Clinical trials: Antenatal Care
Congenital Cytomegalovirus Infection
Prevention of Maternal-fetal Cytomegalovirus Transmission After Primary Maternal Infection, GW ≤ 14 (PreCyssion)
A phase 3, open-label, single-arm, prospective, multi-center trial of Cytotect CP Biotest (BT097) for prevention of maternal-fetal CMV transmission after primary maternal CMV infection.
- Trial name
- PreCyssion (NCT05170269)
- Testing
- BT097
- Where
- 5 sites in Germany
- Volunteers
- 48 people
- Sponsor
- Biotest
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
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
Maternal Fetal Device Performance Singleton
Maternal Fetal Monitoring devices assist the health care professional in acquiring, monitoring, and storing fetal and maternal physiologic data which supports the decision making for pregnant women and the overall fetal health…
- Trial name
- NCT06726343
- Testing
- Fetal Monitoring Device, Investigational Fetal Monitoring Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- GE Healthcare
Preterm Delivery
Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers
This protocol seeks to longitudinally collect blood samples from a cohort of pregnant women. The biological specimens will be used to determine the predictive power of biochemical markers routinely used in Down syndrome screening…
- Trial name
- NCT01009723
- Where
- 2 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Esoterix Genetic Laboratories, LLC
Pregnancy
Electrode-based Sensor for Non-invasive Fetal Heart Rate and EMG Monitoring With Improved Reliability
The specific goal of the proposed research is to develop a reliable, non-invasive fetal and maternal heart rate and contraction monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer…
- Trial name
- NCT01400880
- Testing
- Electrode-based Sensor
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Convergent Engineering, Inc.
Pregnancy Related
A Clinical Study to Investigate the Reliability of Fetal Heart Rate and Maternal Heart Rate Signals Extracted From Biopotential Data
Bloom Technologies is developing a wearable device for monitoring pregnancy. In this study, Bloom Technologies wants to investigate the reliability of this new technology.
- Trial name
- NCT05498298
- Testing
- Biopotentials measurement with gtec device
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
Fetal and Neonatal Alloimmune Thrombocytopenia
Kinetics of Blood Platelets Transfused to Healthy Subjects
The current phase 0 trial is preceding the phase 1/2 trial of a newly developed drug, NAITgam, for the prevention of fetal and neonatal alloimmune thrombocytopenia (FNAIT) - a rare, but potentially very severe bleeding condition…
- Trial name
- NCT03561909
- Testing
- Platelet transfusion
- Where
- Germany
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Prophylix Pharma AS
Rhesus D Genotype
Evaluation of a Noninvasive Fetal RHD Genotyping Test
This study will collect whole blood samples from pregnant subjects who are RhD negative by serology to develop an assay for RHD determination of the fetus.
- Trial name
- IRIS (NCT01054716)
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- Sequenom, 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
Fetal Monitoring
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Bloomlife MFM-Pro is a non-invasive, wireless, external monitoring system used to measure fetal heart rate and maternal heart rate on pregnant women with a singleton pregnancy, starting from 32 weeks of gestation.
- Trial name
- NST (NCT04915131)
- Testing
- Bloomlife MFM-Pro
- Where
- 2 sites in United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Bloom Technologies
Pregnancy Following IVF With PGS/PGD
Collection of Maternal Blood Samples for Development of Non-invasive Prenatal Diagnostic Testing
The purpose of this study is to collect blood samples from pregnant women who achieved pregnancy following in-vitro fertilization (IVF) with Natera's preimplantation aneuploidy screening (with or without single gene gene…
- Trial name
- NCT01546324
- Testing
- Blood draw
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Natera, Inc.
Pregnancy Related
Human Factoring Validation of Pulsenmore ES Device
The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and…
- Trial name
- NCT06567067
- Testing
- Pulsenmore ES home ultrasound
- Where
- 2 sites in United States
- Volunteers
- 57 people
- Sponsor
- PulseNmore
Aneuploidy, Trisomy 21
Prenatal Test for Fetal Aneuploidy Detection
The purpose of this study is to develop and evaluate a blood test for pregnant women for detection of fetal aneuploidy.
- Trial name
- NCT01256606
- Where
- 6 sites in United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Roche Sequencing Solutions
Rhesus D Genotype, Pregnancy
Prospective Collection of Whole Blood Specimens From RhD Negative Pregnant Women
The purpose of this research is to collect blood samples and data from pregnant women who are Rh negative. The blood will be used for the future research and the development of non-invasive prenatal tests to identify Rh blood…
- Trial name
- NCT06690099
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Devyser Inc.
Migraine
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
- Trial name
- MONITOR (NCT05046613)
- Testing
- Rimegepant, Not taking Rimegepant
- Where
- United States
- Volunteers
- 780 people
- Sponsor
- Pfizer
Pregnancy, Prenatal Care
Comparing AI and Standard Pregnancy Chatbots
Many pregnant women in India use mobile phones to get health information. Nivi runs a free WhatsApp service called askNivi that answers questions about pregnancy and sends reminders about prenatal care visits.
- Conditions
- Pregnancy, Prenatal Care, Maternal Health
- Trial name
- NCT07883993
- Testing
- Scripted maternal health chatbot, MATRI retrieval-augmented maternal health chatbot
- Where
- India
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Nivi, Inc.
Congenital Heart Disease
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious…
- Trial name
- NCT06392555
- Testing
- Device-Aided performances, Device-Unaided performances
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- BrightHeart
Pregnancy Related
Optimization of Fetal Biometry With 3D Ultrasound and Image Recognition
In the proposed clinical investigation, the investigational device (BabySize3D) will provide automated plane extraction and automated biometry measurements from 3D US volumes. The results obtained from the investigational software
- Trial name
- EPICEA (NCT03812471)
- Testing
- 3D volume acquisitions, 2D standard measurements and 3D volumes acquisitions
- Where
- France
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Copy Number Variations
Development of a NIPTT for Detecting Copy Number Variations
To collect whole blood samples from pregnant women for the purpose of developing, optimizing and evaluating laboratory-developed noninvasive prenatal test (NIPT) for the detection of fetal chromosomal abnormalities of interest…
- Trial name
- NCT04774640
- Testing
- MaterniT GENOME
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Sequenom, Inc.