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

9. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Faktiske)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
      • Cairo, Egypt, 44511
        • Sinai University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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 .

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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
Aktiv komparator: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Healthcare Quality:
Tidsramme: 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.
Pre-test (baseline) and post-test (6 weeks postpartum)
Maternal Complications
Tidsramme: 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.
Pre-test (baseline) and post-test (6 weeks postpartum)
Patient Satisfaction
Tidsramme: 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.
Pre-test (baseline) and post-test (6 weeks postpartum)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical Health and Maternal Outcomes:
Tidsramme: 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.
Pre-test (baseline) and post-test (6 weeks postpartum)

Samarbeidspartnere og etterforskere

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Sponsor

Sinai University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. november 2025

Primær fullføring (Faktiske)

1. mars 2026

Studiet fullført (Faktiske)

1. mai 2026

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

9. mai 2026

Først lagt ut (Faktiske)

15. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB00014233-77

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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