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- Ensaio Clínico NCT06808165
Relaxin e volume placentário no espectro da placenta accreta
Avaliação do volume de relaxina e placenta em Distúrbios do Espectro da Placenta Accreta: Um estudo de caso-controle
This retrospective case-control study investigated the potential role of circulating relaxin levels and estimated placental volumes (EPV) in the pathogenesis and diagnosis of placenta accreta spectrum (PAS) disorders. It compared these parameters in patients diagnosed with PAS versus healthy controls.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
This study aimed to compare relaxin levels in umbilical cord and peripheral blood and estimated placental volumes (EPV) between PAS cases and controls. Additionally, subgroup analysis was conducted to evaluate relaxin levels and EPV among PAS subtypes (accreta, increta, and percreta).A retrospective case-control study was conducted at a tertiary referral center, analyzing data from January 2022 to December 2022.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Turkey
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Istanbul, Turkey, Turquia (Türkiye)
- Basaksehir Cam and Sakura City Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population consisted of two groups. Following retrospective investigation of patients operated in our clinic between 01.01.2022 and 01.12.2022, the case group included 20 patients diagnosed with PAS disorders, suspected with clinical and imaging findings, confirmed through histopathological findings. These patients had undergone elective cesarean hysterectomy and met inclusion criteria aged between 18 and 45 years and availability of complete medical records. Due to ethical considerations, 4 patients diagnosed with PAS who underwent emergency surgery because of vaginal bleeding and 14 patients operated with segmentary resections were excluded from the study to compose more homogenous study cohort for the measurement of EPV. The control group consisted of 20 healthy pregnant women who underwent the first planned cesarean section of the day, without any obstetric complications, on the same days when planned PAS cesarean-hysterectomy cases were performed in 2022.
Descrição
Inclusion Criteria:
Women aged 18-45 years
Confirmed histopathological diagnosis of PAS (case group)
Complete medical records
Healthy pregnant women undergoing cesarean delivery (control group)
Exclusion Criteria:
Multifetal gestation
Emergency surgeries
Incomplete medical records
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: CASE_CONTROL
- Perspectivas de Tempo: RETROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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Placenta Accreta Spectrum Group
|
The primary source of relaxin in pregnancy is the corpus luteum, but it is also produced in other tissues, such as the decidua and placenta. Importantly, relaxin's pleiotropic effects include endothelial-dependent vasodilation, extracellular matrix remodeling, and potential contributions to placental development. These properties make relaxin a molecule of interest in the context of PAS disorders, where abnormal placental invasion may reflect disruptions in vascular and extracellular matrix regulation. Additionally, recent findings have indicated altCirculating relaxin levels were assessed before routinely storing maternal venous blood and umbilical cord arterial blood samples are anelyzed. This study aimed to compare relaxin levels in umbilical cord and peripheral blood and estimated placental volumes (EPV) between PAS cases and controls. Additionally, subgroup analysis was conducted to evaluate relaxin levels and EPV among PAS subtypes (accreta, increta, and percreta). |
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Control Group (No PAS Pathology with Elective Cesarean Section)
|
The primary source of relaxin in pregnancy is the corpus luteum, but it is also produced in other tissues, such as the decidua and placenta. Importantly, relaxin's pleiotropic effects include endothelial-dependent vasodilation, extracellular matrix remodeling, and potential contributions to placental development. These properties make relaxin a molecule of interest in the context of PAS disorders, where abnormal placental invasion may reflect disruptions in vascular and extracellular matrix regulation. Additionally, recent findings have indicated altCirculating relaxin levels were assessed before routinely storing maternal venous blood and umbilical cord arterial blood samples are anelyzed. This study aimed to compare relaxin levels in umbilical cord and peripheral blood and estimated placental volumes (EPV) between PAS cases and controls. Additionally, subgroup analysis was conducted to evaluate relaxin levels and EPV among PAS subtypes (accreta, increta, and percreta). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Circulating relaxin (RLN2) levels in peripheral and umbilical cord blood
Prazo: 11 months
|
The primary source of relaxin in pregnancy is the corpus luteum, but it is also produced in other tissues, such as the decidua and placenta. Importantly, relaxin's pleiotropic effects include endothelial-dependent vasodilation, extracellular matrix remodeling, and potential contributions to placental development. These properties make relaxin a molecule of interest in the context of PAS disorders, where abnormal placental invasion may reflect disruptions in vascular and extracellular matrix regulation. Additionally, recent findings have indicated altered expression of relaxin, its receptor RXFP1, and insulin-like peptide 4 (INSL4) in PAS cases, suggesting potential roles in its pathogenesis. |
11 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
placental volume
Prazo: 11 months
|
Placental volume, assessed through imaging modalities, has been explored as a potential biomarker for abnormal placental development, including PAS. Studies have demonstrated that larger placental volumes may be associated with invasive placentation, suggesting a correlation between placental growth patterns and PAS severity. |
11 months
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Burston HE, Kent OA, Communal L, Udaskin ML, Sun RX, Brown KR, Jung E, Francis KE, La Rose J, Lowitz J, Drapkin R, Mes-Masson AM, Rottapel R. Inhibition of relaxin autocrine signaling confers therapeutic vulnerability in ovarian cancer. J Clin Invest. 2021 Apr 1;131(7):e142677. doi: 10.1172/JCI142677.
- Ma P, Hu T, Chen Y. The Association and diagnostic value between Maternal Serum Placental Markers and Placenta Previa. Eur J Obstet Gynecol Reprod Biol X. 2024 Oct 11;24:100346. doi: 10.1016/j.eurox.2024.100346. eCollection 2024 Dec.
- Goh W, Yamamoto SY, Thompson KS, Bryant-Greenwood GD. Relaxin, its receptor (RXFP1), and insulin-like peptide 4 expression through gestation and in placenta accreta. Reprod Sci. 2013 Aug;20(8):968-80. doi: 10.1177/1933719112472735. Epub 2013 Jan 9.
- Patil NA, Rosengren KJ, Separovic F, Wade JD, Bathgate RAD, Hossain MA. Relaxin family peptides: structure-activity relationship studies. Br J Pharmacol. 2017 May;174(10):950-961. doi: 10.1111/bph.13684. Epub 2017 Jan 19.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KAEK/2023.01.20
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