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Correlation Between Inflammatory Markers in Gingival Crevicular Fluid, Serum and Amniotic Fluids in Periodontal Pregnant Women

23 de dezembro de 2013 atualizado por: Polak David, Hadassah Medical Organization

The main causes of adverse pregnancy outcome(s) are reported to be maternal infection and placental, foetal, or uterine pathosis. Maternal infection and placental pathosis appear to be the most important causal factors, possibly causing pre-term labour, premature pre-term membrane rupture, or result in medically induced pregnancy interruption. There are reports of a link between poor maternal periodontal health and composite adverse pregnancy outcome of pre-term low birth weight (PLBW). however, the reason for such correlation is still not clear.

In the current study the investigators will try to follow a possible path between periodontal infection and uterus physiology, by signaling out inflammatory markers that may leak from the gingival fluid into the serum and from there to the amniotic fluid.

the investigators will collect GCF, serum and amniotic fluid from patients undergoing elective amniocentesis and analyse inflammatory markers in the collected samples.

Visão geral do estudo

Status

Desconhecido

Descrição detalhada

Globally, over 4 million babies die within the first 4 weeks of life and a third of these are secondary to pre-term birth. In the United States, pre-term birth is the second leading cause of neonatal mortality. The US pre-term birth (<37 weeks) rate rose to 12.8% in 2006, an increase of 21% since 1990 and the rate of low birthweight (<2500 g) rose to 8.3% in 2006, an increase of 19% since 1990. Neurological disorders, such as cerebral palsy, which is often combined with mental disability, epilepsy, and cognitive impairment, are of special concern for survivors of pre-term birth. Even though pre-term birth occurs in only a small proportion of the infant population, its societal and personal health impact is considerable because of its disproportionately high perinatal morbidity, mortality, and need for costly medical care. However, it is very disappointing that to date, interventions to prevent pre-term birth have proven to be almost universally ineffective.

The main causes of adverse pregnancy outcome(s) are reported to be maternal infection and placental, fetal, or uterine pathosis. Maternal infection and placental pathosis appear to be the most important causal factors, but each can cause pre-term labour, premature pre-term membrane rupture, or result in medically induced pregnancy interruption. Prominent risk factors for pre-term birth include history of previous pre-term birth, demographic characteristics, periodontal disease, and behavioral factors such as tobacco use.

Offenbacher et al. were the first to report a link in humans between poor maternal periodontal health and composite adverse pregnancy outcome of pre-term low birth weight (PLBW). They reported that women with periodontal disease were much more likely than periodontally healthy women to experience pre-term and low birth weight infants (OR=7.5 for all PLBW cases; OR=7.9 for primiparous PLBW cases). Pro-inflammatory mediators generated within the diseased periodontal tissue may affect the maternal-foetal unit. When present in the amniotic fluid, chronic high levels of cytokines and prostaglandins may lead to intra-uterine growth restriction (IUGR), spontaneous pre-term labour, premature rupture of membranes, and pre-term birth. Several studies report associations of adverse pregnancy outcome with higher gingival crevicular fluid levels of PGE2 and IL-1β and elevated amniotic fluid concentrations of PGE2, IL-1β and IL-8 Dörtbudak. It is possible that IL-6 produced in inflamed periodontal tissues can affect the foetal membranes and cause pre-term uterine contractions. There is evidence that the gingival crevicular fluid levels of IL-6 are higher in gingivitis and periodontitis compared with healthy controls.

Bacteria activate cell-mediated immunological responses, leading to the production and release of cytokines, including interleukin-1 (IL-1), IL-6, tumor necrosis factor-α (TNF-α), prostaglandins, or endotoxins such as lipopolysaccharides, which may precipitate pre-term labour if they reach the foeto-placental unit. Endotoxin or lipopolysaccharide of Gram-negative bacteria may be detected in biological fluids of sterile compartments such as the amniotic cavity. Administration of endotoxin to pregnant animals results in embryo resorption, pre-term labour, and foetal death. A higher risk of spontaneous pre-term delivery has been associated with genetically driven excessive amniotic fluid IL-Iβ or with a disturbance of bioavailability and/or bio-response of this cytokine, which is central to the pro-inflammatory reaction to infectious stimulants. The foetus also has a role in pre-term birth; the foetus recognizes a hostile intrauterine environment and may precipitate labour by premature activation of the foetal-placental parturition pathway.

The causality relationship between periodontal disease and inflammatory mediators' presence in the amnionic fluid was not tested to date. In the present study the investigators aim to investigate the correlation between inflammatory mediators in the serum and their presence in the amniotic fluid. The investigators will further investigate the correlation of the above results with pregnancy outcome (gestation age, foetal weight and health, etc.).

Israel amniocentesis in healthy women is very common. The cellular fraction in the sampled amniotic fluid is used for the amniocentesis test, while the supernatant is discarded. For the present study the investigators aim to use the supernatants of amniocentesis tests done on healthy women (age 21-45) as well as serum. Using ELISA we will quantify the levels of inflammatory markers such as IL-6, TNFα and IL-1β. The investigators will also test the presence of endotoxin and perio-pathogens DNA in the serum and amnionic fluid. Follow-up on data regarding gestational outcome will be also collected.

participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Tipo de estudo

Observacional

Inscrição (Antecipado)

200

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 45 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Fêmea

Método de amostragem

Amostra Não Probabilística

População do estudo

healthy pregnant women, undergoing elective amniocentesis

Descrição

Inclusion Criteria:

  • age 18-45
  • single fetus pregnancy
  • at least 20 teeth present

Exclusion Criteria:

  • high risk pregnancy
  • alcohol consumption
  • smoking
  • pregnancy diabetes

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
periodontitis patients
according to american academy of periodontology classification of periodontal diagnosis.
healthy periodontium
according to american academy of periodontology classification of periodontal diagnosis.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
cytokines levels
Prazo: analysed at the end of sample collection. participants will be followed for the duration of pregnancy, an expected average of 5 months
Using ELISA we will quantify the levels of inflammatory markers such as IL-6, TNFα and IL-1β.
analysed at the end of sample collection. participants will be followed for the duration of pregnancy, an expected average of 5 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
presence of endotoxin and perio-pathogens DNA in the serum and amnionic fluid
Prazo: analysed at the end of sample collection. participants will be followed for the duration of pregnancy, an expected average of 5 months
We will also test the levels of endotoxin and perio-pathogens DNA in the serum and amniotic fluid using real time PCR and ELISA. Measures are a composite outcome measure consisting of multiple measures (results to be reported as a single value for each Arm/Group).
analysed at the end of sample collection. participants will be followed for the duration of pregnancy, an expected average of 5 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2014

Conclusão Primária (Antecipado)

1 de janeiro de 2015

Conclusão do estudo (Antecipado)

1 de março de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

11 de dezembro de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de dezembro de 2013

Primeira postagem (Estimativa)

30 de dezembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

30 de dezembro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de dezembro de 2013

Última verificação

1 de dezembro de 2013

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • HMO-12-0412

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Doença periodontal

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