Clinical trials: Perinatal Disorder
Perinatal Depression, Postpartum Depression
Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study
During this project the investigators will develop and pilot test a companion intervention for fathers (Fathers and Babies-FAB), to supplement the Mothers and Babies Course (MB) that provides stress and mood management tools for…
- Conditions
- Perinatal Depression, Postpartum Depression, Depression
- Trial name
- NCT03427528
- Testing
- Fathers and Babies (FAB), MB 1-on-1 plus TXT
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Northwestern University
Pregnancy, Cannabis
Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use
This study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a Lifestyle Physical Activity program.
- Trial name
- NCT05528380
- Testing
- LPA + Fitbit Intervention
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Butler Hospital
Human Immunodeficiency Virus, Depression
Support for Perinatal Adherence and Depression
The main aim was to conduct a pilot field test of a group-based depression and adherence counseling intervention with HIV-infected women in the perinatal period.
- Trial name
- INSPireD (NCT03069417)
- Testing
- Integrating Nuanced Support for Perinatal adherence and Depression
- Where
- 2 sites in United States, South Africa
- Volunteers
- 23 people
- Sponsor
- Massachusetts General Hospital
Asphyxia Neonatorum, Hypoxia
TOBY (TOtal Body hYpothermia): a Study of Treatment for Perinatal Asphyxia
Hypothesis: Prolonged whole body cooling in term infants with perinatal asphyxial encephalopathy reduces death and severe neurodevelopmental disability.
- Conditions
- Asphyxia Neonatorum, Hypoxia, Encephalopathy, Seizures
- Trial name
- NCT00147030
- Testing
- Whole body mild induced hypothermia
- Where
- United Kingdom
- Volunteers
- 325 people
- Sponsor
- Imperial College London
Human Immunodeficiency Virus, Perinatal Depression
Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe
In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce…
- Trial name
- Periscope (NCT04143009)
- Testing
- Enhanced Friendship Bench, Enhanced Standard Care (Control), Adapted Friendship Bench
- Where
- 3 sites in Malawi
- Volunteers
- 92 people
- Sponsor
- University of North Carolina, Chapel Hill
Pregnancy Related, Stress, Psychological
The Stony Brook University Calm-Mom Study
The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress.
- Conditions
- Pregnancy Related, Stress, Psychological, Anxiety, Perinatal Depression
- Trial name
- NCT04018625
- Testing
- SMART Mom, Mama Support
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Stony Brook University
Depressive Disorder, Major, Postpartum Depression
Mommy-Baby Treatment for Perinatal Depression
Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family.
- Trial name
- NCT01744041
- Testing
- Dyadic Interpersonal Psychotherapy, Enhanced Treatment as Usual
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Washington University School of Medicine
Infant, Newborn, Hypoxia, Brain
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33.5°C; (2) cooling for 120…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01192776
- Testing
- Whole-body Cooling
- Where
- 19 sites in United States
- Volunteers
- 364 people
- Sponsor
- NICHD Neonatal Research Network
Stroke, Hemiparesis
Perinatal Stroke: Understanding Brain Reorganization
The incidence of perinatal stroke is relatively common, as high as 1 in 2,300 births, but little is known about the resulting changes in the brain that eventually manifest as cerebral palsy (CP).
- Trial name
- NCT02743728
- Testing
- Magnetic Resonance Imaging, Transcranial Magnetic Stimulation, General Movement Assessment
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Minnesota
Infant Mortality, Preterm Birth
Antenatal Micronutrient Supplementation and Infant Survival
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth…
- Conditions
- Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality
- Trial name
- JiVitA-3 (NCT00860470)
- Testing
- Iron (27 mg) - folic acid (600 ug), Multiple micronutrient
- Where
- 2 sites in United States, Bangladesh
- Volunteers
- 44,567 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
HIV
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Postnatal Depression, Social Isolation
Online Singing Interventions for Postnatal Depression in Times of Social Isolation: a Single Arm Study
Melodies for Mums (M4M) is an intervention developed and tested as part of a collaboration between the Royal College of Music, Imperial College London and University College London from 2015-2017.
- Trial name
- SHAPER-PNDO (NCT04857593)
- Testing
- Melodies for Mums
- Where
- United Kingdom
- Volunteers
- 37 people
- Sponsor
- King's College London
Thromboembolism, Venous Thromboembolism
Retrospective Study of Patients Who Were Treated With Fondaparinux Pre-, Peri- and/or Postpartum for Prophylaxis or Treatment of Venous Thromboembolism
The objective of this retrospective study is to gather information about how fondaparinux is used pre-, peri- and/or postpartum for both the prophylaxis and treatment of venous thromboembolism (VTE) in order to fill an…
- Trial name
- FondaPPP (NCT01004939)
- Testing
- fondaparinux
- Where
- 7 sites in Germany
- Volunteers
- 120 people
- Sponsor
- GlaxoSmithKline
Infant, Newborn, Hypoxia, Brain
Preemie Hypothermia for Neonatal Encephalopathy
This study is a randomized, controlled trial to assess safety and effectiveness of whole body hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at <6 hours postnatal age with moderate to…
- Conditions
- Infant, Newborn, Hypoxia, Brain, Hypoxia-Ischemia, Brain, Encephalopathy, Hypoxic-Ischemic
- Trial name
- NCT01793129
- Testing
- Hypothermia, Normothermic Control
- Where
- 18 sites in United States
- Volunteers
- 168 people
- Sponsor
- NICHD Neonatal Research Network
Genetic Diseases, Genetic Syndrome
Perinatal Precision Medicine
This study will seek to determine if rapid genomic sequencing improves outcomes for acutely ill infants. The investigator will enroll up to 1,000 acutely ill infants in a prospective, randomized, blinded study to either rapid…
- Conditions
- Genetic Diseases, Genetic Syndrome, Mendelian Disorders
- Trial name
- NSIGHT2 (NCT03211039)
- Testing
- Genomic sequencing and molecular diagnostic results, if any.
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- Rady Pediatric Genomics & Systems Medicine Institute
Perinatal Depression, Postpartum Depression
A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
Depressed mothers (pregnant and post-delivery) make up a significant portion of Maternal, Infant, and Early Childhood Home Visiting (MIECHV) clients.
- Conditions
- Perinatal Depression, Postpartum Depression, Family Conflict
- Trial name
- NCT04741776
- Testing
- Resilience Enhancement Skills Training, Problem-Solving Individual Therapy
- Where
- United States
- Volunteers
- 166 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus.
- Trial name
- NCT00992017
- Testing
- Influenza A (H1N1) monovalent vaccine
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 130 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Pregnancy
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts…
- Trial name
- NCT04571684
- Testing
- HITSystem 2.1
- Where
- 12 sites in Kenya
- Volunteers
- 1,639 people
- Sponsor
- University of Kansas Medical Center