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Effectiveness of Shortened Time Interval to Postpartum Visit in Improving Postpartum Attendance

14 de agosto de 2017 actualizado por: Virginia Commonwealth University
Due to potential to improve family planning, clinicians are increasingly interested in shortening the time to postpartum visits, but lack an evidence base to change policy.There are no studies that have examined the effectiveness of shortened interval to postpartum visit on attendance rate, contraception use, and rapid repeat of pregnancy (RROP). With this research, the investigators propose to conduct a randomized controlled trial (RCT) to examine the effect of reduced time interval to postpartum visit (3-4 weeks rather than 6-8 weeks) on postpartum visit attendance rate, contraceptive use, and RROP.

Descripción general del estudio

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

Intervencionista

Inscripción (Actual)

364

Fase

  • No aplica

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

Géneros elegibles para el estudio

Femenino

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

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

  • 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:
  • Estándar de cuidado

¿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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Saba W Masho, Virginia Commonwealth University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

18 de noviembre de 2013

Finalización primaria (Actual)

3 de marzo de 2016

Finalización del estudio (Actual)

20 de junio de 2017

Fechas de registro del estudio

Enviado por primera vez

8 de mayo de 2017

Primero enviado que cumplió con los criterios de control de calidad

23 de mayo de 2017

Publicado por primera vez (Actual)

24 de mayo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de agosto de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

14 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HM20000032

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

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. .

Ensayos clínicos sobre Postpartum Visit 3-4 Weeks

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