Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases (IMSP-PregCD)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Physical Therapy; Musculoskeletal Disorders; Pregnancy-Related Pain
• Intervention / Treatment: Device: Physiotherapy-based Care; Other: control group

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 44511
    • Sinai university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Physiotherapy-based Care; Aerobic exercises for cardiovascular endurance.; Resistance exercises to improve muscle strength.; Posture correction exercises to improve body alignment.; Core stabilization exercises to improve overall strength and stability.; Pelvic floor muscle training for better support during pregnancy.; Breathing exercises to enhance relaxation and reduce
Active Comparator: 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.	Other: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare Quality:	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.	Pre-test (baseline) and post-test (6 weeks postpartum)
Maternal Complications	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.	Pre-test (baseline) and post-test (6 weeks postpartum)
Patient Satisfaction	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.	Pre-test (baseline) and post-test (6 weeks postpartum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Health and Maternal Outcomes:	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.	Pre-test (baseline) and post-test (6 weeks postpartum)

Collaborators and Investigators

• Sponsor: Sinai University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Actual): May 1, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Physical Function; Physiotherapy; Intervention Study; Pregnant Women; Pregnancy Pain; Non-Randomized Trial
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: IRB00014233-77

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No