| 1 |
NCT02284399 |
Completed |
National Prevalence and Impact of Noninvasive Prenatal Testing |
|
- Other: non-invasive prenatal testing
|
Observational |
|
- Obstetrix Medical Group
- Mednax Center for Research, Education, Quality and Safety
|
Industry |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
- The number of invasive prenatal diagnostic testing for fetal karyotype (IDTFKs) performed after NIPT became commercially available
- The reasons for invasive prenatal diagnostic testing for fetal karyotype (IDTFK) after NIPT became commercially available
|
4382 |
Female |
18 Years to 60 Years (Adult) |
NCT02284399 |
OBX0032 |
|
January 2014 |
June 28, 2016 |
December 1, 2016 |
November 6, 2014 |
September 27, 2017 |
|
- Phoenix Perinatal Associates
Phoenix, Arizona, United States - Long Beach Memorial Medical Center
Long Beach, California, United States - Good Samaritan Hospital
San Jose, California, United States - (and 4 more...)
|
| 2 |
NCT02586428 |
Terminated |
Noninvasive Prenatal Testing |
|
- Other: what patients elect noninvasive prenatal testing (NIPT)
|
Observational |
|
|
Other |
- Time Perspective: Prospective
|
- will measure what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling
- will measure patients' reasons for electing or not electing testing
- Measure if patients' understand the different testing options.
|
33 |
Female |
14 Years to 55 Years (Child, Adult) |
NCT02586428 |
25878 |
|
September 2015 |
April 2016 |
April 2016 |
October 26, 2015 |
October 14, 2016 |
|
- St. Mary's Hospital
St. Louis,, Missouri, United States
|
| 3 |
NCT00686062 |
Completed |
Evaluation of a Decision Assisting Tool for Prenatal Testing |
|
- Other: Control - computerized age-appropriate prenatal testing educational brochure
- Other: PT Tool - interactive, computerized, prenatal testing decision tool
|
Interventional |
Not Applicable |
- University of California, San Francisco
- Agency for Healthcare Research and Quality (AHRQ)
|
Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
|
|
494 |
Female |
16 Years to 50 Years (Child, Adult) |
NCT00686062 |
H8937-16337
AHRQ Grant # R18-HS10214 |
|
April 2001 |
April 2003 |
April 2004 |
May 29, 2008 |
May 29, 2008 |
|
- UCSF
San Francisco, California, United States
|
| 4 |
NCT02127515 |
Unknown † |
Non Invasive Prenatal Testing of Down Syndrome |
|
- Procedure: Non Invasive Prenatal Testing
- Procedure: Invasive Prenatal Testing
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number or miscarriages
- Number or invasive tests
- false positive and negative rates of NIPT
- (and 2 more...)
|
2450 |
Female |
18 Years and older (Adult, Senior) |
NCT02127515 |
P130601
2013-A00998-37 |
SAFE 21 |
April 2014 |
April 2016 |
December 2016 |
April 30, 2014 |
November 13, 2015 |
|
- Hôpital Necker- Enfants Malades
Paris, France
|
| 5 |
NCT00505596 |
Completed |
Expanded Prenatal Testing Options and Informed Choice |
|
- Behavioral: Informed free choice
|
Interventional |
Not Applicable |
- University of California, San Francisco
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- March of Dimes
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Prenatal test use
- Patient reported outcome questionnaire
|
744 |
Female |
18 Years to 50 Years (Adult) |
NCT00505596 |
R01HD049686
12-FY09-213 |
EPIC |
December 2007 |
January 2013 |
January 2013 |
July 23, 2007 |
October 21, 2014 |
|
- UCSF
San Francisco, California, United States
|
| 6 |
NCT00514553 |
Completed |
Informed Choice Regarding Invasive Prenatal Testing |
- Pregnancy - Prenatal Testing
|
|
Observational |
|
- National Human Genome Research Institute (NHGRI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Time Perspective: Prospective
|
|
37 |
Female |
18 Years to 55 Years (Adult) |
NCT00514553 |
070204
07-HG-0204 |
|
August 7, 2007 |
|
May 31, 2011 |
August 10, 2007 |
July 2, 2017 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 7 |
NCT02821988 |
Not yet recruiting |
Antenatal Testing in Obese Woman, is it Really Necessary? |
|
- Device: External fetal monitor for Nonstress test
- Device: Ultrasonography for Biophysical profile
|
Interventional |
Not Applicable |
- University of Tennessee Health Science Center
- Regional One Health
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Stillbirth
- Mode of delivery
- Neonatal intensive care unit admission admission
- Apgar score of less than 7 at 5 minutes
|
100 |
Female |
18 Years to 45 Years (Adult) |
NCT02821988 |
16-04574-XP |
ATOWS |
July 2016 |
May 2017 |
May 2017 |
July 4, 2016 |
July 4, 2016 |
|
|
| 8 |
NCT03214328 |
Not yet recruiting |
Causes of Fetal Death: Comparison of Diagnostic Accuracy Between Extensive and Selective Protocol Testing |
|
- Diagnostic Test: Determination of causes of fetal death
|
Observational |
|
- University Hospital, Rouen
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Concordance of the causes of fetal death between selective and systematic protocol testing
|
602 |
Female |
18 Years to 45 Years (Adult) |
NCT03214328 |
2014/209/HP |
EMIBICI |
September 2017 |
January 2021 |
January 2021 |
July 11, 2017 |
July 11, 2017 |
|
- Rouen University Hospital
Rouen, France
|
| 9 |
NCT01494961 |
Completed |
Couple-oriented Prenatal HIV Counseling in Low and Medium HIV Prevalence Countries |
- Partner HIV Testing
- Couple HIV Counseling
- Couple Communication
- HIV Incidence
|
- Behavioral: Couple-oriented post-test HIV counseling
|
Interventional |
Not Applicable |
- French National Agency for Research on AIDS and Viral Hepatitis
- Elizabeth Glaser Pediatric AIDS Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Partner HIV testing
- Couple HIV counseling
- HIV incidence
- Couple communication of sexual and reproductive health
|
1943 |
Female |
15 Years and older (Child, Adult, Senior) |
NCT01494961 |
ANRS 12127 Prenahtest |
Prenahtest |
February 2009 |
August 2011 |
October 2011 |
December 19, 2011 |
December 19, 2011 |
|
- Centre Mère - Enfant Chantal Biya
Yaoundé, Cameroon - Hospital Materno-Infantil "San Lorenzo" de los Mina
Santo Domingo, Dominican Republic - Maternity Hospital N°5
Tbilisi, Georgia - Sane Guruji Hospital
Pune, India
|
| 10 |
NCT03156751 |
Completed |
Feasibility of Introducing an Onsite Test for Syphilis in the Package of Antenatal Care in Burkina Faso |
- Syphilis Infection
- Diagnoses Disease
|
- Diagnostic Test: Feasibility of introducing onsite test for syphilis in the package of antenatal care at rural primary health care in Burkina Faso
|
Observational |
|
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- World Health Organization
- African Population and Health Research Center
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Pregnant women who were screened for syphilis
|
1205 |
Female |
18 Years and older (Adult, Senior) |
NCT03156751 |
IRSS003 |
|
May 1, 2013 |
September 30, 2013 |
September 30, 2013 |
May 17, 2017 |
May 17, 2017 |
|
|
| 11 |
NCT00631384 |
Completed |
Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania |
|
- Behavioral: Couples VCT
- Behavioral: Individual VCT
|
Interventional |
Not Applicable |
- Johns Hopkins Bloomberg School of Public Health
- Johns Hopkins University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- HIV Testing and receiving results
- use of nevirapine
- use of protection at time of sexual intercourse
- domestic violence
|
1521 |
All |
18 Years to 50 Years (Adult) |
NCT00631384 |
H.32.02.05.29 |
CVCT |
March 2003 |
September 2004 |
September 2004 |
March 7, 2008 |
April 20, 2018 |
|
- Muhimbili University College of Health Sciences
Dar es Salaam, Tanzania
|
| 12 |
NCT02339402 |
Recruiting |
Non Invasive Prenatal Testing (NIPT) of Single-gene Disorders |
|
|
Observational |
|
- Maastricht University Medical Center
- Radboud University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Development of a targeted molecular test (mostly standard PCR or real-time PCR) for non-invasive prenatal testing of single-gene disorders.
|
160 |
All |
18 Years to 50 Years (Adult) |
NCT02339402 |
NL48304/METC azM/UM 14-02-012 |
|
June 2014 |
January 2018 |
May 2018 |
January 15, 2015 |
January 13, 2017 |
|
- Radboud UMC
Nijmegen, Gelderland, Netherlands - Maastricht UMC
Maastricht, Netherlands
|
| 13 |
NCT02454816 |
Unknown † |
Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in Colombia |
|
- Device: Single HIV RDT and single syphilis RDT
- Device: Dual HIV/syphilis RDT
|
Interventional |
Phase 2
Phase 3 |
- Universidad Nacional de Colombia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Number of participants in syphilis testing with SRDT compared to DRDT post intervention
- Differences in Number of participants with uptake of HIV testing between Arm A and Arm B.
- Number of participants with syphilis treatment between Arm A and Arm B
- (and 3 more...)
|
12 |
Female |
14 Years and older (Child, Adult, Senior) |
NCT02454816 |
HIV2.0 |
|
May 2015 |
October 2015 |
|
May 27, 2015 |
May 27, 2015 |
|
- Hospital Carlos Holmes Trujillo
Cali, Valle del cauca, Colombia
|
| 14 |
NCT03420274 |
Recruiting |
Ensuring Patients' Informed Access to Noninvasive Prenatal Testing |
- Genetic Disease
- Genetic Syndrome
- Prenatal Disorder
- (and 2 more...)
|
- Behavioral: NEST
- Behavioral: Usual care
|
Interventional |
Not Applicable |
- The Cleveland Clinic
- Indiana University
- National Human Genome Research Institute (NHGRI)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Health Services Research
|
- Shared decision-making (SDM)
- Informed choice
- Decisional regret:
|
420 |
All |
18 Years and older (Adult, Senior) |
NCT03420274 |
17-987
R01HG010092 |
NEST |
February 19, 2018 |
January 2021 |
June 2021 |
February 2, 2018 |
February 20, 2018 |
|
- Cleveland Clinic
Cleveland, Ohio, United States
|
| 15 |
NCT00503308 |
Completed
Has Results |
HIV Testing Strategies in the Perinatal Setting |
- HIV Infections
- Pregnancy Related
|
- Procedure: Abbreviated HIV test counseling
|
Interventional |
Not Applicable |
- University of California, San Francisco
- Pfizer
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Health Services Research
|
- Satisfaction With HIV Testing Experience (O'Connor Decisional Conflict Scale)
|
281 |
Female |
16 Years and older (Child, Adult, Senior) |
NCT00503308 |
2004-0319 |
|
October 2006 |
September 2007 |
February 2008 |
July 18, 2007 |
May 22, 2015 |
July 1, 2011 |
- UCSF, San Francisco General Hospital
San Francisco, California, United States
|
| 16 |
NCT03449225 |
Recruiting |
Prenatal Computer-Aided Genetics Education Module |
- Autosomal Recessive Disorder
- Aneuploidy
|
- Other: Computer-Aided Genetic Education Module
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Knowledge of Genetics
- Testing Intention
|
100 |
Female |
18 Years and older (Adult, Senior) |
NCT03449225 |
115217B3E |
CAGEM |
March 13, 2018 |
December 31, 2018 |
December 31, 2018 |
February 28, 2018 |
March 7, 2018 |
|
- Hutzel Women's Hospital
Detroit, Michigan, United States
|
| 17 |
NCT01836003 |
Completed |
An Intervention to Improve Antenatal Access to CD4 Testing and HAART in Botswana |
|
- Other: Tokafatso programmatic intervention
|
Interventional |
Not Applicable |
- Harvard School of Public Health
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Proportion of eligible pregnant women with CD4 enumeration prior to 26 weeks gestation
- Proportion of eligible women with HAART initiation prior to 30 weeks gestation
- Proportion of eligible women with CD4 testing prior to delivery
- (and 3 more...)
|
422 |
|
Child, Adult, Senior |
NCT01836003 |
BHP044
3R01HD044391-06S1 |
|
July 2011 |
October 2012 |
October 2012 |
April 19, 2013 |
April 19, 2013 |
|
- Botswana Harvard AIDS Institute
Gaborone, Botswana
|
| 18 |
NCT01546324 |
Completed |
Collection of Maternal Blood Samples for Development of Non-invasive Prenatal Diagnostic Testing |
- Pregnancy Following IVF With PGS/PGD
|
|
Observational |
|
|
Industry |
- Time Perspective: Cross-Sectional
|
- Collection of 500 maternal blood samples to be used for development of non-invasive prenatal diagnostic testing.
|
16 |
Female |
18 Years and older (Adult, Senior) |
NCT01546324 |
IVF013 |
|
February 2012 |
May 2012 |
August 2013 |
March 7, 2012 |
August 12, 2013 |
|
- Natera, Inc
Redwood City, California, United States
|
| 19 |
NCT00341822 |
Completed |
Invasive Prenatal Testing Decisions in Pregnancy After Infertility |
|
|
Observational |
|
- National Human Genome Research Institute (NHGRI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
200 |
Female |
35 Years and older (Adult, Senior) |
NCT00341822 |
999906132
06-HG-N132 |
|
March 29, 2006 |
|
December 28, 2007 |
June 21, 2006 |
July 2, 2017 |
|
- Johns Hopkins University
Baltimore, Maryland, United States
|
| 20 |
NCT00342069 |
Completed |
Prevalence of Ambivalence Regarding Prenatal Testing |
|
|
Observational |
|
- National Human Genome Research Institute (NHGRI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
|
Female |
18 Years and older (Adult, Senior) |
NCT00342069 |
999905067
05-HG-N067 |
|
December 17, 2004 |
|
December 10, 2007 |
June 21, 2006 |
July 2, 2017 |
|
- Georgetown University
Washington, D.C., District of Columbia, United States - Johns Hopkins University
Baltimore, Maryland, United States - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States - (and 3 more...)
|
| 21 |
NCT02965287 |
Completed |
Validation of a Test for Fetal Malformations |
|
- Other: Serum metabolomics profiling
|
Observational |
|
- Theoreo Srl
- Auckland UniServices Ltd.
- Massachusetts General Hospital
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Diagnostic test performance evaluation in dichotomic classification at 19-21 weeks' gestation
- Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 19-21 weeks' gestation
- Diagnostic test performance evaluation in dichotomic classification at 14-16 weeks gestation
- Diagnostic test performance evaluation in the individuation of the exact diagnosis of fetal malformation at 14-16 weeks gestation
|
1943 |
Female |
Child, Adult, Senior |
NCT02965287 |
MV-01 |
|
September 2016 |
December 2017 |
December 2017 |
November 16, 2016 |
March 22, 2018 |
|
- Theoreo srl
Montecorvino Pugliano, Salerno, Italy
|
| 22 |
NCT00001536 |
Completed |
Issues Surrounding Prenatal Genetic Testing for Achondroplasia |
|
|
Observational |
|
- National Human Genome Research Institute (NHGRI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
2000 |
All |
Child, Adult, Senior |
NCT00001536 |
960123
96-HG-0123 |
|
August 1996 |
|
July 2000 |
December 10, 2002 |
March 4, 2008 |
|
- National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, United States
|
| 23 |
NCT01597063 |
Completed |
Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies |
- Aneuploidy
- Down Syndrome
- Noninvasive Prenatal Screening
|
- Device: SEQureDx Trisomy Test
|
Observational |
|
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Estimate the false positive rate of SEQureDx Trisomy 21 Test
|
3333 |
Female |
18 Years to 34 Years (Adult) |
NCT01597063 |
SQNM-T21-303 |
|
July 2012 |
February 2014 |
December 2015 |
May 11, 2012 |
April 20, 2016 |
|
- University of South Alabama
Mobile, Alabama, United States - New Horizon Women's Care
Chandler, Arizona, United States - Precision Trials
Phoenix, Arizona, United States - (and 24 more...)
|
| 24 |
NCT01852708 |
Recruiting |
Development of Non-invasive Prenatal Screening Test for Microdeletions Based on Fetal DNA Isolated From Maternal Blood |
- Trisomy 21
- Trisomy 18
- Trisomy 13
- (and 2 more...)
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sensitivity and Specificity of the test to diagnose microdeletions (eg. 22q and 5p-) and aneuploidy in a fetus at chromosomes 13, 18, 21, X and Y.
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT01852708 |
12-014-NPT |
|
November 2012 |
November 2018 |
November 2018 |
May 14, 2013 |
September 25, 2017 |
|
- Natera, Inc.
San Carlos, California, United States - MFM Group of Southern CA
San Gabriel, California, United States - Washington Women's Wellness Center
Washington, D.C., District of Columbia, United States - (and 2 more...)
|
| 25 |
NCT01256606 |
Completed |
Prenatal Test for Fetal Aneuploidy Detection |
|
|
Observational |
|
- Roche Sequencing Solutions
|
Industry |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Comparison of blood test to results from chorionic villus sampling or amniocentesis for fetal aneuploidy detection
|
4000 |
Female |
18 Years to 60 Years (Adult) |
NCT01256606 |
TT001 |
|
August 2010 |
November 2011 |
November 2011 |
December 8, 2010 |
January 10, 2013 |
|
- East Bay Perinatal Medical Associates
Oakland, California, United States - Prenatal Diagnosis of Northern California
Sacramento, California, United States - University of California - San Diego
San Diego, California, United States - (and 3 more...)
|
| 26 |
NCT01784783 |
Completed |
Home-based Partner Education and Testing (HOPE) Study |
|
- Behavioral: HOPE Intervention
- Behavioral: INVITE Intervention
|
Interventional |
Not Applicable |
- University of Washington
- National Institutes of Health (NIH)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Male self-report of uptake of HIV testing
- Female self-report of delivery location
- Female self-report of delivery assistance
- (and 20 more...)
|
601 |
All |
14 Years and older (Child, Adult, Senior) |
NCT01784783 |
44357-A
R01HD075108-01 |
HOPE |
September 2013 |
August 2015 |
August 2015 |
February 6, 2013 |
February 25, 2016 |
|
- Kisumu District Hospital
Kisumu, Nyanza, Kenya
|
| 27 |
NCT03200041 |
Recruiting |
Clinical Evaluation of the IONA Test for Non-invasive Pre Natal Screening in Twin Pregnancies |
- Down Syndrome
- Patau Syndrome
- Edward's Syndrome
|
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Number of IONA test results which are concordant or discordant with Invasive test or Birth outcome.
|
1000 |
Female |
16 Years and older (Child, Adult, Senior) |
NCT03200041 |
PMH/0915/01 |
TWIN |
February 2016 |
July 2019 |
July 2019 |
June 27, 2017 |
January 18, 2018 |
|
- Premaitha Health
Manchester, United Kingdom
|
| 28 |
NCT03154177 |
Enrolling by invitation |
Group Antenatal/Postnatal Care in Rwanda |
- Pregnancy Complications
- Preterm Birth
- Preterm Labor
- (and 3 more...)
|
- Behavioral: Group ANC/PNC
- Procedure: Ultrasound+Pregnancy Testing
|
Interventional |
Not Applicable |
- University of California, San Francisco
- University of Rwanda
- Rwanda Biomedical Center
- Ministry of Health, Rwanda
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Gestational Age
- Preterm birth rate
- Preterm 28-day and 42-day mortality rate
- (and 6 more...)
|
11000 |
Female |
13 Years to 64 Years (Child, Adult) |
NCT03154177 |
A123218-Rw (UCSF RAS #) |
PTBi Rwanda |
May 15, 2017 |
March 24, 2019 |
May 24, 2019 |
May 16, 2017 |
October 30, 2017 |
|
- Rwanda Biomedical Center
Kigali, Rwanda - University of Rwanda
Kigali, Rwanda
|
| 29 |
NCT02109770 |
Recruiting |
Development of Non-invasive Prenatal Test for Microdeletion and Other Genetic Syndromes Based on Cell Free DNA |
- Microdeletion Syndromes
- Trisomy 21
- Trisomy 18
- (and 2 more...)
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sensitivity and Specificity of the test to diagnose chromosomal microdeletions and aneuploidy in a fetus
|
200 |
All |
Child, Adult, Senior |
NCT02109770 |
GSN014 |
Microdel Triad |
October 2012 |
December 2018 |
December 2019 |
April 10, 2014 |
September 25, 2017 |
|
- Natera
San Carlos, California, United States - Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
|
| 30 |
NCT01925742 |
Completed |
Study of the Efficacy of New Non-invasive Prenatal Tests for Screening for Fetal Trisomies Using Maternal Blood |
- Trisomy 21
- Trisomy 18
- Trisomy 13
|
- Other: Integrated prenatal screening for Down's syndrome
- Other: Serum QUAD Assay for aneuploidy screening
- Other: Semiconductor MPSS NIPT assay using ccfDNA in maternal blood
- (and 2 more...)
|
Interventional |
Not Applicable |
- CHU de Quebec-Universite Laval
- Laval University
- Genome Canada
- (and 3 more...)
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Number of cases with Fetal trisomy 21, 18 or 13
- Number of women with assay failure
|
3819 |
Female |
19 Years and older (Adult, Senior) |
NCT01925742 |
2014-1236; SIRUL-102531
B13-06-1236 |
PEGASUS |
November 2013 |
June 2017 |
June 2017 |
August 20, 2013 |
February 22, 2018 |
|
- Foothills Medical Centre
Calgary, Alberta, Canada - Children's & Women's Health Centre
Vancouver, British Columbia, Canada - The Ottawa Hospital
Ottawa, Ontario, Canada - (and 2 more...)
|
| 31 |
NCT02379351 |
Completed |
Use Of An In-Home Non-Stress Test Device For Remote Fetal Monitoring |
|
- Device: In-Home Non-Stress Test Device
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Integration of Airstrip ® Sense4Baby™ remote non-stress test monitoring into health care system
- Frequency of uninterpretable and/or abnormal NSTs requiring on-site follow-up
- Patient and provider satisfaction with remote NST compared to on-site NST (questionnaire)
- Cost-effectiveness analysis for the health system and for patients
|
60 |
Female |
18 Years and older (Adult, Senior) |
NCT02379351 |
77591 |
|
July 2015 |
May 2017 |
May 2017 |
March 4, 2015 |
May 19, 2017 |
|
- University of Utah
Salt Lake City, Utah, United States
|
| 32 |
NCT01545674 |
Active, not recruiting |
Prenatal Non-invasive Aneuploidy Test Utilizing SNPs Trial |
- Trisomy 13
- Trisomy 18
- Trisomy 21
- Aneuploidy
|
|
Observational |
|
- Natera, Inc.
- Columbia University
- George Washington University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Industry / Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sensitivity and Specificity of the test to diagnose aneuploidy in a fetus at chromosomes 13, 18, 21, X and Y.
|
1000 |
Female |
Child, Adult, Senior |
NCT01545674 |
GSN012B
1R44HD062114 |
PreNATUS |
January 2012 |
April 2014 |
December 2019 |
March 7, 2012 |
March 30, 2018 |
|
- University of Alabama
Birmingham, Alabama, United States - Cedars-Sinai Medical Center
Los Angeles, California, United States - California Pacific Medical Center
San Francisco, California, United States - (and 26 more...)
|
| 33 |
NCT01708746 |
Completed |
Investigation of the Impact of Noninvasive Prenatal Testing for Fetal Aneuploidy on Utilization of Prenatal Diagnostic Procedures and Pregnant Women's Views |
|
|
Observational |
|
|
Industry |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Invasive prenatal procedures rate measure by the occurance of chorionic villus sampling (CVS) and/or amniocentesis
- Preferences of pregnant women on prenatal testing by completion of preference questionnaire.
|
205 |
Female |
18 Years and older (Adult, Senior) |
NCT01708746 |
VER-0008 |
|
November 2012 |
September 2013 |
October 2013 |
October 17, 2012 |
September 26, 2014 |
|
- Southern California Kaiser Permanente Medical Group
Baldwin Park, California, United States - Southern California Kaiser Permanente Medical Group
Los Angeles, California, United States - Southern California Kaiser Permanente Medical Group
Panorama City, California, United States - Southern California Kaiser Permanente Medical Center
Woodland Hills, California, United States
|
| 34 |
NCT01451671 |
Recruiting |
Development of a Prenatal Test for Fetal Aneuploidy Detection |
|
|
Observational |
|
- Roche Sequencing Solutions
|
Industry |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Identification of aneuploidy
|
1500 |
Female |
18 Years and older (Adult, Senior) |
NCT01451671 |
TD002 |
|
November 2010 |
November 2017 |
November 2017 |
October 14, 2011 |
July 18, 2016 |
|
- University of California San Diego
San Diego, California, United States - Norton Healthcare
Louisville, Kentucky, United States - Medical College of Wisconsin
Milwaukee, Wisconsin, United States
|
| 35 |
NCT01451684 |
Recruiting |
Development of a Non-invasive Prenatal Test |
|
|
Observational |
|
- Roche Sequencing Solutions
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Absence of chromosomal abnormality
|
10000 |
Female |
18 Years and older (Adult, Senior) |
NCT01451684 |
TD003 |
|
June 2011 |
December 2017 |
December 2017 |
October 14, 2011 |
July 18, 2016 |
|
- Ariosa Diagnostics
San Jose, California, United States
|
| 36 |
NCT00669383 |
Unknown † |
Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants |
- Respiratory Compliance
- Functional Residual Capacity
- Pulmonary Function Testing
|
- Drug: betamethasone
- Drug: placebo
|
Interventional |
Not Applicable |
- Oregon Health and Science University
- American Lung Association
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Measurements of respiratory compliance and functional residual capacity in preterm infants.
- Other respiratory outcomes and clinical outcomes.
|
80 |
Female |
15 Years and older (Child, Adult, Senior) |
NCT00669383 |
OHSU eRIB#1845 |
|
June 2001 |
July 2007 |
|
April 30, 2008 |
January 19, 2012 |
|
- Oregon Health & Science University
Portland, Oregon, United States
|
| 37 |
NCT03027258 |
Recruiting |
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome |
- HIV
- Sickle Cell Disease
- Hepatitis B
|
|
Interventional |
Not Applicable |
- University of Nevada, Las Vegas
- John E. Fogarty International Center (FIC)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Reach
- Effectiveness
- Adoption
- Acceptability
|
300 |
Female |
18 Years and older (Adult, Senior) |
NCT03027258 |
820085-3
R21TW010252-01 |
mHealth |
September 2016 |
January 2018 |
January 2018 |
January 23, 2017 |
October 17, 2017 |
|
- Catholic Caritas Foundation
Makurdi, Benue, Nigeria
|
| 38 |
NCT03047967 |
Not yet recruiting |
Effects of Prenatal Tobacco Smoke Exposure on Lung Function and Respiratory Epithelium Functionality in Newborns |
- Pregnancy Related
- Tobacco Smoking
- Lung Smokers
- Newborn
|
- Diagnostic Test: lung function tests
- Diagnostic Test: Nasal brushing
|
Interventional |
Not Applicable |
- Institut National de la Santé Et de la Recherche Médicale, France
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- α7-nAChR functionnality
- CFTR functionality
- Lung function test
- ciliary frequency mesurement
|
60 |
All |
up to 6 Days (Child) |
NCT03047967 |
C15-60 |
|
February 2017 |
January 2019 |
December 2019 |
February 9, 2017 |
February 9, 2017 |
|
|
| 39 |
NCT01021085 |
Completed |
Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies |
|
|
Observational |
|
|
Industry |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- Develop a prenatal sex test using blood and/or urine samples from pregnant women.
- Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance.
|
500 |
Female |
18 Years to 45 Years (Adult) |
NCT01021085 |
SQNM-IVF-FS-102 |
PREVIEW |
April 2009 |
August 2011 |
September 2011 |
November 26, 2009 |
September 5, 2011 |
|
- San Diego Fertility Center
San Diego, California, United States - Fertility Centers of Illinois
Glenview, Illinois, United States - Fertility Center of Las Vegas
Las Vegas, Nevada, United States
|
| 40 |
NCT00194415 |
Terminated |
A Study of HSV Testing Among Pregnant Women |
|
- Behavioral: Safer-sex counseling
- Procedure: Type specific serologic HSV testing
|
Interventional |
Not Applicable |
- University of Washington
- National Institutes of Health (NIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The reduction of unprotected coital or oral-genital activity in women who are identified as being susceptible to HSV-1 or HSV-2.
- To determine HSV seroconversion rates in Group 1 versus Group 2
- To determine rates of neonatal HSV infection in Groups 1 & 2.
- To determine viral shedding characteristics in those mother-infant pairs where seroconversion occurs.
|
173 |
Female |
14 Years and older (Child, Adult, Senior) |
NCT00194415 |
03-9950-E/A
P01AI030731 |
|
January 2004 |
November 2006 |
November 2006 |
September 19, 2005 |
January 10, 2008 |
|
- Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
|
| 41 |
NCT02424474 |
Completed |
T21,18 and 13 Screening by Cell Free Fetal DNA in Low Risk Patients |
- Trisomy 21, 18 and 13 Screening
|
- Device: Genetic NIPT
- Biological: Regular serum screening
|
Interventional |
Not Applicable |
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- Diagnostic performance measured by specificity (%) of genetic Non Invasive Prenatal Testing (NIPT) in the two populations (with and without IVF) compared to regular serum screening
- Diagnostic performance measured by positive predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening
- Diagnostic performance measured by negative predictive values (%) of genetic NIPT (Non Invasive Prenatal Testing) in the two populations compared to regular serum screening
|
933 |
Female |
18 Years and older (Adult, Senior) |
NCT02424474 |
P141001 |
DEPOSA |
June 2015 |
September 2016 |
February 14, 2017 |
April 23, 2015 |
August 15, 2017 |
|
- AP-HP, Antoine Béclère Hospital
Clamart, France
|
| 42 |
NCT01837979 |
Unknown † |
Down Syndrome Screening Based on Dried Blood Spots and Cell-free Fetal DNA |
|
- Procedure: cell-free fetal DNA
|
Observational |
|
- Peking Union Medical College Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- detection rate
- positive predictive value and negative predictive value
|
2000 |
Female |
18 Years to 35 Years (Adult) |
NCT01837979 |
Down syndrome screening |
DBS&CFF |
April 2013 |
January 2015 |
January 2015 |
April 23, 2013 |
April 23, 2013 |
|
- Department of ob gyn, Peking Union Medical College Hospital
Beijing, Beijing, China
|
| 43 |
NCT02445846 |
Completed |
Dual Rapid HIV & Syphilis Tests in Zambia |
|
- Device: dual HIV/syphilis rapid diagnostics tests
|
Observational |
|
- University of North Carolina, Chapel Hill
- World Health Organization
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- performance of dual rapid HIV/syphilis tests
- acceptability of use of dual rapid HIV/syphilis tests
|
3010 |
Female |
18 Years and older (Adult, Senior) |
NCT02445846 |
14-0528 |
|
May 2014 |
December 2015 |
January 2016 |
May 15, 2015 |
April 21, 2017 |
|
- Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
|
| 44 |
NCT00877292 |
Completed |
A New Prenatal Blood Test for Down Syndrome |
|
|
Observational |
|
- Women and Infants Hospital of Rhode Island
- Sequenom, Inc.
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- The RNA study is an observational trial whose primary aim is to document the performance (sensitivity and specificity) of a laboratory developed test (LDT), using fetal nucleic acid in maternal plasma to identify Down syndrome in early pregnancy.
- The secondary aim is to develop a sample bank to allow documentation of subsequent improvements in the existing LDT or documenting performance of new methodologies.
|
4664 |
Female |
18 Years and older (Adult, Senior) |
NCT00877292 |
09-0004 |
RNA |
February 2009 |
January 2011 |
May 2011 |
April 7, 2009 |
June 3, 2015 |
|
- University of Alabama at Birmingham
Birmingham, Alabama, United States - Cedars-Sinai Medical Center
Los Angeles, California, United States - Yale University School of Medicine
New Haven, Connecticut, United States - (and 24 more...)
|
| 45 |
NCT02763176 |
Not yet recruiting |
Measuring hCG Levels in Pregnant Women |
|
|
Observational |
|
- Gynuity Health Projects
- Stanford University
|
Other |
- Time Perspective: Prospective
|
|
150 |
Female |
18 Years and older (Adult, Senior) |
NCT02763176 |
6007 |
|
July 2016 |
April 2017 |
December 2017 |
May 5, 2016 |
July 14, 2016 |
|
|
| 46 |
NCT00871195 |
Completed |
A Noninvasive Test for Fetal RHD Genotype |
|
|
Observational |
|
|
Industry / Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To test as to whether advancing gestational age is associated with accuracy of fetal typing for RhD.
|
520 |
Female |
18 Years and older (Adult, Senior) |
NCT00871195 |
SQNM-RHD-301 |
NAFTnet RHD |
April 2009 |
November 2011 |
April 2012 |
March 30, 2009 |
May 10, 2012 |
|
- Obstetrix Medical Group of Phoenix
Phoenix, Arizona, United States - Wayne State University
Detroit, Michigan, United States - Columbia University
New York City, New York, United States - (and 10 more...)
|
| 47 |
NCT00314691 |
Terminated |
Development of New Prenatal Diagnostic Tests From Maternal Blood |
|
|
Interventional |
Not Applicable |
- University Hospital, Strasbourg, France
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Feasibility of fetal gender and genotype determination out of maternal blood
|
10 |
All |
18 Years and older (Adult, Senior) |
NCT00314691 |
3612 |
|
April 2006 |
|
September 2006 |
April 14, 2006 |
July 28, 2011 |
|
- Sihcus-Cmco
Strasbourg, Schiltigheim, France
|
| 48 |
NCT02262390 |
Unknown † |
Syphilis Treatment of Partners Trial |
|
- Procedure: Partner Notification Reminders
|
Interventional |
Not Applicable |
- Makerere University
- Infectious Diseases Institute, Uganda
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Health Services Research
|
- Proportion of male partners who present at clinic and receive syphilis testing
- Male partners tested (standard vs. intervention in 3 arm randomization)
- Proportion of male partners who test positive for syphilis when they report to the clinic after notification.
- (and 4 more...)
|
1752 |
All |
14 Years and older (Child, Adult, Senior) |
NCT02262390 |
ST/0109/14 |
STOP |
November 2014 |
December 2015 |
December 2016 |
October 13, 2014 |
October 13, 2014 |
|
- Infectious Diseases Institute
Kampala, Uganda
|
| 49 |
NCT00940043 |
Completed |
Monitoring of the Inflammatory Response of Patients With Premature Rupture of Membranes With Bedside Tests |
- Premature Rupture of Fetal Membranes
|
|
Observational |
|
- Université de Sherbrooke
- Canadian Institutes of Health Research (CIHR)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- comparison between the results of the bedside test and the ELISA tests performed in the laboratory
- description of the inflammatory status following a rupture of membranes at term and during labor
|
60 |
Female |
18 Years to 40 Years (Adult) |
NCT00940043 |
08-072 |
EFFARM |
September 2008 |
September 2009 |
December 2009 |
July 15, 2009 |
January 16, 2013 |
|
- Centre hospitalier de l'Université de Sherbrooke
Sherbrooke, Quebec, Canada
|
| 50 |
NCT00829959 |
Completed |
Attitudes About Childbearing And Fertility With Inherited Breast And Ovarian Cancer Syndromes (HBOC) |
- Breast Cancer
- Ovarian Cancer
|
- Behavioral: Questionnaire
|
Observational |
|
- M.D. Anderson Cancer Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Women Endorsing Prenatal Diagnostic Testing (Questionnaire response)
|
156 |
Female |
18 Years and older (Adult, Senior) |
NCT00829959 |
2008-0624 |
|
February 2009 |
August 2016 |
August 2016 |
January 27, 2009 |
August 4, 2016 |
|
- University of Texas MD Anderson Cancer Center
Houston, Texas, United States
|
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