Clinical trials: Prenatal Screening
22q11 Deletion Syndrome, DiGeorge Syndrome
SNP-based Microdeletion and Aneuploidy RegisTry (SMART)
This multi-center prospective observational study is designed to track birth outcomes and perinatal correlates to the Panorama prenatal screening test in the general population among ten thousand women who present clinically and…
- Conditions
- 22q11 Deletion Syndrome, DiGeorge Syndrome, Trisomy 21, Trisomy 18
- Trial name
- SMART (NCT02381457)
- Where
- 21 sites in United States, Australia and 4 more
- Volunteers
- 20,960 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Preeclampsia, Preterm Birth
Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes".
- Conditions
- Preeclampsia, Preterm Birth, Fetal Growth Restriction, Intra Uterine Fetal Death
- Trial name
- PREDICTION2 (NCT03067298)
- Where
- Canada
- Volunteers
- 805 people, healthy volunteers welcome
- Sponsor
- Emmanuel Bujold
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
Viral Hepatitis B, Contraception
Blood-borne Infection Screening in an Afghan Antenatal Population
Baseline information indicates there are measurable levels of hepatitis B SAg and low utilization of postpartum contraception, correct breastfeeding practices, or adherence to infant vaccination schedules in Kabul, Afghanistan.
- Conditions
- Viral Hepatitis B, Contraception, Breast Feeding, Exclusive, Effects of; Lack of Care of Infants
- Trial name
- NCT01199601
- Testing
- Concentrated postpartum counseling
- Where
- Afghanistan
- Volunteers
- 1,291 people, healthy volunteers welcome
- Sponsor
- Columbia University
Hiv, Syphilis
The TRIple Elimination Model Of Mother-to-child Transmission Program (TRI-MOM)
The TRI-MOM program aims to implement and evaluate a simplified (based on inexpensive rapid diagnostic tests), integrated (in governmental health facilities) and coordinated (between health care workers) strategy for the triple…
- Conditions
- Hiv, Syphilis, HBV
- Trial name
- TRI-MOM (NCT05951751)
- Testing
- TRI-MOM intervention
- Where
- 2 sites in Burkina Faso, The Gambia
- Volunteers
- 2,800 people, healthy volunteers welcome
- Sponsor
- Institut de Recherche pour le Developpement
Obesity in Pregnancy
Antenatal Testing in Obese Woman, is it Really Necessary?
It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress…
- Trial name
- ATOWS (NCT02821988)
- Testing
- External fetal monitor for Nonstress test, Ultrasonography for Biophysical profile
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Tennessee
Hereditary Cancer Syndrome
Feasibility Trial of Combination of Obstetrical Carrier Screening and Hereditary Cancer Screening
The investigators hypothesize that preconception and pregnancy may be a feasible and effective time to offer inherited cancer risk screening.
- Trial name
- FOCUS (NCT07195071)
- Testing
- Natera empower comprehensive hereditary cancer panel, Obstetrical carrier screening
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Columbia University
Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy
Evaluation of Fetal Bladder Emptying During the 11-14 Weeks' Ultrasound Examination as a Negative Predictive Marker for Chromosomal Abnormalities
Template-Based Brief Summary (Sağlık Profesyonelleri İçin) Study Title: The Negative Predictive Value of First-Trimester Fetal Bladder "Rapid Emptying" (≤40 minutes and post-void ≤2 mm) for Major Chromosomal Aneuploidies: A…
- Trial name
- NCT07165743
- Testing
- 40-Minute Real-Time First-Trimester Ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Haseki Training and Research Hospital
Autosomal Recessive Disorder, Aneuploidy
Prenatal Computer-Aided Genetics Education Module
A standard part of obstetrical care is offering prenatal genetic screening. Numerous professional guidelines have emphasized the importance of pretest counseling for prenatal genetic screenings.
- Trial name
- CAGEM (NCT03449225)
- Testing
- Computer-Aided Genetic Education Module
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Wayne State University
Trisomy 21, Trisomy 18
Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood
Each year, 450,000 Canadian women become pregnant and, as a result of their participation in prenatal screening for Down syndrome, approximately 10,000 of them will have an amniocentesis (i.e.
- Conditions
- Trisomy 21, Trisomy 18, Trisomy 13
- Trial name
- PEGASUS (NCT01925742)
- Testing
- Integrated prenatal screening for Down's syndrome, Serum QUAD Assay for aneuploidy screening, Semiconductor MPSS NIPT assay using ccfDNA in maternal blood
- Where
- 5 sites in Canada
- Volunteers
- 3,819 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Trisomy 21
Down Syndrome Screening Based on Dried Blood Spots and Cell-free Fetal DNA
There are 26,600 Down Syndrome newborns every year in China. The economic burden of this disease is 65,000 USD for lifetime of every patient.
- Trial name
- DBS&CFF (NCT01837979)
- Testing
- cell-free fetal DNA
- Where
- China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Peking Union Medical College Hospital
Spinal Muscular Atrophy
Prenatal Carrier Screening for Spinal Muscular Atrophy Among Thai Pregnant Women
Spinal muscular atrophy (SMA) prenatal carrier screening is recommended by American College of Medical Genetics (ACMG) and American College of Obstetrics and Gynecology (ACOG).
- Trial name
- NCT04859179
- Where
- Thailand
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Depression, Anxiety
Perinatal Mental Health Study (PMHS) India
The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.
- Conditions
- Depression, Anxiety, Suicidal Ideation, Somatization
- Trial name
- PMHS (NCT05485701)
- Testing
- Screening tools for common mental disorders
- Where
- 2 sites in India
- Volunteers
- 2,332 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Disorder of Cardiac Function
Myocardial Screening in Fetuses With Congenital Cytomegalovirus (CMV) Infection
BACKGROUND Myocarditis and pericarditis are inflammatory conditions of the heart commonly due to viral or autoimmune etiologies. Human CMV represents one of the leading causes of congenital infections worldwide.
- Trial name
- NCT02787382
- Testing
- echocardiographic examination
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Syphilis
The Feasibility of Implementing Syphilis Point-of-care Testing Into a Prenatal Clinic for People Facing Barriers to Care
The goal of this clinical trial is to learn if a finger-prick blood test for rapid diagnosis of syphilis infection can be implemented in a low-barrier prenatal clinic for people at risk of syphilis in pregnancy.
- Trial name
- PRESSING (NCT06829602)
- Testing
- Rapid Syphilis/HIV point-of-care test
- Where
- Canada
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- McMaster University
Prenatal Disorder, Aneuploidy
PErsonalized Genomics for Prenatal Abnormalities Screening USing Maternal Blood
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…
- Trial name
- PEGASUS-2 (NCT03831256)
- Testing
- Traditional integrated prenatal screening, Second-tier Non-invasive prenatal screening (NIPS), First-tier Non-invasive prenatal screening (NIPS)
- Where
- 6 sites in Canada
- Volunteers
- 7,849 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Neonatal Screening, Kernicterus
Bilistick Point-of-care System 2.0 Bilirubin Validation
This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected…
- Conditions
- Neonatal Screening, Kernicterus, Newborn Jaundice, Point-of-Care Testing
- Trial name
- NCT06058910
- Testing
- Bilistick System 2.0 point-of-care testing device
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Kettering Health Network
Fetal and Neonatal Alloimmune Thrombocytopenia
Towards Routine HPA-screening In Pregnancy to Prevent FNAIT
Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) is the most common cause of severe thrombocytopenia in otherwise healthy born neonates.
- Trial name
- HIP (NCT04067375)
- Testing
- Clinical data collection.
- Where
- Netherlands
- Volunteers
- 3,660 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Trisomy 13, Trisomy 18
Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial
This prospective blinded study will assess the diagnostic capability of an informatics enhanced SNP based technology (Parental Support) to identify pregnant women who are carrying a fetus with an aneuploidy from fee floating DNA…
- Conditions
- Trisomy 13, Trisomy 18, Trisomy 21, Aneuploidy
- Trial name
- PreNATUS (NCT01545674)
- Testing
- Blood Draw
- Where
- 29 sites in United States, Canada and 4 more
- Volunteers
- 937 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Heart Diseases
Development of an Screening System in Children With Congenital Heart Disease Based on Cloud Computing and Big Data
This study intends to establish an automatic system for screening on children with congenital heart disease, the system include the auscultation of cardiac murmur and the test of oxygen saturation, the data was analyzed based on…
- Trial name
- NCT03929133
- Testing
- automatic screening machine on congenital heart disease
- Where
- China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine