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- Ensayo clínico NCT07647809
Clinical Pilates and Prenatal Education on Perinatal Depressive Symptoms (CPE-PE)
Combined Clinical Pilates Exercise and Prenatal Education and Perinatal Depressive Symptoms, Low Back Pain and Obstetric Outcomes: A Prospective Non-Randomized Controlled Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This was a prospective, non-randomized, controlled (quasi-experimental) study conducted at a single tertiary women's health center between January 2021 and June 2022. Eighty-five nulliparous women with singleton pregnancies between 16 and 28 weeks of gestation, aged 18-35 years and with a pre-pregnancy body mass index below 30 kg/m2, were enrolled.
Participants were allocated to two parallel groups according to their availability to attend the intervention program. Women who could commit to the scheduled sessions were assigned to the intervention group (n=41) and received a supervised Clinical Pilates Exercise program (two 60-minute sessions per week until 32 weeks of gestation, moderate intensity, Borg 12-14, designed per ACOG recommendations) combined with a structured Prenatal Education program (four weekly sessions). After 32 weeks, exercises were continued at home with modifications. Women unable to attend due to scheduling constraints formed the control group (n=44) and received routine antenatal care only.
Depressive symptoms were assessed with the Edinburgh Postnatal Depression Scale (EPDS) at baseline (16-28 weeks), at 32 weeks of gestation, and at 6 months postpartum. Pregnancy-related low back pain was assessed with the Numeric Pain Rating Scale, labor pain with a Visual Analog Scale (vaginal deliveries), and obstetric outcomes (duration of labor, mode of delivery, gestational age at delivery, birth weight, Apgar scores) were recorded after delivery.
Because allocation was not randomized and significant baseline differences were observed between groups, baseline-adjusted analyses (mixed-effects models, ANCOVA) and propensity-score sensitivity analyses were used. Given the non-randomized design, findings are considered hypothesis-generating. The study was registered retrospectively.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Ankara, Turquía (Türkiye)
- Etlik Zübeyde Hanım Women's Health Training and Research Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Nulliparous
- Singleton pregnancy
- Gestational age 16-28 weeks at enrollment
- Age 18-35 years
- Pre-pregnancy body mass index < 30 kg/m2
Exclusion Criteria:
- Multiple pregnancy
- Systemic disease, including diabetes mellitus, hypertension, or cardiovascular disorders
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Clinical Pilates Exercise + Prenatal Education
Supervised Clinical Pilates Exercise (two 60-minute moderate-intensity sessions per week, Borg 12-14, until 32 weeks of gestation; home-based thereafter with modifications) plus a structured Prenatal Education program of four weekly sessions, in addition to routine antenatal care
|
Supervised, moderate-intensity (Borg 12-14) clinical Pilates program emphasizing core stabilization, controlled breathing, and postural alignment; two 60-minute sessions per week until 32 weeks of ges
Structured prenatal education delivered in four weekly sessions covering pregnancy physiology, labor and birth preparation, coping strategies, and newborn/postpartum care, structured per ACOG recommendations.' - Arm/Group: 'Clinical Pilates Exercise + Prenatal Education |
|
Sin intervención: Routine Antenatal Care
Routine antenatal care only, including regular obstetric examinations, basic prenatal education, nutritional counseling, and management of common pregnancy-related complaints.
No structured exercise or additional psychological support was provided.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Edinburgh Postnatal Depression Scale (EPDS) score
Periodo de tiempo: Baseline (16-28 weeks of gestation), 32 weeks of gestation, and 6 months postpartum
|
Self-reported depressive symptoms measured with the 10-item EPDS (total score 0-30; higher scores indicate more depressive symptoms; >=13 indicates clinically relevant symptoms).
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Baseline (16-28 weeks of gestation), 32 weeks of gestation, and 6 months postpartum
|
|
Low back pain
Periodo de tiempo: Baseline and 32 weeks of gestation
|
Presence and severity of pregnancy-related low back pain measured with the Numeric Pain Rating Scale (0-10).
|
Baseline and 32 weeks of gestation
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Labor pain (VAS)
Periodo de tiempo: During labor / delivery
|
Pain intensity during childbirth measured with a 10-cm Visual Analog Scale (0-10), in women with vaginal delivery.
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During labor / delivery
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Dolor
- Manifestaciones neurológicas
- Desordenes mentales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Trastornos del estado de ánimo
- Dolor de espalda
- Trastornos Puerperales
- Desorden depresivo
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Lumbalgia
- El dolor del parto
- Depresión, Posparto
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Servicios de salud preventivos
- Educación para la salud
- La educación del paciente como tema
- Educación prenatal
Otros números de identificación del estudio
- GOP-CPE-PE-2021
- 2018/27 (Otro identificador: Etlik Zubeyde Hanim Women's Health Training and Research Hospital Clinical Research Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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