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NCT Number: NCT07647809

Clinical Pilates and Prenatal Education on Perinatal Depressive Symptoms

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.

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Key information

Conditions

Postpartum Depression Back Pain Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Labor Pain Low Back Pain Mental Disorders Mood Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Related Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Etlik Zübeyde Hanım Women's Health Training and Research Hospital

Ankara, Turkey (Türkiye)

About this 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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

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

Primary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS) score

    Time frame: 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).

  2. Low back pain

    Time frame: Baseline and 32 weeks of gestation

    Presence and severity of pregnancy-related low back pain measured with the Numeric Pain Rating Scale (0-10).

Secondary outcomes

  1. Labor pain (VAS)

    Time frame: During labor / delivery

    Pain intensity during childbirth measured with a 10-cm Visual Analog Scale (0-10), in women with vaginal delivery.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

Combined Clinical Pilates Exercise and Prenatal Education and Perinatal Depressive Symptoms, Low Back Pain and Obstetric Outcomes: A Prospective Non-Randomized Controlled Study

Acronym: CPE-PE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2026
Registry last updated
Jun 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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