (PMID: 35762808)
J Glob Health. 2018 Dec;8(2):020415. (PMID: 30202518)
Trials. 2010 Apr 16;11:40. (PMID: 20398351)
PLoS One. 2018 Sep 25;13(9):e0203810. (PMID: 30252860)
BJOG. 2016 Dec;123(13):2076-2086. (PMID: 27006180)
Lancet Glob Health. 2014 Jun;2(6):e323-33. (PMID: 25103301)
Lancet. 2017 May 27;389(10084):2105-2116. (PMID: 28456509)
BMC Pregnancy Childbirth. 2020 Mar 29;20(1):184. (PMID: 32223759)
Int J Gynaecol Obstet. 2020 Mar;148(3):290-299. (PMID: 31709527)
BMJ Open. 2019 Jul 26;9(7):e029083. (PMID: 31350247)
PLoS One. 2020 Jul 10;15(7):e0236060. (PMID: 32649710)
PLoS One. 2021 Jan 8;16(1):e0245054. (PMID: 33417602)
Reprod Health. 2021 Jul 14;18(1):149. (PMID: 34261508)
BMC Pregnancy Childbirth. 2018 Jan 30;18(1):44. (PMID: 29382306)
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Grant Information:
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MR/T038985/1 United Kingdom MRC_ Medical Research Council; United States GATES Bill & Melinda Gates Foundation
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Contributed Indexing:
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Keywords: Kenya; Nigeria; South Africa; Tanzania; oxytocin; postpartum hemorrhage; quality assessment; tranexamic acid
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Substance Nomenclature:
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50-56-6 (Oxytocin)
6T84R30KC1 (Tranexamic Acid)
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Entry Date(s):
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Date Created: 20220628 Date Completed: 20220630 Latest Revision: 20230315
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Update Code:
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20240105
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PubMed Central ID:
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PMC9543376
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DOI:
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10.1002/ijgo.14197
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PMID:
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35762808
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Objective: To check the quality of oxytocin and tranexamic acid-two recommended products for prevention and treatment of postpartum hemorrhage (PPH)-used in facilities taking part in an implementation research project to improve PPH diagnosis and management.
Methods: Between September 2020 and August 2021, oxytocin and tranexamic acid products used in the study facilities in Kenya, Nigeria, South Africa, and Tanzania were collected and transported in cold storage for analysis. Samples were analyzed according to the International (oxytocin) and British Pharmacopeia (tranexamic acid) standards.
Results: Of the 17 unique oxytocin products, 33 individual measurements were made. Only six unique products had adequate content and no related substances exceeding the recommended limits. Of 14 tranexamic acid samples, 10 showed adequate content. One product in Kenya and two products in Nigeria from different manufacturers had a high content of related substances, which classified them as substandard.
Conclusion: While we were unable to investigate the origin regarding poor manufacturing or poor storage or both, the high number of substandard oxytocin samples is of great concern. Most of the tranexamic acid samples had adequate content but the presence of impurities in multiple products is worrying and requires further study.
(© 2022 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)
