Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases

NCT07589946 | Completed DMC

• 1 other identifier: IRB00014233-77
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy-Related Pain; Musculoskeletal Disorders; Physical Therapy; Pregnancy

Keywords

Pregnant Women; Physiotherapy; Pregnancy Pain; Intervention Study; Physical Function; Non-Randomized Trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Physical Health and Maternal Outcomes:

  Pre-test (baseline) and post-test (6 weeks postpartum)

Study Arms (2)

Integrated Medical-Surgical and Physiotherapy Community-Based Care Model

EXPERIMENTAL

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

Standard antenatal Care

ACTIVE COMPARATOR

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

Interventions

Physiotherapy-based Care DEVICE

* 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

Integrated Medical-Surgical and Physiotherapy Community-Based Care Model

control group OTHER

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.

Standard antenatal Care

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 18 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Multiple pregnancy.
• Severe medical conditions such as cancer or kidney disease.
• History of previous pregnancy complications .

Sponsors & Collaborators

• Sinai University: lead

Study Sites (1)

Sinai university

Cairo, 44511, Egypt

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: "No blinding was used for participants, care providers, or investigators."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: "Participants were allocated to either the intervention group (integrated physiotherapy care model) or the control group (standard care) to assess healthcare quality, complications, and patient satisfaction."

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 15, 2026
• Study Start: November 15, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

EG (1)