Clinical trials: Fetal Conditions
Small for Gestational Age Infant, Fetal Growth Restriction
Developing and Testing AI Models for Fetal Biometry and Amniotic Volume Assessment in Fetal Ultrasound Scans.
Routine fetal ultrasound scan during the second trimester of the pregnancy is a low-cost, noninvasive screening modality that has been proven to lower fetal mortality by up to 20%.
- Conditions
- Small for Gestational Age Infant, Fetal Growth Restriction, Oligohydramnios, Polyhydramnios
- Trial name
- NCT05059093
- Testing
- Classification and segmentation deep learning models
- Where
- 6 sites in Morocco
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Deepecho
Amyotrophic Lateral Sclerosis
GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS)
GM604 is an endogenous human embryonic stage neural regulatory and signaling peptide that controls the development, monitoring and correction of the human nervous system.
- Trial name
- GALS (NCT01854294)
- Testing
- GM604
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Genervon Biopharmaceuticals, LLC
Pregnant Individuals, Aneuploidy
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of…
- Conditions
- Pregnant Individuals, Aneuploidy, Down Syndrome (Trisomy 21), 22q11.2 Deletion Syndrome
- Trial name
- ADVANCE (NCT07643896)
- Where
- 9 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- BillionToOne Inc.
Trisomy 21, Trisomy 18
Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood
The purpose of this study is to collect maternal blood samples from pregnant women carrying a fetus with a confirmed diagnosis of chromosomal abnormality or genetic disorder including microdeletions in order to further develop a…
- Conditions
- Trisomy 21, Trisomy 18, Trisomy 13, Sex Chromosome Abnormalities
- Trial name
- MAPS (NCT01852708)
- Where
- 9 sites in United States, Spain and 1 more
- Volunteers
- 1,059 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Grief, Post Traumatic Stress Disorder
Walk With Me (WWM) for Perinatal Grief
The goal of this clinical trial is to learn if the Along With Me web-based intervention works to decrease posttraumatic stress symptoms and suicidal ideation among bereaved parents following pregnancy and early infant loss.
- Conditions
- Grief, Post Traumatic Stress Disorder, Suicidal Ideation, Miscarriage
- Trial name
- PeriGrief-II (NCT07011940)
- Testing
- Along With Me, Peer Guide
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Oregon Research Behavioral Intervention Strategies, Inc.
Erosive Esophagitis, Heartburn
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
The main objective of the study is to compare the maternal, fetal, and infant outcomes of pregnant women who are exposed to vonoprazan during pregnancy with outcomes of an internal comparison cohort of pregnant women who are…
- Conditions
- Erosive Esophagitis, Heartburn, Symptomatic Non-erosive Gastroesophageal Reflux Disease, Helicobacter Pylori Infection
- Trial name
- NCT06660342
- Testing
- Vonoprazan
- Where
- United States
- Volunteers
- 728 people
- Sponsor
- Phathom Pharmaceuticals, Inc.
Fetal Distress
Trans-abdominal Fetal Pulse Oximetry: Signal Integrity
This project is set up to advance and integrate the established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters,
- Trial name
- NCT04081623
- Testing
- Raydiant Oximetry Sensing System
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Vaginal Vault Prolapse
Study of Cytrix Use in Pelvic Floor Prolapse Treatment
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
- Trial name
- NCT01244165
- Testing
- Cytrix, Other treatments for pelvic organ prolapse
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Down Syndrome, Fetal Aneuploidy
Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies
Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
- Trial name
- NCT01555346
- Where
- 29 sites in United States, Canada
- Volunteers
- 3,062 people
- Sponsor
- Sequenom, Inc.
Microdeletion Syndromes, Trisomy 21
Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA
The purpose of this study is to collect blood from families with a child who has been diagnosed with a chromosomal disorder including microdeletions in order to further develop a non-invasive prenatal screening test based on…
- Conditions
- Microdeletion Syndromes, Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- Microdel Triad (NCT02109770)
- Where
- 2 sites in United States
- Volunteers
- 216 people
- Sponsor
- Natera, Inc.
Growth Disorders, Intrauterine Growth Retardation
Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation
To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation
- Trial name
- NCT01073605
- Testing
- Genotonorm
- Where
- 31 sites in France
- Volunteers
- 208 people
- Sponsor
- Pfizer
Fetal Hypoxia, Fetal Distress
Trans-abdominal Fetal Pulse Oximetry
The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy.
- Conditions
- Fetal Hypoxia, Fetal Distress, Fetal Acidemia, Fetal or Neonatal Effect of Complication of Labor
- Trial name
- NCT05147584
- Testing
- Dual fetal oxygen sensors
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Fetal Distress
Trans-abdominal Fetal Pulse Oximetry: Tissue Light Scattering
This study is being conducted to study light scattering properties of maternal-fetal tissue.
- Trial name
- NCT04081584
- Testing
- ISS Device
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Raydiant Oximetry, Inc.
Pregnancy Related
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12…
- Trial name
- NCT06258902
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ipsen
Trisomy 21 and Other Fetal Aneuploidy
Automated Screen for Fetal Aneuploidy
The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.
- Trial name
- FAST1 (NCT03635359)
- Testing
- blood test
- Where
- 6 sites in Australia, Belgium and 4 more
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- BioCeryx
Pregnancy Complications, Pregnancy Outcome
BioThrax® (Anthrax) Vaccine in Pregnancy Registry
The purpose of this study is to determine if inadvertent receipt of the BioThrax vaccine during pregnancy is independently associated with adverse maternal, pregnancy, or infant health outcomes.
- Conditions
- Pregnancy Complications, Pregnancy Outcome, Congenital Abnormalities
- Trial name
- NCT01653392
- Testing
- Observational Intervention
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Nutritional and Metabolic Diseases
Efficacy and Safety of Stannsoporfin in Neonates
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the…
- Trial name
- NCT02685137
- Testing
- stannsoporfin
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Aneuploidy
National Prevalence and Impact of Noninvasive Prenatal Testing
Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be retrospectively gathered and an analysis of the…
- Trial name
- NCT02284399
- Testing
- non-invasive prenatal testing
- Where
- 7 sites in United States
- Volunteers
- 4,488 people, healthy volunteers welcome
- Sponsor
- Obstetrix Medical Group
Fetal Hypoxia, Fetal Distress
Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE
The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy.
- Conditions
- Fetal Hypoxia, Fetal Distress, Fetal Conditions, Fetal Complications
- Trial name
- NCT06405984
- Testing
- Fetal Oxygenation Measurements
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Pregnancy Related
Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period [LMP]).
- Trial name
- NCT07556913
- Testing
- Elafibranor
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Ipsen