Exercise in Pregnancy and Risk of Postpartum Depression

NCT ID: NCT06355375

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-22

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Exercise during pregnancy
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

exercise

aerobic exercise during pregnancy

Group Type ACTIVE_COMPARATOR

exercise in pregnancy

Intervention Type BEHAVIORAL

aerobic exercise

no exercise

no recommendation regarding exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exercise in pregnancy

aerobic exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* singleton gestation
* low risk pregnancy
* age between 20 and 40

Exclusion Criteria

* high risk pregnancy
* multiple gestation
* prior post partum depression
* any psychiatric disase
* controindication for exercise
* lung or heart disease
* prior preterm birth
* IVF pregnancy
* women who already perform agonistic sport activity
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federico II University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gabriele Saccone

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gabriele Saccone

Naples, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gabriele Saccone, MD

Role: CONTACT

3394685179

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gabriele Saccone

Role: primary

0817461111

References

Explore related publications, articles, or registry entries linked to this study.

Saccone 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. 2025 Sep 21. doi: 10.1111/1471-0528.70010. Online ahead of print.

Reference Type DERIVED
PMID: 40976261 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

02.24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Postpartum Depression
NCT05595512 COMPLETED
Prenatal Yoga to Prevent Postpartum Depression
NCT06004232 ACTIVE_NOT_RECRUITING NA