Exercise in Pregnancy and Risk of Postpartum Depression

NCT06355375 | Recruiting

• 1 other identifier: 02.24
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• edinburgh depression scale

  Edinburgh Postnatal Depression Scale (EDPS)

  3 months after delivery

Secondary Outcomes (2)

• Postpartum depression

  3 months after delivery

• preterm birth

  37 weeks of gestation

Study Arms (2)

exercise

ACTIVE COMPARATOR

aerobic exercise during pregnancy

Behavioral: exercise in pregnancy

no exercise

NO INTERVENTION

no recommendation regarding exercise

Interventions

exercise in pregnancy BEHAVIORAL

aerobic exercise

exercise

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Gabriele Saccone

Naples, 80100, Italy

RECRUITING

Related Publications (1)

• 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. 2026 Jan;133(2):211-217. doi: 10.1111/1471-0528.70010. Epub 2025 Sep 21.

  PMID: 40976261 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Exercise; Pregnancy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Central Study Contacts

Gabriele Saccone, MD

CONTACT

3394685179; gabriele.saccone.1990@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Exercise during pregnancy

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 9, 2024
• Study Start: March 22, 2024
• Primary Completion: January 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)