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- Ensayo clínico NCT03165838
Effectiveness of Shortened Time Interval to Postpartum Visit in Improving Postpartum Attendance
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Postpartum care is an essential component of women's reproductive health. During this time, the health care provider and the new mother review the previous pregnancy course, assess the mother's wellbeing, and establish treatment plans for any ongoing problems. Prospective guidance is given for both the mother and the baby in areas such as breastfeeding, nutrition, depression screening, and perineal/vulvar care. However, one of the most important goals of the postpartum visit is to discuss the new mother's desire for future pregnancies and the interval she wishes before another pregnancy. Inadequate reproductive health planning may result in unintended or rapid repeat of pregnancy (RROP), clinically defined as a second pregnancy within 24 months of the end of a previous pregnancy. A short inter-pregnancy interval is a risk factor for poor pregnancy outcomes including stillbirth, early neonatal death, extreme preterm births, and babies born small for gestational age. Compared to women who conceived 18-23 months after a previous birth, women conceiving less than five months after a previous birth had increased third trimester bleeding, uterine infection, premature rupture of membranes, and maternal death.Central to these outcomes is the rate of postpartum contraception use.
In fact, research shows an association between a postpartum visit and use of a reliable contraceptive method after pregnancy.
The optimal time for postpartum visit may be 3-4 weeks post-delivery rather than 6-8 weeks post-delivery with regard to visit attendance and proactive management of reproductive health, including contraception and time intervals between pregnancies. The timing of the postpartum visits are also linked to economic outcomes and healthcare utilization; postpartum care that results in decreased RROP and unintended pregnancies will likely decrease healthcare costs associated with the adverse consequences of inadequate reproductive health planning. Despite the obvious potential benefits of a decreased interval between delivery and the postpartum visit, to date, there have been no studies to systematically compare the impact of postpartum visit timing on visit attendance, contraception use and, subsequently, RROP.
This study is designed to investigate the effect of reduced time interval to postpartum visit on postpartum visit attendance rate, contraceptive use, and RROP. Additionally, the study will assess the impact of the two visit schedules on these outcomes by race, providing critical information about high risk populations. Finally, this research will assess the cost effectiveness of the shortened postpartum visit schedule relative to the standard of care. In order to account for potential bias in increased attendance rate due to intervention effect, compensation and other factors, this study will also compare the effectiveness of shortened time interval to postpartum visit on postpartum attendance rate and contraceptive use to a historic cohort.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- at least 18 years of age
- delivered vaginally a healthy, full-term (at least 37 weeks gestation) baby
- received prenatal care services at the VCUMCV OB clinic
- speak English
- provide informed consent for study participation.
Exclusion Criteria:
- cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent
- surgically sterilized
- have complicated deliveries that require extended hospital stays
- need early follow-up to monitor their conditions
- any problems with infants such as preterm birth, admission to the Neonatal Intensive Care Unit (NICU), congenital malformations or respiratory problems that would require frequent clinic visits or prolonged hospital admissions for the infants.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Postpartum Visit 3-4 Weeks
Participants will have postpartum visit scheduled 3-4 weeks after birth
|
This visit will be the same as the standard of care postpartum visit, but it will be scheduled earlier.
|
Experimental: Postpartum Visit 6-8 Weeks
Participants will have postpartum visit scheduled 6-8 weeks after birth
|
This standard of care postpartum visit will be scheduled for the standard time interval.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Postpartum Clinic Attendance
Periodo de tiempo: assessed at 12 weeks postpartum
|
To compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on improving the rate of postpartum visit attendance.
The investigators hypothesize that study participants with postpartum visits scheduled 3-4 weeks after delivery will be more likely to attend visits than study participants scheduled for visits 6-8 weeks after delivery.
|
assessed at 12 weeks postpartum
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Contraception Use
Periodo de tiempo: Assessed at 3, 6, 9, 12, & 18 month follow-ups
|
Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on consistent contraceptive use
|
Assessed at 3, 6, 9, 12, & 18 month follow-ups
|
Rapid Repeat Pregnancy
Periodo de tiempo: Assessed at 3, 6, 9, 12, & 18 month follow-ups
|
Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on repeat pregnancy
|
Assessed at 3, 6, 9, 12, & 18 month follow-ups
|
Cost effectiveness
Periodo de tiempo: 18 month postpartum
|
Compare overall cost of postpartum care
|
18 month postpartum
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Racial Differences
Periodo de tiempo: baseline, postpartum, 3, 6, 9, 12, & 18 month follow-ups
|
Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on reducing racial differences in postpartum visit attendance rates and contraceptive use.
Specifically, the study team hypothesizes that the difference in postpartum visit attendance and consistent contraceptive use rates between AA and CA study participants will be lower among study participants with postpartum visits scheduled 3-4 weeks after delivery compared to study participants scheduled for visits 6-8 weeks after delivery.
|
baseline, postpartum, 3, 6, 9, 12, & 18 month follow-ups
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Saba W Masho, Virginia Commonwealth University
Publicaciones y enlaces útiles
Publicaciones Generales
- Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
- Masho SW, Ihongbe TO, Wan W, Graves WC, Karjane N, Dillon P, Bazzoli G, McGee E. Effectiveness of shortened time interval to postpartum visit in improving postpartum attendance: Design and rationale for a randomized controlled trial. Contemp Clin Trials. 2019 Jun;81:40-43. doi: 10.1016/j.cct.2019.04.012. Epub 2019 Apr 18.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HM20000032
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
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