Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases (IMSP-PregCD)
2026年5月9日 更新者：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.
研究概览
详细说明
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).
研究类型
介入性
注册 (实际的)
200
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Cairo、埃及、44511
- Sinai University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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 .
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Healthcare Quality:
大体时间：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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Physical Health and Maternal Outcomes:
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年11月15日
初级完成 (实际的)
2026年3月1日
研究完成 (实际的)
2026年5月1日
研究注册日期
首次提交
2026年5月4日
首先提交符合 QC 标准的
2026年5月9日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月9日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.