DepressionNCT06355375
Exercise in Pregnancy and Risk of Postpartum Depression
A study testing exercise in pregnancy in people with Depression and Pregnancy Related, run by Federico II University at 1 site in Italy.
Trial summary
The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Depression, Pregnancy Related
- What is being tested?
- exercise in pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteItaly
- Study dates
- 22 Mar 2024to 1 Dec 2025
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton gestation
- low risk pregnancy
- age between 20 and 40
Who cannot join
- high risk pregnancy
- multiple gestation
- prior post partum depression
- any psychiatric disase
- controindication for exercise
- lung or heart disease
Show all 9Show fewer
- prior preterm birth
- IVF pregnancy
- women who already perform agonistic sport activity
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gabriele Saccone
Naples, 80100
Gabriele Saccone, 0817461111, gabriele.saccone.1990@gmail.com
About this study
The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day
Read the detailed description
The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day
- Conditions
- Depression, Pregnancy Related
- Being tested
- exercise in pregnancy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise in pregnancyBehavioural
aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| exercise | Active comparator | aerobic exercise during pregnancy Receives: Behavioral: exercise in pregnancy |
| no exercise | No intervention | no recommendation regarding exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
edinburgh depression scale
Edinburgh Postnatal Depression Scale (EDPS)
Measured: 3 months after delivery
Secondary outcomes (2)
Postpartum depression
DSM-5 (SCID-5)
Measured: 3 months after delivery
preterm birth
defined as delivery before 37 weeks of gestation
Measured: 37 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start22 Mar 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exercise during pregnancy
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355375
- Sponsor's protocol ID
- 02.24
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saccone G, Perrino C, Bardi L, Fico V, Ilardi F, Motta M, Sarno L, Di Spiezio Sardo A, Esposito G, Bifulco G. Exercise in pregnancy and maternal cardiovascular changes. BMC Pregnancy Childbirth. 2026 Jan 13;26(1):177. doi: 10.1186/s12884-026-08637-w.
PubMed 41527031Saccone G, Buonomo G, Ammendola A, Bardi L, Motta M, Gragnano E, Locci M. Exercise in Pregnancy and Risk of Postpartum Depression: A Randomised Controlled Trial. BJOG. 2026 Jan;133(2):211-217. doi: 10.1111/1471-0528.70010. Epub 2025 Sep 21.
PubMed 40976261
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Pregnancy and Risk of Postpartum Depression
- ClinicalTrials.gov ID
- NCT06355375
- Acronym / sponsor ID
- 02.24
- Conditions
- Depression, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Apr 2024 (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.
The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day
Detailed description
The prevalence of postpartum depression (PPD) varies between 11.9% and 19.2% during the perinatal period. PPD refers to minor and major depression incidents that occur during pregnancy or shortly after (up until 12 months after birth). The symptoms of PPD embrace feeling sad or having a depressed mood, being uninterested in the new-born, unreasonable crying and fear of injuring or harming the baby. Consequently, PPD can negatively impact the mother's well-being and the baby's development. The impact on a child can be short for cognitive and motor development . Although medication is a feasible alternative, many women have constraints due to continuing breastfeeding. Therefore, exercise can be an alternative that could help to deal with PPD. Exercise can be used as a preventive or treatment of mild depression at an early stage and as an addition to a treatment plan for major depressive disorder. Exercising during pregnancy and postpartum improves psychological health and also benefits physical fitness, weight gain control and the prevention or reduction of musculoskeletal discomfort and pain. Therefore, the American College of Obstetrics and Gynaecologists has recommended that women during pregnancy and postpartum engage in moderate-intensity physical activity almost every day for 30 min a day
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exercise during pregnancy
| Arm | Type | Receives |
|---|---|---|
| exercise | Active comparator | Behavioral: exercise in pregnancyaerobic exercise during pregnancy |
| no exercise | No intervention | –no recommendation regarding exercise |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- singleton gestation
- low risk pregnancy
- age between 20 and 40
Key exclusion criteria (9 listed)
- high risk pregnancy
- multiple gestation
- prior post partum depression
- any psychiatric disase
- controindication for exercise
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 |
|---|---|---|
| exercise in pregnancyaerobic exercise | Behavioural | exercise |
Primary outcome
edinburgh depression scale
Time frame: 3 months after delivery
Edinburgh Postnatal Depression Scale (EDPS)
2 secondary outcomes
Postpartum depression
Time frame: 3 months after delivery
preterm birth
Time frame: 37 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 41527031Saccone G, Perrino C, Bardi L, Fico V, Ilardi F, Motta M, Sarno L, Di Spiezio Sardo A, Esposito G, Bifulco G. Exercise in pregnancy and maternal cardiovascular changes. BMC Pregnancy Childbirth. 2026 Jan 13;26(1):177. doi: 10.1186/s12884-026-08637-w.
- Derived from this study: PubMed 40976261Saccone G, Buonomo G, Ammendola A, Bardi L, Motta M, Gragnano E, Locci M. Exercise in Pregnancy and Risk of Postpartum Depression: A Randomised Controlled Trial. BJOG. 2026 Jan;133(2):211-217. doi: 10.1111/1471-0528.70010. Epub 2025 Sep 21.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in pregnancy in people with Depression and Pregnancy Related, run by Federico II University at 1 site in Italy.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriele Saccone, MD (3394685179, gabriele.saccone.1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
edinburgh depression scale (time frame: 3 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06355375, which also lists 2 linked publications.
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 9 Apr 2024.