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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
"No blinding was used for participants, care providers, or investigators."
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Multiple pregnancy.
- •Severe medical conditions such as cancer or kidney disease.
- •History of previous pregnancy complications .
研究组 & 干预措施
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.
干预措施: 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.
干预措施: control group (Other)
研究者
Amany Gomaa Atiaa
lecturer
Sinai University