- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02371356
Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health (PCORIPTD)
12 de marzo de 2020 actualizado por: Kaiser Permanente
Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW).
Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments.
We propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination.
The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups.
Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes.
Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW).
Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments.
Kaiser Permanente Northern California has implemented a large scale universal peripartum depression screening program, annually screening more than 35,000 pregnant women.
Taking advantage of this unique infrastructure, we propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination.
The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups.
Stakeholders (patients, advocacy groups, and providers) are an integral part of the research team.
Four cohorts with different treatment options including untreated will be formed within each depression type (with or without comorbidity): (A) "Antidepressant only": screen positive for depression and use only antidepressants during pregnancy; (B) "Psychotherapy only": screen positive and receive psychotherapy only; (C) "Combination therapy": screen positive and receive both antidepressants and psychotherapy; (D)"Untreated depression": screen positive and receive no treatment.
A total of eight cohorts will be formed.
A final cohort (E) "No depression": screen negative and receive no treatment, will be examined for baseline comparison.
Information on depression treatment and PTD and LBW will be available for all participating women who will be followed until the end of pregnancy.
Within each depression category, comparison of Cohort A, B & C to D, respectively, will determine if treating depression is effective.
Pair-wise comparisons among Cohorts A, B & C will determine the comparative effectiveness of treatment regimens.
Comparison of Cohort D to E provides baseline fetal risks of untreated depression.
Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes.
Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.
Tipo de estudio
De observación
Inscripción (Actual)
91084
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
Pregnant KPNC members who have been screened as part of KPNC's peripartum depression screening program, assigned to cohorts according to depression and treatment status.
Descripción
Inclusion Criteria:
- Kaiser member
- Pregnant
Exclusion Criteria:
- Not a member of Kaiser Permanente
- Not pregnant
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Depressed, Medication only
Screen positive for depression and use only antidepressants during pregnancy
|
Depressed, Psychotherapy only
Screen positive for depression and receive psychotherapy only.
|
Depressed, Medication & Psychotherapy
Screen positive for depression and receive both antidepressants and psychotherapy.
|
Depressed, untreated
Screen positive for depression and receive no treatment.
|
Not depressed
Screen negative for depression and receive no treatment.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Preterm Delivery
Periodo de tiempo: Through the end of pregnancy, an average of 40 weeks
|
Delivery prior to 37 completed weeks of gestational age
|
Through the end of pregnancy, an average of 40 weeks
|
Low Birth Weight
Periodo de tiempo: Through the end of pregnancy, an average of 40 weeks
|
Birth weight <2500 grams
|
Through the end of pregnancy, an average of 40 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2014
Finalización primaria (Actual)
31 de enero de 2017
Finalización del estudio (Actual)
30 de abril de 2019
Fechas de registro del estudio
Enviado por primera vez
28 de enero de 2015
Primero enviado que cumplió con los criterios de control de calidad
24 de febrero de 2015
Publicado por primera vez (Estimar)
25 de febrero de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de marzo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
12 de marzo de 2020
Última verificación
1 de marzo de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CN-13-1650-H
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .