Cognitive Challenge for Premature Birth
(PTB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how stress and past trauma might contribute to preterm birth (having a baby earlier than 37 weeks) by studying mitochondria, tiny cell components passed from mother to child. The research will explore whether a cognitive challenge (a task requiring thinking or problem-solving) can reveal links between stress and early births, particularly in Non-Hispanic Black women, who experience higher rates of preterm birth. Healthy pregnant women with a single baby who don't smoke, drink, or take regular medications other than prenatal vitamins may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve maternal and infant health outcomes.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any regular medications, except for prenatal vitamins, to participate in this trial.
What prior data suggests that this cognitive challenge is safe?
Research shows that brain exercises and problem-solving tasks are generally safe. Studies have found that people tolerate these activities well, with very few reports of negative effects. Most participants do not experience side effects from these brain challenges.
These activities aim to stimulate the brain and often boost mental sharpness and thinking skills. No evidence suggests significant risks from participating in these exercises, making them a safe choice for those considering a clinical trial involving brain challenges.
Why are researchers excited about this trial?
Most treatments for preventing preterm birth focus on medical interventions like progesterone supplements or cervical cerclage. However, the Cognitive Challenge is unique because it targets stress-related factors that may contribute to preterm birth. Researchers are excited about this approach because it explores the connection between stress and preterm birth, potentially offering a non-medical way to address this condition. Unlike traditional treatments, the Cognitive Challenge could provide insights into how mental and emotional health influence pregnancy outcomes, paving the way for holistic care strategies.
What evidence suggests that the Cognitive Challenge is effective for reducing preterm birth risk?
Research shows that certain mental exercises can enhance brain function, potentially improving stress management. Studies have found that these exercises can increase processing speed, attention, and impulse control, all crucial for handling stress. Improved mental skills might aid in managing stress associated with preterm birth (PTB). Although the direct link between mental challenges and reduced early births remains unproven, using mental training to alleviate stress is a promising concept. This trial will investigate the "Cognitive Challenge" method to determine if it can lower the risk of early births by addressing stress.12345
Who Is on the Research Team?
Catherine Monk, PhD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 18-45 with a single baby, not on drugs or regular medications (except prenatal vitamins), and planning to deliver at CUMC. It excludes those with multiple babies, inflammatory diseases like arthritis or lupus, smokers, and alcohol drinkers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
First Trimester Assessment
Assessment of psychosocial stress, discrimination, mood, social support, hair cortisol, childhood trauma, and physiological stress reactivity
Ongoing Monitoring
Monitoring of stress levels and social support throughout pregnancy
Follow-up
Participants are monitored for safety and effectiveness after birth
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Challenge
Trial Overview
The study investigates the role of mitochondria in preterm birth by examining stress and its biological impact on mothers-to-be. The focus is on understanding how psychosocial stress might contribute to premature delivery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
New York State Psychiatric Institute
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Citations
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Ten-Year Effects of the ACTIVE Cognitive Training Trial on ...
Reasoning and speed, but not memory, training resulted in improved targeted cognitive abilities for 10 years.
Efficacy of technology-based cognitive and exercise ...
T-CEIs are effective in improving global cognition and core subdomains of cognition in individuals with MCI. This review highlights the superior effects of ...
Effects of physical activity interventions on cognitive ...
Results showed that acute interventions (n=44) significantly improved processing speed (ES=0.39), attention (ES=0.34) and, inhibition (ES=0.32).
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