Postpartum DepressionCPE-PENCT07647809
Clinical Pilates and Prenatal Education on Perinatal Depressive Symptoms
A study testing Clinical Pilates Exercise and Prenatal Education in people with Postpartum Depression and Pregnancy Related, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Pregnancy Related, Low Back Pain
- What is being tested?
- Clinical Pilates Exercise and Prenatal Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Jun 2022
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous
- Singleton pregnancy
- Gestational age 16-28 weeks at enrollment
- Age 18-35 years
- Pre-pregnancy body mass index < 30 kg/m2
Who cannot join
- Multiple pregnancy
- Systemic disease, including diabetes mellitus, hypertension, or cardiovascular disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik Zübeyde Hanım Women's Health Training and Research Hospital
Ankara
About this study
Official title: Combined Clinical Pilates Exercise and Prenatal Education and Perinatal Depressive Symptoms, Low Back Pain and Obstetric Outcomes: A Prospective Non-Randomized Controlled Study
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.
Read the detailed description
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.
- Conditions
- Postpartum Depression, Pregnancy Related, Low Back Pain, Labor Pain
- Being tested
- Clinical Pilates Exercise, Prenatal Education
- Keywords
- clinical pilates, prenatal education, perinatal depression, EPDS, antenatal exercise
- Medical subject headings
- Depression, Postpartum, Low Back Pain, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pilates ExerciseBehavioural
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 EducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Clinical Pilates Exercise; Behavioral: Prenatal Education |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and 32 weeks of gestation
Secondary outcomes (1)
Labor pain (VAS)
Pain intensity during childbirth measured with a 10-cm Visual Analog Scale (0-10), in women with vaginal delivery.
Measured: During labor / delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jan 2021
- Primary completion10 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DepressionStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Alperen Aksan, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647809
- Sponsor's protocol ID
- GOP-CPE-PE-2021
- Other IDs
- 2018/27
- Acronym
- CPE-PE
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data are available in the Zenodo repository.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Clinical Pilates Exercise and Prenatal Education and Perinatal Depressive Symptoms, Low Back Pain and Obstetric Outcomes: A Prospective Non-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07647809
- Acronym / sponsor ID
- CPE-PE / GOP-CPE-PE-2021
- Conditions
- Postpartum Depression, Pregnancy Related, Low Back Pain, Labor Pain
- Keywords
- clinical pilates, prenatal education, perinatal depression, EPDS, antenatal exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 Jun 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 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Pilates Exercise + Prenatal Education | Experimental | Behavioral: Clinical Pilates Exercise, Behavioral: Prenatal EducationSupervised 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 |
| 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Nulliparous
- Singleton pregnancy
- Gestational age 16-28 weeks at enrollment
- Age 18-35 years
- Pre-pregnancy body mass index < 30 kg/m2
Key exclusion criteria (2 listed)
- Multiple pregnancy
- Systemic disease, including diabetes mellitus, hypertension, or cardiovascular disorders
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 |
|---|---|---|
| Clinical Pilates ExerciseSupervised, 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 | Behavioural | Clinical Pilates Exercise + Prenatal Education |
| Prenatal EducationStructured 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 | Behavioural | Clinical Pilates Exercise + Prenatal Education |
Primary outcome
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).
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).
1 secondary outcome
Labor pain (VAS)
Time frame: During labor / delivery
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 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified participant data are available in the Zenodo repository.
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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 Clinical Pilates Exercise and Prenatal Education in people with Postpartum Depression and Pregnancy Related, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 2 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 Jun 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 Turkey (Türkiye). 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?
Edinburgh Postnatal Depression Scale (EPDS) score (time frame: Baseline (16-28 weeks of gestation), 32 weeks of gestation, and 6 months postpartum). The study lists 2 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 Jun 2026.