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Completed

NCT Number: NCT07589946

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

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.

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Key information

Conditions

Pregnancy Musculoskeletal Diseases Musculoskeletal Disorders Physical Therapy Pregnancy-Related Pain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sinai university

Cairo, 44511, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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

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.

Primary outcomes

  1. Healthcare Quality:

    Time frame: Pre-test (baseline) and post-test (6 weeks postpartum)

    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.

  2. Maternal Complications

    Time frame: Pre-test (baseline) and post-test (6 weeks postpartum)

    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.

  3. Patient Satisfaction

    Time frame: Pre-test (baseline) and post-test (6 weeks postpartum)

    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.

Secondary outcomes

  1. Physical Health and Maternal Outcomes:

    Time frame: Pre-test (baseline) and post-test (6 weeks postpartum)

    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.

Sponsors and collaborators

Lead sponsor

Sinai University

Other

Registry information

Official study title

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

Acronym: IMSP-PregCD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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