PregnancyIMSP-PregCDNCT07589946
Integrated Medical, Surgical and Physiotherapy Care for Pregnant Women With Chronic Diseases
A study testing Physiotherapy-based Care in people with Pregnancy and Pregnancy-Related Pain, run by Sinai University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Pregnancy-Related Pain, Musculoskeletal Disorders
- What is being tested?
- Physiotherapy-based Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Multiple pregnancy.
- Severe medical conditions such as cancer or kidney disease.
- History of previous pregnancy complications .
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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).
- Being tested
- Physiotherapy-based Care, control group
- Keywords
- Pregnant Women, Physiotherapy, Pregnancy Pain, Intervention Study, Physical Function, Non-Randomized Trial
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy-based CareDevice
- 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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Pre-test (baseline) and post-test (6 weeks postpartum)
Secondary outcomes (1)
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.
Measured: Pre-test (baseline) and post-test (6 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start15 Nov 2025
- Primary completion1 Mar 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- "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."
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589946
- Sponsor's protocol ID
- IRB00014233-77
- Acronym
- IMSP-PregCD
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07589946
- Acronym / sponsor ID
- IMSP-PregCD / IRB00014233-77
- Keywords
- Pregnant Women, Physiotherapy, Pregnancy Pain, Intervention Study, Physical Function, Non-Randomized Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "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."
| Arm | Type | Receives |
|---|---|---|
| Integrated Medical-Surgical and Physiotherapy Community-Based Care Model | Experimental | Device: Physiotherapy-based CareThis 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. |
| Standard antenatal Care | Active comparator | Other: control groupThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Multiple pregnancy.
- Severe medical conditions such as cancer or kidney disease.
- History of previous pregnancy complications .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Integrated Medical-Surgical and Physiotherapy Community-Based Care Model |
| control groupThe 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. | Other | Standard antenatal Care |
Primary outcome
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.
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.
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.
1 secondary outcome
Physical Health and Maternal Outcomes:
Time frame: Pre-test (baseline) and post-test (6 weeks postpartum)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy-based Care in people with Pregnancy and Pregnancy-Related Pain, run by Sinai University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare Quality: (time frame: Pre-test (baseline) and post-test (6 weeks postpartum)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.