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- Ensaio Clínico NCT03774667
Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women
Characteristics, Complications and Perinatal Outcomes in Placenta Previa Women: a Prospective, Matched Case-control Study
Visão geral do estudo
Status
Condições
Descrição detalhada
Placenta previa (PP) is defined as the placenta overlying the endocervical os and grades according to the relationship and the distance between the lower placental edge and the internal os of the uterine cervix: low-lying previa, marginal previa, partial previa, and complete previa.
Cesarean delivery and assisted reproductive technology are associated with an increased risk of placenta previa in subsequent pregnancies. Other risk factors for previa include previous spontaneous, elective pregnancy terminations, previous uterine surgery, increasing maternal age and maternal parity, multiple gestations, smoking, cocaine use, and prior previa.
It is associated with numerous adverse maternal and fetal-neonatal complications, such as perinatal hemorrhage, preterm birth, blood transfusion, hysterectomy, maternal intensive care unit admission, disseminated intravascular coagulation, septicemia, thrombophlebitis, and even fetal-neonatal and maternal death.
This is a 1:2 prospective, matched and hospital-based case-control study to investigate the characteristics, complications and perinatal outcomes in pregnant women with placenta previa. For each placenta previa women, the investigators selected two none-placenta previa pregnant women as control from the same department matched on the mode of delivery, using simple random selection when excess matches are available. The date of their admission is limited to two days.
This hospital is a tertiary university-affiliated medical center with a stable number of approximately 12,000 deliveries per year. Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Zhengping Liu, MD
- Número de telefone: 86 757 82969772
- E-mail: liuzphlk81@outlook.com
Estude backup de contato
- Nome: Dazhi Fan, MD
- Número de telefone: 86 757 82969772
- E-mail: fandazhigw@163.com
Locais de estudo
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Guangdong
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Foshan, Guangdong, China, 528000
- Recrutamento
- Maternal and Child Health Hospital of Foshan
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Contato:
- Zhengping Liu, MD
- Número de telefone: 86 757 82969772
- E-mail: liuzphlk81@outlook.com
-
Contato:
- Dazhi Fan, MD
- Número de telefone: 86 757 82969772
- E-mail: fandazhigw@163.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Single Pregnancy
- Informed consent
- Fetal gestational age 28 to < 42 weeks
Exclusion Criteria:
- Multiple pregnancy
- Refuses to consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Placenta Previa
Pregnant women is diagnosed with placenta previa after delivery.
Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
|
None-Placenta Previa
Pregnant women is diagnosed without placenta previa after delivery.
Placenta previa is diagnosed by experienced ultrasonologists based on a transabdominal ultrasonic finding of placental tissue covering the internal cervical os before delivery, and further confirmed by obstetricians at delivery.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants with postpartum hemorrhage
Prazo: 24 hours after delivery
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Blood loss > 1000ml during cesarean section or > 500 ml during vaginal delivery
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24 hours after delivery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants with antepartum hemorrhage
Prazo: From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
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At least one episode of bleeding from the genital tract during the antenatal period
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From the time of viability of pregnancy to the delivery of the baby, assessed up to 42 weeks
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Number of Participants with preterm birth
Prazo: From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks
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Before 37 completed gestational weeks
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From the time of viability of pregnancy to the delivery of the baby, assessed up to 37 weeks
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Number of Participants with very preterm birth
Prazo: From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
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Before 32 completed gestational weeks
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From the time of viability of pregnancy to the delivery of the baby, assessed up to 32 weeks
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Number of participant needed for blood transfusion
Prazo: 72 hours after delivery
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Calculation of the number of participant needed for blood transfusion
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72 hours after delivery
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Number of urological injury
Prazo: 72 hours after delivery
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Calculation of the number of participant with bladder or ureteric injury
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72 hours after delivery
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Number of needed for extra surgical maneuvers
Prazo: 72 hours after delivery
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internal iliac ligation or hysterectomy
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72 hours after delivery
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Number of need for caesarean hysterectomy
Prazo: 72 hours after delivery
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Yes or no
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72 hours after delivery
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Number of needed for neonatal ICU
Prazo: 72 hours after delivery
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Yes or no
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72 hours after delivery
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Number of needed for maternal ICU
Prazo: 72 hours after delivery
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Yes or no
|
72 hours after delivery
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
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
- MCHHFoshan-1901
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Prazo de Compartilhamento de IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
- CSR
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