Clinical trials: Fetal Disease
Pregnancy, Aneuploidy
Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker
The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy…
- Conditions
- Pregnancy, Aneuploidy, Down Syndrome, Edwards Syndrome
- Trial name
- NCT00971334
- Where
- 35 sites in United States, France
- Volunteers
- 2,502 people
- Sponsor
- Sequenom, Inc.
Persistent Pulmonary Hypertension of the Newborn
IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn
To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation…
- Trial name
- NCT01360671
- Testing
- Sildenafil
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
PPHN, Persistent Pulmonary Hypertension of the Newborn
Study To Investigate Safety And Efficacy Of Sildenafil In The Newborns With Persistent Pulmonary Hypertension (PPHN)
Sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.
- Conditions
- PPHN, Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
- Trial name
- NCT01069861
- Testing
- sildanefil
- Where
- United Kingdom
- Volunteers
- 4 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Fetal and Neonatal Alloimmune Thrombocytopenia
Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia
A prospective, non-interventional, natural history study to assess the occurrence of higher FNAIT risk across a broad population of different racial and ethnic characteristics and the occurrence of HPA-1a alloimmunization in…
- Trial name
- NCT05345561
- Testing
- Clinical data collection
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 14,390 people, healthy volunteers welcome
- Sponsor
- Rallybio
Persistent Pulmonary Hypertension of the Newborn
Persistent Pulmonary Hypertension of the Newborn
The AC-052-391-study is a phase 3 study to investigate whether adding bosentan to inhaled nitric oxide in newborns with persistent pulmonary hypertension of newborns (PPHN) is a supporting and safe therapy and to evaluate the…
- Trial name
- FUTURE 4 (NCT01389856)
- Testing
- Bosentan
- Volunteers
- 23 people
- Sponsor
- Actelion
Insomnia Disorder
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy
- Trial name
- NCT06393504
- Testing
- Daridorexant, Non-orexin receptor antagonist insomnia medication, No insomnia medication
- Where
- United States
- Volunteers
- 2,095 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Congenital Anomalies, Neonatal Complications
AI-Powered Neonatal Risk Assessment for Improved Perinatal Outcomes
This study aims to develop advanced artificial intelligence (AI) models that predict neonatal risks and complications based on historical multimodal health data, including ultrasound and MRI scans.
- Conditions
- Congenital Anomalies, Neonatal Complications, Perinatal Outcomes, Perinatal Outcomes of the Mother and Fetus
- Trial name
- NCT07064356
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- FetalFirst Limited
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.
Fetal Anomaly
Validation of a Test for Fetal Malformations
The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and…
- Trial name
- NCT02965287
- Testing
- Serum metabolomics profiling
- Where
- Italy
- Volunteers
- 1,943 people, healthy volunteers welcome
- Sponsor
- Theoreo Srl
Hemolytic Disease of the Fetus and Newborn
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
The purpose of this non-interventional study is to prospectively evaluate the risk of anemia (decreased red blood cells) in fetuses (baby before birth) and neonates (baby just after birth) of pregnant participants who are at risk…
- Trial name
- GERANIUM (NCT07194070)
- Testing
- Standard of Care
- Where
- 17 sites in United States, Australia and 7 more
- Volunteers
- 175 people
- Sponsor
- Janssen Research & Development, LLC
Fetal and Neonatal Alloimmune Thrombocytopenia
Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
The purpose of this Phase 2 study is to assess the pharmacokinetics (PK) and safety of RLYB212 in HPA-1b/b pregnant women at higher risk for HPA-1a alloimmunization and FNAIT.
- Trial name
- NCT06435845
- Testing
- Anti-(integrin beta-3) human monoclonal antibody
- Where
- 3 sites in Netherlands, Norway and 1 more
- Volunteers
- 1 people
- Sponsor
- Rallybio
Single Gene NIPT
EXpanding Prenatal Cell Free DNA Screening Across moNogenic Disorders (EXPAND)
The purpose of this research is to develop and validate a single gene Non-Invasive Prenatal Test. The development of this investigational single-gene noninvasive prenatal testing (sgNIPT) for conditions such as cystic fibrosis…
- Trial name
- EXPAND (NCT06808880)
- Testing
- Single-gene Noninvasive Prenatal Testing (sgNIPT)
- Where
- 18 sites in United States
- Volunteers
- 4,000 people
- Sponsor
- Natera, Inc.
Antenatal Care, Maternal Health
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural…
- Conditions
- Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia
- Trial name
- FS2 (NCT07677670)
- Testing
- SPAQ E-con AI blind-sweep ultrasound
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- SOIK Corporation Sarl
Hepatitis
Twinrix Pregnancy Registry
The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information…
- Trial name
- NCT03619590
- Testing
- Data Collection
- Volunteers
- 245 people
- Sponsor
- GlaxoSmithKline
Pregnant Women, Prenatal Care
MatErnal BLood IS Source to Accurately Diagnose Fetal Aneuploidy
The primary objective of this study is to determine the performance characteristics (sensitivity and specificity) of the Verinata Health Test to detect fetal Trisomy 21 (T21) compared to karyotype results obtained by…
- Trial name
- MELISSA (NCT01122524)
- Where
- 11 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Verinata Health, Inc.
Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18)
Non-Invasive Determination of Fetal Chromosome Abnormalities
The overall significance of this study is to develop a laboratory developed test (LDT) to use a new marker in the maternal blood to better identify pregnancies that have a child with a chromosome abnormality such as Down syndrome…
- Conditions
- Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Klinefelter Syndrome (47, XXY)
- Trial name
- NCT00891852
- Where
- 7 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Lenetix Medical Screening Laboratory
Fetal Hypoxia, Fetal Acidemia
Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.
- Trial name
- NCT07296419
- Testing
- Fetal Pulse Oximetery
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Pregnant With Complication, Preeclampsia
Developing & Evaluating Models for Early Predicting Obstetrical Diseases in Pregnant Women by Non-invasive Prenatal Test
This is Observational study, aiming to investigate the potentiality of cffDNA and cfRNA by a non-invasive test, in combination with clinical characteristics, to establish models for early screening and predicting high-risk…
- Conditions
- Pregnant With Complication, Preeclampsia, Preterm Birth, Gestational Diabetes
- Trial name
- NCT06385366
- Where
- Vietnam
- Volunteers
- 1,105 people
- Sponsor
- Gene Solutions
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.
Preterm Delivery, Preterm Birth
fFN & E3 in the Prediction of PTB in Women With Twin Pregnancies Receiving 17OHP or Placebo
Among women with a twin pregnancy, currently enrolled in a study in which they are receiving weekly injections of 17-alpha-hydroxyprogesterone caproate verses placebo injections, fetal fibronectin (fFN) and salivary estriol (E3 )…
- Trial name
- NCT00156000
- Testing
- Fetal Fibronectin, Salivary Estriol
- Where
- 2 sites in United States
- Sponsor
- Obstetrix Medical Group