Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section. (SDvMD)
Single Dose Ceftriaxone and Metronidazole Versus Multiple Doses for Antibiotic Prophylaxis at Elective Cesarean Section in Mulago Hospital. A Randomized Clinical Trial.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is going to be an open label randomized controlled clinical trial that will involve 174 mothers delivered by elective cesarean section in Mulago National Referral hospital ward 5B antenatal and post natal wards.
Mulago hospital is at the apex of a 6 tier health system and is the largest public hospital with 31,400 deliveries annually 26.14% by cesarean section and of these 5.6% are elective cesarean sections.
Simple randomization was done where 174 cards were numbered 1-174 {(87 labelled Single Dose (SD) and 87 labelled Multiple Dose (MD)} inserted in an envelop shuffled and then the mother was allowed to pick a card randomly. This was done by the research assistant who reviewed the mother again in theater to ascertain if they still met the eligibility before the intervention was done.
Method This will be an open label single center superiority randomized clinical trial involving 174 eligible participants (87 in each arm) who will have delivered by elective cesarean section in Mulago hospital. They will be randomly allocated into two arms. One arm will receive single dose IV ceftriaxone 2g and metronidazole 500mg 30-60 minutes before the operation and the second arm will receive IV ceftraixone 1g with 500 mg of metronidazole during the operation and continue for 72 hours and discharged with oral antibiotics.
The mothers will be reviewed twice daily for evidence of infection. Their vitals (BP, Pulse, Temperature and respiratory rate), state of the wound and uterus, amount color and smell of the lochia during the first 2-3 post operative days. Both arms will have a 14 day follow up where they will come back for review on the 7th and 14th post operative day.
Objective:
The general objective is to compare the incidence of post operative infections among mothers that receive single dose pre operative Ceftriaxone and metronidazole compared to multiple doses at delivery by elective cesarean section in Mulago National Referral Hospital. at 14 day post operative.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Kampala, Uganda, 00256
- Mulago National Refferal Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Antenatal mothers who have an indication for elective cesarean section in New Mulago hospital.
Exclusion Criteria:
- Mothers who have a history of allergy to any of the drugs in the study, Mother with visible infection at any site or elevated body temperature before going to theatre, Those with rapture of membranes, Mothers who went into labor, Mother who has had use of antibiotics in the last 7 days, WHO Clinical HIV stage III and IV and mothers who do not consent to the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Single dose antibiotic
2g of intra venous Ceftriaxone and 500 mgs Intra venous metronidazole is administered to the mothers as a Single dose pre-operative30-60 minutes before surgery.
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Single dose arm receive 2g of IV Ceftriaxone and 500 mgs ofIntra venous Metronidazole given to the mothers 30-60 minutes pre operative.
Outros nomes:
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Comparador Ativo: multiple dose antibiotic.
Multiple doses of IV Ceftriaxone 1g and metronidazole 500mgs given to the mother during surgery there after Ceftriaxone 1g every day for 3 days and IV metronidazole 500 mgs every 8 hours for 3 days.
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Multiple dose arm receive 1 g of IV Cetriaxone plus 500 mgs during surgery and there after IV ceftriaxone once a day for 3 days and IV Metronidazole 500mgs during surgery and there after every 8 hours for 3 days.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Post operative wound infections
Prazo: 14 days
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Compare for incidence of post operative wound infection among mothers that receive single dose versus multiple dose antibiotics
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14 days
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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clinical endometritis
Prazo: 14 days
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Compare the incidence of clinical endometritis among mothers that receive single versus multiple dose antibiotics
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14 days
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febrile morbidity
Prazo: 14 days
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compare the incidence of post operative febrile morbidity among mothers that receive single versus multiple doses
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14 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mugisa Alex Gideon, MBChB., Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology
- Diretor de estudo: Paul Kiondo, MD, MMeD,PhD, Makerere University Collage of Health Sciences, Department of Obstetrics and Gynecology
- Diretor de estudo: Imelda Namagembe, MD, MMeD, MPH, Mulago National Referral Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2013/HD07/658U
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