Depression Clinical Trial
Official title:
Exercise in Pregnancy and Risk of Postpartum Depression
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 |
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
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Gabriele Saccone | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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