Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases (IMSP-PregCD)
9 de mayo de 2026 actualizado por: Amany Gomaa Atiaa, Sinai University
Design and Evaluation of an Integrated Medical-Surgical and Physiotherapy Community-Based Care Model for Pregnant Women With Chronic Diseases: A Non-Randomized Controlled Quasi-Experimental Study
This non-randomized controlled quasi-experimental study evaluates the effectiveness of an integrated medical-surgical and physiotherapy community-based care model for pregnant women with chronic diseases.
Eligible pregnant women aged 18 years or older and enrolled before 20 weeks of gestation are allocated to either an intervention group receiving coordinated multidisciplinary care plus individualized physiotherapy or a control group receiving standard antenatal care.
The intervention includes standardized clinical pathways, care coordination, self-management education, community linkages, and physiotherapy exercises tailored to gestational age, chronic disease type, and baseline functional assessment.
Outcomes are assessed at baseline, delivery, and 6 weeks postpartum and include maternal complications, neonatal outcomes, quality of life, treatment adherence, patient satisfaction, healthcare utilization, and maternal physical-function indicators.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Pregnant women with chronic diseases are at increased risk of maternal and neonatal complications.
The study tests whether a coordinated care model that integrates medical, surgical, nursing, community-based and physiotherapy services improves outcomes compared with standard fragmented care.
Participants in the intervention arm receive multidisciplinary coordination, evidence-based chronic-disease management protocols, self-management support, antenatal education, postnatal follow-up, community linkages, and individualized physiotherapy.
Physiotherapy includes baseline assessment of pain, mobility, postural alignment, core strength, pelvic-floor function, and disease-specific safety monitoring.
Exercise components include moderate-intensity aerobic training, low-load resistance training, core stabilization, postural training, pelvic-floor muscle training, breathing/relaxation techniques, pelvic tilt exercises, and home exercise.
Participants in the control arm receive routine antenatal care without the formal integrated model.
Assessments occur at enrollment (T0), delivery (T1), and 6 weeks postpartum (T2).
Tipo de estudio
Intervencionista
Inscripción (Actual)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Cairo, Egipto, 44511
- Sinai University
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Confirmed pregnancy.
- Gestational age less than 20 weeks at enrollment.
- Aged 18 years or older.
- Confirmed diagnosis of a relevant chronic medical or surgical condition prior to or during pregnancy.
- Willing and able to provide written informed consent. 6. Willing to participate in study procedures and follow-up appointments.
Exclusion Criteria:
- Multiple pregnancy.
- Severe medical conditions such as cancer or kidney disease.
- History of previous pregnancy complications .
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: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Integrated Medical-Surgical and Physiotherapy Community-Based Care Model
This group receives the Integrated Medical-Surgical and Physiotherapy Community-Based Care Model. The model includes: A structured physiotherapy program individualized according to gestational age, chronic disease type, and baseline assessment findings. Exercises such as aerobic, resistance, posture correction, core stabilization, pelvic floor muscle training, and breathing exercises. Aimed at enhancing maternal functional status, reducing complications, and improving healthcare quality. |
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Comparador activo: Standard antenatal Care
This group receives Standard Care without the addition of physiotherapy.
The care model is focused on routine antenatal care for pregnant women with chronic diseases, without the structured physiotherapy interventions.
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The participants in the control group received the usual routine antenatal care without the added physiotherapy program.
The focus was on the management of chronic diseases during pregnancy but did not include the structured exercise regimen provided to the intervention group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Healthcare Quality:
Periodo de tiempo: Pre-test (baseline) and post-test (6 weeks postpartum)
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This outcome assesses the improvement in the overall quality of healthcare provided to pregnant women with chronic diseases after participating in the integrated care model.Healthcare quality was evaluated using questionnaires and possibly clinical records, focusing on the general effectiveness of the intervention.
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Pre-test (baseline) and post-test (6 weeks postpartum)
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Maternal Complications
Periodo de tiempo: Pre-test (baseline) and post-test (6 weeks postpartum)
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The occurrence of pregnancy-related complications in women with chronic diseases was monitored.Complications were tracked and compared between the intervention and control groups, with a focus on any reduction in health risks.
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Pre-test (baseline) and post-test (6 weeks postpartum)
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Patient Satisfaction
Periodo de tiempo: Pre-test (baseline) and post-test (6 weeks postpartum)
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This outcome measures how satisfied the pregnant women were with the care model they received.Patient satisfaction was evaluated using structured questionnaires that assessed their overall experience with the intervention.
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Pre-test (baseline) and post-test (6 weeks postpartum)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical Health and Maternal Outcomes:
Periodo de tiempo: Pre-test (baseline) and post-test (6 weeks postpartum)
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This assesses the improvements in physical health for pregnant women, such as increased physical fitness, reduced pain, and better functionality due to the physiotherapy program.Physical health may have been evaluated through subjective self-reports or objective measures, such as range of motion or strength, based on the physiotherapy exercises.
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Pre-test (baseline) and post-test (6 weeks postpartum)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
15 de noviembre de 2025
Finalización primaria (Actual)
1 de marzo de 2026
Finalización del estudio (Actual)
1 de mayo de 2026
Fechas de registro del estudio
Enviado por primera vez
4 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00014233-77
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
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