Exercise in Pregnancy and Risk of Postpartum Depression

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 Overview

• Status: Recruiting
• Conditions: Depression; Pregnancy Related
• Intervention / Treatment: Behavioral: exercise in pregnancy

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 Type: Interventional
• Enrollment (Estimated): 398
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriele Saccone, MD; Phone Number: 3394685179; Email: gabriele.saccone.1990@gmail.com

Study Locations

• Italy
  • Naples, Italy, 80100
    • Recruiting
    • Gabriele Saccone
    • Contact: Gabriele Saccone; Phone Number: 0817461111; Email: gabriele.saccone.1990@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: exercise; aerobic exercise during pregnancy	Behavioral: exercise in pregnancy; aerobic exercise
No Intervention: no exercise; no recommendation regarding exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
edinburgh depression scale	Edinburgh Postnatal Depression Scale (EDPS)	3 months after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum depression	DSM-5 (SCID-5)	3 months after delivery
preterm birth	defined as delivery before 37 weeks of gestation	37 weeks of gestation

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 02.24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No