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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06355375
Other study ID # 02.24
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 22, 2024
Est. completion date December 1, 2025

Study information

Verified date April 2024
Source Federico II University
Contact Gabriele Saccone, MD
Phone 3394685179
Email gabriele.saccone.1990@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 398
Est. completion date December 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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

Study Design


Intervention

Behavioral:
exercise in pregnancy
aerobic exercise

Locations

Country Name City State
Italy Gabriele Saccone Naples

Sponsors (1)

Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary edinburgh depression scale Edinburgh Postnatal Depression Scale (EDPS) 3 months after delivery
Secondary Postpartum depression DSM-5 (SCID-5) 3 months after delivery
Secondary preterm birth defined as delivery before 37 weeks of gestation 37 weeks of gestation
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