Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
25 de novembro de 2019 atualizado por: CAPT Dennis Spence, NC, USN, PhD, CRNA, United States Naval Medical Center, San Diego
Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes
Prospective, randomized controlled trial.
Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group.
Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care.
All subjects will complete a sleep study again between 8 to 12 weeks postpartum.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index [AHI] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation).
At 8 to 12 months postpartum subjects in both groups will complete a sleep study.
Tipo de estudo
Intervencional
Inscrição (Real)
193
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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California
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San Diego, California, Estados Unidos, 92134
- Naval Medical Center
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-
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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria
- At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
- Between 6 and 16 weeks gestation at time of enrollment.
Exclusion Criteria
- Current diagnosis and treatment of OSA.
- Patient refusal to randomization.
- Permanent Pacemaker (interfere with WATCHPAT sleep study).
- Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
- Coronary artery disease or congestive heart failure or cardiomyopathy.
- Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
- Inability to read or understand the consent.
- <18 years of age.
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
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Sleep Study + CPAP group
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
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Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
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|
Outro: Standard Prenatal Care group
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
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Standard Pre-Natal Care
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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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Number of Participants With Adverse Pregnancy Outcomes
Prazo: time of delivery
|
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
|
time of delivery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Prazo: early pregnancy (6-16 weeks)
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Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only.
Data were not collected for Control group at this time point.
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early pregnancy (6-16 weeks)
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Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Prazo: 27-33 weeks
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Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks).
Data were not collected for Control group at this time point
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27-33 weeks
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Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Prazo: 8-12 weeks postpartum
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Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
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8-12 weeks postpartum
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Hospital Costs at Time of Delivery
Prazo: Hospital costs at time of delivery
|
Hospital costs at time of delivery in treatment and control group.
|
Hospital costs at time of delivery
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Dennis L Spence, PhD, United States Naval Medical Center, San Diego
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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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 (Real)
20 de fevereiro de 2017
Conclusão Primária (Real)
14 de outubro de 2019
Conclusão do estudo (Real)
14 de outubro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
11 de março de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de abril de 2016
Primeira postagem (Estimativa)
29 de abril de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de novembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de novembro de 2019
Última verificação
1 de novembro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NMCSD.2016.0029
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
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