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| ID | Type | Description | Link |
|---|---|---|---|
| 2018/27 | Other Identifier | Etlik Zubeyde Hanim Women's Health Training and Research Hospital Clinical Research Ethics Committee |
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This study evaluated whether a combined program of supervised Clinical Pilates Exercise and structured Prenatal Education, added to routine antenatal care, reduces perinatal depressive symptoms compared with routine antenatal care alone in nulliparous pregnant women. Secondary aims were to assess effects on pregnancy-related low back pain, labor pain, and obstetric outcomes. Allocation to the two groups was based on participants' availability to attend the program rather than on randomization; the study is therefore a non-randomized (quasi-experimental) controlled study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Pilates Exercise + Prenatal Education | Experimental | 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 |
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| Routine Antenatal Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Pilates Exercise | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Edinburgh Postnatal Depression Scale (EPDS) score | 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). | Baseline (16-28 weeks of gestation), 32 weeks of gestation, and 6 months postpartum |
| Low back pain | Presence and severity of pregnancy-related low back pain measured with the Numeric Pain Rating Scale (0-10). | Baseline and 32 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Labor pain (VAS) | Pain intensity during childbirth measured with a 10-cm Visual Analog Scale (0-10), in women with vaginal delivery. | During labor / delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etlik Zübeyde Hanım Women's Health Training and Research Hospital | Ankara | Turkey (Türkiye) |
De-identified participant data are available in the Zenodo repository.
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D017116 | Low Back Pain |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D064186 | Prenatal Education |
| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
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| Prenatal Education | Behavioral | 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 |
|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 |
| Health Care Facilities Workforce and Services |