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41 Prenatal Disorder Trials Near You
Power is an online platform that helps thousands of Prenatal Disorder patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerBabies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:DiGeorge Syndrome, Untreated Psychiatric, Others
50 Participants Needed
AI Chatbot for Prenatal Disorder
Cleveland, Ohio
The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \& Diagnostic Testing (PS\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\&D and decreases decisional conflict associated with those decisions.
Using data from NEST (Ensuring Patients Informed Access to NIPT \[non-invasive prenatal testing\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\&D options, and resources to learn about insurance coverage for PS\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Under 18, Not Pregnant, Others
600 Participants Needed
Prenatal Yoga for Postpartum Depression
Detroit, Michigan
Although psychological interventions exist for the prevention of PPD, a yoga-based intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation (i.e., mindfulness), may be more acceptable to women of minority status, and may confer additional physical activity benefits. The purpose of this pilot study is to determine the effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of PPD among at-risk women in a diverse health care system and explore preliminary factors which influence implementation of the intervention. This study has 2 phases: Phase 1 will evaluate facilitators and barriers to intervention implementation among patient, clinician, and health system stakeholders, followed by an open trial, and Phase 2 will include conducting an 8-session pilot randomized controlled trial to assess the feasibility and acceptability of the proposed prenatal yoga intervention among women with a history of depression, as well as the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize delivery of a yoga intervention within a healthcare system to prevent PPD through examining facilitators and barriers of implementation, 2) Examine feasibility, acceptability and satisfaction of the intervention within a health care system, and 3) Evaluate preliminary effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus groups with patient stakeholders and clinician and administrative stakeholders will inform intervention implementation, and an open trial to refine and optimize the intervention. For Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the intervention will be feasible and acceptable, engage women of racial/ethnic minority status, and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed mediators. Knowledge gained from this study can support prevention efforts for PPD and improve the adverse public health impact of this disorder.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Exercise Restrictions
62 Participants Needed
Chronotherapy for Perinatal Depression
Charlottesville, Virginia
This trial tests if adding light exposure and a set sleep routine to regular care can reduce depression and anxiety in pregnant women. It targets women aged 18-40 in late pregnancy who have depression. The treatment aims to adjust the body's natural rhythms and stabilize sleep patterns to improve mood. Light exposure is a promising treatment for depression during pregnancy, being easily accessible, effective, affordable, and safe for both mother and child.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychosis, Bipolar, Seizure, Migraines, Others
Must Not Be Taking:Photosensitizing Medications
158 Participants Needed
Educational Game vs Genetic Counseling for Prenatal Screening Education
Chapel Hill, North Carolina
Advancements in prenatal genetic screening have significantly improved the identification of chromosomal abnormalities and heritable conditions during pregnancy, yet current standards for patient education in this domain are largely ineffective. The most effective approach to education about prenatal screening is one-on-one genetic counseling, but due to the limited number of counselors this is not feasible, especially in rural and frontier areas. The investigators will address this national problem using a novel education game that can more effectively address this gap in healthcare decision-making.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Previous Prenatal Screening, Genetic Counseling, Others
1125 Participants Needed
Transcranial Alternating Current Stimulation for Prenatal Depression
Chapel Hill, North Carolina
The purpose of this study is to develop the safety, feasibility, and tolerability of a personalized transcranial alternating current stimulation (tACS) approach in antenatal depression.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Diabetes, Hypertension, Others
Must Not Be Taking:Psychotropics, Neurostimulation
10 Participants Needed
Prenatal Support Program for Premature Birth
Chapel Hill, North Carolina
The goal of this clinical trial is to learn if a personalized prenatal support program \[(Personalized Toolkit Building a Comprehensive Approach to Resource optimization and Empowerment in Pregnancy \& Beyond, (PTBCARE+)\] works to lower stress and lower the risk of early delivery in pregnant individuals at high-risk for delivering preterm. The main question\[s\] it aims to answer are:
* Does the PTBCARE+ patient support program lower patient-reported stress levels during pregnancy?
* Does the PTBCARE+ patient support program improve biologic measures of stress during pregnancy?
* Does the PTBCARE+ patient support program result in a higher chance of delivering a healthy baby at or close to full term?
Researchers will compare people who participate in the PTBCARE+ patient support program to those receive usual care to see if the PTBCARE+ patient support program lowers patient-reported stress, improves biologic measures of stress, and increases the chance of delivering a healthy baby at or close to full term.
Participants will be randomly assigned to receive the PTBCARE+ patient support program or usual prenatal care.
All participants will be asked to:
* complete 2 study visits during pregnancy - including completing electronic surveys, providing a blood and urine sample, measuring the heart rate variability by a clip or the ear or finger, and body composition evaluation using a simple scale-like device.
* complete one study visit postpartum that includes completing electronic surveys, and measuring heart rate variability. Blood and urine sample collection and body composition evaluation via InBody scale are optional at the postpartum visit.
People who are randomly assigned to receive the PTBCARE+ support program will receive several resources to help them during pregnancy. These things include items such as:
* a stress reduction toolkit;
* access to an online website that can also be downloaded as a smart phone app;
* the option to receive an electronic massage while in clinic, and more.
* additional support gifts provided at routine clinical appointments
People who are randomly assigned to receive usual prenatal care will not receive any additional support resources from the study during pregnancy.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Illicit Drug Use, Radical Trachelectomy, Major Congenital Anomaly, Others
1228 Participants Needed
STAC Intervention for Health Equity
Madison, Wisconsin
This study is being done to adapt the Staying Healthy After Childbirth (STAC) intervention for implementation among Black Women and Birthing Persons (WBP).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Heart Disease, Heart Failure, Others
Must Not Be Taking:Antihypertensives
36 Participants Needed
PALS Program for Developmental Delay
Burlington, Vermont
The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 7
Key Eligibility Criteria
Disqualifiers:Illicit Drug Use, Major Birth Defects, Others
Must Not Be Taking:Opiates, Heroin, Cocaine, Others
20 Participants Needed
Prenatal Screening for Down Syndrome and Chromosomal Anomalies
Montreal, Quebec
This project aims to provide high- quality evidence to inform decisions by health care organisations about using first-tier non-invasive prenatal screening (NIPS) to replace traditional screening tests for trisomy 21, and potentially to screen for other fetal chromosome anomalies. We will compare the current screening approach of second-tier NIPS with the use of first-tier NIPS in a large cohort of pregnant women.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:19+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Fetal Anomaly, Multiple Gestation, Others
7849 Participants Needed
Genetic Counseling for Inherited Disorders
Minneapolis, Minnesota
The goal of the GC-PRO study is to try to make genetic counseling better for people of all backgrounds. We are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. The purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. The research team is also working with partners from the Somali, Latino/Hispanic, Black/African American, and Hmong communities to make sure the research is being done in a way that will benefit underserved communities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Unable To Provide Consent, Others
994 Participants Needed
In-Person vs. Virtual Therapy for Postpartum Depression
Denver, Colorado
The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
900 Participants Needed
Prenatal Education for Postpartum PTSD
San Diego, California
The goal of this randomized controlled trial is determine if education on common events in labor in nulliparous women can reduce the postpartum traumatic symptoms. The main question it aims to answer are:
* Does prenatal education on labor events reduce post-traumatic symptoms, as measured by thePost Traumatic Stress Disorder Cecklist for Diagnostic and Statistical Manual for Mental Health Disorders (PCL-5) at 6 weeks postpartum?
* Does prenatal education on labor affect labor outcomes?
Participants will be given surveys:
* At enrollment on mental health and previous traumatic experiences
* After education on expectations on childbirth
* After delivery on experience of childbirth
* At 6 weeks and 6 months postpartum on traumatic symptoms and mental health outcomes.
They will also have the option to participate in collection of discarded cerebrospinal fluid, blood and serum and physiologic sensitivity testing.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 51
Sex:Female
Key Eligibility Criteria
Disqualifiers:Prenatal Care Outside UCSD, Others
400 Participants Needed
Trigeminal Nerve Stimulation for ADHD
Los Angeles, California
This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE). TNS has been successful in treating pediatric ADHD generally and it is US Food and Drug Administration (FDA)-cleared for this condition. But this will be the first time it is tried for ADHD specifically associated with PAE. In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS is administered at home by the parent to the child. TNS is safe and well tolerated. Efficacy of TNS in ADHD is \~50%. The purpose of the present pilot study is to determine the feasibility of TNS for children with PAE and ADHD. Feasibility means safety (any serious side effects?), tolerability (do children comply with TNS? are they comfortable with it?), and a rough idea of efficacy (does TNS seem to work in most kids?) A secondary goal of the study is to get a more precise idea of brain mechanisms of TNS with magnetic resonance imaging (MRI). Families who participate will make three clinic visits: eligibility (4-5 hours), pre-TNS (2-3 hours including MRI), and post-TNS (2-3 hours including MRI). Children will receive TNS, applied by the parent, for 8 hours every night while sleeping for 4 weeks. Four weeks after treatment, families will take part in a telephone follow-up, to see whether any improvements made last.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12
Key Eligibility Criteria
Disqualifiers:Genetic Syndromes, Serious Illness, Autism, Others
30 Participants Needed
Families Moving Forward Bridges for FASD
Shoreline, Washington
This is an unblinded, feasibility study of an adapted positive parenting intervention to be carried out in a small sample (n=12 dyads) of young children with FASD and their primary caregiver in King County, WA.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:6+
Key Eligibility Criteria
Disqualifiers:Visual Impairment, Hearing Impairment, Seizures, Others
24 Participants Needed
Mom Power for Opioid Use Disorder
Ann Arbor, Michigan
Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. This interdisciplinary multisite project will begin with the high risk R61 phase, in which the investigators will administer the parenting intervention "Mom Power" to mothers with OUD during the first 6 months postpartum and look for effects on drug use, mood and brain mechanisms; and, If validated, the investigators will continue in the R33 with more brain mechanism investigation and outcome studies a larger sample. The completion of this grant will clarify the effects of parenting intervention for mothers with OUD, and yield brain-based biomarkers that may be connected with inexpensive measures toward improved treatment of families suffering OUD, their children and society - which ultimately bears much of the cost for the common trans-generational problems of peripartum drug use.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Suicidal Risk, Psychosis, Neurological Condition, Others
Must Be Taking:Buprenorphine, Methadone
50 Participants Needed
This study tests the efficacy of interpersonal psychotherapy (IPT) for major depression following perinatal loss (early and late fetal death and early neonatal death) in a sample of 274 women in Flint and Detroit, Michigan. The trial will be the first fully powered randomized trial of treatment for any psychiatric disorder following perinatal loss.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Schizophrenia, Substance Use, Others
Must Not Be Taking:Antidepressants
200 Participants Needed
ROSE Program for Preventing Postpartum Depression
Chicago, Illinois
The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression.
Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Major Depressive Episode, Substance Use Disorder, Others
76 Participants Needed
Baby2Home Mobile Application for Mental Health Wellness
Chicago, Illinois
This trial tests Baby2Home, a digital program to help new parents and their babies. It aims to improve health outcomes and reduce disparities for families affected by COVID-19. The program provides education, wellness tracking, mental health support, and regular check-ins.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Severe Mental Illness, NICU, Others
642 Participants Needed
Brief Behavioral Activation Treatment for Postpartum Depression
Evanston, Illinois
SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
1230 Participants Needed
Why Other Patients Applied
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
Perinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically, the microbial composition of the gut along with their metabolites are directly involved in disease onset and course. Recent clinical studies have identified diet as the most powerful environmental factor in manipulating gut microbiome. Given vulnerability and resistance of pregnant women to pharmacotherapy, particularly in those with a predisposition to mood disorders, as well as pregnant women's high motivation and commitment to improving gestational diet, a dietary/supplemental intervention to 'optimize' gut microbiome, is a favored approach in disease management. The study investigators aim to exploit microbial responsiveness to diet together with this maternal motivation, to alter the risk and severity of a universal public health concern that has dire and long-term consequences for new moms and their children.
The investigators of this trial, will first study the challenges in pursuing a study aimed at changing the microbiome of pregnant women with a history of mood disorders. Pregnant women in their second trimester will be recruited. Each will be assigned or randomized to one of four groups that will use a combination of diet, supplementation with probiotics, fish oil or no intervention. Each participant will meet with the study team virtually every 3 months until 1 year after delivery. At each study visit participants will be required to complete some questionnaires about their food intake, mood, and other health related measures and will provide a stool sample using the stool collection kits provided.
The findings from this study will help strategize for a larger study that will allow for comparison of the effects of diet, and/or supplementation with Omega-3 Fatty Acids (O3FA) and probiotics on the microbiome and the onset and severity of PDA.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:18 - 43
Sex:Female
Key Eligibility Criteria
Disqualifiers:Bipolar, Psychosis, Schizophrenia, Others
100 Participants Needed
Group Prenatal Care for Depression During Pregnancy
Saint Louis, Missouri
This study will provide high-quality, representative data on the capacity of Elevating Voices, Addressing Depression, Toxic Stress and Equity in Group Prenatal Care (EleVATE GC) to reduce perinatal depression, preterm birth, and low birthweight in African-American women. If findings from this study indicate that EleVATE GC is feasible and effective, this model could be implemented nationwide to help achieve mental and obstetric health parity for low-income women of color in the United States.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:13+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Multiple Gestation, Major Fetal Anomaly, Serious Medical/psychiatric Illness, Others
390 Participants Needed
Penny COPILOT for Opioid Use Disorder
Philadelphia, Pennsylvania
To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. The newly adapted chatbot, Penny COPILOT, will allow for two way short message service (SMS) messaging to respond appropriately and accurately to user generated input. The investigative team, in collaboration with the Penn Mixed Methods Research Lab (MMRL) and Penn's Way 2 Health Team, will use intervention mapping guided by the Consolidated Framework for Implementation Science. The investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction. The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care and decrease perceived loneliness.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Untreated Psychosis, Mania, Suicidality
Must Be Taking:Opioid Treatments
20 Participants Needed
Cognitive Behavioral Skills App for Perinatal Mood Management
New York, New York
This trial tests a new mobile app designed to help pregnant and postpartum individuals manage mood, anxiety, and stress. The app uses cognitive behavioral therapy techniques to teach users helpful skills. The study aims to see if the app is easy to use and effective for this group. Mobile cognitive behavioral therapy (CBT) has been shown to be effective in managing postpartum depression and reducing the occurrence of depression among pregnant and postpartum women.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Substance Use Disorder, Bipolar, Psychosis, Others
50 Participants Needed
CARE Program for Postpartum Mental Health
Bronx, New York
This trial is testing a group therapy program called CARE for parents with postpartum depression or anxiety. The program helps parents understand their own and their baby's thoughts and feelings to improve mental health and reduce stress. The study targets parents with infants aged 3 to 12 months who are receiving care at Montefiore Medical Center.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychosis, Mania, Severe Cognitive Impairment, Others
21 Participants Needed
Health at Every Size for Obesity
Worcester, Massachusetts
Perinatal mental health disorders occur in 1 in 5 pregnancies and have significant negative intergenerational consequences including being the leading cause of overall and preventable mortality during pregnancy and the first year postpartum. Perinatal mental health disorders impact not only the individual but can also have adverse effects on immediate and long-term child and family wellbeing. Untreated mental health disorders in pregnancy are associated with preterm birth, low birth weight, impaired bonding and lead to issues with neonatal neurodevelopment. Interventions to prevent perinatal mental health disorders are of the utmost importance in helping to improve maternal and child health outcomes in the United States.
In Massachusetts, almost a quarter of pregnant people have a BMI \>30 kg/m2. Rates of perinatal mental health disorders are higher among individuals with elevated body mass index (BMI) \> 30 kg/m2 compared to people with BMI \< 30 kg/m2. People with BMI \> 30 are 50% more likely to have antenatal depression, 40% more likely to have postpartum depression, and 25% more likely to develop postpartum anxiety compared to those with BMI \<30 kg/m2. The etiology for the increased risk for perinatal mental health disorders among persons with a higher BMI has not been extensively investigated. However, some postulate this could be due to an increase in the medicalization of pregnancy, along with complications for the birthing person or with fetal/neonatal health. Over the last few years, some researchers have begun to hypothesize that weight stigma may also play a significant role in the development of perinatal mental health disorders in this population.
Weight stigma - the social rejection and devaluing of people who live in bodies which do not conform to the societal standards of weight - is associated with the development of depression among people with BMI \>30. Weight stigma has been demonstrated through many fields of healthcare. Many providers hold beliefs regarding people with elevated BMIs, including that they are lazy and unintelligent. Providers may also blame individuals for their medical complications and are less likely to offer them interventions including surgery. This leads to worse outcomes and people avoiding care. Additionally, external weight stigma can lead to weight bias internalization, where individuals accept and self-direct negative stereotypes toward themselves.
Weight stigma leads to a cycle of internalized bias which is then compounded by traumatic experiences of stigmatization by healthcare providers. This may lead patients to avoid care and be at increased risk for adverse health outcomes (include adverse mental health outcomes). In fact, the American Association of Endocrinology recommends incorporating the experience of bias and stigmatization into the diagnosis and staging of obesity. Therefore, one could postulate that weight stigma and weight bias internalization likely contribute to the high prevalence of perinatal mental health conditions among individuals with elevated BMI.
In order to combat weight stigma and weight bias internalization in people seeking healthcare, the Association for Size Diversity and Health created the Health at Every Size (HAES) intervention. HAES characterizes health as a continuum that is specific to the individual and varies with time and circumstance. HAES has five principles including weight inclusivity, health enhancement, eating for well-being, respectful care, and life enhancing movement. Previously studied HAES interventions consist of a number of group sessions led by trained clinicians that are based on these principles. The sessions range in topics from nutrition, physical activity, self-efficacy and acceptance in order to decrease internalization of weight bias.
Previous data from the primary care literature demonstrates the efficacy of HAES interventions on improving overall well-being, decreasing rates of depression and other mental health disorder symptoms, and even in improving cardiovascular and lipid profiles.
Despite these findings, HAES has not yet been adapted for use in an obstetric context despite the traditional model for prenatal care being highly focused on weight. Patients are weighed at each prenatal visit, and the amount of "appropriate" weight gain is calculated based on BMI. People with an elevated BMI receive extra laboratory testing, ultrasounds and fetal monitoring. This almost extreme perseverance on weight during pregnancy causes individuals in larger bodies to experience significant weight stigma during their prenatal care.
Obstetric providers and perinatal people are interested in interventions to assist in the provision of sensitive care for people who experience weight stigma. This project aims to utilize patient and expert input to adapt a HAES intervention to an obstetric context (OB-HAES).
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Pregnant, Others
10 Participants Needed
Mindfulness Training for Postpartum Depression
Providence, Rhode Island
Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Dispositional optimism is malleable, although prior interventions have been time and resource intensive and thus are not well-tailored to the peripartum period. The purpose of this pilot study is to evaluate the feasibility and acceptability of a pregnancy-oriented mindfulness phone application (Expectful) versus standard care among first-time mothers with low dispositional optimism in early pregnancy. Other aims include evaluating the impact of Expectful use on dispositional optimism, adverse pregnancy outcomes (cesarean delivery, hypertensive disorders of pregnancy, and gestational diabetes) and postpartum post-traumatic stress symptoms.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Mind-body Practice, Hypertension, Diabetes, Others
100 Participants Needed
App-Based CBT for Postpartum Depression
Providence, Rhode Island
Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers \& Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 60
Sex:Female
Key Eligibility Criteria
Disqualifiers:Depression, Anxiety, Psychiatric Conditions, Others
90 Participants Needed
WET + EFST for PTSD During Pregnancy
Boston, Massachusetts
The majority of women with perinatal posttraumatic stress disorder (PTSD) do not receive mental health treatment despite the documented associations between PTSD and adverse pregnancy outcomes; this is likely due to workforce shortages, lack of data on the effectiveness of existing evidence-based treatment for PTSD in usual care obstetrics settings, and patient-level barriers to engagement such as stigma. The proposed study is a randomized controlled trial, which will examine the effectiveness of a brief evidence-based treatment for PTSD (i.e., Written Exposure Therapy) during pregnancy and the non-inferiority of delivery of this treatment by community health workers vs. delivery by mental health clinicians.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychosis, Unstable Bipolar, Incarceration, Others
240 Participants Needed
Accelerated TMS for Postpartum Depression
Boston, Massachusetts
We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals. TMS is a focal, non-invasive form of brain stimulation that is cleared by the Food and Drug Administration for depression. Typically, traditional TMS involves daily treatments for 6-8 weeks. In this study, we will offer an accelerated form of TMS that involves multiple daily treatments for 5 days.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 55
Sex:Female
Key Eligibility Criteria
Disqualifiers:Preeclampsia, Neurosurgical Intervention, Others
Must Not Be Taking:Ketamine, Esketamine, ECT
24 Participants Needed
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Frequently Asked Questions
How much do Prenatal Disorder clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Prenatal Disorder clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Prenatal Disorder trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Prenatal Disorder is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Prenatal Disorder medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Prenatal Disorder clinical trials?
Most recently, we added Prenatal Support Program for Premature Birth, Psychological Intervention for Parents of Babies with Congenital Heart Defects and Penny COPILOT for Opioid Use Disorder to the Power online platform.
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