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Clinical trials for Prenatal Period

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   43895   clinical trials with a EudraCT protocol, of which   7301   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    13 result(s) found for: Prenatal Period. Displaying page 1 of 1.
    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 (Temporarily Halted)
    Trial results: (No results available)
    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: 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: 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 (Ongoing)
    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: 2021-006766-21 Sponsor Protocol Number: MINI-SPIOMET Start Date*: 2022-09-02
    Sponsor Name:Hospital de Girona Dr. Josep Trueta
    Full Title: Towards a treatment for accelerated maturation in girls testing spiomet in a randomised placebo controlled, multicentre study.
    Medical condition: Girls with advanced puberty and accelerated bone maturation. Polycystic Ovary Syndrome (PCOS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004860 10014054 Early puberty LLT
    Population Age: Children, Under 18 Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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: 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
    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: 2014-001826-13 Sponsor Protocol Number: 200721 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Medical condition: preterm labor
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Completed) DE (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-001119-38 Sponsor Protocol Number: 116945 Start Date*: 2015-09-21
    Sponsor Name:GlaxoSmithKline
    Full Title: A Phase IV, observer-blind, randomised, cross-over, placebo-controlled, multicentre study to assess the immunogenicity and safety of a single dose of Boostrix? in pregnant women.
    Medical condition: Booster immunisation against diphtheria, tetanus and pertussis diseases. The study population for this study will include pregnant women.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10047976 Whooping cough due to bordetella pertussis (B. pertussis) LLT
    18.0 100000004862 10009663 Clostridium tetani infection LLT
    18.0 100000004862 10054237 Corynebacterium diphtheriae infection LLT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed) CZ (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015953-18 Sponsor Protocol Number: DORIPED3002 Start Date*: 2010-05-28
    Sponsor Name:Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infec...
    Medical condition: Complicated Urinary Tract Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10046571 Urinary tract infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) CZ (Completed) PL (Temporarily Halted) LV (Prematurely Ended) DE (Completed) Outside EU/EEA
    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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