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Clinical trials for Prenatal diagnosis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    27 result(s) found for: Prenatal diagnosis. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2015-003699-60 Sponsor Protocol Number: KIBB01 Start Date*: 2018-09-28
    Sponsor Name:Karolinska Institutet
    Full Title: An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal intravenous administration of allogeneic expanded fetal...
    Medical condition: Treatment of Osteogenesis Imperfecta (OI) type III and severe type IV.
    Disease:
    Population Age: In utero, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000043-74 Sponsor Protocol Number: PNAS0122 Start Date*: 2023-07-27
    Sponsor Name:Medical University of Vienna
    Full Title: Defining and predicting neonatal inadaptation after gestational exposure to antidepressants: longitudinal exploratory analysis of psychoneuroendocrine risk factors and complications
    Medical condition: major depressive disorder poor neonatal adaptation syndrome (after antidepressant use during pregnancy)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003996-32 Sponsor Protocol Number: 69HCL14-0447 Start Date*: 2015-11-03
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study
    Medical condition: Patient with Congenital Adrenal Hyperplasia (CAH) or sibling of a CAH patient . Patient no connection with Congenital Adrenal Hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10061630 Adrenogenital syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002702-30 Sponsor Protocol Number: ALXN1101-MCD-202 Start Date*: Information not available in EudraCT
    Sponsor Name:Origin Biosciences, Inc.
    Full Title: A PHASE 2/3, MULTICENTER, MULTINATIONAL, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ALXN1101 IN NEONATES WITH MOLYBDENUM COFACTOR DEFICIENCY (MOCD) TYPE A
    Medical condition: Molydenum CoFactor Deficiency (MoCD) Type A
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10069687 Molybdenum cofactor deficiency PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) ES (Completed) FR (Completed) IT (Prematurely Ended) NO (Completed)
    Trial results: View results
    EudraCT Number: 2016-003181-12 Sponsor Protocol Number: HOTPOT1 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002430-36 Sponsor Protocol Number: AntibioTICS Start Date*: 2012-07-02
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: Multicentre, randomised, double-blinded, placebo-controlled trial of efficacy of amoxicilline/clavulanic acid in patients affected by tic disorder colonized by GAS. No-proft stidy.
    Medical condition: Chronic tic disorder
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10043834 Tic disorder, unspecified LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing) ES (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003325-10 Sponsor Protocol Number: 1.01 Start Date*: 2012-08-10
    Sponsor Name:VU University Medical Center
    Full Title: A randomized controlled trail on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth
    Medical condition: congenital anomalies
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10004953 Birth premature LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10007607 Cardiac septal defects congenital HLT
    14.1 10010331 - Congenital, familial and genetic disorders 10041524 Spina bifida PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-006253-60 Sponsor Protocol Number: EC07/90847 Start Date*: 2008-04-11
    Sponsor Name:MAR ESPINO HERNANDEZ
    Full Title: Eficacia de la profilaxis antibiótica en dosis única nocturna frente al control clínico y tratamiento precoz de las infecciones urinarias para prevenir secuelas parenquimatosas y pielonefritis de r...
    Medical condition: Demostrar que en los reflujos de alto grado (de III a V de la Clasificación Internacional del Reflujo) no hay menos incidencia de cicatrices renales ni de pielonefritis con el uso de la dosis única...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10047371 Vesicoureteral reflux LLT
    9.1 10066700 Prophylaxis urinary tract infection LLT
    9.1 10065144 Renal scarring LLT
    9.1 10037596 Pyelonephritis LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000988-14 Sponsor Protocol Number: CCD05 Start Date*: 2016-10-12
    Sponsor Name:PROMETHERA Biosciences S.A./N.V.
    Full Title: Title: Open, Prospective, Historic-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Infusion of Liver Cell Suspension (HHLivC) in Children with Urea Cycle Disorders
    Medical condition: Neonatal-onset type of the following urea cycle disorders (UCD): ornithine transcarbamylase deficiency (OTCD), carbamoylphosphate synthetase I deficiency (CPS1D), or argininosuccinate synthetas...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001905-33 Sponsor Protocol Number: FSJD-TRACIP-2017 Start Date*: 2017-10-25
    Sponsor Name:Fundació Sant Joan de Déu
    Full Title: TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN: RANDOMIZED CLINICAL TRIAL (TRACIP STUDY)
    Medical condition: EARLY INTRAUTERINE GROWTH RESTRICTION
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000114573 10048488 Growth intrauterine retard LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002924-35 Sponsor Protocol Number: APHP180592 Start Date*: 2021-01-18
    Sponsor Name:ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
    Full Title: Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir
    Medical condition: Step 1: Maternal administration of 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP Step 2: Maternal daily administration of 240 or 480 milligrams of letermovir (1x240 mg-ta...
    Disease:
    Population Age: Children, Under 18, Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-000649-30 Sponsor Protocol Number: P150905 Start Date*: 2016-09-29
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Impact of the administration of Fludrocortisone the fluid and electrolyte balance in great premature. Pilot study.
    Medical condition: Great prematurity
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10053593 Premature baby 26 to 32 weeks LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000818-20 Sponsor Protocol Number: 2009/318 Start Date*: 2011-05-04
    Sponsor Name:Klinisk Biokemisk Afdeling, Aarhus Universitetshospital, Skejby
    Full Title: Kan behandling med lavmolekylært heparin under graviditet med intrauterin væksthæmning øge fostervæksten?
    Medical condition: Intrauterin væksthæmning
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10022819 Intrauterine growth retardation LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-001726-22 Sponsor Protocol Number: COLIGROW Start Date*: 2022-12-12
    Sponsor Name:Dr. Ignacio Herraiz García
    Full Title: COok's ballon versus dinoprostone for Labor Induction of term pregnancies with fetal GROWth restriction (COLIGROW study).
    Medical condition: Induction of term pregnancies with fetal growth restriction.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10070532 Fetal growth restriction LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-002532-23 Sponsor Protocol Number: ER004-CLIN01/F60082AI201 Start Date*: 2021-10-25
    Sponsor Name:EspeRare Foundation [...]
    1. EspeRare Foundation
    2. Pierre Fabre Médicament
    Full Title: A prospective, open-label, genotype-match controlled, multicenter clinical trial to investigate the efficacy and safety of intra-amniotic ER004 as a prenatal treatment for male subjects with X-link...
    Medical condition: X-linked hypohidrotic ectodermal dysplasia (XLHED)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10072592 Hypohidrotic ectodermal dysplasia LLT
    Population Age: In utero, Under 18 Gender: Male
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-003512-30 Sponsor Protocol Number: ASB-008 Start Date*: 2007-04-05
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 4 Multi-center, Multi-national, Open-label, Randomized, Two Dose Level Study of Naglazyme (galsulfase) in Infants with Maroteaux-Lamy Syndrome (MPS VI)
    Medical condition: Mucopolysaccharidosis Type VI (MPS VI; Maroteaux-Lamy Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    6.0 10056892 PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000770-29 Sponsor Protocol Number: Ireland-RctV8 Start Date*: 2018-06-18
    Sponsor Name:The Rotunda Hospital
    Full Title: Investigating the role of early low-dose aspirin in diabetes: A phase III multicentre double-blinded placebo-controlled randomised trial of low-dose aspirin initiated in the first trimester of diab...
    Medical condition: Pregestational type I or type II diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045228 Type I diabetes mellitus LLT
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-000062-14 Sponsor Protocol Number: MN42988 Start Date*: 2021-10-08
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY
    Medical condition: Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10071068 Clinically isolated syndrome PT
    Population Age: In utero, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-003730-13 Sponsor Protocol Number: OST07/11 Start Date*: 2012-05-22
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: Effects of plasma expanders administration in pregnancies complicated by intra uterine growth restriction
    Medical condition: intra uterine growth restriction
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10022819 Intrauterine growth retardation LLT
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10061452 Complication of pregnancy PT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003326-41 Sponsor Protocol Number: 200719 Start Date*: 2016-01-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
    Medical condition: Preterm Labour
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed) IT (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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