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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sinai University
- Enrollment
- 200
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
"No blinding was used for participants, care providers, or investigators."
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
- •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 .
Arms & Interventions
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.
Intervention: Physiotherapy-based Care (Device)
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.
Intervention: control group (Other)
Investigators
Amany Gomaa Atiaa
lecturer
Sinai University