Mental and emotional health care for pregnant women during COVID-19
Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After COVID-19
This study is testing whether a moderate exercise program can help pregnant women feel better mentally and physically during and after the COVID-19 pandemic.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Universidad Politecnica de Madrid Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05295264 on ClinicalTrials.gov |
What this trial studies
This study focuses on providing mental and emotional health support to pregnant women during and after the COVID-19 pandemic. It aims to address the increased prevalence of stress, anxiety, and depression among pregnant individuals due to the pandemic's impact on their lifestyle and social support. Participants will engage in a moderate exercise program designed to enhance their physical activity levels, which is crucial for both maternal and fetal health. The study will assess the effectiveness of this intervention in improving mental wellness and overall health outcomes for mothers and their newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old with singleton pregnancies who are planning to manage their delivery at the participating hospitals.
Not a fit: Patients with absolute contraindications to exercise or those with serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental and emotional well-being of pregnant women, leading to better health outcomes for both mothers and their babies.
How similar studies have performed: Other studies have shown success in using physical activity interventions to improve mental health outcomes in pregnant women, suggesting that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Pregnant women fulfilling the following criteria: \>18 years old, singleton pregnancies and planning management and delivery at the research hospitals, and also do not participate in any other program of supervised physical exercise. Exclusion Criteria: Women with absolute contraindications. Women with relative contraindications need permission from obstetric care providers prior to participation: Absolute contraindications to exercise: * Ruptured membranes. * Premature labor. * Unexplained persistent vaginal bleeding. * Placenta praevia after 28 weeks gestation. * Pre-eclampsia. * Incompetent cervix. * Intrauterine growth restriction. * High-order multiple pregnancies (eg, triplets). * Uncontrolled type I diabetes. * Uncontrolled hypertension. * Uncontrolled thyroid disease. * Other serious cardiovascular, respiratory, or systemic disorders. Relative contraindications to exercise: * Recurrent pregnancy loss. * Gestational hypertension. * A history of spontaneous preterm birth. * Mild/moderate cardiovascular or respiratory disease. * Symptomatic anemia. * Malnutrition. * Eating disorder. * Twin pregnancy after the 28th week. * Other significant medical conditions. Women in the CG were asked about their exercise once each trimester using a "Decision Algorithm" and those who are excessively actives were excluded.
Where this trial is running
Madrid
- Facultad de Ciencias de la Actividad Física y el Deporte - INEF — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Cristina Silva-Jose, Msc
- Email: cristina.silva.jose@upm.es
- Phone: 662556019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.