NCT05838404 M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy
| NCT ID | NCT05838404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tulane University |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2023-11-01 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and communities. Trauma and severe stress are directly linked to pregnancy complications, and raise blood pressure during pregnancy, alter stress hormones, and increase vulnerability to infection, all of which predispose to reduced fetal growth and preterm birth. Disasters also worsen mental health, and depression during pregnancy and postpartum, for instance, is associated with worse physical health during pregnancy, maternal impairment, poorer quality parenting, negative child behavior, and poorer infant cognitive development.The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region. The main questions this intervention aims to answer are: * Assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, and sustainability) of a pilot intervention in a disaster recovery environment. * Assess the effectiveness of the M-O-M-S pilot intervention in a disaster recovery environment. The study will recruit pregnant women in areas that have experienced a natural disaster. Women will be recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a "mentor," a mother who has experienced pregnancy, labor, and motherhood.
Eligibility Criteria
Inclusion Criteria: * Pregnant * Below 20 weeks' gestation * Enrolled in prenatal care Exclusion Criteria: * Not pregnant * Under age 18 * Does not speak English or Spanish * Does not plan to carry to term * Does not plan to remain in the study area through pregnancy * Fetal defects likely to lead to death or extensive hospitalization postpartum
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05838404 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05838404 currently recruiting?
Yes, NCT05838404 is actively recruiting participants. Contact the research team at eharvill@tulane.edu for enrollment information.
Where is the NCT05838404 trial being conducted?
This trial is being conducted at New Orleans, United States.
Who is sponsoring the NCT05838404 clinical trial?
NCT05838404 is sponsored by Tulane University. The trial plans to enroll 240 participants.
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