No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
240 (estimated)
Sponsor
Tulane University · Other
Who this trial is looking for
This trial is looking for pregnant women who are under 20 weeks along and have received prenatal care. Participants will attend classes aimed at improving mental health after experiencing a natural disaster.
Are You a Good Fit for This Trial?
You may be able to join if
I am pregnant
I am under 20 weeks' gestation
I am enrolled in prenatal care
You may not be able to join if
I am not pregnant
I am under age 18
I do not speak English or Spanish
I do not plan to carry my pregnancy to term
I do not plan to stay in the study area through my pregnancy
My baby has fetal defects likely to lead to death or extensive hospitalization postpartum
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 complicat…
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.
Trial Locations
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City
State
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Status
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 lea…
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
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