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Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth.
Widmer, Mariana; Piaggio, Gilda; Nguyen, Thi M H; Osoti, Alfred; Owa, Olorunfemi O; Misra, Sujata; Coomarasamy, Arri; Abdel-Aleem, Hany; Mallapur, Ashalata A; Qureshi, Zahida; Lumbiganon, Pisake; Patel, Archana B; Carroli, Guillermo; Fawole, Bukola; Goudar, Shivaprasad S; Pujar, Yeshita V; Neilson, James; Hofmeyr, G Justus; Su, Lin L; Ferreira de Carvalho, Jose; Pandey, Uma; Mugerwa, Kidza; Shiragur, Shobha S; Byamugisha, Josaphat; Giordano, Daniel; Gülmezoglu, A Metin.
Afiliação
  • Widmer M; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Piaggio G; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Nguyen TMH; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Osoti A; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Owa OO; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Misra S; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Coomarasamy A; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Abdel-Aleem H; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Mallapur AA; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Qureshi Z; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Lumbiganon P; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Patel AB; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Carroli G; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Fawole B; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Goudar SS; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Pujar YV; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Neilson J; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Hofmeyr GJ; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Su LL; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Ferreira de Carvalho J; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Pandey U; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Mugerwa K; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Shiragur SS; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Byamugisha J; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Giordano D; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
  • Gülmezoglu AM; From the Department of Reproductive Health and Research, World Health Organization (WHO), United Nations Development Program-United Nations Population Fund-UNICEF-WHO-World Bank Special Program of Research, Development, and Research Training in Human Reproduction, Geneva (M.W., T.M.H.N., A.M.G.); St
N Engl J Med ; 379(8): 743-752, 2018 Aug 23.
Article em En | MEDLINE | ID: mdl-29949473
ABSTRACT

BACKGROUND:

Postpartum hemorrhage is the most common cause of maternal death. Oxytocin is the standard therapy for the prevention of postpartum hemorrhage, but it requires cold storage, which is not available in many countries. In a large trial, we compared a novel formulation of heat-stable carbetocin with oxytocin.

METHODS:

We enrolled women across 23 sites in 10 countries in a randomized, double-blind, noninferiority trial comparing intramuscular injections of heat-stable carbetocin (at a dose of 100 µg) with oxytocin (at a dose of 10 IU) administered immediately after vaginal birth. Both drugs were kept in cold storage (2 to 8°C) to maintain double-blinding. There were two primary

outcomes:

the proportion of women with blood loss of at least 500 ml or the use of additional uterotonic agents, and the proportion of women with blood loss of at least 1000 ml. The noninferiority margins for the relative risks of these outcomes were 1.16 and 1.23, respectively.

RESULTS:

A total of 29,645 women underwent randomization. The frequency of blood loss of at least 500 ml or the use of additional uterotonic agents was 14.5% in the carbetocin group and 14.4% in the oxytocin group (relative risk, 1.01; 95% confidence interval [CI], 0.95 to 1.06), a finding that was consistent with noninferiority. The frequency of blood loss of at least 1000 ml was 1.51% in the carbetocin group and 1.45% in the oxytocin group (relative risk, 1.04; 95% CI, 0.87 to 1.25), with the confidence interval crossing the margin of noninferiority. The use of additional uterotonic agents, interventions to stop bleeding, and adverse effects did not differ significantly between the two groups.

CONCLUSIONS:

Heat-stable carbetocin was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents. Noninferiority was not shown for the outcome of blood loss of at least 1000 ml; low event rates for this outcome reduced the power of the trial. (Funded by Merck Sharpe & Dohme; CHAMPION Australian New Zealand Clinical Trials Registry number, ACTRN12614000870651 ; EudraCT number, 2014-004445-26 ; and Clinical Trials Registry-India number, CTRI/2016/05/006969 .).
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Contexto em Saúde: 2_ODS3 / 5_ODS3_mortalidade_materna / 6_ODS3_enfermedades_notrasmisibles Problema de saúde: 2_mortalidade_materna / 5_Complications_during_labor_delivery / 5_haemorrhage / 6_other_malignant_neoplasms Assunto principal: Ocitócicos / Ocitocina / Hemorragia Pós-Parto Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Limite: Adult / Female / Humans / Pregnancy Idioma: En Revista: N Engl J Med Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Contexto em Saúde: 2_ODS3 / 5_ODS3_mortalidade_materna / 6_ODS3_enfermedades_notrasmisibles Problema de saúde: 2_mortalidade_materna / 5_Complications_during_labor_delivery / 5_haemorrhage / 6_other_malignant_neoplasms Assunto principal: Ocitócicos / Ocitocina / Hemorragia Pós-Parto Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Limite: Adult / Female / Humans / Pregnancy Idioma: En Revista: N Engl J Med Ano de publicação: 2018 Tipo de documento: Article
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