Clinical trials: Prenatal Disorder
Down Syndrome, Edwards Syndrome
Non-Invasive Screening for Fetal Aneuploidy
The purpose of this study is to detect whole chromosome abnormalities in maternal blood.
- Trial name
- NCT02317965
- Testing
- Maternal Blood Draw
- Where
- 10 sites in United States
- Volunteers
- 340 people
- Sponsor
- Progenity, Inc.
Pulmonary Hypertension, Familial Persistent, of the Newborn
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.
- Trial name
- NCT01720524
- Testing
- iv sildenafil
- Where
- 42 sites in United States, Belgium and 10 more
- Volunteers
- 59 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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.
Preterm Delivery
A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
The hypothesis is that administration of two courses of antenatal corticosteroids, compared to one course, will show a 40% reduction in the incidence of composite neonatal morbidity in patients delivering prior to 34 weeks'…
- Trial name
- ACS (NCT00201643)
- Testing
- Betamethasone or Dexamethasone (2nd course of ACS)
- Where
- 22 sites in United States
- Volunteers
- 437 people
- Sponsor
- Obstetrix Medical Group
Fetal Membranes, Premature Rupture
PROMComplete for Determination of Rupture of Fetal Membranes
Premature rupture of membranes refers to the rupture of the fetal membranes prior to the onset of labor. Premature rupture of membranes is associated with a number of neonatal and maternal complications including an increased…
- Trial name
- (PROMComplete (NCT02369601)
- Testing
- non- intervention study
- Where
- 6 sites in United States
- Volunteers
- 600 people
- Sponsor
- Pro-Lab Diagnostics
Phenylketonuria, Maternal
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and…
- Trial name
- PALomino (NCT05579548)
- Testing
- Pegvaliase
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- BioMarin Pharmaceutical
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
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
Spermatogenesis and Semen Disorders, Infertility, Male
Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results
Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis.
- Trial name
- NCT05951075
- Testing
- Power Prenatal for Sperm
- Where
- United States
- Volunteers
- 174 people, healthy volunteers welcome
- Sponsor
- The Bird and Be Co Inc
Down Syndrome, Aneuploidy
Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies
To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from…
- Trial name
- CHARMM-AP (NCT01052688)
- Testing
- Maternal blood draw of 30 to 50ml
- Where
- 10 sites in United States
- Volunteers
- 150 people
- Sponsor
- Sequenom, Inc.
Anemia in Pregnancy, Pre-eclampsia
A Retrospective Analysis of Neevo® and NeevoDHA® Compared to a Standard Prenatal Vitamin in Anemia During Pregnancy
This study is a multi-site, retrospective chart review to determine the effect of Neevo® or NeevoDHA® (with higher folate and B12) versus standard prenatal vitamins on hemoglobin (Hgb) levels in pregnant women throughout the…
- Trial name
- NCT01193192
- Testing
- Neevo®, Prenatal vitamins
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pamlab, L.L.C.
Down Syndrome, Edwards Syndrome
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal…
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome
- Trial name
- NCT02787486
- Testing
- Blood sampling for Laboratory Developed Test (LDT) analysis
- Where
- 8 sites in United States
- Volunteers
- 760 people
- Sponsor
- Progenity, Inc.
Down Syndrome, Edwards Syndrome
Clinical Performance of the MaterniT21 PLUS LDT in Multiple Gestation Pregnancies
This study will evaluate the clinical performance of massively parallel sequencing (MPS) using the MaterniT21 PLUS LDT in the detection of fetal aneuploidy in circulating cfDNA extracted from a maternal blood sample obtained from…
- Conditions
- Down Syndrome, Edwards Syndrome, Patau Syndrome, Turner Syndrome
- Trial name
- NCT02226315
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Sequenom, Inc.
Hypertensive Disorders of Pregnancy (HDP), Maternal Health Care
Cost-Effectiveness of an mHealth Application in Pregnancy Care
Participants will be randomly assigned to either the intervention arm (mHealth application users) or the control arm, in which participants will record their data on paper or in Excel according to standard practice or the…
- Conditions
- Hypertensive Disorders of Pregnancy (HDP), Maternal Health Care, Mobile Health Technology (mHealth), Preeclampsia (PE)
- Trial name
- Penelope (NCT07621133)
- Testing
- mHealth application Penelope, Control
- Where
- Czechia
- Volunteers
- 166 people
- Sponsor
- Principal Engineering s.r.o.
Crohn's Disease, Prenatal Exposure
Pregnancy Exposure Registry for Tysabri®
The primary objective of the Registry was to evaluate the outcomes of pregnancy in women with Multiple Sclerosis (MS) or Crohn's Disease (CD) who were exposed to TYSABRI® at any time within 90 days prior to first day of Last…
- Conditions
- Crohn's Disease, Prenatal Exposure, Multiple Sclerosis, Pregnancy
- Trial name
- NCT00472992
- Where
- United States
- Volunteers
- 376 people
- Sponsor
- Biogen
Spermatogenesis and Semen Disorders, Infertility, Male
Power Prenatal Supplements for Sperm Quality
Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis [WHO 2020 - https://www.who.int/publications/i/item/9789240030787].
- Trial name
- NCT05410782
- Testing
- Power Prenatal for Sperm
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The Bird and Be Co Inc
Fetal Hypoxia
Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
The overall purpose of this study is to evaluate maternal-fetal tissue light scattering properties. The objectives of the study are: (i) integrate established mathematical principles of oxygen saturation to model with increasing…
- Trial name
- NCT04876846
- Testing
- GEN 3 Monitoring of Fetus
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Raydiant Oximetry, Inc.
Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy
Non-invasive Prenatal Diagnostic Validation Study
The primary purpose of this study is to collect maternal blood samples from pregnant women to develop a non-invasive prenatal diagnostic test based on fetal DNA isolated from maternal blood.
- Conditions
- Chromosome 13 Aneuploidy, Chromosome 18 Aneuploidy, Chromosome 21 Aneuploidy, Sex Chromosome Aberrations
- Trial name
- NIPD (NCT01574781)
- Testing
- Blood draw, Cheek swab/Saliva Sampling
- Where
- United States
- Volunteers
- 1,781 people, healthy volunteers welcome
- Sponsor
- Natera, Inc.
Pregnancy Preterm, Labor; Irregular
Multichannel EMG Diagnosing True Preterm Labor
We have designed new electromyography sensors for measuring uterine activity. These sensors are directional - they preferentially report uterine muscle contractions at specific locations, called regions.
- Conditions
- Pregnancy Preterm, Labor; Irregular, Preterm Labor
- Trial name
- PTL (NCT03785795)
- Testing
- Uncertain diagnosis of true labor
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- PreTeL, Inc
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.